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{
"abstract": "OBJECTIVE\nTo utilize transcatheter arterial steroid injection therapy (TASIT) via the hepatic artery to reduce hepatic macrophage activity in patients with severe acute hepatic failure.\n\n\nMETHODS\nThirty-four patients with severe acute hepatic failure were admitted to our hospital between June 2002 to June 2006 providing for the possibility of liver transplantation (LT). Seventeen patients were treated using traditional liver supportive procedures, and the other 17 patients additionally underwent TASIT with 1000 mg methylprednisolone per day for 3 continuous days.\n\n\nRESULTS\nOf the 17 patients who received TASIT, 13 were cured without any complications, 2 died, and 2 underwent LT. Of the 17 patients who did not receive TASIT, 4 were self-limiting, 7 died, and 6 underwent LT. Univariate logistic analysis revealed that ascites, serum albumin, prothrombin time, platelet count, and TASIT were significant variables for predicating the prognosis. Multivariate logistic regression analysis using stepwise variable selection showed that prothrombin time, platelet count, and TASIT were independent predictive factors.\n\n\nCONCLUSIONS\nTASIT might effectively prevent the progression of severe acute hepatic failure to a fatal stage of fulminant liver failure.",
"affiliations": "Department of Medicine and Bioregulatory Science, Graduate School of Medical Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan. kotoh-k@intmed3.med.kyushu-u.ac.jp",
"authors": "Kotoh|Kazuhiro|K|;Enjoji|Munechika|M|;Nakamuta|Makoto|M|;Yoshimoto|Tsuyoshi|T|;Kohjima|Motoyuki|M|;Morizono|Shusuke|S|;Yamashita|Shinsaku|S|;Horikawa|Yuki|Y|;Yoshimitsu|Kengo|K|;Tajima|Tsuyoshi|T|;Asayama|Yoshiki|Y|;Ishigami|Kousei|K|;Hirakawa|Masakazu|M|",
"chemical_list": "D000893:Anti-Inflammatory Agents; D008775:Methylprednisolone",
"country": "United States",
"delete": false,
"doi": "10.3748/wjg.v12.i41.6678",
"fulltext": null,
"fulltext_license": null,
"issn_linking": "1007-9327",
"issue": "12(41)",
"journal": "World journal of gastroenterology",
"keywords": null,
"medline_ta": "World J Gastroenterol",
"mesh_terms": "D000328:Adult; D000893:Anti-Inflammatory Agents; D018450:Disease Progression; D005260:Female; D006499:Hepatic Artery; D006801:Humans; D007269:Injections, Intra-Arterial; D017114:Liver Failure, Acute; D008264:Macrophages; D008297:Male; D008775:Methylprednisolone; D008875:Middle Aged; D015999:Multivariate Analysis; D011379:Prognosis; D016896:Treatment Outcome",
"nlm_unique_id": "100883448",
"other_id": null,
"pages": "6678-82",
"pmc": null,
"pmid": "17075983",
"pubdate": "2006-11-07",
"publication_types": "D016430:Clinical Trial; D016428:Journal Article",
"references": "8320931;4693151;15561247;1716546;16534681;7004995;14742981;7035299;12820474;15588781;15692789;9635624;16279913;15288011;12695559;16142721;192431;16249741;7040555;15629511;8503773",
"title": "Arterial steroid injection therapy can inhibit the progression of severe acute hepatic failure toward fulminant liver failure.",
"title_normalized": "arterial steroid injection therapy can inhibit the progression of severe acute hepatic failure toward fulminant liver failure"
} | [
{
"companynumb": "JP-PFIZER INC-2021303460",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE SODIUM SUCCINATE"
},
"drugadditional": "3",
"drugadministrationroute": null,
"drugauthorizationnumb": "011856",
"drugbatchnumb": null,
"drugcharacterization": "1",
"drugcumulativedosagenumb": null,
"drugcumulativedosageunit": null,
"drugdosageform": "POWDER FOR SOLUTION FOR INJECTION",
"drugdosagetext": "1000 MG, INFUSED FOR 2 H PER DAY",
"drugenddate": null,
"drugenddateformat": null,
"drugindication": "ACUTE HEPATIC FAILURE",
"drugintervaldosagedefinition": null,
"drugintervaldosageunitnumb": null,
"drugrecurreadministration": null,
"drugrecurrence": null,
"drugseparatedosagenumb": null,
"drugstartdate": null,
"drugstartdateformat": null,
"drugstructuredosagenumb": "1000",
"drugstructuredosageunit": "003",
"drugtreatmentduration": null,
"drugtreatmentdurationunit": null,
"medicinalproduct": "METHYLPREDNISOLONE SODIUM SUCCINATE."
}
],
"patientagegroup": null,
"patientonsetage": null,
"patientonsetageunit": null,
"patientsex": null,
"patientweight": null,
"reaction": [
{
"reactionmeddrapt": "Drug ineffective",
"reactionmeddraversionpt": "23.1",
"reactionoutcome": "5"
},
{
"reactionmeddrapt": "Hepatic failure",
"reactionmeddraversionpt": "23.1",
"reactionoutcome": "5"
}
],
"summary": null
},
"primarysource": {
"literaturereference": "KOTOH, K.. ARTERIAL STEROID INJECTION THERAPY CAN INHIBIT THE PROGRESSION OF SEVERE ACUTE HEPATIC FAILURE TOWARD FULMINANT LIVER FAILURE. WORLD JOURNAL OF GASTROENTEROLOGY. 2006?12 (41):6678?6682",
"literaturereference_normalized": "arterial steroid injection therapy can inhibit the progression of severe acute hepatic failure toward fulminant liver failure",
"qualification": "3",
"reportercountry": "JP"
},
"primarysourcecountry": "JP",
"receiptdate": "20210323",
"receivedate": "20210323",
"receiver": {
"receiverorganization": "FDA",
"receivertype": "6"
},
"reporttype": "2",
"safetyreportid": 19044445,
"safetyreportversion": 1,
"sender": {
"senderorganization": "FDA-Public Use",
"sendertype": "2"
},
"serious": 1,
"seriousnesscongenitalanomali": null,
"seriousnessdeath": 1,
"seriousnessdisabling": null,
"seriousnesshospitalization": null,
"seriousnesslifethreatening": null,
"seriousnessother": null,
"transmissiondate": "20210420"
}
] |
{
"abstract": "A 12-year-old male patient suffering from congenital glaucoma developed bradycardia, left ventricular failure, and hypotension after induction of anesthesia. Electrocardiography and echocardiography revealed a complete normalization of ECG and a complete spontaneous recovery in the cardiac function 72 hours from the beginning of the clinical manifestations, while cardiac Magnetic Resonance Imaging was performed, and coronary Computed Tomography scan revealed a myocardial bridge of a tract of the left anterior descendent coronary artery. Diagnosis of Kounis syndrome (KS) was made, a relatively novel, under-recognized clinical condition, defined as the manifestation of an acute coronary syndrome accompanied by mast cell activation and platelet aggregation involving interrelated and interacting inflammatory cells in the setting of allergic, hypersensitivity, anaphylactic or anaphylactoid insults. We described one of the first pediatric cases of KS related to anesthetic medications. In children, this syndrome has been only described in isolated case reports or small case series. Thus, it appears critical to report new cases of KS in children to increase the awareness of this disease in pediatric healthcare workers so as to enhance its early recognition and optimal therapeutic strategy. Furthermore, it appears of paramount importance the implementation of universal guidelines accepted by allergology and cardiology societies, in order to standardize the management of pediatric and adult patients with KS. Finally, a close collaboration between pediatric allergists and cardiologists seems fundamental for an optimal multidisciplinary patient care.",
"affiliations": "Cardiology Unit, Department of Pediatrics, Meyer Children's University Hospital, Florence, Italy.;Allergy Unit, Department of Pediatrics, Meyer Children's University Hospital, Florence, Italy.;Electrophysiology and Device Department, University Hospital of South Manchester NHS Foundation Trust, Manchester, United Kingdom.;Allergy Unit, Department of Pediatrics, Meyer Children's University Hospital, Florence, Italy.;Department of Pediatrics, Meyer Children's Hospital, Florence, Italy.;Cardiology Unit, Department of Pediatrics, Meyer Children's University Hospital, Florence, Italy.;Cardiology Unit, Department of Pediatrics, Meyer Children's University Hospital, Florence, Italy.;Cardiology Unit, Department of Pediatrics, Meyer Children's University Hospital, Florence, Italy.;Allergy Unit, Department of Pediatrics, Meyer Children's University Hospital, Florence, Italy.;Department of Pediatrics, Meyer Children's Hospital, Florence, Italy.;Cardiology Unit, Department of Pediatrics, Meyer Children's University Hospital, Florence, Italy.;Department of Pediatrics, Meyer Children's Hospital, Florence, Italy.",
"authors": "Capponi|Guglielmo|G|;Giovannini|Mattia|M|;Koniari|Ioanna|I|;Mori|Francesca|F|;Rubino|Chiara|C|;Spaziani|Gaia|G|;Calabri|Giovanni Battista|GB|;Favilli|Silvia|S|;Novembre|Elio|E|;Indolfi|Giuseppe|G|;De Simone|Luciano|L|;Trapani|Sandra|S|",
"chemical_list": null,
"country": "Switzerland",
"delete": false,
"doi": "10.3389/fcvm.2021.676188",
"fulltext": "\n==== Front\nFront Cardiovasc Med\nFront Cardiovasc Med\nFront. Cardiovasc. Med.\nFrontiers in Cardiovascular Medicine\n2297-055X\nFrontiers Media S.A.\n\n10.3389/fcvm.2021.676188\nCardiovascular Medicine\nCase Report\nCase Report: Perioperative Kounis Syndrome in an Adolescent With Congenital Glaucoma\nCapponi Guglielmo 1\n\nGiovannini Mattia 2\n\nKoniari Ioanna 3\nMori Francesca 2\n\nRubino Chiara 4\n\nSpaziani Gaia 1\nCalabri Giovanni Battista 1\nFavilli Silvia 1\nNovembre Elio 2\n\nIndolfi Giuseppe 4 5\n\nDe Simone Luciano 1 †\nTrapani Sandra 4 6 * †\n\n1Cardiology Unit, Department of Pediatrics, Meyer Children's University Hospital, Florence, Italy\n2Allergy Unit, Department of Pediatrics, Meyer Children's University Hospital, Florence, Italy\n3Electrophysiology and Device Department, University Hospital of South Manchester NHS Foundation Trust, Manchester, United Kingdom\n4Department of Pediatrics, Meyer Children's Hospital, Florence, Italy\n5Department of NEUROFARBA, Meyer Children's Hospital, University of Florence, Florence, Italy\n6Department of Health Sciences, Meyer Children's Hospital, University of Florence, Florence, Italy\nEdited by: Giovanni Biglino, University of Bristol, United Kingdom\n\nReviewed by: Ju Liu, Shandong University, China; Sezen Ugan Atik, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Turkey\n\n*Correspondence: Sandra Trapani sandra.trapani@unifi.it\nThis article was submitted to Pediatric Cardiology, a section of the journal Frontiers in Cardiovascular Medicine\n\n†These authors share last authorship\n\n10 9 2021\n2021\n8 67618804 3 2021\n13 7 2021\nCopyright © 2021 Capponi, Giovannini, Koniari, Mori, Rubino, Spaziani, Calabri, Favilli, Novembre, Indolfi, De Simone and Trapani.\n2021\nCapponi, Giovannini, Koniari, Mori, Rubino, Spaziani, Calabri, Favilli, Novembre, Indolfi, De Simone and Trapani\nhttps://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.\nA 12-year-old male patient suffering from congenital glaucoma developed bradycardia, left ventricular failure, and hypotension after induction of anesthesia. Electrocardiography and echocardiography revealed a complete normalization of ECG and a complete spontaneous recovery in the cardiac function 72 hours from the beginning of the clinical manifestations, while cardiac Magnetic Resonance Imaging was performed, and coronary Computed Tomography scan revealed a myocardial bridge of a tract of the left anterior descendent coronary artery. Diagnosis of Kounis syndrome (KS) was made, a relatively novel, under-recognized clinical condition, defined as the manifestation of an acute coronary syndrome accompanied by mast cell activation and platelet aggregation involving interrelated and interacting inflammatory cells in the setting of allergic, hypersensitivity, anaphylactic or anaphylactoid insults. We described one of the first pediatric cases of KS related to anesthetic medications. In children, this syndrome has been only described in isolated case reports or small case series. Thus, it appears critical to report new cases of KS in children to increase the awareness of this disease in pediatric healthcare workers so as to enhance its early recognition and optimal therapeutic strategy. Furthermore, it appears of paramount importance the implementation of universal guidelines accepted by allergology and cardiology societies, in order to standardize the management of pediatric and adult patients with KS. Finally, a close collaboration between pediatric allergists and cardiologists seems fundamental for an optimal multidisciplinary patient care.\n\nKounis syndrome\nperioperative\nmidazolam\nsevoflurane\ncoronary artery\npediatrics\n==== Body\npmcIntroduction\n\nKounis syndrome (KS) is defined as the manifestation of an acute coronary syndrome accompanied by mast cell activation and platelet aggregation involving interrelated and interacting inflammatory cells in the setting of allergic, hypersensitivity, anaphylactic or anaphylactoid insults (1, 2). However, the exact physiopathology of this syndrome has not been fully elucidated.\n\nAlthough this condition could potentially occur in every age, only a minority of cases (9.1%) are described in subjects younger than 20 years of age compared to older ages (68.0% at 40–70 years old) (3). The main reason could be attributed to an underestimation of this relatively novel syndrome in the pediatric age (4). Several triggers have been associated with KS, including drug administration, food consumption, and insect bites. Antibiotics (27.4%) and insect bites (23.4%) are demonstrated as the most common triggers eliciting this syndrome (1, 3). KS caused by anesthetic medications has already been reported as a cause of acute coronary syndrome (5–8). However, to the best of our knowledge, we describe one of the first pediatric cases of KS associated to anesthetic drugs (4, 8–14).\n\nCase Description\n\nA 12-year-old male suffering from congenital glaucoma was admitted to Meyer Children's University Hospital for the surgical revision of his ocular Baerveldt implant, a device that maintains a patent connection between the anterior chamber of the eye and an equatorial bleb capsule and improves the drainage of the aqueous out of the eye (15). This patient suffered from a pathologic mutation on CYP1B1, encoding a dioxin-inducible enzyme belonging to the cytochrome P450 superfamily, that is involved in the proper development and balance of trabecular meshwork (16). Because of this chronic ocular disease, the patient had previously undergone other surgical procedures with no reported anesthesiologic complications. A previous surgery was performed 3 months before and the anesthesia was administered with inhaled sevoflurane and intravenous fentanyl, accompanied with intravenous ondansetron as antiemetic drug, without any clinical reaction. His past medical history was negative for any cardiac issue or atopic condition, and his family medical history was unremarkable.\n\nAbout 30 minutes after the induction phase of the anesthesia with intravenous midazolam bolus, followed by continuous inhaled sevoflurane, the patient experienced an episode of bradycardia associated with hypotension, apparently without reporting any clinical signs and symptoms (dyspnoea, chest pain, pulmonary or peripheral oedema). Specifically, his heart rate decreased from 90 to 40 bpm; however, this clinical manifestation seemed to respond to the administration of a bolus of atropine that further induced a transient episode of sinus tachycardia. At the same time, his blood pressure dropped to 80/45 mmHg. In the acute phase, the physical examination revealed a mild apical systolic murmur (2/6 on the Levine grading scale), without any other clinical manifestations of heart failure.\n\nAn electrocardiogram (ECG) showed sinus rhythm with ventricular repolarization abnormalities in the inferior lateral wall (Figure 1). Moreover, the echocardiographic study demonstrated global left ventricular (LV) hypokinesia and dilatation with preserved right ventricular function (Figure 1). Laboratory work-up documented an increase of creatine kinase-myocardial band (CK-MB) and troponin. Furthermore, N-terminal-prohormone B-type natriuretic peptide (NT-proBNP) was increased as well, consistent with LV dysfunction. Further blood investigations did not show any inflammatory markers increase, eosinophilia, electrolytic imbalance, and liver, or kidney dysfunction (Table 1).\n\nFigure 1 First electrocardiogram and echocardiogram after the onset of the clinical manifestations (A). The electrocardiogram shows sinus rhythm with 100 rpm, PR 0.14 s, QRS 0.08 s, QT/QTc 320/422 ms and diffuse alterations in ventricular repolarization with negative T waves in precordial leads (V4–V6), D2, D3 and aVF (B1–B4). The echocardiogram shows a diffusely hypokinetic left ventricle with an ejection fraction of 34%. Left ventricular inner dimension diastole 50 mm (Z score +2.3), left ventricular inner dimension systole 39 mm (Z score +4.25), left posterior ventricular wall diastole 6.6 mm (Z score −0.23), interventricular septum diastole 5.5 mm (Z score −1.22), right ventricular inner dimension diastole 14 mm (Z score +0.20) [Z score is derived from Kampman et al. (17)] (B1,B2). Moderate mitral valve regurgitation (left ventricular delta Pressure/delta Time 699 mmHg/s) (B3). Left and right coronary artery originating from left and right Valsalva sinus, respectively (B4).\n\nTable 1 Laboratory tests trend from the admission to the discharge of the patient.\n\n\tAdmission\t2 days\t4 days\tDischarge\tNormal\t\n\t\tafter admission\tafter admission\t\tvalues\t\nWBC (x 103/μL)\t\t\t6.36\t\t4.10–12.00\t\nRBC (x 106/μL)\t\t\t4.66\t\t4.30–5.80\t\nHb (g/dL)\t\t\t13.7\t\t12.60–17.00\t\nPLT (x 103/μL)\t\t\t230\t\t190–460\t\nN (%)\t\t\t54.4\t\t35.0–65.0\t\nL (%)\t\t\t32.7\t\t15.0–55.0\t\nM (%)\t\t\t7.9\t\t2.0–15.0\t\nE (%)\t\t\t2.6\t\t0.0–6.0\t\nB (%)\t\t\t0.5\t\t0.0–3.0\t\nCRP (mg/dL)\t<0.290\t\t\t\t0.0–0.5\t\nNa (mEq/L)\t\t\t139\t\t133–145\t\nK (mEq/L)\t\t\t3.8\t\t3.3–5.2\t\nCl (mEq/L)\t\t\t104\t\t95–110\t\nAST (IU/L)\t\t\t26\t\t8–60\t\nALT (IU/L)\t\t\t31\t\t7–55\t\nCreatinine (mg/dL)\t0.56\t\t\t\t0.40–0.80\t\nCK (IU/L)\t86\t81\t\t\t20–200\t\nCK-MB (ng/mL)\t7.5\t1.3\t\t\t0.5–3.6\t\nTroponin (μg/L)\t2.03\t0.21\t0.14\t\t0.00–0.09\t\nNT-proBNP(pg/mL)\t830\t1,300\t1,835\t601\t5–242\t\nALT, alanine transaminase; AST, aspartate transaminase; B, basophils; CK, creatine kinase; CK-MB, creatine kinase-myocardial band; Cl, chloride; CRP, C-reactive protein; E, eosinophils; Hb, hemoglobin; K, potassium; L, lymphocytes; M, monocytes; N, neutrophils; Na, sodium; NT-proBNP, N-terminal-prohormone B-type natriuretic peptide; PLT, platelets; RBC, red blood cells; WBC, white blood cells.\n\nThe patient was hemodynamically stable, but a close follow-up was planned, including a daily electrocardiogram and echocardiography for prompt evaluation of any additional ECG-ischemic changes or cardiomyopathy deterioration.\n\nTwo days after admission, in order to exclude other causes of cardiomyopathy, such as myocarditis, a cardiac contrast-enhancement magnetic resonance imaging (CE-MRI) demonstrated a significant improvement of LV function without any regional wall abnormality. Oedema was noticed on the anterior ventricular wall (Figure 2), possibly consistent with reversible myocardial injury potentially related to myocardial ischemia, while no signs of fibrosis were demonstrated after gadolinium enhancement. A daily cardiac evaluation revealed a complete normalization of ECG and a complete recovery in the cardiac function 72 hours from the beginning of the clinical manifestations, along with a marked reduction in CK-MB, troponin and NT-proBNP, at discharge, 6 days after admission (Figure 3), while the patient was in good clinical condition, in absence of drug therapy.\n\nFigure 2 (A) Cardiac contrast-enhancement magnetic resonance imaging demonstrates an increase of T2 signal on anterior left ventricular wall. (B1–B4) Coronary computed tomography reveals a right dominant coronary artery (B1), left common trunk coronary artery (B2), left circumflex coronary artery (B3) and left anterior descending (LAD) coronary artery (B4) without any dissection, lumen obstruction or anatomical variants. A tract of LAD coronary artery runs through the width of the myocardial wall for 12.3 mm and with a parietal thickness of 1.4 mm (B4).\n\nFigure 3 Trend of troponin, NT-proBNP (A) and ejection fraction (B) from the admission to the discharge of the patient. NT-proBNP, N-terminal-prohormone B-type natriuretic peptide.\n\nA coronary computed tomography (CT), 10 days after the onset of the clinical manifestations, excluded any lumen obstruction, dissection or other anatomical variants of the aorta and coronary arteries. However, it was clearly observed myocardial bridge of a tract of the left anterior descending (LAD) coronary artery (Figure 2). As a precaution, it was chosen not to perform a provocative stress test during the acute phase of the disease, but in order to exclude further stress-induced ischemia an exercise test was performed 21 days after the onset of the clinical manifestations. It showed a linear increase in heart rate and blood pressure, without ischemic signs, symptoms or ST-T ECG alterations.\n\nThe patient underwent skin prick testing with midazolam (5 mg/ml) and sevoflurane (100%) with negative results. According to current standards, histamine 10 mg/ml (Lofarma, Milan, Italy) and normal saline were used as positive and negative control substances, respectively.\n\nDiscussion\n\nKS is a rare and poorly characterized entity in children (2, 4, 8–14). In adults, this condition could be associated with other factors, such as previous allergy, hypertension, smoking, diabetes and hyperlipidemia, whereas these features may be less important in children and adolescents (3, 18, 19). The clinical suspicion is based on clinical signs and symptoms (including acute chest pain, chest discomfort, dyspnoea, bradycardia, hypotension, pallor, palpitations or clinical manifestations of a reaction) associated with a potential trigger. KS diagnosis should be highly suspected when these clinical findings are accompanied by ECG signs (including atrial fibrillation, sinus bradycardia, sinus tachycardia, ST-segment elevation or depression, T-wave flattening or inversion), an increase of myocardial injury biomarkers or possible evidence of coronary spasm/thrombosis on coronary angiography (1).\n\nThe differential diagnosis of KS includes other conditions related to myocardial injury, including spontaneous coronary artery dissection, fibromuscular dysplasia, myocardial bridging, myocarditis and takotsubo syndrome (20, 21).\n\nAccording to diagnostic criteria of myocarditis in our patient the diagnosis of infectious myocarditis could be excluded, due to the absence of fever or previous infectious clinical signs and symptoms, values of the blood tests, and findings of the MRI (22).\n\nSometimes, it can be difficult to distinguish takotsubo syndrome from KS and, as already reported, in some cases they can even coexist (23, 24). Interestingly, both these conditions share some common pathologic mechanisms: vascular hyperreactivity of coronary arteries and local/systemic cellular or humoral inflammatory response in inducing myocardial damage (25, 26).\n\nIn our patient, there was a close relationship between the administration of anesthetic medications and the onset of the clinical manifestations [probable association according to Naranjo scale (27)]. Furthermore, there was an increase of troponin and CK-MB, together with ECG abnormalities (diffuse repolarization abnormalities in inferior and lateral leads) and echocardiographic features (diffuse hypokinesia of LV wall). The latter characteristics strongly supported the diagnosis of KS.\n\nOkur et al. defined the cardiac MRI criteria for KS type 1 diagnosis: early phase subendocardial contrast defect, T2 weight images showing high-intensity signal consistent with oedema of all lesion areas, lack of the late gadolinium enhancement, and no transmural involvement (28). This study reported different percentages of left-wall myocardial involvement with a prevalence in interventricular septum (53.8%), followed by LV lateral wall (30.7%). It is interesting to note that MRI in our patient highlighted an augmented T2 signal in the anterior LV wall without late gadolinium enhancement, probably supporting vasospasm in the left anterior descending coronary artery, concordant with the ECG data.\n\nCoronary angiography is the gold standard to demonstrate the anatomy of coronary arteries and to exclude other causes of lumen obstruction. The coronary-CT of our patient demonstrated myocardial bridging of a tract of LAD coronary artery. Drug reactions and the narrowing of the coronary lumen due to myocardial bridging have already been reported as participating co-factors leading to myocardial ischemia (29). Indeed, it seems unlikely a direct role of a myocardial bridging as the unique cause of the transient myocardial damage, even if it could be accounted as a potential favoring condition.\n\nIn a recent retrospective analysis, allergic reactions due to sedative e/o analgesic medications during pediatric pre-procedural sedation were described with an incidence of about 1:4,219, with midazolam being the third most frequently reported drug (1:2,035) (30). Midazolam can also be associated with severe adverse events, for example, anaphylactic and anaphylactoid reactions (31–34). Moreover, an acute coronary syndrome has already been described in the literature as a side effect of this anesthetic drug in a previous case report of KS in an adult patient during the preoperative phase of a transurethral prostatectomy (5). Furthermore, inhaled anesthetic medications, such as isoflurane, have already been reported as a possible precipitating factor of acute coronary vasospasm in a 59-year-old man and in a 2-year-old boy (6, 8). Sevoflurane was used in our case and, of note, our patient had received anesthesia comprising sevoflurane without clinical reactions 3 months before. However, he was suggested to strictly avoid drugs potentially associated to the event in the future.\n\nAs occurred in our case, diagnosis of KS can be difficult when the patient is not able to report signs and symptoms. In such conditions the suspicion and the diagnosis establishment should be based mostly on the close association between a trigger, for example a drug, and the occurrence of ECG signs, the increase of myocardial injury biomarkers or possible evidence of coronary spasm/thrombosis on coronary angiography (1).\n\nIn anaphylaxis, cutaneous manifestations can lack in a minority of cases. In a cohort of adult and pediatric patients with this disease, skin was affected in 84% of them, followed by clinical manifestations involving cardiovascular (72%) or respiratory (68%) systems (35, 36). In severe anaphylaxis the phenomenon has been hypothesized due to the state of shock that prevents or delays the released anaphylactic mediators from reaching and acting on the skin, thus inducing redness, rash and/or itching (37, 38). The absence of skin lesions can also occur in KS, in which rash has been described in 26.8% of cases, preceded by chest pain (86.8%) and anaphylaxis (53%) (3, 39, 40). Indeed, the latter event may be particularly true especially if the blood pressure is low as in the described patient.\n\nSkin prick tests could be useful in demonstrating IgE-mediated hypersensitivity (41). However, especially for some drugs, in case of negative results is not possible to completely rule out the diagnosis of hypersensitivity. Interestingly, skin tests themselves can induce KS and caution has to be paid to carry them out, especially when the diagnostic performance for the specific allergen is suboptimal (42). Unfortunately, serum tryptase dosage was not performed in our patient. However, although positive serum tryptase could be a useful biomarker in case of anaphylaxis and KS, negative results cannot rule them out completely (2).\n\nIn this case we highlighted the importance of recognition of KS in pediatric patients, differentiating this condition from other ones associated with acute ventricular systolic disfunction. Firstly, a hypersensitivity reaction should be taken into consideration as a potential cause of an acute coronary syndrome; secondly we pointed out the critical role of observing closely the patient, as the situation could evolve unpredictably to a cardiopulmonary emergency. Moreover, when a myocarditis or another cause are suspected, they benefit from a specific management (22). In the context of diagnostic investigations, in addition to ECG and echocardiography, cardiac MRI and coronary CT scan were performed, which were fundamental to assess our patient. In addition, his blood investigations did not show inflammatory markers increase.\n\nIn the present report, after the management of the acute phase, the stable clinical condition and the rapid improvement of systolic function allowed us to avoid the administration of specific drugs.\n\nConclusion\n\nIn conclusion, we described one of the first pediatric cases of KS related to anesthetic medications. Cases reported of this syndrome are increasing progressively in the literature, and more and more drugs/agents have been identified as potential triggers of this clinical condition. The treatment of KS could be challenging, and it is mainly based on the treatment of the allergic reaction and of the cardiological clinical manifestations. In children, this syndrome has been only described in isolated case reports or small case series. Thus, it appears critical to report new cases of KS in children to increase the awareness of this disease in pediatric healthcare workers so as to enhance its early recognition and optimal therapeutic strategy. Furthermore, it appears of paramount importance the implementation of universal guidelines accepted by allergology and cardiology societies, in order to standardize the management of pediatric and adult patients with KS. Finally, a close collaboration between pediatric allergists and cardiologists seems fundamental for an optimal multidisciplinary patient care.\n\nData Availability Statement\n\nThe original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.\n\nEthics Statement\n\nWritten informed consent was obtained from the minor(s)' legal guardian/next of kin for the publication of any potentially identifiable images or data included in this article.\n\nAuthor Contributions\n\nGC, MG, LDS, and ST conceptualized the work. GC, MG, IK, FM, SF, LDS, and ST drafted the manuscript. GC, MG, FM, CR, GS, GBC, SF, EN, GI, LDS, and ST performed the investigations. GC, MG, IK, FM, CR, GS, GBC, SF, EN, GI, LDS, and ST critically revised the manuscript. All authors approved the final version of the manuscript as submitted and agreed to be accountable for all aspects of the work.\n\nConflict of Interest\n\nThe authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.\n\nPublisher's Note\n\nAll claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.\n\nThe authors want to thank Prof. Nicholas George Kounis (Department of Cardiology, Patras University School of Medicine, Patras, Greece) for critical review of the manuscript.\n==== Refs\nReferences\n\n1. Kounis NG . Kounis syndrome: An update on epidemiology, pathogenesis, diagnosis and therapeutic management. Clin Chem Lab Med. (2016) 54 :1545–59. 10.1515/cclm-2016-0010 26966931\n2. Giovannini M Koniari I Mori F Ricci S De Simone L Favilli S . Kounis syndrome: a clinical entity penetrating from pediatrics to geriatrics. J Geriatr Cardiol. (2020) 17 :294–9. 10.11909/j.issn.1671-5411.2020.05.011 32547613\n3. Abdelghany M Subedi R Shah S Kozman H . Kounis syndrome: A review article on epidemiology, diagnostic findings, management and complications of allergic acute coronary syndrome. Int J Cardiol. (2017) 232 :1–4. 10.1016/j.ijcard.2017.01.124 28153536\n4. Biteker M Duran NE Biteker FS Ertürk E Aykan AÇ Civan HA . Kounis Syndrome secondary to amoxicillin/clavulanic acid use in a child. Int J Cardiol. (2009) 136 :e3–5. 10.1016/j.ijcard.2008.04.064 18632172\n5. Ateş AH Kul S . Acute coronary syndrome due to midazolam use: Kounis syndrome during a transurethral prostatectomy. Turk Kardiyol Dern Ars. (2015) 43 :558–61. 10.5543/tkda.2015.44567 26363750\n6. Sidi A Dahleen L Gaspardone A . Coronary vasospasm during anesthesia induction: awareness, recognition, possible mechanisms, anesthetic factors, and treatment. J Clin Anesth. (2008) 20 :64–9. 10.1016/j.jclinane.2007.02.016 18346615\n7. Kounis GN Hahalis G Kounis NG . Anesthetic drugs and Kounis syndrome. J Clin Anesth. (2008) 20 :562–3. 10.1016/j.jclinane.2008.06.004 19019657\n8. Parent B Wearden P Kounis NG Chrysostomou C . Kounis syndrome or allergic coronary vasospasm in a two-year-old. Congenit Heart Dis. (2011) 6 :499–503. 10.1111/j.1747-0803.2011.00499.x 21418536\n9. Kounis GN Kouni SA Hahalis G Kounis NG . Mesalamine hypersensitivity and Kounis syndrome in a pediatric ulcerative colitis patient. World J Gastroenterol. (2008) 14 :7141–2. 10.3748/wjg.14.7141 19084925\n10. Biteker M Duran NE Biteker F Civan HA Gündüz S Gökdeniz T . Kounis syndrome: first series in Turkish patients. Anadolu Kardiyol Derg. (2009) 9 :59–60.19196576\n11. Ilhan E Akbulut T Gürsürer M . An underdiagnosed syndrome; Kounis syndrome secondary to amoxicillin/clavulanic acid use in a 16 year-old child. Int J Cardiol. (2013) 167 :e90–1. 10.1016/j.ijcard.2013.03.158 23623347\n12. Terlemez S Eryilmaz U Tokgöz Y Uysal P Coşan A Bulut Y . Kounis syndrome caused by metronidazole - A case of 14 year-old boy. Int J Cardiol. (2015) 179 :222–4. 10.1016/j.ijcard.2014.11.049 25464452\n13. Yaman M Mete T Ozer I Yaman E Beton O . Reversible myocarditis and pericarditis after black widow spider bite or kounis syndrome? Case Reports Cardiol. (2015) 2015 :768089. 10.1155/2015/768089 26509087\n14. Castellano-Martinez A Rodriguez-Gonzalez M . Coronary artery spasm due to intravenous atropine infusion in a child: possible Kounis syndrome. Cardiol Young. (2018) 28 :616–8. 10.1017/S1047951117002785 29316984\n15. Sidoti PA Dunphy TR Baerveldt G LaBree L Minckler DS Lee PP . Experience with the Baerveldt glaucoma implant in treating neovascular glaucoma. Ophthalmology. (1995) 102 :1107–18. 10.1016/S0161-6420(95)30904-9 9121760\n16. Faiq MA Dada R Qadri R Dada T . CYP1B1-mediated pathobiology of primary congenital glaucoma. J Curr Glaucoma Pract. (2015) 9 :77–80. 10.5005/jp-journals-10008-1189 26997841\n17. Kampmann C Emschermann T Stopfkuchen H Wiethoff CM Wenzel A Stolz G . Normal values of M mode echocardiographic measurements of more than 2000 healthy infants and children in central Europe. Heart. (2000) 83 :667–72. 10.1136/heart.83.6.667 10814626\n18. Biteker M Ekşi Duran N Sungur Biteker F Ayyildiz Civan H Kaya H Gökdeniz T . Allergic myocardial infarction in childhood: Kounis syndrome. Eur J Pediatr. (2010) 169 :27–9. 10.1007/s00431-009-0965-5 19277706\n19. Giovannini M Alletto A Koniari I Mori F Favilli S Sarti L . Kounis Syndrome: a pediatric perspective. Minerva Pediatr. (2020) 72 :383–92. 10.23736/S0026-4946.20.06007-7 32960008\n20. Raparelli V Elharram M Shimony A Eisenberg MJ Cheema AN Pilote L . Myocardial infarction with no obstructive coronary artery disease: angiographic and clinical insights in patients with premature presentation. Can J Cardiol. (2018) 34 :468–76. 10.1016/j.cjca.2018.01.004 29571427\n21. Kounis NG Koniari I Soufras GD Tsigkas G Chourdakis E Despotopoulos S . Kounis syndrome: an additional etiologic factor of myocardial infarction with non-obstructive coronary arteries. Cardiol J. (2018) 25 :648–9. 10.5603/CJ.2018.0132 30394519\n22. Caforio ALP Pankuweit S Arbustini E Basso C Gimeno-Blanes J Felix SB . Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: A position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. (2013) 34 :2636–48. 10.1093/eurheartj/eht210 23824828\n23. Margonato D Abete R Di Giovine G Delfino P Grillo M Mazzetti S . Mortara A. Takotsubo cardiomyopathy associated with Kounis syndrome: A clinical case of the ATAK complex. J Cardiol Cases. (2019) 20 :52–6. 10.1016/j.jccase.2019.03.007 31440312\n24. Yanagawa Y Nishi K Tomiharu N Kawaguchi T . A case of takotsubo cardiomyopathy associated with Kounis syndrome. Int J Cardiol. (2009) 132 :e65–7. 10.1016/j.ijcard.2007.08.022 18031840\n25. Kounis NG Filippatos GS . Takotsubo and Kounis syndrome: is there any association? Circ J. (2007) 71 :170. 10.1253/circj.71.170 17205665\n26. Scally C Abbas H Ahearn T Srinivasan J Mezincescu A Rudd A . Myocardial and systemic inflammation in acute stress-induced (Takotsubo) cardiomyopathy. Circulation. (2019) 139 :1581–92. 10.1161/CIRCULATIONAHA.118.037975 30586731\n27. Naranjo CA Busto U Sellers EM Sandor P Ruiz I Roberts EA . A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. (1981) 30 :239–45. 10.1038/clpt.1981.154 7249508\n28. Okur A Kantarci M Karaca L Ogul H Aköz A Kizrak Y . The utility of cardiac magnetic resonance imaging in Kounis syndrome. Postep w Kardiol Interwencyjnej. (2015) 11 :218–23. 10.5114/pwki.2015.54017 32974449\n29. Caglar IM Vural A Turhan Caglar FN Ugurlucan M Karakaya O . Kounis syndrome together with myocardial bridging leading to acute myocardial infarction at young age. Case Rep Med. (2011) 2011 :490310. 10.1155/2011/490310 22007234\n30. Hertzog JH Preisberga K Penfil S . The Incidence and Nature of Allergic and Anaphylactic Reactions During Pediatric Procedural Sedation: A Report From the Pediatric Sedation Research Consortium. Hosp Pediatr. (2019) 9 :16–23. 10.1542/hpeds.2018-0089 30541918\n31. Shin JG Hwang JH Lee BS Park HJ Lee SH Lee JN . case of midazolam anaphylaxis. Clin Endosc. (2014) 47 :262–5. 10.5946/ce.2014.47.3.262 24944992\n32. Shrivastava S . An experience with midazolam anaphylactoid reaction. J Anesth. (2012) 26 :642–3. 10.1007/s00540-012-1386-6 22467090\n33. Ayuse T Kurata S Ayuse T . Anaphylactoid-like reaction to midazolam during oral and maxillofacial surgery. Anesth Prog. (2015) 62 :64–5. 10.2344/0003-3006-62.1.64 26061575\n34. Fujita Y Ishikawa H Yokota K . Anaphylactoid reaction to midazolam. Anesth Analg. (1994) 79 :811–2. 10.1213/00000539-199410000-00043 7943804\n35. Muraro A Roberts G Worm M Bilò MB Brockow K Fernández Rivas M . Anaphylaxis: guidelines from the European Academy of Allergy and Clinical Immunology. Allergy. (2014) 69 :1026–45. 10.1111/all.12437 24909803\n36. Worm M Edenharter G Ruëff F Scherer K Pföhler C Mahler V . Symptom profile and risk factors of anaphylaxis in Central Europe. Allergy. (2012) 67 :691–8. 10.1111/j.1398-9995.2012.02795.x 22335765\n37. Kounis NG Koniari I Velissaris D Plotas P Tsigkas G Soufras GD . Too many cooks spoil the broth: the more antigens present, the easier, the quicker, and the more severe the anaphylaxis. J Investig Allergol Clin Immunol. (2019) 29 :333–4. 10.18176/jiaci.0389 31478532\n38. Garvey LH Dewachter P Hepner DL Mertes PM Voltolini S Clarke R . Management of suspected immediate perioperative allergic reactions: an international overview and consensus recommendations. Br J Anaesth. (2019) 123 :e50–64. 10.1016/j.bja.2019.04.044 31130272\n39. Adachi H Ihara M Nojima Y Kurimoto T Nanto S . Kounis syndrome caused by anaphylaxis without skin manifestations after cefazolin administration. J Allergy Clin Immunol Pract. (2019) 7 :317–9. 10.1016/j.jaip.2018.05.030 29902529\n40. Andrews ID Scheinman P . Systemic hypersensitivity reaction (without cutaneous manifestations) to an implantable cardioverter-defibrillator. Dermatitis. (2011) 22 :161–4. 10.2310/6620.2011.10088 21569746\n41. Demoly P Adkinson NF Brockow K Castells M Chiriac AM Greenberger PA . International Consensus on drug allergy. Allergy. (2014) 69 :420–37. 10.1111/all.12350 24697291\n42. González-De-Olano D Gandolfo-Cano M Mohedano-Vicente E González-Mancebo E Matito A Kounis NG . Kounis syndrome following the performance of skin test to amoxicillin. Int J Cardiol. (2014) 174 :856–7. 10.1016/j.ijcard.2014.04.191 24801079\n\n",
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"abstract": "Agents that block vascular endothelial growth factor (VEGF) and its downstream pathway have been reported to be associated with nephrotoxicity including hypertension, proteinuria, and renal dysfunction. Bevacizumab, a monoclonal antibody against VEGF, is known to cause thrombotic microangiopathy (TMA), while tyrosine kinase inhibitors (TKIs) that block VEGF downstream are mainly associated with minimal change disease or focal segmental glomerulosclerosis. The question regarding the source of the diverse phenotypes of nephrotoxicity associated with these agents remains enigmatic. Nintedanib, a multitargeted TKI, blocks fibroblast growth factor and platelet-derived growth factor receptor as well as VEGF receptor, and is indicated for the treatment of idiopathic pulmonary fibrosis. We describe a case of a 45-year-old male who presented with isolated proteinuria of 1.3 g/g Cr 3 years after beginning nintedanib treatment. The kidney biopsy revealed histological features consistent with renal TMA. He underwent single lung transplantation 6 months later, which enabled cessation of nintedanib, and, 1 month later, his proteinuria results were negative. Unlike other types of TKIs, the pathological findings of nintedanib-induced nephrotoxicities have been limitedly reported. This is the first case of isolated proteinuria likely caused by nintedanib-induced TMA.",
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"authors": "Inoue|Daisuke|D|;Nishi|Hiroshi|H|;Honda|Kenjiro|K|;Ishii|Taisuke|T|;Abe|Hiroyuki|H|;Sato|Masaaki|M|;Nangaku|Masaomi|M|",
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] |
{
"abstract": "BACKGROUND\nTacrolimus is a cornerstone of immunosuppression after transplantation but is highly susceptible to changes from interacting variables and has a narrow therapeutic index. Clotrimazole troches are commonly used as a non-systemic antifungal to prevent oral candidiasis. Studies suggest that clotrimazole troches, though minimally absorbed systemically, may affect tacrolimus concentrations by inhibition of metabolic enzyme activity in the intestines. However, the magnitude of the impact of clotrimazole on tacrolimus dosing requirements to maintain goal levels is not well described.\n\n\nMETHODS\nTo assess this, tacrolimus dose adjustments and trough concentrations were retrospectively examined in 95 heart transplant recipients before and after the discontinuation of clotrimazole.\n\n\nRESULTS\nThe median percent tacrolimus dose change was an increase of 66.7% (IQR 28.6%, 100%) after clotrimazole discontinuation, and the median trough concentration percent change from baseline to the first trough after clotrimazole discontinuation (in the absence of a dose change) was -42.5% (IQR -52.3%, -30.9%). Five cases of allograft rejection were observed.\n\n\nCONCLUSIONS\nIn conclusion, clotrimazole troches exert a meaningful interaction with tacrolimus that requires close monitoring and dose adjustment. The data from this single-center study provide novel information that could guide providers on the degree of tacrolimus dose adjustment needed when discontinuing clotrimazole prophylaxis after heart transplantation.",
"affiliations": "Division of Pharmacy Services, Mayo Clinic Hospital, Rochester, Minnesota.;Division of Pharmacy Services, Mayo Clinic Hospital, Rochester, Minnesota.;Division of Pharmacy Services, Mayo Clinic Hospital, Rochester, Minnesota.;Division of Biomedical Statistics and Informatics, Mayo Clinic Hospital, Rochester, Minnesota.;Division of Cardiovascular Diseases, Mayo Clinic Hospital, Rochester, Minnesota.;Division of Infectious Diseases, Mayo Clinic Hospital, Rochester, Minnesota.",
"authors": "Laub|Melissa R|MR|http://orcid.org/0000-0002-6251-9153;Crow|Stacy A|SA|;Personett|Heather A|HA|;Dierkhising|Ross|R|;Boilson|Barry|B|;Razonable|Raymund|R|",
"chemical_list": "D000935:Antifungal Agents; D007166:Immunosuppressive Agents; D003022:Clotrimazole; D016559:Tacrolimus",
"country": "Denmark",
"delete": false,
"doi": "10.1111/tid.12979",
"fulltext": null,
"fulltext_license": null,
"issn_linking": "1398-2273",
"issue": "20(6)",
"journal": "Transplant infectious disease : an official journal of the Transplantation Society",
"keywords": "clotrimazole; heart transplant; prophylaxis; tacrolimus; thrush",
"medline_ta": "Transpl Infect Dis",
"mesh_terms": "D000284:Administration, Oral; D000935:Antifungal Agents; D002180:Candidiasis, Oral; D003022:Clotrimazole; D004347:Drug Interactions; D005260:Female; D006084:Graft Rejection; D016027:Heart Transplantation; D006801:Humans; D007165:Immunosuppression Therapy; D007166:Immunosuppressive Agents; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016559:Tacrolimus; D016896:Treatment Outcome",
"nlm_unique_id": "100883688",
"other_id": null,
"pages": "e12979",
"pmc": null,
"pmid": "30120865",
"pubdate": "2018-12",
"publication_types": "D016428:Journal Article",
"references": null,
"title": "Effects of clotrimazole troches on tacrolimus dosing in heart transplant recipients.",
"title_normalized": "effects of clotrimazole troches on tacrolimus dosing in heart transplant recipients"
} | [
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{
"abstract": "Although gastric metastases have been estimated to occur in less than 2% of cancer patients, an increased use of upper digestive tract endoscopy allows for a higher detection of secondary gastric tumors. We describe the case of a 66-year-old male patient presenting with mild pain in the sternum and upper abdominal area. Physical examination revealed a right parietal skull tumor, with no other significant clinical changes. Upon exclusion of an acute coronary syndrome, upper digestive tract endoscopy was performed, showing the presence of an ulcerated tumor located in the gastric fundus. Histopathologic examination of the biopsy sample and immunohistochemical tests suggested a pulmonary origin of the gastric tumor. Whole body computer tomography showed the presence of tumors in the gastric fundus, left lung, liver, kidneys, bones and brain. Transbronchial biopsy of the lung tumor certified the diagnosis of non-small cell lung cancer, with the same immunohistochemical profile as the gastric tumor. Hence, it was considered the origin of the metastases. Biopsy of the skull tumor also had the identical tumor histology. Whole brain radiotherapy was performed for the brain metastases and subsequent chemotherapy was administered. Although non-specific, gastrointestinal signs and symptoms occurring in lung cancer patients should alert the clinicians as to the possibility of gastrointestinal metastases and prompt endoscopic evaluation.",
"affiliations": "Department of Oncology, Elias University Clinical Hospital, Carol Davila University, Medicine and Pharmacy Faculty, 011461 Bucharest, Romania.;Department of Surgery, 'Sf. Ioan' Clinical Emergency Hospital, Carol Davila University, Faculty of Dental Medicine, 042122 Bucharest, Romania.;Department of Dermatology, Elias University Clinical Hospital, Carol Davila University, Medicine and Pharmacy Faculty, 011461 Bucharest, Romania.;Department of Histopathology, Elias University Clinical Hospital, Carol Davila University, Medicine and Pharmacy Faculty, 011461 Bucharest, Romania.;Department of Gastroenterology, Elias University Clinical Hospital, Carol Davila University, Medicine and Pharmacy Faculty, 011461 Bucharest, Romania.;Department of Oncology, Elias University Clinical Hospital, Carol Davila University, Medicine and Pharmacy Faculty, 011461 Bucharest, Romania.;Department of Oncology, Elias University Clinical Hospital, Carol Davila University, Medicine and Pharmacy Faculty, 011461 Bucharest, Romania.;Department of Oncology, Elias University Clinical Hospital, Carol Davila University, Medicine and Pharmacy Faculty, 011461 Bucharest, Romania.;Department of Pathology, Emergency University Military Hospital, Carol Davila University, Medicine and Pharmacy Faculty, 020021 Bucharest, Romania.;Department of Surgery, 'Sf. Pantelimon' Clinical Emergency Hospital, Carol Davila University, Medicine and Pharmacy Faculty, 021659 Bucharest, Romania.;Department of Forensic Medicine and Toxicology, National and Kapodistrian University of Athens, Medical School, 10679 Athens, Greece.;Department of Toxicology, Faculty of Pharmacy, 'Carol Davila' University of Medicine and Pharmacy, 020956 Bucharest, Romania.;Department of Oncology, Elias University Clinical Hospital, Carol Davila University, Medicine and Pharmacy Faculty, 011461 Bucharest, Romania.",
"authors": "Nitipir|Cornelia|C|;Ginghina|Octav|O|;Popa|Liliana|L|;Andrei|Florin|F|;Tudor|Nicolaie|N|;Radu|Irina|I|;Iaciu|Cristian|C|;Orlov|Cristina|C|;Vasilescu|Florina|F|;Balalau|Cristian|C|;Leon|Grigoris|G|;Negrei|Carolina|C|;Barbu|Maria Alexandra|MA|",
"chemical_list": null,
"country": "England",
"delete": false,
"doi": "10.3892/mco.2018.1565",
"fulltext": null,
"fulltext_license": null,
"issn_linking": "2049-9450",
"issue": "8(4)",
"journal": "Molecular and clinical oncology",
"keywords": "gastric metastases; immunohistochemistry; non-small cell lung cancer",
"medline_ta": "Mol Clin Oncol",
"mesh_terms": null,
"nlm_unique_id": "101613422",
"other_id": null,
"pages": "595-599",
"pmc": null,
"pmid": "29541469",
"pubdate": "2018-04",
"publication_types": "D016428:Journal Article",
"references": "21098094;11577478;6274500;11156325;18512073;8153934;21565397;16810769;24697130;8739742;17010474;11437044;19696259;25663915;5939878;2311070;17186432;22090788;21519812;22634567;8277608;17468816;22183069;21160891;14487721;3028602;27833973;1190198;16899604;24179627;10847441;26742998;21864934;18594328;16177864",
"title": "A rare case of advanced lung cancer presenting as a symptomatic gastric tumor.",
"title_normalized": "a rare case of advanced lung cancer presenting as a symptomatic gastric tumor"
} | [
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{
"abstract": "BACKGROUND\nIt is common clinical experience that, after structured withdrawal, some patients with chronic migraine and medication overuse headache (CM with MOH) are more prone than others to relapse and to be in need of further structured treatments. Our aim was to explore similarities and differences between frequent relapsers (FRs) and non-frequent relapsers (NFRs) by considering their point of view, perceptions, and perspective of their subjective experience with relapse into CM with MOH.\n\n\nMETHODS\nPatients were consecutively recruited on occasion of a structured withdrawal treatment and were interviewed individually about their headache experience and their perspectives on relapse into CM with MOH. We considered FR those patients requiring 2 or more structured withdrawals for MOH within 3 years. A narrative approach with no preconceived coding schemes was employed. To facilitate coding, categorization and organization of data the software QRS NVivo 11.0 was used: themes were defined as common to FR and NFR, or peculiar (by frequency or content) to one of the 2 groups.\n\n\nRESULTS\nSixteen patients (13 women; mean age of 53) were interviewed: 7 were classified as FRs. A total of 22 themes emerged from 552 single quotations (the 10 most relevant covered 82% of the entire body of quotations). Four themes were commonly reported by both FR and NFR patients, and 6 were peculiar to one group only. Common aspects included issues connected to the dilemma between disclosing, concealing and the feelings of isolation around MOH, the idea of being addicted to medication, presence of anxiety, and the attempt to use non-pharmacological therapies as an alternative to medication. Peculiar aspects included causal attribution (FRs attributed headache to uncontrollable factors); future expectations at the time point of withdrawal (FRs were generally resigned); high-performance functioning (FRs believed they are \"forced\" to reach high levels of performance as a consequence of others' inability); coping strategies (FRs tended to \"passively accept\" problems and showed avoidance-related behaviors). Moreover, FRs were less frequently aware of their problems and described more frequently depressive symptoms.\n\n\nCONCLUSIONS\nOur results highlight that some differences between FR and NFR patients with CM and MOH exist. Frequent relapsers among patients with CM and MOH reported some important peculiarities of the lived experience of having chronic migraine; clinicians should recognize these psychosocial aspects such as social relationships, future expectations, the experience of illness, medication management, and how the withdrawal experience is regarded, as they may be associated with frequent relapse into MOH.",
"affiliations": "Public Health and Disability Unit, Neurological Institute \"C. Besta\" IRCCS Foundation, Neurology, Milan, Italy.;e-Campus University, Novedrate, Italy.;Public Health and Disability Unit, Neurological Institute \"C. Besta\" IRCCS Foundation, Neurology, Milan, Italy.;Public Health and Disability Unit, Neurological Institute \"C. Besta\" IRCCS Foundation, Neurology, Milan, Italy.;Headache and Neuroalgology Unit, Neurological Institute \"C. Besta\" IRCCS Foundation, Milan, Italy.;John R. Graham Headache Center, Department of Neurology, Brigham and Women's Faulkner Hospital, Boston, MA, USA.;Headache and Neuroalgology Unit, Neurological Institute \"C. Besta\" IRCCS Foundation, Milan, Italy.;Public Health and Disability Unit, Neurological Institute \"C. Besta\" IRCCS Foundation, Neurology, Milan, Italy.",
"authors": "Scaratti|Chiara|C|;Covelli|Venusia|V|;Guastafierro|Erika|E|;Leonardi|Matilde|M|;Grazzi|Licia|L|;Rizzoli|Paul B|PB|;D'Amico|Domenico|D|;Raggi|Alberto|A|",
"chemical_list": null,
"country": "United States",
"delete": false,
"doi": "10.1111/head.13385",
"fulltext": null,
"fulltext_license": null,
"issn_linking": "0017-8748",
"issue": "58(9)",
"journal": "Headache",
"keywords": "chronic migraine; medication-overuse headache; qualitative study; relapse; withdrawal",
"medline_ta": "Headache",
"mesh_terms": "D000328:Adult; D000368:Aged; D001007:Anxiety; D003863:Depression; D005260:Female; D051271:Headache Disorders, Secondary; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders; D036301:Qualitative Research; D012008:Recurrence; D012919:Social Behavior; D013375:Substance Withdrawal Syndrome",
"nlm_unique_id": "2985091R",
"other_id": null,
"pages": "1373-1388",
"pmc": null,
"pmid": "30125944",
"pubdate": "2018-10",
"publication_types": "D003160:Comparative Study; D016428:Journal Article",
"references": null,
"title": "A Qualitative Study On Patients With Chronic Migraine With Medication Overuse Headache: Comparing Frequent And Non-Frequent Relapsers.",
"title_normalized": "a qualitative study on patients with chronic migraine with medication overuse headache comparing frequent and non frequent relapsers"
} | [
{
"companynumb": "PHHY2018IT165025",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": "3",
"drugadministrationroute": "065",
"drugauthorizationnumb": null,
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"drugindication": "MIGRAINE",
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"medicinalproduct": "ACETYLSALICYLIC ACID"
}
],
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"reaction": [
{
"reactionmeddrapt": "Drug abuse",
"reactionmeddraversionpt": "21.1",
"reactionoutcome": "6"
},
{
"reactionmeddrapt": "Overdose",
"reactionmeddraversionpt": "21.1",
"reactionoutcome": "6"
},
{
"reactionmeddrapt": "Headache",
"reactionmeddraversionpt": "21.1",
"reactionoutcome": "6"
}
],
"summary": null
},
"primarysource": {
"literaturereference": "SCARATTI C, COVELLI V, GUASTAFIERRO E, LEONARDI M, GRAZZI L, RIZZOLI PB ET AL.. A QUALITATIVE STUDY ON PATIENTS WITH CHRONIC MIGRAINE WITH MEDICATION OVERUSE HEADACHE: COMPARING FREQUENT AND NON-FREQUENT RELAPSERS. HEADACHE. 2018?58:1373-88",
"literaturereference_normalized": "a qualitative study on patients with chronic migraine with medication overuse headache comparing frequent and non frequent relapsers",
"qualification": "3",
"reportercountry": "IT"
},
"primarysourcecountry": "IT",
"receiptdate": "20181129",
"receivedate": "20181129",
"receiver": {
"receiverorganization": "FDA",
"receivertype": "6"
},
"reporttype": "1",
"safetyreportid": 15673256,
"safetyreportversion": 1,
"sender": {
"senderorganization": "FDA-Public Use",
"sendertype": "2"
},
"serious": 1,
"seriousnesscongenitalanomali": null,
"seriousnessdeath": null,
"seriousnessdisabling": null,
"seriousnesshospitalization": null,
"seriousnesslifethreatening": null,
"seriousnessother": 1,
"transmissiondate": "20190205"
},
{
"companynumb": "PHHY2018IT165028",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"drugadditional": "3",
"drugadministrationroute": "065",
"drugauthorizationnumb": null,
"drugbatchnumb": null,
"drugcharacterization": "1",
"drugcumulativedosagenumb": null,
"drugcumulativedosageunit": null,
"drugdosageform": null,
"drugdosagetext": "UNK",
"drugenddate": null,
"drugenddateformat": null,
"drugindication": "MIGRAINE",
"drugintervaldosagedefinition": null,
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"drugrecurreadministration": "3",
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"medicinalproduct": "ACETYLSALICYLIC ACID"
}
],
"patientagegroup": null,
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"patientsex": null,
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"reaction": [
{
"reactionmeddrapt": "Drug abuse",
"reactionmeddraversionpt": "21.1",
"reactionoutcome": "6"
},
{
"reactionmeddrapt": "Headache",
"reactionmeddraversionpt": "21.1",
"reactionoutcome": "6"
}
],
"summary": null
},
"primarysource": {
"literaturereference": "SCARATTI C, COVELLI V, GUASTAFIERRO E, LEONARDI M, GRAZZI L, RIZZOLI PB ET AL. A QUALITATIVE STUDY ON PATIENTS WITH CHRONIC MIGRAINE WITH MEDICATION OVERUSE HEADACHE: COMPARING FREQUENT AND NON-FREQUENT RELAPSERS. HEADACHE. 2018?58:1373-88",
"literaturereference_normalized": "a qualitative study on patients with chronic migraine with medication overuse headache comparing frequent and non frequent relapsers",
"qualification": "3",
"reportercountry": "IT"
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"receiptdate": "20181129",
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"sender": {
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},
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"seriousnessdeath": null,
"seriousnessdisabling": null,
"seriousnesshospitalization": null,
"seriousnesslifethreatening": null,
"seriousnessother": 1,
"transmissiondate": "20190205"
}
] |
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