bluuebunny/crossref_metadata_2025 huggingface dataset:
Phase 1 clinical study of cell therapy with effective-mononuclear cells (E-MNC) for radiogenic xerostomia (first-in-human study) (FIH study on E-MNC therapy for radiogenic xerostomia)
Authors: Sumita Yoshinori , Iwamoto Naoki , Seki Makoto , Yoshida Takako , Honma Ryo , Iwatake Mayumi , Ohba Seigo , Takashi I. , Hotokezaka Yuka , Harada Hiroshi , Kuroshima Shinichiro , Nagai Kazuhiro , Asahara Takayuki , Atsushi Kawakam I , Asahina Izumi
Published: June 2020

Background:

Treatment for most patients with head and neck cancers includes ionizing radiation with or without chemotherapy. This treatment causes irreversible damage to salivary glands in the irradiation field accompanied by a loss of fluid-secreting acinar cells and a considerable decrease of saliva secretion. There is currently no adequate conventional treatment for this condition. In recent years, we developed an effective culture method to enhance the anti-inflammatory and vasculogenic phenotypes of peripheral blood mononuclear cells (PBMNCs), and such effectively conditioned PBMNC (E-MNC) therapy has shown promising improvements to the function of radiation-injured salivary glands in preclinical studies. However, the safety and effect of E-NMC therapy have yet assessed in human. The objective of this ongoing first-in-man study is to assess the safety, tolerability, and in part the efficacy of E-MNC therapy for treating radiation-induced xerostomia.

Methods/design:

This phase 1 first-in-man study is an open-label, single-center, two-step dose escalation study. A total of 6 patients, who had no recurrence of head and neck cancer over 5 years following radiation therapy and suffered from radiation-induced xerostomia, will receive a transplantation of E-NMCs derived from autologous PBMNCs to a submandibular gland. The duration of the intervention will be 1 year. To analyze the recovery of salivary secretion, a gum test will be performed. To analyze the recovery of atrophic salivary glands, computed tomography (CT), and magnetic resonance imaging (MRI) of salivary glands will be conducted. The primary endpoint is the safety of the protocol. The secondary endpoints are the changes from baseline in whole saliva secretion and salivary gland atrophy.

Discussion:

This will be the first clinical study of regenerative therapy using E-MNCs for patients with severe radiation-induced xerostomia. The results of this study are expected to contribute to developing the low-invasive cell-based therapy for radiation-induced xerostomia.

Trial registration:

This study was registered with the Japan Registry of Clinical Trials (http://jrct.niph.go.jp) as jRCTb070190057.
Multimode tumor ablation therapy induced different diffusion and microvasculature related parameters change on functional magnetic resonance imaging compared to radiofrequency ablation in liver tumor
Authors: Zhang Guangyuan , Li Wentao , Wang Guangzhi , He Xinhong , Xu Lichao , Wang Shengping , Peng Weijun
Published: June 2020

To explore different posttreatment changes between multimode tumor ablation therapy (MTAT) and radiofrequency ablation (RFA) using intravoxel incoherent motion diffusion-weighted imaging (IVIM-DWI) and diffusion kurtosis imaging (DKI) in patients with hepatic malignancies.

Eighty - seven patients with one hundred and twenty eight hepatic lesions receiving MTAT or RFA underwent IVIM-DWI and DKI before and after treatment. The mean value of apparent diffusion coefficient (ADC), IVIM-DWI parameters, including true diffusion coefficient (D), pseudo-diffusion coefficient (DP), perfusion fraction (f), and DKI parameters including diffusion coefficient (DK), apparent diffusional kurtosis (K) were retrospectively compared prior to and following treatment as well as between treatment groups. The degree of parameters change after ablation was compared between 2 treatment modalities.

The mean value of ADC, D, and DK increased while f, and K decreased significantly in MTAT group. In RFA group, just ADC and K showed significantly change following treatment. The ADC and D value were higher in MTAT group than in RFA group 1 month after treatment. While f was lower in MTAT group after treatment compared with RFA group. The ADC, D and DK increased (21.89 ± 24.95% versus 8.76 ± 19.72%, P = .04 for ADC, 33.78 ± 54.01% versus 7.91 ± 25.16%, P = .03 for D, 25.91 ± 36.28% versus 1.75 ± 46.42%, P = .01 for DK) while f declined (-32.62 ± 41.48% versus 6.51 ± 44.16%, P < .001) more in MTAT group.

The MTAT induced different posttreatment changes on water molecule diffusion and microvasculature related functional MR parameters compared to RFA in patients with liver tumors.
Improvement of image quality on low-dose dynamic myocardial perfusion computed tomography with a novel 4-dimensional similarity filter
Authors: Tsuneta Satonori , Oyama-Manabe Noriko , Kameda Hiroyuki , Harada Taisuke , Kato Fumi , Smit Ewoud J. , Prokop Mathias , Kudo Kohsuke
Published: June 2020

The aim of this study was to evaluate the effect of a novel 4-dimensional similarity filter (4DSF) on quantitative and qualitative parameters of low-dose dynamic myocardial computed tomography perfusion (CTP) images.

In this retrospective study, medical records of 32 patients with suspected or known coronary artery disease who underwent dynamic myocardial CTP at 80 kV were included. The 4DSF reduces noise by averaging voxels that have similar dynamic behavior after adaptive iterative dose reduction 3D (AIDR3D) and deformable image registration were applied. Qualitative (artefact, contour sharpness, and myocardial homogeneity [1 = poor; 2 = intermediate; 3 = good]) and quantitative measurement (standard deviation [SD] and signal-to-noise ratio [SNR]) were compared between the 4DSF and AIDR3D. Contrast-to-noise ratio (CNR) between ischemic and normal remote myocardium was also assessed using myocardial perfusion magnetic resonance imaging as the reference standard in seven patients.

The 4DSF was successfully applied to all the images. Improvement in subjective image quality yielded by 4DSF was higher than that yielded by AIDR3D (homogeneity, 1.0 [3 vs 2]; artefact, 1.5 [3 vs 1.5]; P < .001) in all patients. The 4DSF significantly decreased the SD by 59% (AIDR3D vs 4DSF: 33.5 ± 0.4 vs 13.8 ± 0.4, P < .001), increased the SNR by 134% (AIDR3D vs 4DSF: 4.4 ± 0.2 vs 10.3 ± 0.2, P < .001), and increased the CNR by 131% (AIDR3D vs 4DSF: 1.6 ± 0.2 vs 3.7 ± 0.2, P < .001).

The 4DSF improved the qualitative and quantitative parameters of low-dose dynamic myocardial CTP images.
Primary pulmonary extranodal natural killer/T-cell lymphoma (ENKTL), nasal type
Authors: Hu Qun , Xu Liyu , Zhang Xiaoming , Wang Jie , Zhou Zizi
Published: June 2020

Introduction:

Extranodal natural killer/T-cell lymphoma (ENKTL) – nasal type is an aggressive form of malignant non-Hodgkin lymphoma with a very poor prognosis. Especially primary pulmonary ENKTL is a relatively rare form of non-Hodgkin lymphoma. Until now, the prevalence of primary pulmonary ENKTL is unknown. Since 2001, only 18 cases of primary pulmonary ENKTL have been published, in addition to the 2 cases reported here.

Patient concerns:

We describe 2 cases of primary pulmonary ENKTL. Both patients were male non-smokers, aged 61 and 49 years. Their main clinical symptoms included cold-like symptoms and intermittent fever (39.3°C and 38.8°C) for some days (40 days and 3 weeks). Both patients had no relevant personal or family medical history.

Diagnosis:

The patients were initially misdiagnosed with community-acquired pneumonia. Primary pulmonary ENKTL was confirmed by immunohistochemical staining of computed tomography-guided transthoracic needle biopsy specimens. Both cases were positive for CD56, CD3, and in situ hybridization for Epstein-Barr virus-encoded small RNA, but negative for CD20.

Interventions:

Initially, both patients were treated inadequately with intravenous moxifloxacin administration (unknown dosage and 400 mg q.d) in their local hospitals. Once diagnosed with primary pulmonary ENKTL in our hospital, they received 3 cycles of chemotherapy with combined regimens of dexamethasone, methotrexate, ifosfamide, L-asparaginase, and etoposide (SMILE), and in the second patient, bone marrow transplantation was performed following the third chemotherapy cycle.

Outcomes:

Clinical follow-up after the chemotherapy showed that the condition of the first patient progressively deteriorated. He died 2 months following the initial diagnosis. However, the presence of the hemophagocytic lymphohistocytosis gradually improved in the second patient during chemotherapy. Ultimately, the second patient died of acute transplant rejection 6 months after the initial diagnosis.

Conclusion:

The diagnosis of ENKTL should be considered when patients present with fever and expansile consolidation of the lung not responding to antibiotics. The diagnosis depends on histopathology and immunophenotyping. Percutaneous transthoracic needle biopsy is a safe and effective biopsy method. Chemotherapy may improve the prognosis, but this should be confirmed by prospective multicenter studies.
Atypical primary pulmonary amyloidosis
Authors: Peng Xiong , Wang Xiaolei , Luo Daya , Zuo Wei , Yao Huiming , Zhang Wei
Published: June 2020

Rationale:

Pulmonary amyloidosis is a rare respiratory disease characterized by amyloid deposition in the lungs. The clinical manifestations of pulmonary amyloidosis are variable and without specific symptoms.

Patient concerns:

We report a rare case of tracheobronchial amyloidosis to improve our understanding of the disease.

Diagnoses:

The diagnosis of tracheobronchial amyloidosis was finally established by transbronchoscopic lung biopsy and histological examination.

Interventions:

The patient significantly improved with methylprednisolone sodium succinate for injection (40 mg/day) for 5 days and low-dose oral prednisone for 10 days.

Outcomes:

After treatment, discomfort, such as cough, stridor, dyspnea, and chest tightness, disappeared, and he was discharged. The patient was in good clinical condition after 8 months of follow-up.

Conclusion:

This case clearly shows that it is difficult to distinguish tracheobronchial amyloidosis from other diseases with manifestations of cough, dyspnea and chest tightness because of their similar symptoms and imaging findings. Thus, the role of transbronchoscopic lung biopsy and histological examination in the diagnosis of tracheobronchial amyloidosis is very important.
Efficacy comparison of different acupuncture methods for herpes zoster
Authors: Xu Huachong , Shi Yucong , Liu Pei , Deng Li
Published: June 2020

Background:

Acupuncture methods (include moxibustion) are used frequently in the treatment of herpes zoster. However, the choice is usually made only based on personal experience among different acupuncture methods. This study aims to compare the efficacy of different acupuncture methods for herpes zoster.

Methods:

All randomized controlled trials of acupuncture methods for herpes zoster will be searched in 7 databases including Cochrane Library, Embase, PubMed, Web of Science, Wan-fang database, China National Knowledge Infrastructure database, and VIP Chinese Science and Technique Journals database database. After screening process, effectiveness rate will be extracted from all the included randomized controlled trials as primary outcomes. The Bayesian network meta-analysis will be conducted by generate mixed treatment comparisons 0.14.3, Stata13.0, and Review Man 5.3.

Results:

The results of this study will be submitted to a peer-reviewed journal for publication.

Conclusions:

Our review will compare the efficacy of different acupuncture treatments for herpes zoster and find a better selection guideline for clinicians and patients.

PROSPERO registration number:

CRD42020175189.
The role of an antibiotic envelope in the prevention of major cardiac implantable electronic device infections
Authors: Asbeutah Abdul Aziz A. , Salem Majed H. , Asbeutah Saad A. , Abu-Assi Mona A.
Published: June 2020

Background:

Over the past decade, rates of cardiac implantable electronic device (CIED) related infections have increased and been associated with increased morbidity, mortality and financial burden on healthcare systems.

Methods:

To examine the effect of an antibacterial envelope in reducing major CIED related infections, we performed a systematic review and meta-analysis by searching PubMed/MEDLINE, CENTRAL, Google scholar and Clinicaltrials.gov for studies that examined the effect of an antibiotic envelope in reducing major related CIED infections, comprising of device-related endocarditis, systemic infection requiring systemic antibiotics and or device extraction, compared to control up till February 15th, 2020. A random-effects meta-analysis was conducted by calculating risk ratios (RR) and respective 95% confidence intervals (CI).

Results:

We include 6 studies that comprise of 11,897 patients, of which 5844 received an antibiotic envelope and 6053 did not. Compared with control, utilization of an antibiotic envelope at the time of procedure was associated with a significant 74% relative risk reduction in major CIED related infections among patients at high risk for infection (RR: 0.26 [95% CI, 0.08–0.85]; P = .03), while no significant reduction was observed among patients enrolled from studies with any risk for infection (RR: 0.53 [95% CI, 0.06–4.52]; P = .56). Additionally, no reduction in mortality among patients that received an envelope compared to control was observed (RR: 1.15 [95% CI, 0.53–2.50]; P = .72).

Conclusion:

The utilization of an antibiotic envelope at the time of device implantation or upgrade reduces major CIED infections, especially if used in patients perceived to be at higher risk for infection.
Evaluation of rehabilitation effect of five-step exercises on patients with radiculopathy of cervical vertebra
Authors: Xu Xia , Wang Yajie , Yang Chen , Song Xinyu , Chen Zhilong , Yang Lingge , Li Yaxin
Published: June 2020

Background:

Among all types of cervical spondylitis, cervical spondylitis radiculopathy (CSR) has the highest incidence. The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life. This study proposes to improve the recovery rate of patients with CSR, delay the recurrence, improve the symptoms of patients, and improve the quality of life of patients through the rehabilitation and exercise of five-step cervical vertebra exercises.

Methods:

For 90 patients with CSR that met the inclusion criteria, SPSS 23.0 software random number generator was used to randomly divide the patients into an experimental group and control group, with 45 cases in each group. The control group took basic nursing measures, and the experimental group took five steps of cervical vertebra rehabilitation exercises on the basis of elementary nursing measures. The rehabilitation effect of five-step exercises on CSR patients was evaluated by Neck Disability Index (NDI), Visual Analogue Scale (VAS), and Cervical range of motion measured (CROM) before and after intervention.

Results:

The results of this trial will be published on the website of China Clinical Trial Registration Center (http://www.chictr.org.cn/searchproj.aspx) and in peer-reviewed journals or academic conferences.

Conclusions:

This study will examine the feasibility and preliminary effects of five-step exercises for the treatment of patients with CSR.

Trial registration:

This protocol was registered in Clinical Trials platform with the number ChiCTR1900027299.
Poor bladder compliance due to malacoplakia with xanthogranulomatous cystitis
Authors: Xiao Ning , Tang RongYu , Ge Bo , Zhao HuaSheng , Wang JianFeng
Published: June 2020

Rationale:

Either malacoplakia or xanthogranulomatous cystitis (XC) is a rare chronic infection disease of urinary bladder, which often mimics bladder masses undifferentiated from malignance and results in severe lower urinary tract symptoms. The malacoplakia combined with XC is even rarer in the literature.

Patient concerns:

A 64-year-old female, who presented with nocturia, frequency of micturition, severe urgency with occasional urinary incontinence, and recurrent hematuria for >2 years, was diagnosed with azotemia and anemia. In addition, two 1.0 × 1.0 cm masses of bladder were detected by computer tomography.

Diagnoses:

Malacoplakia combined with xanthogranulomas cystitis was diagnosed histologically. Video urodynamic test showed poor bladder compliance (9 mL/comH2O), markedly decreased maximum bladder capacity (120 mL), and right vesicoureteral reflux at a low intravesical pressure level (25 cmH2O).

Interventions:

Transurethral resection of bladder masses was carried out after treatment of urinary infection by intravenous piperacillin-tazobactam. Oral Ciprofloxacin and Tolterodine were postoperatively used to prevent recurrent lower urinary tract infections and alleviate detrusor overactivity.

Outcomes:

The treatment did not alleviate azotemia, frequency, urgency with incontinence, and bilateral hydroureteronephrosis, but the patient refused to undergo bladder augmentation on account of her poor economic status.

Lessons:

Malacoplakia or/and xanthogranulomas cystitis may lead to poor bladder compliance and video urodynamic study should be considered in patients with refractory chronic lower urinary tract symptoms.
Primary hepatic neuroendocrine carcinoma coexisting with distal cholangiocarcinoma
Authors: Xin Qi , Lv Rong , Lou Cheng , Ma Zhe , Liu Gui-Qiu , Zhang Qin , Yu Hai-Bo , Zhang Chuan-Shan
Published: June 2020

Introduction:

Although primary hepatic neuroendocrine carcinomas, whose prognostic mechanisms remain unclear, are rare, coexistence of neuroendocrine carcinomas and other tumors is rarer. In this report, we describe a unique case of coexistence between primary hepatic neuroendocrine carcinoma and a distal cholangiocarcinoma in the pancreas.

Patient concerns:

A 64-year-old woman with a history of diabetes, but none of hepatitis, was admitted to hospital because of intermittent epigastric distension and pain discomfort for more than 1 month aggravated 1 day. A contrast-enhanced computed tomography (CT) scan of the upper abdomen and abdominal magnetic resonance imaging (MRI) revealed a thickening of the bile duct wall in the middle and lower segment of common bile duct and the corresponding lumen is narrow and low-density tumors with ring enhancement (1.83 cm × 1.9 cm) in lobi hepatis dexte.

Diagnosis:

Primary neuroendocrine carcinoma of the liver was diagnosed to be coexisting with a distal cholangiocarcinoma, which had invaded the pancreas. Immunohistochemical examination revealed that the neoplastic cells strongly expressed chromogranin A, synaptophysin, and CD56 proteins. The tumor cells did not express HepPar-1, glypican-3, S-100, CK7, and CK19 in the liver tumor. A distal bile duct in pancreatic tissues shows the characteristics of typical bile duct carcinoma, as an invasion of carcinoma is also seen in the pancreatic tissues. Gastrointestinal endoscopy, chest and abdominal CT, abdominal MRI, and positron emission tomography (PET)-CT were used to exclude metastatic neuroendocrine tumors of the liver.

Interventions:

Resection of the pancreas-duodenum, the right anterior lobe of the liver, and regional lymph nodes was performed in patients.

Outcomes:

The patient had survived for 5 months after the operation.

Conclusion:

A unique case of a coexistence of primary hepatic neuroendocrine carcinoma and a distal cholangiocarcinoma, which had invaded the pancreas. No treatment guidelines are established for the treatment of the unique case.
Deep surgical site infection after posterior instrumented fusion for rheumatoid upper cervical subluxation treated with antibiotic-loaded bone cement
Authors: Ogihara Satoshi , Murase Shuhei , Oguchi Fumihiko , Saita Kazuo
Published: June 2020

Introduction:

Patients with rheumatoid arthritis (RA) tend to be immunosuppressed due to RA itself and the therapeutic drugs administered. The management of surgical site infection (SSI) following upper cervical spinal instrumented fusion in RA patients is challenging; however, literature on the treatment for such conditions is scarce. We report 3 consecutive patients with RA, who developed deep SSI following upper cervical posterior fusion and were treated using antibiotic-loaded bone cement (ALBC).

Patient Concerns:

All 3 patients reported in the current study experienced compression myelopathy with upper cervical spinal deformity and received prednisolone and methotrexate for controlling RA preoperatively. The patient in Case 1 underwent C1–2 posterior fusion and developed deep SSI due to methicillin-sensitive Staphylococcus aureus at 3 months postoperatively; the patient in Case 2 underwent occipito-C2 posterior fusion and developed deep SSI due to methicillin-sensitive Staphylococcus aureus at 2 weeks postoperatively; and the patient in Case 3 underwent occipito-C2 posterior instrumented fusion and laminoplasty at C3–7, and developed deep SSI due to methicillin-resistant coagulase negative staphylococci at 3 weeks postoperatively.

Diagnosis:

All patients developed deep staphylococcal SSI in the postoperative period.

Interventions:

All 3 patients were treated using ALBC placed on and around the instrumentation to cover them and occupy the dead space after radical open debridement.

Outcomes:

The deep infection was resolved uneventfully after the single surgical intervention retaining spinal instrumentation. Good clinical outcomes of the initial surgery were maintained until the final follow-up without recurrence of SSI in all 3 cases.

Conclusion:

ALBC embedding spinal instrumentation procedure can be a viable treatment for curing SSI in complex cases, such as patients with RA who undergo high cervical fusion surgeries without implant removal.
Apoptosis in cerebrospinal fluid as outcome predictors in severe traumatic brain injury
Authors: Jiang Wenqing , Jin Peng , Wei Wenfeng , Jiang Wei
Published: June 2020

Traumatic brain injury (TBI), due to its high mortality and morbidity, is an important research topic. Apoptosis plays a pathogenic role in a series of neurological disorders, from neurodegenerative diseases to acute neurological lesions.

In this study, we analyzed the association between apoptosis and the Glasgow Outcome Scale (GOS), to examine the potential of apoptosis as a biomarker for a TBI outcome. Patients with severe TBI were recruited at the Department of Neurosurgery, Wujin Hospital Affiliated with Jiangsu University, between January 2018 and December 2019. As a control group, healthy subjects were recruited. The concentrations of caspase-3, cytochrome c, sFas, and caspase-9 in the cerebrospinal fluid (CSF) were analyzed by enzyme-linked immunosorbent assay (ELISA). The association between the GOS and the clinical variables age, sex, initial Glasgow Coma Scale (GCS) score, intracranial pressure (ICP), cerebral perfusion pressure (CPP), initial computed tomography (CT) findings, and apoptotic factors was determined using logistic regression. The area under the receiver operator characteristic (ROC) curve (AUC), and thus the sensitivity and specificity of each risk factor, were obtained.

The levels of caspase-3, cytochrome c, sFas, and caspase-9 in the TBI group were significantly higher than those in the control group (P < .05). The logistic regression results showed that ICP and caspase-3 were significant predictors of outcome at 6 months post-TBI (P < .05). The AUC was 0.925 and 0.888 for ICP and caspase-3, respectively. However, the AUC for their combined prediction was 0.978, with a specificity and sensitivity of 96.0% and 95.2%, respectively, showing that the combined prediction was more reliable than that of the 2 separate factors.

We demonstrated that caspase-3, cytochrome C, sFas, and caspase-9 were significantly increased in the CSF of patients following severe TBI. Furthermore, we found that ICP and caspase-3 were more reliable for outcome prediction in combination, rather than separately.
Can a relatively large spinal cord for the dural sac influence severity of paralysis in elderly patients with cervical spinal cord injury caused by minor trauma?
Authors: Koike Hironori , Hatta Yoichiro , Tonomura Hitoshi , Nonomura Masaru , Takatori Ryota , Nagae Masateru , Ikoma Kazuya , Mikami Yasuo
Published: June 2020

Retrospective review

The degree of spinal cord compression and bony spinal canal stenosis are risk factors for the occurrence of spinal cord injury (SCI) without major fracture or dislocation, but they do not affect the severity of neurological symptoms. However, whether a relatively large spinal cord for the dural sac influences the severity of symptoms in SCI cases is unknown.

The purpose of this study was to verify the influence of spinal cord size relative to dural sac on the severity of paralysis in elderly patients with cervical SCI caused by minor trauma.

Subjects were 50 elderly patients with SCI caused by falls on flat ground. At 72 hours after injury, neurological assessment was performed using the Japanese Orthopaedic Association (JOA) scoring system. Bony canal anteroposterior diameters (APD) at mid C5 vertebral body were measured with computed tomography. We measured dural sac and spinal cord APD at the injured level and mid C5 with magnetic resonance imaging. Spinal cord compression ratio was calculated by dividing spinal cord at the injured level by spinal cord at mid C5. As the evaluation of spinal cord size relative to the dural sac, spinal cord/dural sac ratio was calculated at the injured level and mid C5. To clarify the factors influencing the severity of paralysis, the relationships between JOA score and those parameters were examined statistically.

A significant negative correlation was observed between JOA score and spinal cord/dural sac ratio at mid C5. No clear relationship was observed between JOA score and bony canal APD or spinal cord compression ratio.

In elderly patients with SCI caused by minor trauma, a relatively large spinal cord for the dural sac was shown to be a factor that influences the severity of paralysis. This result can be useful for the treatment and prevention of SCI in the elderly.
GLI1 expression in pancreatic ductal adenocarcinoma correlates the clinical significance and prognosis
Authors: Li Ruidan , Liu Zheran , Chen Ye , Hu Xiaolin , Peng Xingchen
Published: June 2020

Background:

Glioma-associated oncogene homolog 1(GLI1) expression correlates with the clinical significance and prognosis of several cancers. However, the evaluation of the role GLI1 expression plays in pancreatic ductal adenocarcinoma (PDAC) clinicopathological features and outcomes still lacks.

Objective:

The present study systemic reviewed the association of GLI1 expression and clinical significance as well as patients survival in PDAC.

Methods:

We systematically searched the database of The Cochrane Library, PubMed, Embase, CNKI, Weipu data, and Wanfang data according to the inclusion and exclusion criteria. (The search ended on January 1, 2019; no language restrictions). The Newcastle-Ottawa Scale (NOS) scale was implemented to assess the quality of the literature and the Review Manager 5.3 Software was used to conduct a meta-analysis. Finally, 9 studies, a total of 1058 patients, have been included.

Results:

GLI1 is more likely expressed in PDAC tissue rather than para-carcinoma tissue (OR = 2.86, 95%CI = 1.87–4.36, P < .00001). GLI1 expression is associated with the TNM stage (OR = 3.11, 95%CI = 2.01–4.79, P < .00001), perineural invasion (OR = 2.50, 95%CI = 1.28–4.91, P = .008), and lymphatic metastasis (OR = 2.73, 95%CI = 1.71–4.36, P < .0001). But the association with differentiation (OR = 1.20, 95%CI = 0.74–1.96, P = .46) and tumor size (OR = 2.41, 95%CI = 0.97–6.00, P = .06) was not significant. GLI1 expression is related to the worse overall survival in PDACs (HR = 1.68, 95%CI = 1.40–2.02, P < .00001).

Conclusion:

Positive GLI1 expression promotes the progression and metastasis of PDACs and plays an important role in the clinical significance and the patients survival.
A comparison of the effects of Chinese non-pharmaceutical therapies for premature ovarian failure
Authors: Zhang Jinhuan , Huang Xingxian , Liu Yongfeng , He Yuhai , Yu Haibo
Published: June 2020

Background:

Premature ovarian failure (POF) is commonly treated with hormone replacement therapy (HRT). Many patients with POF choose acupuncture as a complementary therapy over HRT, due to possible adverse reactions. This systematic review and network meta-analysis (NMA) compares the efficacy of different forms of acupuncture therapies for POF.

Methods:

Seven databases including PubMed, the Cochrane Library, Embase, Wanfang database, China National Knowledge Infrastructure database, VIP Chinese Science, and Chinese Biomedical Database were searched for randomized controlled trials (RCTs) of various acupuncture treatments for POF. This time spanned from the date of database inception to January 13, 2020. RevMan 5.3 was used to assess the bias risk of the studies. A NMA of the included studies was performed using Stata14.0.

Results:

A total of 408 items were searched in this study, and finally this NMA included 16 RCTS, involving 1,307 patients. It showed that acupuncture (OR:1.35,95%1.24 to 1.47) has the best effectiveness among the four acupuncture (standardized mean difference [SMD]-16.30,95% −31.33 to −1.28) is the most effective and the best in reducing follicle-stimulating hormone levels among the four acupuncture treatments. Acupuncture (SMD 26.67,95%5.95 to 47.40) and acupoint embedding (SMD41.14,95%11.90 to 70.37) were ranked in the top 2 positions, in improving estradiol, whereas acupuncture (SMD-4.90,95% −8.10 to −1.70) was than acupoint embedding and HRT, in reducing luteinizing hormone level. In addition, our conclusions have not changed significantly after the sensitivity analysis.

Protocol registration number: CRD42020150508.

Conclusion:

With clinical evidence summarized by NMA, it is observed that acupuncture is the most promising therapy for improving menopausal symptoms, decreasing serum follicle-stimulating hormone and luteinizing hormone level. Therefore, acupuncture could be effective for patients with POF, who are intolerant to the adverse effects of hormone replacement therapy or who would prefer non-drug therapies. Further multi-center and high-quality RCT studies should be conducted to make our conclusion more rigorous.
Xiaoaiping injection as adjunct therapy for patients with advanced esophageal carcinoma
Authors: Liu Zhen , Dong Yanling , Zhu Meili , Mu Ying , Chen Lemei
Published: June 2020

Background:

Esophageal carcinoma (EC) is one of the worst malignant digestive neoplasms with a strong tendency of invasion and metastasis. Despite the improvement of diagnostic and therapeutic methods in the past decades, the prognosis of EC remains unsatisfactory. Xiaoaiping injection (XAPI), a famous traditional Chinese herbal medicine, has been widely applied as a promising adjunctive drug for EC. However, the exact effects and safety of XAPI have yet to be systematically investigated. We aimed to summarize the efficacy and safety of XAPI for the treatment of advanced EC through the meta-analysis, in order to provide scientific reference for the design of future clinical trials.

Methods:

Relevant randomized controlled trials (RCTs) were searched from Cochrane Library, PubMed, Google Scholar, Web of Science, Excerpt Medica Database, Medline, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, China Scientific Journal Database and Wanfang Database. Papers in English or Chinese published from January 2000 to May 2020 will be included without any restrictions.

Study selection and data extraction will be performed independently by 2 investigators. The clinical outcomes including overall response rate, complete response rate, overall survival, Disease-free survival, quality of life, immune function and adverse events, were systematically evaluated. Review Manager 5.3 and Stata 14.0 were used for data analysis, and the quality of the studies was also evaluated.

Results:

The results of this study will be published in a peer-reviewed journal, and provide more evidence-based guidance in clinical practice.

Conclusion:

Our study will draw an objective conclusion of the effects of XAPI combined with conventional treatment for advanced EC and provide a helpful evidence for clinicians to formulate the best postoperative adjuvant treatment strategy for EC patients.

INPLASY registration number:

INPLASY202050094.
Bilateral pediatric pial arteriovenous fistulas accompanying a giant arachnoid cyst with torticollis
Authors: Li Junrao , Wang Ting , Richard Seidu A. , Zhang Changwei , Xie Xiaodong , Wang Chaohua
Published: June 2020

Rationale:

Pial arteriovenous fistula (PAVF) occurs when intracranial arteries communicate directly with veins. PAVFs are very rare congenital vascular lesions that are commonly seen in infants and children. Arachnoid cysts are congenital cavitation often filled with cerebrospinal fluid. We present a very rare associated occurrence of bilateral pediatric PAVF and a giant arachnoid cyst presenting as torticollis in a child. So far, this is the first case.

Patient concerns:

A 6-year-old male child was referred to our facility from a local hospital due to severe torticollis.

Diagnoses:

An enhanced computed tomography scan revealed 2 slightly high-density masses at the anterior pontine cistern, right circumferential cistern, as well as left posterior occipital region. The same computed tomography scan revealed a giant arachnoid cyst in the left occipital as well as the temporal region with a thin cerebral cortex adjacent to the cyst.

Interventions:

Digital subtraction angiography confirmed that the 2 high-flow lesions were PAVFs. The patient was treated with a combination of detachable coils and Onyx Liquid Embolic System (Onyx HD-500) (Covidien/ev3 Neurovascular) via the transarterial endovascular route while the giant arachnoid cyst was managed conservatively.

Outcomes:

The torticollis resolved 2 days after the procedure. He is currently well with no neurologic deficit.

Lessons:

We advocate that in cases of PAVF with accompanying cyst, the cyst should be managed conservatively if it is not associated with intracranial hemorrhage or focal neurologic deficit.
Budesonide versus systemic corticosteroids in IgA Nephropathy
Authors: Ismail Gener , Obrişcă Bogdan , Jurubiţă Roxana , Andronesi Andreea , Sorohan Bogdan , Vornicu Alexandra , Sinescu Ioanel , Hârza Mihai
Published: June 2020

IgA Nephropathy (IgAN) is characterized by mesangial deposition of dominant, polymeric, galactose-deficient IgA1 molecules of gut-associated lymphoid tissue origin. We sought to evaluate the efficacy of targeting the mucosal immune system dysregulation underlying IgAN pathogenesis with a pH-modified formulation of budesonide with a maximum release of active compound in the distal ileum and proximal colon.

We did a retrospective study evaluating the efficacy of budesonide (Budenofalk) in the treatment of IgAN. From a retrospective cohort of 143 patients with IgAN followed in our department we identified 21 patients that received treatment with budesonide. These patients received budesonide at a dose of 9 mg/d in the first 12 months, followed by a dose reduction to 3 mg/d for the subsequent period. Only patients that received a 24-month treatment with budesonide were included in the analysis (n = 18). We matched the budesonide-treated cohort to 18 patients with IgAN treated with systemic steroids from the same retrospective cohort. Efficacy was measured as change in proteinuria, hematuria and estimated glomerular filtration rate over a 24-month period.

Treatment with budesonide was associated with a 24-month renal function decline of -0.22 (95%CI, -8.2 to 7.8) ml/min/1.73m2, compared to -5.89 (95%CI, -12.2 to 0.4) ml/min/1.73m2 in the corticosteroid treatment group (p = 0.44, for between group difference). The median reduction in proteinuria at 24-month was 45% (interquartile range [IQR]: -79%; -22%) in the budesonide group and 11% (IQR: -39%; 43%) in the corticosteroid group, respectively (P = .009, for between group difference). The median reduction in hematuria at 24-month was 72% (IQR: -90%; -45%) in the budesonide group and 73% (IQR: -85%; 18%) in the corticosteroid group, respectively (P = .22, for between group difference). Treatment with budesonide was well tolerated with minimal side effects.

Budesonide (Budenofalk) was effective in the treatment of patients with IgAN at high-risk of progression in terms of reducing proteinuria, hematuria and preserving renal function over 24 months of therapy.
Effectiveness and safety of endoscopic treatment for duodenal variceal bleeding: a systematic review
Authors: Yipeng Wan , Cong Liu , Sizhe Wan , Chenkai Huang , Anjiang Wang , Xuan Zhu
Published: June 2020

Duodenal varix is a rare condition that involves massive bleeding, diagnostic difficulties, and a high rate of rebleeding and mortality. The purpose of this study was to systematically review endoscopic treatment for duodenal variceal bleeding to evaluate its effectiveness and safety. We searched PubMed, Embase, Web of Science, and the Cochrane Library up to 21 November 2019. Ninety-two studies containing 156 patients were finally included, and individual data from 101 patients (mean age: 52.67 ± 13.82 years, male: 64.4%) were collected and further analyzed. We used an analysis of variance and χ
2 or Fisher’s exact tests to analyze individual data from 101 patients. The cause of duodenal variceal bleeding was cirrhosis-related intrahepatic portal hypertension (IPH) in 76.2% of patients. The overall rates of initial hemostasis and treatment success of endoscopic treatment for duodenal variceal bleeding were 89.1 and 81.2%, respectively. The median duration of follow-up was 4.5 (1.0, 12.0) months. The overall rates of rebleeding and mortality were 8.9 and 13.9%, respectively. Among a variety of endoscopic treatments available, only the initial hemostasis rate was significantly different between the endoscopic injection sclerotherapy and endoscopic tissue adhesive (ETA) groups (72.7 vs. 94.7%, P = 0.023); differences in treatment success, rebleeding, mortality, and adverse events were not statistically significant among the four groups. Endoscopic intervention is a feasible, well tolerated, and effective modality for the treatment of duodenal variceal bleeding. Among the variety of endoscopic treatments available, ETA with cyanoacrylate may be preferable for duodenal variceal bleeding.
Liver cirrhosis affects serum lactate level measurement while assessing disease severity in patients with sepsis
Authors: Cheng Chi-Yung , Kung Chia-Te , Wu Kuan-Han , Chen Fu-Cheng , Cheng Hsien-Hung , Cheng Fu-Jen , Huang Jyun-Bin , Su Chih-Min
Published: June 2020

Background

Elevated serum lactate is associated with higher mortality in sepsis, whereas liver dysfunction is associated with higher serum lactate levels. We assessed the predictive ability of serum lactate in patients with liver cirrhosis and sepsis.

Methods

This retrospective study included 12 281 cases of suspected infection with initial serum blood lactate drawn during January 2007–December 2013.

Results

Using one-to-two propensity score matching analysis, 1053 and 2106 septic patients with and without underlying liver cirrhosis, respectively, were successfully matched. Lactate levels of survivors and nonsurvivors were 2.58 and 5.93 mmol/L, respectively, in patients without liver cirrhosis (WLC), 2.96 and 7.29 mmol/L, respectively, in patients with nondecompensated liver cirrhosis (NDLC), and 4.08 and 7.16 mmol/L, respectively, in patients with decompensated liver cirrhosis (DLC). In receiver operating characteristic curve analysis, the sensitivity and specificity for predicting mortality were 0.81 and 0.55, respectively, in the WLC group, 0.85 and 0.45, respectively, in the NDLC group, and 0.86 and 0.33, respectively, in the DLC group, using serum lactate levels >2.0 mmol/L.

Conclusions

The serum lactate level can be used to predict the severity of sepsis in patients with liver cirrhosis; however, its specificity would be lower at a cutoff of 2.0 mmol/L.
Symptom Profiles of Latina Breast Cancer Survivors
Authors: Crane Tracy E. , Badger Terry A. , Sikorskii Alla , Segrin Chris , Hsu Chiu-Hsieh , Rosenfeld Anne G.
Published: June 2020

Background

Symptom research among Latinas with breast cancer is limited—especially as it relates to multiple co-occurring symptoms.

Objective

The aim of the study was to identify subgroups (latent classes) of Latinas who have distinct symptom profiles while receiving radiation, chemotherapy, and/or hormonal therapy for breast cancer.

Methods

This secondary analysis included intake data from three randomized trials of supportive care psychosocial interventions for Latinas treated for breast cancer (n = 290). Prevalence of 12 symptoms—measured using the General Symptom Distress Scale—was entered into the latent class analysis to identify classes of women with different symptom profiles.

Results

Most of the participants had Stage II or III disease, and 81% reported receiving chemotherapy. On average, women reported 4.2 (standard deviation [SD] = 3) symptoms with an overall symptom distress score of 6.4 (SD = 2.5) on a 1–10 scale, with 10 being most distressing. Latent class analysis resulted in three classes that were labeled based on symptoms with the highest prevalence. Class 1 (n = 192) was “Disrupted Sleep and Tired,” Class 2 (n = 74) was “Tired,” and Class 3 (n = 24) was “Pain, Disrupted Sleep, and Tired.” Depression, anxiety, and difficulty concentrating had moderate prevalence in each of the three classes.

Discussion

Beyond the core six symptoms (depression, anxiety, fatigue, pain, disrupted sleep, difficulty concentration), the classes differed in the prevalence of other burdensome symptoms (e.g., nausea, vomiting, constipation), which provide implications for treatment. Thus, it is important to assess for the full range of symptoms so that supportive care interventions can be tailored for the distinct symptom profiles of Latinas with breast cancer.
Risk Factors for Peri-intubation Cardiac Arrest in a Pediatric Emergency Department
Authors: Pokrajac Nicholas , Sbiroli Emily , Hollenbach Kathryn A. , Kohn Michael A. , Contreras Edwin , Murray Matthew
Published: June 2020

Objectives

Cardiac arrest is a significant complication of emergent endotracheal intubation (ETI) within the pediatric population. No studies have evaluated risk factors for peri-intubation cardiac arrest (PICA) in a pediatric emergency department (ED) setting. This study identified risk factors for PICA among patients undergoing emergent ETI in a pediatric ED.

Methods

We performed a nested case-control study within the cohort of children who underwent emergent ETI in our pediatric ED during a 9-year period. Cases were children with PICA within 20 minutes of ETI. Controls (4 per case) were randomly selected children without PICA after ETI. We analyzed potential risk factors based on published data and physiologic plausibility and created a simple risk model using univariate results, model fit statistics, and clinical judgment.

Results

In the cohort of patients undergoing ETI, PICA occurred in 21 of 543 subjects (3.9%; 95% confidence interval [CI], 2.2–5.9%), with return of spontaneous circulation in 16 of 21 (76.2%; 95% CI, 52.8–91.8%) and survival to discharge in 12 of 21 (57.1%; 95% CI, 34.0–78.2%). On univariate analysis, cases were more likely to be younger, have delayed capillary refill time, systolic or diastolic hypotension, hypoxia, greater than one intubation attempt, no sedative or paralytic used, and pulmonary disease compared with controls. Our 4-category risk model for PICA combined preintubation hypoxia (or an unobtainable pulse oximetry value) and younger than 1 year. The area under the receiver operating characteristic curve for this model was 0.87 (95% CI, 0.77–0.97).

Conclusions

Hypoxia (or an unobtainable pulse oximetry value) was the strongest predictor for PICA among children after emergent ETI in our sample. A simple risk model combining pre-ETI hypoxia and younger than 1 year showed excellent discrimination in this sample. Our results require independent validation.
HIV-exposed uninfected infant morbidity and mortality within a nationally representative prospective cohort of mother-infant pairs in Zimbabwe
Authors: Patel Monita R. , Mushavi Angela , Balachandra Shirish , Shambira Gerald , Nyakura Justice , Mugurungi Owen , Kilmarx Peter H. , Rivadeneira Emilia , Dinh Thu-Ha
Published: June 2020

Objective:

To examine morbidity and mortality risk among HIV-exposed uninfected (HEU) infants.

Design:

Secondary data analysis of HEU infants in a prospective cohort study of mother-infant pairs.

Methods:

Infants were recruited from immunization clinics (n = 151) in Zimbabwe from February to August 2013, enrolled at 4–12 weeks age, and followed every 3 months until incident HIV-infection, death, or 18-month follow-up. We estimated cumulative mortality probability and hazard ratios with 95% confidence intervals (CIs) using Kaplan–Meier curves and Cox regression, respectively. We also described reported reasons for infant hospitalization and symptoms preceding death. Median weight-for-age z-scores (WAZ) and median age were calculated and analyzed across study visits.

Results:

Of 1188 HIV-exposed infants, 73 (6.1%) contracted HIV; we analyzed the remaining 1115 HEU infants. In total, 54 (4.8%) infants died, with median time to death of 5.5 months since birth (interquartile range: 3.6–9.8 months). Diarrhea, difficulty breathing, not eating, fever, and cough were commonly reported (range: 7.4–22.2%) as symptoms preceding infant death. Low birth weight was associated with higher mortality (adjusted hazard ratio 2.66, CI: 1.35–5.25), whereas maternal antiretroviral therapy predelivery (adjusted hazard ratio 0.34, CI: 0.18–0.64) and exclusive breastfeeding (adjusted hazard ratio 0.50, CI: 0.28–0.91) were associated with lower mortality. Overall, 9.6% of infants were hospitalized. Infant median WAZ declined after 3 months of age, reaching a minimum at 14.5 months of age, at which 50% of infants were underweight (WAZ below −2.0).

Conclusion:

Clinical interventions including maternal antiretroviral therapy; breastfeeding and infant feeding counseling and support; and early prevention, identification, and management of childhood illness; are needed to reduce HEU infant morbidity and mortality.
Perceived Roles of Bhutanese Health Care Professionals in Improving Patient Safety: A Qualitative Exploratory Descriptive Study
Authors: Pelzang Rinchen , Hutchinson Alison M.
Published: June 2020

Background and Objectives:

Patient safety is a vital component of high quality health care and all health care professionals have a responsibility for ensuring the delivery of safe care to patients. However, little is known about how Bhutanese health care professionals perceive their roles in improving patient safety. This study aimed to explore how Bhutanese health care professionals, educators, managers, and policy makers perceived their roles in improving patient safety.

Methods:

Undertaken as a naturalistic inquiry using a qualitative exploratory descriptive research approach, a criterion-based stratified purposive sample of 94 health care professionals and managers from the Ministry of Health, a training institute, and 3 levels of hospitals were interviewed. All interview data were analyzed using content and thematic analysis strategies.

Results:

Data analysis identified 4 broad themes. Health care professionals' perceived role in safety and quality included formulating and implementing patient safety rules; management and administration of units and hospitals; patient assessment and management; and setting professional norms (including norms about peer influence and patient care/interaction).

Conclusion:

The findings revealed that Bhutanese health care professionals were aware of their roles in improving patient safety processes and practices, and providing interprofessional education or training to all levels of health care professionals could help improve communication and patient safety in the Bhutanese health care system.