bluuebunny/crossref_metadata_2025 huggingface dataset:
Masked morning hypertension correlated with target organ damage in non-dialysis patients with chronic kidney disease
Authors: Li Xue , Lian Rongli , Zhu Ye , Ke Jianting , Li Man , Wang Cheng , Lou Tanqi
Published: July 2020

Objective:

To determine the prevalence of masked morning hypertension and investigate its role in target organ damage in nondialysis patients with chronic kidney disease.

Methods:

A total of 1841 patients with chronic kidney disease admitted to our hospital were recruited. According to measurements of clinic blood pressure and ambulatory blood pressure, they were divided into four groups: normotension, white-coat hypertension, masked morning hypertension, and sustained hypertension. Multivariate logistic regression analyses were used to evaluate the association between masked morning hypertension and cardiovascular and renal parameters.

Results:

Overall, 288 (15.6%) patients were diagnosed with masked morning hypertension. Patients with masked morning hypertension had a higher prevalence of left ventricular hypertrophy, abnormal carotid intima–media thickness, and impaired renal function when compared with normotensive patients, although lower than those with sustained hypertension. After adjustment for demographics and clinical characteristics, masked morning hypertension was related to cardiovascular damage and renal dysfunction compared with normotension. The odds ratio for left ventricular hypertrophy, abnormal carotid intima–media thickness and impaired renal function was 1.955 [95% confidence interval (CI), 1.247–3.065], 1.469 (95% CI: 1.011–2.133), and 1.819 (95% CI: 1.112–2.976), respectively. Masked morning hypertension correlated with target organ damage even when patients with a history of cardiovascular disease were excluded.

Conclusion:

The prevalence of masked morning hypertension in nondialysis chronic kidney disease patients was high, and masked morning hypertension was associated with target organ damage in chronic kidney disease patients.
Central SBP and executive function in children and adolescents with primary and secondary hypertension
Authors: Stabouli Stella , Chrysaidou Katerina , Kotsis Vasilios , Chainoglou Nancy , Chatzipapa Nikoleta , Gidaris Dimos , Zafeiriou Dimitrios
Published: July 2020

Objectives:

The aims of the study were to assess executive function performance in children and adolescents with primary and secondary hypertension, and to investigate for associations with central SBP and ambulatory blood pressure.

Methods:

Forty-six pediatric patients with secondary hypertension because of kidney diseases and 46 patients with primary hypertension underwent ambulatory blood pressure monitoring, pulse wave analysis, and assessment of executive function using Behavior Rating Inventory of Executive Function. Results for comparisons are presented as mean (SD). Analysis of covariance was performed to examine the effect of blood pressure parameters and hypertension cause.

Results:

Patients with secondary hypertension had higher T scores in parent and self-reported Metacognition Indices compared with those with primary hypertension (51.2 ± 8.9 vs. 47.6 ± 7.5, P = 0.05 and 49.6 ± 9.1 vs. 42.1 ± 7.9, P = 0.001, respectively), but did not differ in Behavior Regulation Index T scores, as well as in mean arterial pressure z-score. Patients with secondary hypertension had higher central SBP z-scores (P = 0.05). Adjustment for central SBP attenuated differences in parent Metacognition Index between groups. Central SBP z-score associated with parent Metacognition (B = 0.95, 95% CI 0.02–1.87), Behavior Regulation (B = 1.14, 95% CI 0.07–2.21), and self-reported Metacognition Indices T scores (B = 1.48, 95% CI 0.39–2.56), independent of mean arterial pressure z-score, age, sex, socioeconomic status, hypertension cause, and antihypertensive treatment.

Conclusion:

Central SBP associates with executive function performance in youth with hypertension and could have complementary role to ambulatory blood pressure for identifying children at risk for adverse cognitive outcomes.
Predictive value of admission blood pressure for 3-month mortality in patients undergoing revascularization for critical limb ischemia
Authors: Yannoutsos Alexandra , Lin Franck , Billuart Olivier , Gaisset Roxane , Sacco Emmanuelle , Beaussier Hélène , Buronfosse Anne , Mourad Jean-Jacques , Emmerich Joseph , Lazareth Isabelle , Priollet Pascal
Published: July 2020

Objective:

In patients with critical limb ischemia (CLI), blood pressure (BP) impact on mortality is unknown. We analyzed the predictive value of SBP, DBP and pulse pressure (PP) at hospital admission on 3-month mortality in patients with CLI undergoing revascularization procedure.

Methods:

From November 2013 to December 2018, 297 consecutive patients were retrospectively included. Admission BP was recorded using automated brachial sphygmomanometer, before revascularization procedure. A median of seven (IQR3–13) separate readings were recorded for each patient and the average represented patient's mean BP (mBP). Clinical and biological parameters were recorded at baseline.

Results:

The cohort included 163 men (55%) and 134 women (45%) with a mean age of 77.7 ± 11.9 years. Treated hypertension and diabetes were present in, respectively, 62 and 48% of patients. Mean SBP, DBP and PP were 132 ± 18, 70 ± 8 and 62 ± 16 mmHg. Thirty-four patients (11.4%) died during 3-month follow-up, mostly from cardiovascular causes. In univariate analysis, age, female sex, brain natriuretic peptide and C-reactive protein were positively correlated with mortality. BMI, mSBP, mDBP, mPP, hemoglobin, serum albumin and statin treatment were negatively correlated with mortality. In single-pressure multivariate analyses, mSBP (P = 0.024) and mPP (P = 0.030) were negatively correlated with mortality. Association between mSBP and mortality had an asymptotic curve pattern and SBP level 135 mmHg or less was significantly correlated with mortality.

Conclusion:

In patients undergoing revascularization for CLI, admission SBP is an independent predictor for short-term mortality with a negative relationship. SBP level 135 mmHg or less represents a warning sign to explore and correct associated comorbidities.
Home device-monitored sleep blood pressure reflects large artery stiffness: the Nagahama study
Authors: Tabara Yasuharu , Matsumoto Takeshi , Murase Kimihiko , Setoh Kazuya , Kawaguchi Takahisa , Kosugi Shinji , Nakayama Takeo , Hirai Toyohiro , Wakamura Tomoko , Chin Kazuo , Matsuda Fumihiko
Published: July 2020

Background:

High sleep blood pressure (BP) has been suggested to be an independent risk factor for cardiovascular outcomes. To assess the applicability of sleep BP measured using a timer-equipped home device, we investigated the association between home device-measured sleep BP and large artery stiffness.

Methods:

We performed a cross-sectional analysis of a dataset from the Nagahama study (N = 5916), a general population-based cohort study. Home morning BP and sleep BP were measured using a timer-equipped cuff-oscillometric device (HEM-7080IC). Office BP, carotid intima--media thickness (IMT), and brachial--ankle pulse wave velocity (baPWV) were measured at the follow-up investigation of the Nagahama study.

Results:

Sleep hypertension (SBP ≥120 mmHg and/or DBP ≥70 mmHg) was associated with the arterial parameters (IMT: β = 0.051, baPWV: β = 0.141, both P < 0.001) independently of morning hypertension (IMT: β = 0.093, baPWV: β = 0.216, both P < 0.001) irrespective of antihypertensive medication status. Individuals exhibiting isolated sleep hypertension (N = 801) had thicker IMT (0.69 ± 0.14 vs. 0.64 ± 0.13 mm, P = 0.017) and faster baPWV (1,299 ± 197 vs. 1,183 ± 178 cm/s, P < 0.001) than normotensives. A sleep SBP at least 110 mmHg and a sleep DBP at least 65 mmHg were identified as the lower threshold BP values for the association with arterial parameters.

Conclusion:

Sleep BP measurement using a home device may be a simple way to assess cardiovascular risks overlooked by office and home morning BP measurements.
The anti-inflammatory effect of resistance training in hypertensive women: the role of purinergic signaling
Authors: Lammers Mônica D. , Anéli Nyasmin M. , de Oliveira Gabriela G. , de Oliveira Maciel Sarah F.V. , Zanini Daniela , Mânica Aline , de Resende e Silva Débora T. , Bagatini Margarete D. , Sévigny Jean , De Sá Clodoaldo A. , Manfredi Leandro H. , Cardoso Andréia M.
Published: July 2020

Background and methods:

Essential arterial hypertension triggers a chronic inflammatory process that seems to be linked to purinergic signaling. Physical exercise exhibit anti-inflammatory properties and is able to modulates purinergic system. The aim of this study was to evaluate the effect of 6 months of resistance training on inflammatory markers, purinergic system components, hemodynamic and anthropometric parameters in hypertensive woman.

Methods:

A total of 31 hypertensive group and 28 normotensive (control group) middle-aged sedentary women were submitted to 6 months of resistance training. All measurements and blood collection were carried out before (pretest), after 3 months and after 6 months (posttest) of training. Purinergic enzymes [nucleoside triphosphate diphosphohydrolase (NTPDase) and adenosine deaminase] were assessed in lymphocytes; IL-6, IL-10, ATP and C-reactive protein levels were measured in serum.

Results:

Six months of resistance training was able to significantly reduce blood pressure (BP), IL-6, C-reactive protein, ATP levels as well as NTPDase and adenosine deaminase activities in hypertensive group. Physical training was also able to increase IL-10 levels in hypertensive group. A positive correlation was found between BP, enzyme activities and levels of ATP and IL-6. A negative correlation was found between BP and IL-10. Positive correlation was found between NTPDase and IL-6 levels (P < 0.05) as well as ATP levels and IL-6 levels.

Conclusion:

Our findings demonstrated the relationship between purinergic signaling and inflammation in hypertension and suggests that resistance training serve as tool to reduce inflammation in hypertensive woman by modulating purinergic system.
HUMAN AMNIOTIC MEMBRANE TO TREAT MACULAR HOLES THAT FAILED TO CLOSE, SULFUR HEXAFLUORIDE ENDOTAMPONADE VERSUS AIR ENDOTAMPONADE
Authors: Caporossi Tomaso , Tartaro Ruggero , Finocchio Lucia , Pacini Bianca , De Angelis Lorenzo , Bacherini Daniela , Rizzo Stanislao
Published: July 2020

Background/Purpose:

To determinate the efficacy of the human amniotic membrane plugs with sulfur hexafluoride versus human amniotic membrane plug with air as endotamponade to treat macular holes that failed to close after vitrectomy plus internal limiting membrane peeling. Multimodal imaging was focused to evaluate preoperative features and postoperative changes.

Methods:

Prospective interventional comparative study. Twenty eyes of 20 patients affected with macular hole that failed to close were divided into 2 groups: 10 eyes received an amniotic membrane plug with 20% sulfur hexafluoride tamponade and 10 eyes received an amniotic membrane plug with air tamponade. All eyes were studied using multimodal advanced diagnostic tools, such as spectral-domain optical coherence tomography, optical coherence tomography angiography, microperimetry, and adaptive optics to investigate the postoperative results.

Results:

In both groups, all macular holes were found successfully closed after 12 months. Mean preoperative best-corrected visual acuity was 20/400 in the SF6 group and 20/250 in air group. Final mean best-corrected visual acuity was 20/63 in both groups. The superficial capillary plexus, studied using optical coherence tomography angiography, showed a statistically significant difference between the treated and the fellow eyes. Adaptive optics images revealed the presence of a photoreceptor cell mosaic in the area of the amniotic membrane plug.

Conclusion:

The human amniotic membrane combined with air endotamponade demonstrated its effectiveness to seal macular holes that failed to close after vitrectomy plus internal limiting membrane peeling. Advanced multimodal diagnostic imaging helped us to better understand the modifications associated with the use of the amniotic membrane in these cases.
A Case of Annular Iris Cyst Diagnosed With the Help of Ultrasound Biomicroscopy
Authors: Segi Ashwin , Maheshwari Devendra , Dabke Shylesh , Rao Sanjana , Kadar Mohideen A. , Rengappa Ramakrishna
Published: July 2020

Purpose:

To report a case of annular iris cyst presenting as a secondary angle closure managed with Nd:YAG laser iridotomy.

Design:

Case report.

Methods:

Institutional review board exemption for this case report was obtained from the institutional ethics committee, Aravind eye hospital, Tirunelveli. All research adhered to the tenets of the Declaration of Helsinki. Informed consent was obtained.

A 45-year-old woman presented with a 2-week history of sudden onset of pain and redness in the right eye. Slit-lamp biomicroscopy showed corneal edema, with the shallow anterior chamber, convex bowing of iris, irregular shape of the pupil, and glaucomflecken on the clear lens. Ultrasound biomicroscopy revealed an annular iris cyst of the iris pigment epithelium. Nd:YAG laser iridotomy was done to drain the cyst and relieve the angle closure.

Results:

Laser treatment resulted in the collapse of the cyst, confirmed by ultrasound biomicroscopy and disappearance of the subject symptoms.

Conclusion:

Iris cysts are usually benign in nature. An annular iris cyst is a rare presentation. They can present with a secondary angle closure as in our report. Correct diagnosis and timely intervention bring about a desirable result. With this report, the authors aim to catalog and familiarize ophthalmologists with a rare ocular pathology and its management.
COVID-19 and cataract surgery backlog in Medicare beneficiaries
Authors: Aggarwal Shruti , Jain Punya , Jain Amit
Published: July 2020

Purpose:

To forecast the volume of cataract surgery in Medicare beneficiaries in the United States in 2020 and to estimate the surgical backlog that may be created due to COVID-19.

Setting:

Medicare Beneficiaries, United States.

Design:

Epidemiologic modeling.

Methods:

Baseline trends in cataract surgery among Medicare beneficiaries were assessed by querying the Medicare Part B Provider Utilization National Summary data. It was assumed that once the surgical deferment is over, there will be a ramp-up period; this was modeled using a stochastic Monte Carlo simulation. Total surgical backlog 2 years postsuspension was estimated. Sensitivity analyses were used to test model assumptions.

Results:

Assuming cataract surgeries were to resume in May 2020, it would take 4 months under an optimistic scenario to revert to 90% of the expected pre-COVID forecasted volume. At 2-year postsuspension, the resulting backlog would be between 1.1 and 1.6 million cases. Sensitivity analyses revealed that a substantial surgical backlog would remain despite potentially lower surgical demand in the future.

Conclusions:

Suspension of elective cataract surgical care during the COVID-19 surge might have a lasting impact on ophthalmology and will likely result in a cataract surgical patient backlog. These data may aid physicians, payers, and policymakers in planning for postpandemic recovery.
Machine learning suggests sleep as a core factor in chronic pain
Authors: Miettinen Teemu , Mäntyselkä Pekka , Hagelberg Nora , Mustola Seppo , Kalso Eija , Lötsch Jörn
Published: July 2020

Patients with chronic pain have complex pain profiles and associated problems. Subgroup analysis can help identify key problems. We used a data-based approach to define pain phenotypes and their most relevant associated problems in 320 patients undergoing tertiary pain management. Unsupervised machine learning analysis of parameters “pain intensity,” “number of pain areas,” “pain duration,” “activity pain interference,” and “affective pain interference,” implemented as emergent self-organizing maps, identified 3 patient phenotype clusters. Supervised analyses, implemented as different types of decision rules, identified “affective pain interference” and the “number of pain areas” as most relevant for cluster assignment. These appeared 698 and 637 times, respectively, in 1000 cross-validation runs among the most relevant characteristics in an item categorization approach in a computed ABC analysis. Cluster assignment was achieved with a median balanced accuracy of 79.9%, a sensitivity of 74.1%, and a specificity of 87.7%. In addition, among 59 demographic, pain etiology, comorbidity, lifestyle, psychological, and treatment-related variables, sleep problems appeared 638 and 439 times among the most important characteristics in 1000 cross-validation runs where patients were assigned to the 2 extreme pain phenotype clusters. Also important were the parameters “fear of pain,” “self-rated poor health,” and “systolic blood pressure.” Decision trees trained with this information assigned patients to the extreme pain phenotype with an accuracy of 67%. Machine learning suggested sleep problems as key factors in the most difficult pain presentations, therefore deserving priority in the treatment of chronic pain.
Peripherally inserted central catheter versus central venous catheter for intravenous access
Authors: Santos Felipe Kenzo Yadoya , Flumignan Ronald Luiz Gomes , Areias Libnah Leal , Sarpe Anna Karina Paiva , Amaral Fabio Cabral Freitas , Ávila Rafael Bernardes de , Vasconcelos Vladimir Tonello de , Guedes Neto Henrique Jorge , Amorim Jorge Eduardo de , Nakano Luis Carlos Uta
Published: July 2020

Background:

Since the first description of the central venous catheter (CVC) in 1952, it has been used for the rapid administration of drugs, chemotherapy, as a route for nutritional support, blood components, monitoring patients, or combinations of these. When CVC is used in the traditional routes (eg, subclavian, jugular, and femoral veins), the complication rates range up to 15% and are mainly due to mechanical dysfunction, infection, and thrombosis. The peripherally inserted central catheter (PICC) is an alternative option for CVC access. However, the clinical evidence for PICC compared to CVC is still under discussion. In this setting, this systematic review (SR) aims to assess the effects of PICC compared to CVC for intravenous access.

Methods:

We will perform a comprehensive search for randomised controlled trials (RCTs), which compare PICC and traditional CVC for intravenous access. The search strategy will consider free text terms and controlled vocabulary (eg, MeSH and Entree) related to “peripherally inserted central venous catheter,” “central venous access,” “central venous catheter,” “catheterisation, peripheral,” “vascular access devices,” “infusions, intravenous,” “administration, intravenous,” and “injections, intravenous.” Searches will be carried out in these databases: MEDLINE (via PubMed), EMBASE (via Elsevier), Cochrane CENTRAL (via Wiley), IBECS, and LILACS (both via Virtual Health Library). We will consider catheter-related deep venous thrombosis and overall successful insertion rates as primary outcomes and haematoma, venous thromboembolism, reintervention derived from catheter dysfunction, catheter-related infections, and quality of life as secondary outcomes. Where results are not appropriate for a meta-analysis using RevMan 5 software (eg, if the data have considerable heterogeneity and are drawn from different comparisons), a descriptive analysis will be performed.

Results:

Our SR will be conducted according to the Cochrane Handbook of Systematic Reviews of Interventions and the findings will be reported in compliance with PRISMA.

Conclusion:

Our study will provide evidence for the effects of PICC versus CVC for venous access.

Ethics and dissemination:

This SR has obtained formal ethical approval and was prospectively registered in Open Science Framework. The findings of this SR will be disseminated through peer-reviewed publications or conference presentations.

Registration:

osf.io/xvhzf.

Ethical approval:

69003717.2.0000.5505.
Randomized, double-blind, placebo-controlled, parallel-group trial of sirolimus for tocilizumab-resistant idiopathic multicentric Castleman disease
Authors: Koga Tomohiro , Hagimori Naoko , Takemori Sachiko , Morimoto Shimpei , Sumiyoshi Remi , Shimizu Toshimasa , Hosogaya Naoki , Fukushima Chizu , Yamamoto Hiroshi , Kawakami Atsushi
Published: July 2020

Background:

Idiopathic multicentric Castleman disease (iMCD) is a rare lymphoproliferative disorder of unknown etiology with systemic symptoms that include fever, night sweats, weight loss, and fatigue. Although tocilizumab (TCZ), which is a recombinant, humanized, anti-human interleukin 6 receptor monoclonal antibody, has been recommended to treat patients with iMCD, 40% of patients with iMCD do not achieve complete remission with TCZ treatment.

Methods/Design:

In this phase II, investigator-initiated, multicenter, double-blind, randomized, parallel-group trial, the efficacy and safety of sirolimus will be compared with placebo in patients with TCZ-resistant iMCD. The study will be conducted in 8 centers in Japan. Participants (n = 20) will be randomly assigned to receive 2 mg of oral sirolimus (n = 10) or placebo (n = 10) once daily for 16 weeks. The primary endpoint is a decrease in CHAP score by ≥1 from baseline at 16 weeks. Secondary endpoints include levels of hemoglobin, albumin, and C-reactive protein; change in CHAP score; SF-36 Health Survey Questionnaire; physician global assessment (100 mm visual analog scale); patient global assessment (100 mm visual analog scale) at 2, 4, 8, 12, and 16 weeks; change in lymphadenopathy at 16 weeks; and pharmacodynamic assessment, including the measurement of whole blood sirolimus level.

Discussion:

This clinical trial will provide evidence of efficacy and safety of sirolimus as a potential new therapeutic agent for patients with TCZ-resistant iMCD.

Trial Registration:

This study was registered with the Japan Registry of Clinical Trials as jRCT2071190029 on October 8, 2019.
Diagnostic value of a spiral breast computed tomography system equipped with photon counting detector technology in patients with implants
Authors: Ruby Lisa , Shim Sojin , Berger Nicole , Marcon Magda , Frauenfelder Thomas , Boss Andreas
Published: July 2020

To evaluate the value of a breast computed tomography (CT) (B-CT) in assessing breast density, pathologies and implant integrity in women with breast implants.

This retrospective study was approved by the local ethics committee. B-CT images of 21 women with implants (silicone/saline; 20 bilateral, 1 unilateral) who underwent opportunistic screening or diagnostic bilateral B-CT were included. Breast density, implant integrity, extensive capsular fibrosis, soft tissue lesions and micro-/macrocalcifications were rated. In 18 of the 21 women, an additional ultrasound and in two patients breast magnetic resonance imaging was available for comparison. The average dose was calculated for each breast using verified Monte Carlo simulations on 3D image data sets.

Breast density was nearly completely fatty (ACR a) in two patients, scattered fibroglandular (ACR b) in five, heterogeneously dense (ACR c) in ten and very dense (ACR d) in four women. In three women showed a unilateral positive Linguine sign indicative of an inner capsule rupture. Extensive capsular fibrosis was found in three women. In three women, soft tissue lesions were depicted, which revealed to be cysts (n = 2) and lymph nodes (n = 1) on subsequent sonography. Diffuse, non-clustered microcalcifications were found in nine women. Eleven women showed cutaneous or intramammary macrocalcifications. Average dose was 6.45 mGy (range 5.81–7.28 mGy).

In women with implants, B-CT presents a promising modality for evaluating breast density, implant integrity, extensive capsular fibrosis, soft tissue lesions and micro-/macrocalcifications without the need of breast compression utilizing a lower dose compared to doses reported for conventional four-view mammography.
The effect of a video-guided educational technology intervention on the academic self-concept of adolescent students with hearing impairment
Authors: Asogwa Uche D. , Ofoegbu Theresa O. , Eseadi Chiedu , Ogbonna Chimaobi Samuel , Eskay Michael , Nji Godfrey C. , Ngwoke Oliver Rotachukwu , Nwosumba Victor Chijioke , Onah Benardine Ifeoma
Published: July 2020

Background/Objective:

Academic self-concept is an important construct within the disciplines of medicine, psychology, and education. Enhancing the academic self-concept of students with special educational needs is very crucial because it is associated with their quality of life. This study aimed to examine the effect of a video-guided educational technology intervention on the academic self-concept of adolescents with hearing impairment who were attending inclusive nonresidential public schools in Southeast Nigeria.

Methods:

This study adopted a randomized controlled trial design. The participants were 60 junior secondary students with hearing impairment. We implemented a video-guided educational technology intervention. It relied on the use of 13-minute video clips with captions/subtitles, which covered academic self-concept-related themes. The Academic Self-Concept Questionnaire, which has been developed by Liu and Wang, was used to collect baseline, posttreatment, and follow-up data. We conducted independent-samples and paired t test and computed Cohen d and Glass Δ to analyze the data.

Results:

The video-guided educational technology intervention significantly improved the academic self-concept of the treatment group participants, when compared with the care-as-usual control group participants, t(58) = 9.07, P < .001. These improvements in academic self-concept were sustained at follow up among the treatment group participants, when compared with the care-as-usual control group participants, t(48.56) = 10.898, P < .001. Within-subjects comparisons showed that the academic self-concept of the treatment group participants had significantly improved across the different time points at which they were assessed.

Conclusion:

The video-guided educational technology intervention was effective in improving the academic self-concept of adolescents with hearing impairment who were attending inclusive nonresidential public schools. Large-scale studies are needed to maximize the impact of video-guided educational technology interventions on students with hearing impairments who attend inclusive non residential public schools in Nigeria.
Chinese Herbs Medicine Huatan Huoxue Prescription for obstructive sleep apnea hypopnea syndrome as complementary therapy
Authors: Zhou Min , Liang Qijun , Pei QiuLan , Xu Fan , Wen Hang
Published: July 2020

Objective:

The aim of this systematic review and meta-analysis is to assess effectiveness and safety of Chinese Herbs Medicine Huatan Huoxue Prescription (HTHXP) as complementary therapy in treating bronchiectasis.

Methods:

The following databases will be searched: Embase, Cochrane, PubMed, China National Knowledge Infrastructure, Wan Fang, and VIP database from their inception to April 1, 2020. We performed and completed meta-analysis and methodologic evaluation by Review Manager 5.3.3 and statas 12.0 software. Study selection, data extraction, quality assessment, and assessment of risk bias will be performed by 2 reviewers independently. Odds ratios and correlative 95% confidence intervals will be calculated to present the association between the HTHXP and western medicine treatment using Review Manager version 5.3 when there is sufficient available data.

Results:

The results will be disseminated through a peer-reviewed journal publication.

Conclusion:

These systematic review findings will summarize up-to-date evidence for that HTHXP is more effective and safe as adjunctive treatment for patients with bronchiectasis.

Ethics and dissemination:

Ethics approval and patient consent are not required as this study is a systematic review based on published articles.

PROSPERO registration number:

INPLASY202050079.
Efficacy of alendronate for the treatment of ankylosing spondylitis
Authors: Tang Hua-yu , Li Yu-zhi , Tang Zhao-chen , Jiang Quan-wei , Zhao Yu
Published: July 2020

Background:

Ankylosing spondylitis (AS) is a very tricky orthopedic disorder. If such condition cannot be managed fairly well, it may significantly affect quality of life and even leads to disability among such population. A variety of studies have reported that alendronate is utilized for the treatment of AS. However, their results are still contrary, and no systematic review has addressed on this topic. Thus, this study will systematically assess the efficacy and safety of alendronate for the treatment of patients with AS.

Methods:

A comprehensive literature search will be performed from the below electronic databases from their commencement to the January 31, 2020 without language and publication status limitations: PubMed, Embase, Cochrane Library, Web of Science, Allied and Complementary Medicine Database, WANGFANG, and China National Knowledge Infrastructure. Only randomized controlled trials focusing on the alendronate for the treatment of patients with AS will be considered for inclusion in this study. Two authors will independently select all identified records, extract essential data from all included studies, and appraise study quality for each eligible trial using Cochrane risk of bias. If any differences occur, another experienced author will be invited to solve them by discussion and a consensus decision will be made. We will implement RevMan 5.3 software to analyze the extracted data.

Results:

This study will summarize high-quality randomized controlled trials to assess the efficacy and safety of alendronate for the treatment of patients with AS through primary outcome of bone densitometry; and secondary outcomes of pain intensity, quality of life, disease activity, functional status, and adverse events.

Conclusion:

This study will provide evidence to help determine whether alendronate is an effective and safe management for patient with AS or not.

Study registration:

INPLASY202040153.
Distribution of traditional Chinese medicine syndromes in type 2 diabetes mellitus with chronic heart failure
Authors: Wang Hui , Zhang Jun , Shi Chun-fang , Jia Jing , Zhang Zhi-min , Sun Jia-jia , Lu Bing-bing
Published: July 2020

Introduction:

The incidence of type 2 diabetes has been increasing year by year in recent years. Type 2 diabetes is an important risk factor in the occurrence and development of heart failure, and it is the second potential risk factor after coronary artery disease. At present, there is no unified etiology, pathogenesis, and syndrome differentiation criteria for type 2 diabetes with chronic heart failure, and it is susceptible to subjective factors. Therefore, standardized, objective, and standardized research is needed to provide reference and guidance for clinical diagnosis and treatment. In this study, the theory of syndrome differentiation is used to initially explore the distribution of traditional Chinese medicine syndromes in patients with type 2 diabetes and chronic heart failure through case data collection, syndrome extraction, and clinical data analysis.

Methods/design:

In this study, we will collect at least 500 cases of type 2 diabetes with chronic heart failure that meet the standard outpatient and hospitalization, and fill out the case information collection form. Then we will collect a number of clinical diagnosis and treatment information, and judge the syndrome based on the sum of the contribution of each syndrome to the relevant syndrome. We will use Microsoft Excel to establish a database, enter the relevant diagnosis and treatment, and syndrome information of the case information collection table, and verify and correct in time to ensure the accuracy of the data.

Discussion:

This study will provide reference and guidance for the clinical diagnosis and treatment of type 2 diabetes with chronic heart failure.

Trial registration:

ClinicalTrials.gov, ChiCTR2000033010, Registered on May 18, 2020.
Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I)
Authors: Kawashiri Shin-ya , Shimizu Toshimasa , Sato Shuntaro , Morimoto Shimpei , Kawazoe Yurika , Sumiyoshi Remi , Hosogaya Naoki , Fukushima Chizu , Yamamoto Hiroshi , Kawakami Atsushi
Published: July 2020

Background:

The introduction of biological disease-modifying anti-rheumatic drugs (bDMARDs) into clinical practice has dramatically improve the clinical outcomes of individuals with rheumatoid arthritis (RA). However, bDMARDs are associated with high costs, which has resulted in restricted treatment access and a burden on medical insurance finances. Although biosimilars offer cost-saving, their effectiveness and safety must be established in Post-Marketing Surveillance (PMS). Infliximab (IFX), a chimeric monoclonal antibody to TNF-alpha, is the first bDMARD; its biosimilar, CT-P13, is the first biosimilar DMARD approved for RA treatment in Japan. We will evaluate whether switching from originator IFX to CT-P13 is not inferior for maintaining non-clinical relapse to continued treatment with originator IFX in RA patients achieving clinical remission.

Methods/design:

This study is an interventional, multicenter, open-label, single-arm against historical control and noninferiority clinical trial with a 24-week follow-up. Eighty RA patients who are treated by originator IFX for ≥24 weeks and are achieving clinical remission will be included. Patients will be switched to CT-P13 with the unchanged dosing regimen. We will evaluate disease activity by measuring clinical disease activity indices and by using musculoskeletal ultrasound (MSUS). The primary endpoint is the ratio of patients who experience a nonclinical relapse during the study period. Important secondary endpoints are the changes from the baseline of the MSUS scores. We will also comprehensively analyze the serum levels of many biomarkers such as cytokines and chemokines.

Discussion:

The study results are expected to show the noninferiority of switching to CT-P13 over the continuation of originator IFX. The strength of this study is its prospective evaluation of therapeutic efficacy using not only clinical disease activity indices but also MSUS to accurately and objectively evaluate disease activity at the joint level among patients drawn from multiple centers with a standardized evaluation by MSUS. We will explore whether parameters at baseline can predict a nonclinical relapse after switching from originator IFX to CT-P13 by integrating multilateral assessments, i.e., clinical disease activity indices, MSUS findings, and serum biomarkers.

Trial registration:

This study was registered in the Japan Registry of Clinical Trials (https://jrct.niph.go.jp) on October 11, 2019 as jRCTs071190030.
An autophagy-related model of 4 key genes for predicting prognosis of patients with laryngeal cancer
Authors: Luo Meng-Si , Huang Guan-Jiang , Liu Hong-Bing
Published: July 2020

Autophagy, a major cause of cancer-related death, is correlated with the pathogenesis of various diseases including cancers. Our study aimed to develop an autophagy-related model for predicting prognosis of patients with laryngeal cancer.

We analyzed the correlation between expression profiles of autophagy-related genes (ARGs) and clinical outcomes in 111 laryngeal cancer patients from The Cancer Genome Atlas (TCGA). Afterward, gene functional enrichment analyses of gene ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) were performed to find the major biological attributes. Univariate Cox regression analyses and multivariate Cox regression analyses were performed to screen ARGs whose expression profiles were significantly associated with laryngeal cancer patients overall survival (OS). Furthermore, to provide the doctors and patients with a quantitative method to perform an individualized survival prediction, we constructed a prognostic nomogram.

Thirty eight differentially expressed ARGs were screened out in laryngeal cancer patients through the TCGA database. Related functional enrichments may act as tumor-suppressive roles in the tumorigenesis of laryngeal cancer. Subsequently, 4 key prognostic ARGs (IKBKB, ST13, TSC2, and MAP2K7) were identified from all ARGs by the Cox regression model, which significantly correlated with OS in laryngeal cancer. Furthermore, the risk score was constructed, which significantly divided laryngeal cancer patients into high- and low-risk groups. Integrated with clinical characteristics, gender, N and the risk score are very likely associated with patients OS. A prognostic nomogram of ARGs was constructed using the Cox regression model.

Our study could provide a valuable prognostic model for predicting the prognosis of laryngeal cancer patients and a new understanding of autophagy in laryngeal cancer.
Efficacy and safety of fire-needle in the treatment of gouty arthritis
Authors: Sun Jiya , Fan Yihua , Yang Zhihua , Jin Rui , Xin Ping , Cai Xuemeng , Li Xinju , Wang Shenjun
Published: July 2020

Background:

Fire needle therapy is an ancient external treatment method of traditional Chinese medicine. This therapy is simple to operate and has fewer side effects. Gouty arthritis (GA) is common disease that is often characterized by high excruciating pain on joint. Evidence from clinical studies show that fire needle exerts therapeutic effects on gout arthritis, but no evidence-based medicine is available. This study aimed to evaluate the efficacy and safety of fire acupuncture in the treatment of gout arthritis.

Methods:

Randomized controlled trials of fire needle in the treatment of GA published until May 2020 will be searched in the English databases (PubMed, EMBASE, Web of Science, the Cochrane Library) and Chinese databases (China National Knowledge Infrastructure, the Chongqing VIP Chinese Science and Technology Periodical Database, Wanfang database, and China Biomedical Literature Database). Additional search will be performed on Google academy and Baidu Academy. Data will be extracted from the studies by 2 reviewers working independently. Subsequently, quality assessment and a meta-analysis will be carried out for the studies using RevMan 5.3.

Results:

The efficacy and safety of fire needle in the treatment of GA will be evaluated based on overall effective rate, visual analog scale, blood uric acid, C-reactive protein, joint swelling and pain score, adverse reaction rate, and other clinical outcomes.

Conclusions:

The proposed systematic review and meta-analysis are expected to provide reliable evidence for the clinical benefits of fire-needle therapy in GA.
Treatment outcomes of multidrug-resistant tuberculosis in Hangzhou, China, 2011 to 2015
Authors: Li Qingchun , Shi Cynthia X. , Lu Min , Wu Limin , Wu Yifei , Wang Meng , Wang Le , Zhao Gang , Xie Li , Qian Han-Zhu
Published: July 2020

Treatment of multidrug-resistant tuberculosis (MDR-TB) is challenging. More research is needed to understand treatment outcomes and associated factors.

A retrospective cohort study was conducted to assess trends and predictors of treatment success among 398 MDR-TB and extensively drug resistant TB patients who started treatment in 2011 to 2015 in Hangzhou, China. Sociodemographic and clinical characteristic data were obtained from the national reporting database. Chi-square test for trend was used to evaluate changes in treatment success rates over the study years, and Cox regression analysis was used to identify predictors for poor treatment outcomes.

The treatment success rate was 76% (301/398) for all participants, 77% (298/387) for MDR-TB cases and 27% (3/11) for extensively drug-resistant tuberculosis -TB cases. Treatment success increased significantly from 66% among patients who started treatment in 2011 to 85% in 2015 (P < .01). Of the 97 (24.4%) patients with unsuccessful treatment outcomes, 10 (2.5%) died, 64 (16.1%) failed treatment, and 23 (5.8%) were lost to follow-up. Patients who started treatment in 2013 to 2015 were less likely to have unsuccessful outcomes than those who started in 2011–2012 (adjusted odds ratio [AOR] 0.4, 95% confidence interval [CI] 0.3–0.6), patients ≥25 years were more likely to have unsuccessful outcomes than younger patients (AOR 1.6, 95% CI 1.3–2.1), and cases with kanamycin resistance was associated with three times the odds of having unsuccessful outcomes than kanamycin-susceptible cases (AOR 3.0, 95% CI 1.5–5.8).

With proper case management of MDR-TB, patients can achieve a high treatment success rate. Hangzhou's program offers clinical evidence that can be used to inform MDR-TB programs elsewhere in China and abroad.
Prediction of gastrointestinal bleeding events in patients with acute coronary syndrome undergoing percutaneous coronary intervention
Authors: Zheng Wen , Zhang Yu-Jiao , Liu Ran , Zhao Xue-Dong , Ai Hui
Published: July 2020

Bleeding complications of acute coronary syndromes (ACS) after percutaneous coronary intervention (PCI) are strongly associated with adverse patient outcomes, and gastrointestinal bleeding (GIB) is the most common major bleeding event, especially in the early post-PCI period. Current guidelines recommend routinely conducting bleeding risk assessments. The existing tools are mainly used to evaluate the overall bleeding risk and guide the adjustment of antithrombotic strategies after 1 year. However, there are no specific tools for GIB risk assessment.

Between January 2015 and June 2015, 4943 ACS patients underwent PCI were consecutively enrolled in the derivation cohort. GIB, cardiovascular, and cerebrovascular events were recorded within 1 year of follow-up. A validation cohort including 1000 patients who met the same inclusion and exclusion criteria was also established by propensity-score matching baseline characteristics. Multivariable cox proportional-hazards regression model was used to derive a risk-scoring system, and predictive variables were selected. A risk score nomogram based on the risk prediction model was created to estimate the 1-year risk of GIB.

In this study, we found that the usage of clopidogrel (hazard ratio, HR: 2.52, 95% confidence intervals, CI: 1.573–4.021) and glycoprotein IIb/IIIa receptor inhibitors (HR: 1.863, 95% CI: 1.226–2.829), history of peptic ulcers (HR: 3.601, 95% CI: 1.226–2.829) or tumor (HR: 4.884, 95% CI: 1.226–2.829), and cardiac insufficiency (HR: 11.513, 95% CI: 7.282–18.202), renal insufficiency (HR: 2.010, 95% CI: 1.350–2.993), and prolonged activated partial thromboplastin time (HR: 4.639, 95% CI: 2.146–10.032) were independent risk factors for GIB 1 year after PCI. Based on these 7 factors, a nomogram and scoring system was established. The area under curve of risk score was 0.824 in the deviation cohort and 0.810 in the verification cohort. In both cohorts, the GIB score was significantly better than that of 3 classical bleeding scores (all P < .05).

This score could well predict the risk of GIB within 1 year after PCI and could be used to guide antithrombotic strategies.
Prognostic value of CHADS2 and CHA2DS2-VASc scores for post-discharge outcomes in patients with acute coronary syndrome undergoing percutaneous coronary intervention
Authors: Ma Xiaoteng , Shao Qiaoyu , Dong Lisha , Cheng Yujing , Lv Sai , Shen Hua , Liang Jing , Wang Zhijian , Zhou Yujie
Published: July 2020

The CHADS2 and CHA2DS2-VASc scores were initially developed to assess the risk of stroke or systemic embolism in patients with atrial fibrillation (AF). Recently, these two scoring systems have been demonstrated to predict long- and short-term cardiovascular (CV) outcomes in many patient cohorts. However, to the best of our knowledge, their prognostic value has not been fully elucidated in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). This study aimed to investigate the association of CHADS2 and CHA2DS2-VASc scores with CV outcomes in such patients.

We included a total of 915 ACS patients undergoing PCI in this study. CHADS2 and CHA2DS2-VASc scores were calculated from data collected before discharge. The primary endpoint was defined as a composite of major adverse CV events (MACE) including overall death, nonfatal stroke, nonfatal myocardial infarction (MI) and unplanned repeat revascularization. We assessed MACE's relationship to CHADS2 and CHA2DS2-VASc scores using Cox proportional-hazard regression analyses.

Mean follow-up duration was 918 days. MACE occurred in 167 (18.3%) patients. A higher CHADS2 score was associated with reduced event-free survival (EFS) from MACE (logrank test, P = .007) with differences potentiated if stratified by CHA2DS2-VASc score (logrank test, P < .001). Univariate analysis showed that both CHADS2 and CHA2DS2-VASc scores were good predictors of MACE. In the multivariate Cox proportional-hazard regression analysis, CHA2DS2-VASc score (hazard ratio [HR], 1.15; 95% confidence interval [CI] 1.04–1.27; P = .007) remained a useful predictor of MACE; however, CHADS2 score was no longer associated with increased risk of MACE. C-statistics for CHA2DS2-VASc score, GRACE (Global Registry of Acute Coronary Events) hospital discharge risk score (GRACE Score) and SYNTAX (Synergy between PCI with TAXUS and Cardiac Surgery) Score II (SS II) in predicting MACE were 0.614, 0.598, and 0.609, respectively.

CHA2DS2-VASc score was an independent and significant predictor of MACE in ACS patients undergoing PCI, and its discriminatory performance was not inferior to those of GRACE Score and SS II.
Clinicopathological characteristics and outcomes of metachronous rectal cancer in patients with a history of cervical cancer with and without remote radiotherapy
Authors: Hung Hsinyuan , You Jengfu , Chiang Jyming , Hsieh Paoshiu , Chiang Sumfu , Lai Chengchou , Tasi Wensy , Yeh Chienyuh , Chern Yihjong , Hsu Yujen
Published: July 2020

The purpose of this study was to report the clinicopathological characteristics and treatment outcomes of 45 rectal cancer patients who have a history of cervical cancer with or without remote radiotherapy. Twenty-nine patients (64.4%) with a history of cervical cancer treated with pelvic radiotherapy were classified as group A, 16 (35.6%) patients with a history of cervical cancer not treated with radiotherapy were classified as group B. The median duration between radiotherapy for cervical cancer and rectal adenocarcinoma diagnosis was 18 years. At the time of rectal cancer diagnosis, 5 (17.2%) patients presented stage I disease, 15 (51.7%) had stage II, 1 (3.4%) had stage III, and 8 (27.6%) had stage IV. The patients in group A had older age, higher rates of gross ulcerative lesions, low hemoglobin levels, and a lower rate of lymph node metastases. The patients with secondary rectal cancer developed after radiotherapy for cervical cancer usually presented with abnormal abdominal symptoms, such as proctitis, cystitis, or rectal fistula. Higher colostomy rate was found in this group of patients due to severe pelvic fibrosis or proctitis.