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Methodological quality(risk of bias) assessment tools for primary and secondary medical studies: What are they and which is better?

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Military Medical Research 2020年第3期7卷 359-370页

作者： Lin-Lu Ma Yun-Yun Wang Zhi-Hua Yang Di Huang Hong Weng Xian-Tao Zeng Center for evidence-based and Translational medicine Zhongnan HospitalWuhan University169 Donghu RoadWuchang DistrictWuhan 430071HubeiChina Department of evidence-based medicine and clinical epidemiology the Second Clinical CollegeWuhan UniversityWuhan 430071China Center for evidence-based and Translational medicine Wuhan UniversityWuhan 430071China Global Health Institute Wuhan UniversityWuhan 430072China

Methodological quality(risk of bias)assessment is an important step before study initiation ***,accurately judging study type is the first priority,and the choosing proper tool is also *** this review,we introduced methodological quality assessment tools for randomized controlled trial(including individual and cluster),animal study,non-randomized interventional studies(including follow-up study,controlled before-and-after study,before-after/pre-post study,uncontrolled longitudinal study,interrupted time series study),cohort study,case-control study,cross-sectional study(including analytical and descriptive),observational case series and case reports,comparative effectiveness research,diagnostic study,health economic evaluation,prediction study(including predictor finding study,prediction model impact study,prognostic prediction model study),qualitative study,outcome measurement instruments(including patient-reported outcome measure development,content validity,structural validity,internal consistency,cross-cultural validity/measurement invariance,reliability,measurement error,criterion validity,hypotheses testing for construct validity,and responsiveness),systematic review and meta-analysis,and clinical practice *** readers of our review can distinguish the types of medical studies and choose appropriate *** one word,comprehensively mastering relevant knowledge and implementing more practices are basic requirements for correctly assessing the methodological quality.

关键词： Methodological quality Risk of bias Quality assessment Critical appraisal Methodology checklist Appraisal tool Observational study Qualitative study Interventional study Outcome measurement instrument

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Epidemiological trends of urinary tract infections,urolithiasis and benign prostatic hyperplasia in 203 countries and territories from 1990 to 2019

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Military Medical Research 2022年第4期9卷 432-443页

作者： Cong Zhu Dan-Qi Wang Hao Zi Qiao Huang Jia-Min Gu Lu-Yao Li Xing-Pei Guo Fei Li Cheng Fang Xiao-Dong Li Xian-Tao Zeng Department of Urology Zhongnan Hospital of Wuhan UniversityWuhan 430071China Center for evidence-based and Translational medicine Zhongnan Hospital of Wuhan UniversityWuhan 430071China Department of evidence-based medicine and clinical epidemiology Second School of Clinical MedicineWuhan UniversityWuhan 430071China Institutes of evidence-based medicine and Knowledge Translation Henan UniversityKaifeng 475000HenanChina Department of Urology Huaihe Hospital of Henan UniversityKaifeng 475000HenanChina

Background:Urinary tract infections(UTI),urolithiasis,and benign prostatic hyperplasia(BPH)are three of the most common nonmalignant conditions in ***,there is still a lack of comprehensive and updated epidemiological *** study aimed to investigate the disease burden of UTI,urolithiasis,and BPH in 203 countries and territories from 1990 to ***:Data were extracted from the Global Burden of Disease 2019,including incident cases,deaths,disabilityadjusted life-years(DALYs)and corresponding age-standardized rate(ASR)from 1990 to *** annual percentage changes(EAPC)were calculated to evaluate the trends of *** associations between disease burden and social development degrees were analyzed using a sociodemographic index(SDI).Results:Compared with 1990,the incident cases of UTI,urolithiasis,and BPH increased by 60.40%,48.57%,and 105.70%in 2019,*** age-standardized incidence rate(ASIR)of UTI increased(EAPC=0.08),while urolithiasis(EAPC=–0.83)and BPH(EAPC=–0.03)decreased from 1990 to *** 2019,the age-standardized mortality rate(ASMR)of UTI and urolithiasis were 3.13/100,000 and 0.17/100,000,*** had the largest increase(110.56%)in DALYs in the past three decades,followed by UTI(68.89%)and urolithiasis(16.95%).The burden of UTI was mainly concentrated in South Asia and Tropical Latin America,while the burden of urolithiasis and BPH was recorded in Asia and Eastern ***,the ASIR and SDI of urolithiasis in high-SDI regions from 1990to 2019 were negatively correlated,while the opposite trend was seen in low-SDI *** 2019,the ASIR of UTI in females was 3.59 times that of males,while the ASIR of urolithiasis in males was 1.96 times higher than that in *** incidence was highest in the 30–34,55–59,and 65–69 age groups among the UTI,urolithiasis,and BPH groups,***:Over the past three decades,the disease burden has increased for UTI but decreased for urolithiasis and BPH

关键词： Urinary tract infections Urolithiasis Benign prostatic hyperplasia Disease burden Incidence Mortality Disability-adjusted life-years

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24-Hour Urinary Sodium Excretion Association with Cardiovascular Events:A Systematic Review and Dose-Response Meta-Analysis

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Biomedical and Environmental Sciences 2022年第10期35卷 921-930页

作者： ZHAO Dan LI Hua Min LI Chao Xiu ZHOU Bo Department of clinical epidemiology and evidence-based medicine The First Hospital of China Medical UniversityShenyang 110000LiaoningChina School of Public Health China Medical UniversityShenyang 110000LiaoningChina

Objective The relationship between sodium intake and cardiovascular(CV)events remains ***,we carried out a systematic review and dose-response meta-analysis for evaluating the potential impact of 24-hour sodium excretion on CV ***,24-hour sodium excretion was used to replace daily sodium diet *** We searched ISI Web of Science,Embase,Pub Med,and the Cochrane *** study included cohort studies reporting hazard ratio(HR).The random-effects model was used for summarizing the total relative risks(RRs)between the included *** addition,the generalized least-squares regression was employed to fit the study *** A total of 9 studies involving 645,006 participants were included in this study.A significant non-linear relationship was observed between sodium excretion and CV events(P^(non-linearity)<0.001).In studies collecting 24-h urine samples,the sodium excretion and CV events risk were associated linearly(RR:1.04;95%CI:1.01,1.07).Conclusion In a linear dose-response manner,every 1 g increase in sodium intake was associated with an increased risk of CV events up to 4%.Further studies are required to validate our conclusions further.

关键词： Cardiovascular events Meta-analysis 24-h urinary sodium excretion Dose-response Sodium intake

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Effect of Aidi injection plus chemotherapy on gastric carcinoma:a Meta-analysis of randomized controlled trials

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Journal of Traditional Chinese medicine 2015年第4期35卷 361-374页

作者： Wang Jiancheng Ge Long Zhao Ye Li Jinlong Zhang Pan Mao Lei Yang Kehu evidence based Medical Center of Lanzhou University The First clinical Medical College of Lanzhou University School of Basic Medical Science of Lanzhou University Key Laboratory of evidence based medicine and Knowledge Translation of Gansu Province

OBJECTIVE: To conduct a Meta-analysis of studies on the effect of Aidi injectioncombined with chemotherapy versus chemotherapy alone in the treatment of gastric cancer(GC).METHODS: Nine electronic databases and six gray literature databases were comprehensively searcheduntil April 20,2013. Two reviewers independently selected and assessed included trialsaccording to the inclusion and exclusion criteria. The risk of bias tool from the Cochrane Handbook version 5.1.0was used to assess trial quality. All calculations were performed using Review Manager ***: Thirty-two studies including 1927 participants met the inclusion criteria,most of which were low quality. Compared with chemotherapy alone,Aidi injection plusthe same chemotherapy significantly improved the effective rate [OR = 1.52,95% CI(1.24,1.86),P clinical beneficial rate [OR = 1.77,95% CI(1.33,2.36),P clinical effect of chemotherapy,reducing the incidence of adverse events. Use of the CONSORT statement for randomized controlled trials is recommended for stricter reporting.

关键词： Drug therapy Stomach neoplasms Review Randomized controlled trial Aidi injection

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Organoids of liver diseases: From bench to bedside

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World Journal of Gastroenterology 2019年第16期25卷 1913-1927页

作者： Li-Jun Wu Zi-Yan Chen Yi Wang Jun-Gang Zhao Xiao-Zai Xie Gang Chen Department of Hepatobiliary Surgery The First Affiliated Hospital Wenzhou Medical University Research Center of evidence-based medicine and clinical epidemiology School of Public Health and Management Wenzhou Medical University

Understanding the occurrence, development, and treatment of liver diseases is the main goal of hepatopathology research. Liver diseases are not only diverse but also highly heterogeneous among individuals. At present, research on liver diseases is conducted mainly through cell culture, animal models, pathological specimens, etc. However, these methods cannot fully reveal the pathogenic mechanism and therapeutic characteristics of individualized liver *** advances in three-dimensional cell culture technology(organoid culture techniques) include pluripotent stem cells and adult stem cells that are cultured in vitro to form self-organizing properties, making it possible to achieve individualized liver disease research. This review provides a comprehensive overview of the development of liver organoids, the existing and potential applications of liver regenerative medicine, the pathogenesis of liver disease heterogeneity, and drug screening.

关键词： Organoids Liver diseases Individualized research Liver cancer Threedimensional cell culture Liver organoids

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Risk assessment model for endpoints of ischemic stroke: A study protocol for a registry study

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Journal of Traditional Chinese medicine 2018年第6期38卷 936-942页

作者： Zhang Yin Liu Yue Wang Guiqian Sun Shuailing Gao Yang Xie Yanming Institute of Basic Research in clinical medicine China Academy of Chinese Medical Sciences Center for evidence-based Chinese medicine School of Chinese Medicine Beijing University of Chinese Medicine

OBJECTIVE: To evaluate the risk of ischemic stroke endpoints by establishing risk assessment models that combine Traditional Chinese medicine(TCM)and modern medicine ***/DESIGN: The proposed study is a registry-based participant survey conducted in seven hospitals nationwide in China. After obtaining informed consent, 3000 patients diagnosed with ischemic stroke will be recruited. One-year follow-ups will be performed on-site in hospitals and by telephone to track endpoint events. Comparative analysis of the prevalence of endpoint events and other TCM or modern medicine features in different groups will be conducted using frequency analysis and χ2tests, and the results will be expressed as composition ratios. Comparative analysis of quantitative scores and related patterns or symptoms will be conducted using a rank-sum test. Correlation analysis of endpoint events and TCM or modern medicine factors will be performed using a multivariate Cox proportional hazard ***: Previous reports have described modern medicine indicator-based risk assessment models for ischemic stroke endpoint events, but no such studies have included TCM features. Our new risk assessment model combines TCM and modern medicine indicators and thus has the potential to facilitate early warning, early intervention, and early control of ischemic stroke endpoint events.

关键词： Stroke medicine,Chinese traditional Secondary prevention Endpoint determination Risk assessment Protocol Registry study

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Protein-based functional hydrogel improves cutaneous nerve repair and diabetic wound healing

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Nano Research 2025年第1期18卷 586-596页

作者： Hanzhi Lu Mingrui Cui Yi Wang Xinran Du Xinyi Zhou Yuhan Fang Xiaoyan Gao Ying Peng Jianyong Zhu Guang Yang Fulun Li Department of Dermatology Yueyang Hospital of Integrated Traditional Chinese and Western MedicineShanghai University of Traditional Chinese MedicineShanghai 200437China Shanghai Engineering Research Center of Nano-Biomaterials and Regenerative medicine College of Biological Science and Medical EngineeringDonghua UniversityShanghai 201620China clinical Laboratory medicine Center Yueyang Hospital of Integrated Traditional Chinese and Western MedicineShanghai University of Traditional Chinese MedicineShanghai 200437China

Cutaneous nerve regeneration in diabetic wounds remains a challenge for current clinical ***,a natural protein-based functional hydrogel is developed using keratin as the sole matrix,and protocatechuic aldehyde(PA)and zinc ions as the building blocks through dual-dynamic crosslinking reactions of thiol-aldehyde addition and catecholzinc ions *** unique structural design endows the hydrogel with excellent injectability,skin adhesion,self-healing and antibacterial ability,and *** addition,this hydrogel acts as a drug carrier for the loading and sustained release of phellopterin(PP),a natural compound extracted from traditional Chinese medicine Angelica *** findings demonstrate that the PP-loaded hydrogel promotes cutaneous nerve regeneration,angiogenesis and tissue remodeling in the full-thickness wounds in both db/db and streptozotocin-induced C57BL/6 diabetic mice,notably by the synergistic effect of zinc ions and PP,showing a great potential in diabetic wound therapy.

关键词： functional hydrogel cutaneous nerve regeneration dynamic crosslinking diabetic wounds

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Biotransformation Effect of Bombyx Mori L. May Play An Important Role in Treating Diabetic Nephropathy

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Chinese Journal of Integrative medicine 2016年第11期22卷 872-879页

作者：张蕾张腊李茵郭新峰刘旭生 Department of Nephrology Guangdong Provincial Hospital of Chinese Medicine Guangzhou University of Chinese medicine evidence-based medicine and clinical Research Service Team Guangdong Provincial Hospital of Chinese Medicine

Compared with herbal drugs, medicine processed from animals(animal medicine) was thought to have more bioactive substances and higher activities. Biotransformation effect often plays an important role in their effect. However, researches about effect of animal medicine on diabetic nephropathy and applying animal medicine as natural bio-transformer were seldom reported. The purpose of this paper was to reveal the use of Bombyx Mori L. on diabetic nephropathy from ancient to modern times. The classical literature indicated that Saosi Decoction(缫丝汤), which contains Bombyx Mori L. or silkworm cocoon, was applied to treat disorders congruent with modern disease diabetic nephropathy from the Ming to Qing Dynasty in ancient China. Modern studies showed that Bombyx Mori L. contains four main active constituents. Among these, 1-deoxynojirimycin(1-DNJ) and quercetin showed promising potential to be new agents in diabetic nephropathy treatment. The concentrations of 1-DNJ and the activities of quercetin in Bombyx Mori L. are higher than in mulberry leaves, because of the biotransformation in the Bombyx Mori L. body. However, these specific components need further human and mechanistic studies to determine their therapeutic potential for this challenging condition.

关键词： diabetic nephropathy Bombyx Mori L 1-deoxynojirimycin quercetin biotransformation Chinese medicine

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Influence of population mobility on the novel coronavirus disease(COVID-19)epidemic:based on panel data from Hubei,China

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Global Health Research and Policy 2020年第1期5卷 195-204页

作者： Junfeng Jiang Lisha Luo School of Health Sciences Wuhan UniversityNo.115 Donghu RoadWuhan 430071China Center for evidence-based and Translational medicine Zhongnan Hospital of Wuhan UniversityWuhanChina Department of evidence-based medicine and clinical epidemiology the Second Clinical College of Wuhan UniversityWuhanChina

Background:The novel coronavirus disease(COVID-19)was first reported in Wuhan,*** mass population mobility in China during the Spring Festival has been considered a driver to the transmission of COVID-19,but it still needs more empirical ***:based on the panel data from Hubei,China between January 6th and February 6th,2020,a random effects model was used to estimate the impact of population mobility on the transmission of *** version 12.0 was used,and p<0.05 was considered statistically ***:The COVID-19 was more likely to be confirmed within 11-12 days after people moved from Wuhan to 16 other prefecture-level cities in Hubei Province,which suggests a period of 11-12 days from contact to being *** daily confirmed cases and daily increment in incidence in 16 prefecture-level cities show obvious declines 9-12 days post adaptation of city lockdown at the local ***:Population mobility is found to be a driver to the rapid transmission of COVID-19,and the lockdown intervention in local prefecture-level cities of Hubei Province has been an effective strategy to block the COVID-19 epidemic.

关键词： COVID-19 Population mobility Infectious disease epidemic Lockdown intervention

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Efficacy and safety of ranibizumab for wet age-related macular degeneration in Chinese patients

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International Journal of Ophthalmology(English edition) 2017年第1期10卷 91-97页

作者： Hui-Jun Qi Xiao-Xin Li Jun-Yan Zhang Ming-Wei Zhao Department of Ophthalmology People's HospitalPeking UniversityBeijing 100044China clinical Study Consultant Bothwin Pte.Ltd.Shanghai 200232China Branch of clinical epidemiology and evidence-based medicine Shanghai Medical AssociationShanghai 200240China

AIM： To evaluate the clinical efficacy and safety of ranibizumab for wet age-related macular degeneration （wAMD） in Chinese patients and to determine the mean number of injections administered over one year of follow-up. METHODS： This single centre, retrospective observational case series study included data from 121 patients with wAMD （121 eyes） who were diagnosed by indirect ophthalmoscopy, fluorescence fundus angiography （FFA）, indocyanine green angiography, and optical coherence tomography. Ranibizumab was injected into the vitreous cavities once per month for 3mo and as needed afterwards. Changes in visual acuity and central foveal thickness （CFT） during the follow-up period were compared, and the mean number of injections over the year was calculated. Patients with one or more adverse events related to the drugs and injections were recorded for further adverse events ***： The study population included 70 males and 51 females aged between 50 and 87y （mean： 71.32±9.41y）. The mean number of injections over the first year was 5±1 （range： 3-9）. The mean best-corrected visual acuity by Early Treatment Diabetic Retinopathy Study increased from 43.2±19.3 （95%CI： 39.8-46.7） at baseline to 51.7±20.1 （95%CI： 48.1-55.3）, and central foveal thickness （CFT） decreased from 526.5±277.0 μm （95%CI： 476.6-576.4） to 258.2±161.6 μm （95%CI： 229.2-287.3） at 12mo. The differences were statistically significant （P〈0.001）. Visual acuity significantly improved in 34.1% of the patients （38 eyes）, stabilized in 66.1% of the patients （80 eyes）, and significantly decreased in 2.5% of the patients （3 eyes）. CFT at baseline was an independent risk factor of decreased CFT and increased visual acuity. None of the patients had severe adverse events during the follow-up ***： Ranibizumab can effectively control disease progression and improve visual acuity in patients with wAMD. The disease conditions of most patients stabilized after a one-year treatment with an average

关键词： antiangiogenic drug ranibizumab wet age-relatedmacular degeneration fluorescence fundus angiography indocyanine green angiography optical coherence tomography visual acuity central foveal thickness

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