苦参治疗慢性乙型肝炎病毒感染的系统评价研究方案

背景：慢性乙型肝炎病毒（HBV）感染是一个严重的临床和公共卫生问题，目前尚缺乏有效的治疗措施。现有的临床资料显示苦参在治疗慢性HBV感染方面有一定的潜力。目的：系统评估苦参用于治疗慢性HBV感染的有效性和安全性。检索策略，以苦参，苦参素，苦参制剂及其商品名称和乙型肝炎，乙肝病毒，慢性携带状态为主题词，检索Cochrane肝胆病组临床试验资料库，Cochrane补充医学资料库Cochrane图书馆中心数据库，MEDLINE，EMABSE和中国生物医学光盘数据库（CBM）。手工检索了20种中医，及有关学术会议论汇编。鉴定的相关章附录的参考献作为补充检索。资料纳入标准：所有研究苦参治疗慢性HBV感染的随机临床对照试验均被纳入。评价方法，参照Cochrane系统评价的要求，对选择纳入的临床试验进行方法学质量的评估，数据的提取和数据的分析。     

循证医学的临床实践：不稳定性心绞痛的治疗评价

不稳定性心绞痛是急性冠脉综合征（ACS）的重要表现类型之一，及时有效的治疗干预可以缓解症状，减少或避免心脏性猝死、急性心肌梗塞等严重心血管事件的发生。本文通过对近年Cochrane图书馆（CL）、循证医学评价数据库（EBMR）和相关循证医学杂志（EBM）的检索，对国际上近年来有关不稳定性心绞痛治疗措施的系统评价（SR）或临床随机对照试验（RCT）结果作一简要概括，并进行初步评价。     

苦参治疗慢性乙型肝炎病毒感染的系统评价研究方案

背景 慢性乙型肝炎病毒(HBV)感染是一个严重的临床和公共卫生问题,目前尚缺乏有效的治疗措施。现有的临床资料显示苦参在治疗慢性HBV感染方面有一定的潜力。目的 系统评估苦参用于治疗慢性HBV感染的有效性和安全性。检索策略 以苦参,苦参素,苦参制剂及其商品名称和乙型肝炎,乙肝病毒,慢性携带状态为主题词,检索Cochrane肝胆病组临床试验资料库、Cochrane补充医学资料库Cochrane图书馆中心数据库、MEDLINE、EMBASE和中国生物医学光盘数据库(CBM)。手工检索了20种中医杂志,及有关学术会议论文汇编。鉴定的相关文章附录的参考文献作为补充检索。资料纳入标准:所有研究苦参冶疗慢性HBN感染的随机临床对照试验均被纳入。评价方法参照Cochrane系统评价的要求,对选择纳入的临床试验进行方法学质量的评估、数据的提取和数据的分析。     

中医药治疗绝经综合征的临床证据

目的总结国内外有关中医药治疗绝经综合征的系统评价/Meta分析证据,了解其疗效和安全性。方法以"更年期综合征、绝经综合征、围绝经期综合征"和"中医、中药、中医药"和"系统评价、Meta分析、循证医学"为检索词,检索Cochrane图书馆(2006年第4期)、MEDLINE(1991～2006)、OVID(1990～2006)、中国生物医学文献光盘(1990～2006)、中文科技期刊数据库(1989～2006)、中国学术期刊全文数据库(1979～2006)。查找有关中医药治疗绝经综合征的系统评价/Meta分析。结果外文数据库共检索到4篇,中文数据库共检索到2篇,均为中医药治疗绝经综合征的系统评价/Meta分析,对6篇文献进行归纳和总结。结论中医药治疗绝经综合征有一定的疗效,且安全性较高。但由于国外研究多为单味药研究,且研究数量偏少;国内研究的原始文献质量偏低等原因,降低了上述结论的可靠性,因此目前中医药对于绝经综合征的疗效及安全性的证据尚不够充分,尚需更严谨科学的试验以提供可靠性高的证据。     

银杏叶提取物治疗早期糖尿病肾病的Meta分析

目的采用Cochrane系统评价方法,评价银杏叶提取物治疗早期糖尿病肾病的疗效和安全性。方法检索Cochrane图书馆临床对照试验数据库(2013年第2期)、PubMed(1978²013年)、维普中文期刊数据库(19892013年)、维普中文期刊数据库(1989²013年)、中国期刊全文数据库(19792013年)、中国期刊全文数据库(1979²013年)等数据库和相关会议论文集及查阅检索到的所有文献的参考文献,对纳入文献进行评价及资料提取。按照国际Cochrane协作网推荐的方法进行系统评价。结果共纳入22个试验包括1 649例患者。大多试验方法学质量较差且样本量小,Meta分析结果显示:(1)银杏叶提取物联合常规治疗与常规治疗的比较:能减少糖尿病肾病患者24 h尿微量白蛋白排泄率和24 h尿蛋白,能降低血清肌酐(P<0.000 01、P=0.002、P=0.001);(2)银杏叶提取物联合ACEI或ARB治疗与ACEI或ARB治疗的比较,能减少糖尿病肾病患者24 h尿微量白蛋白排泄率,能降低血清肌酐(P<0.000 1、P=0.04)。结论银杏叶提取物治疗糖尿病肾病有一定的疗效。但由于本系统评价纳入的试验样本量较小且方法学质量低下,现有的证据尚不足以推荐临床常规应用银杏叶提取物治疗糖尿病肾病,仍需大量循证医学证据的进一步积累,从而指导临床实践。     

贲门失弛缓症的循证治疗

目的:评价各种贲门失弛缓症治疗方法的有效性和安全性.方法:检索Medline数据库、Cochrane图书馆的随机对照试验和系统评价以及NGC(national guideline clearinghouse)网站相关临床指南,评价贲门失弛缓症的各种治疗方法,为临床实践提供最佳的循证医学证据.结果:共检索到18项结果,共评估了药物治疗、内镜下治疗和外科治疗贲门失弛缓症的疗效和安全性.结论:基于目前的临床证据,我们认为,药物治疗可作为一种暂时治疗方法;内镜下气囊扩张治疗可作为首选治疗方法;内镜下注射肉毒杆菌毒素治疗可作为那些不适合作明确治疗(气囊扩张或手术治疗)患者的一种辅助治疗.对于那些反复扩张或注射效果不佳患者,推荐外科治疗.     

四种抗变态反应药物的卫生技术评估的研究方案

背景：过敏性疾病自20世纪后叶迅速增加，其治疗药物随之上市。但大量临床研究并未明确药物治疗效果和经济学特性好坏，药物严重不良反应的出现给临床用药和国家基本药物遴选带来困难。目的：运用卫生技术评估方法，评价阿司咪唑、氯雷他丁、西替利嗪和特非那定治疗过敏性鼻炎、荨麻疹的有效性，心脏不良反应和经济学特性。检索策略：数据库包括Cochrane图书馆、Medline、Embase和中生物医学数据库，安全性和经济学另检索相关数据库。选择标准：中或英研究。1）有效性：四种抗变态反应药物中的两种或以上用于过敏性鼻炎和荨麻疹的系统评价／meta－分析和高质量随机对照试验；2）安全性：四种抗变态反应药物用于各种变态反应性疾病后出现心脏不良反应的各种级别的证据；3）经济学特性：四种抗变态反应药物中的两种或以上用于过敏性鼻炎、荨麻疹的成本－效果和成本－效用的研究。评价方法：设计质量评价和资料提取表。系统评价和随机对照试验分别使用QUOROM STATEMENT和Jadad评价表评价研究质量。两名评价独立选择献、评价研究质量和提取原始资料，不同意见经讨论解决。数据分析：Revman 4.1使用固定效应模型分析原始数据，敏感性分析解决研究间异质性，若仍有异质性使用随机效应模型。     

中文神经疾病临床对照试验数据库的建立

目的：建立中文神经疾病临床对照试验数据库。方法：分别采用计算机检索中国生物医学文献光盘数据库(CBMdisc)、中国循证医学图书馆(中文光盘版)临床对照研究数据库和人工检索与神经疾病相关的11种期刊和4本会议论文集，纳入已发表的神经疾病防治性研究的随机对照试验和有对照但未随机分组的临床对照研究，建立数据库并采用，Procite软件进行管理。结果：经计算机检索CBMdisc(1978年～2002年4月)和中国循证医学图书馆(中文光盘版)2002年1期，人工检索期刊11种，论文集4种。数据库共纳入与神经疾病有关的临床对照试验3641篇，其中随机对照试验828篇，占22．74％，临床对照研究(非随机但有对照)2813篇，占77．26％。结论：本数据库较为全面地收集了中国神经疾病领域已发表的防治性对照试验，为临床实践和卫生决策提供了该领域治疗方面中国当前的研究证据，也为Cochrane图书馆以及世界各国的临床对照试验数据库提供了资料，是对系统评价作者有帮助的资料来源     

川芎嗪治疗原发性肾病综合征的系统评价

目的评价川芎嗪治疗原发性肾病综合征的有效性、临床安全性,为临床实践提供循证医学证据.方法计算机检索MEDLINE(1966.1～2002.12)、EMBASE(1975～2002.12)、中国生物医学文献数据库(1979.1～2002.12)、中国循证医学/Cochrane中心数据库、Cochrane图书馆、SCI (1985～2002.12)等数据库和手工检索<中华肾脏病杂志>等15种杂志(1980～2003.2),收集川芎嗪与激素/免疫抑制剂治疗原发性肾病综合征的随机对照试验.根据Jadad质量记分法进行质量评定,选择近期疗效、远期疗效和治疗期及随访期发生副作用的病例数等作为评价指标,提取数据并采用Cochrane协作网专用软件RevMan4.1进行统计分析.结果检索到符合纳入标准的随机对照试验 13篇,共675例病人.均为Jadad质量计分均为1分的低质量研究.4个研究的Meta分析结果显示,川芎嗪可提高近期治疗肾病综合征综合的疗效[OR 4.24, 95%CI (1.76,10.19)] ,改善24 h尿蛋白定量[OR -0.36, 95%CI (-0.71,-0.02)] 、血肌酐水平[儿童组OR -3.34, 95%CI (-5.25,-1.43); 成人组OR -48.29, 95%CI (-68.24,-28.35)]血浆白蛋白水平[OR 3.61, 95%CI(2.61,4.61)]等.但川芎嗪的长期副反应尚不清楚.纳入研究的资料中,缺乏川芎嗪降低原发性肾病综合征复发率的研究.结论目前较低质量研究的Meta分析提示,在激素/免疫抑制剂基础上使用川芎嗪有提高原发性肾病综合征近期疗效的作用,尤其是对高凝状态和一过性肾功能不全患者.无川芎嗪降低原发性肾病综合征复发率的有力证据.尚未发现川芎嗪的严重副作用.但并不能认为川芎嗪治疗原发性肾病综合征安全.其远期疗效和安全性还有待于设计严格的多中心、大样本随机对照试验进一步证实.     

循征医学在糖尿病足治疗中的应用

目的：分析循证医学在糖尿病足治疗中应用的必要性，总结目前治疗糖尿病足的减压肢具，敷料，生物制剂，外科手术的系统评价和随机对照研究现状。 资料来源：应用计算机检索Medline 1985-01／2005-03有关糖尿病足治疗方面系统评价和随机对照实验的文章，检索词“diabetic foot or diabetic wound and(review or RCT)”，限定试验对象为人，语种为英文。 资料选择：对资料进行初筛，选择与糖尿病足治疗相关的文章，通过PML，OVID，EBSCO，Springer，Blackwell，Science direct等数据库或联系作者查找原文，去除重复文献及仅有文摘的文献。 资料提炼：共收集327篇，其中获得全文48篇，9篇为重复同一研究，入选39篇，其中Cochrane系统评价2篇。 资料综合：循征医学在糖尿病足治疗中应用的必要性主要体现为3个方面：循征医学提供了最佳的治疗方法；循证医学是有效治疗方法的甄别手段；循证医学有助患者参与临床决策。糖尿病足的分级目前国际上通用的是Wagner分级法和Texas大学糖尿病创面分级法。一般认为对于Wagner分级I～II的糖尿病创面采用换药，清创，和减压肢具。对于伴临床感染的患者给予广谱抗感染药物。对于Wagner分级III～V的糖尿病创面采用植皮、皮瓣转移修补创面，针对骨髓炎的治疗，改善循环(动脉搭桥手术)，应用静脉广谱抗感染药物和截肢。对糖尿病足治疗的各种策略(减压肢具、敷料、创面收缩、外科手术)进行概述分析。 结论：目前糖尿病足的治疗缺乏规范指导，循证医学可以提供最有效的证据，帮助临床制定最佳治疗方案。通过系统评价和随机对照试验得出的糖尿病足治疗方案可信度较高。但是目前糖尿病足治疗的随机对照研究仍存在样本较小的问题，部分研究由制造商赞助或实施，故仍需大样本的随机对照试验作为糖尿病足治疗决策的依据。     

中医药治疗骨关节炎的Meta分析

目的使用Meta分析评价中医药治疗骨关节炎的临床疗效及安全性。方法检索2014年1月1日至今发表于中国知网(CNKI)、万方数据库、维普数据库、PubMed、Cochrane图书馆中关于中医药治疗骨关节炎的期刊文献,文献类型限于临床随机对照试验(RCT)。中文检索关键词为“中医药”AND“骨关节炎/骨性关节炎/骨痹/骨关节病/退化性关节炎/增生性关节炎”,英文检索关键词为“traditional Chinese medicine”AND“osteoarthritis/bone arthralgia”。文献导入NoteExpress软件,初步进行论文重复率筛选,然后采用RevMan5.3软件进行Meta分析。结果Meta分析显示,中医药治疗骨关节炎的总有效率高于常规西药治疗,不良反应总发生率低于常规西药治疗(P<0.05);采用中医药治疗骨关节炎患者的WOMAC、VAS、中医症候评分均优于常规西药治疗(P<0.05)。结论中医药治疗骨关节炎无论在治疗总有效率还是用药安全性方面,均优于西药常规治疗,值得临床进一步研究推广。     

Chinese Herbal Medicine for Dysfunctional Uterine Bleeding: a Meta-analysis

We conducted a systematic review to evaluate the efficacy and safety of Chinese herbal medicine (CHM) for dysfunctional uterine bleeding (DUB) by performing a meta-analysis. Randomized controlled trials (RCTs) or quasi-RCTs comparing CHM vs no treatment, placebo, conventional western medicine (CWM), or general non-specific surgical treatment for DUB were identified by electronic and manual searches. Trials of CHM treatments with CWM treatments were compared with CWM treatments alone. Jadad scale and allocation concealment were used to assess the quality of included studies. Four RCTs or quasi-RCTs involving 525 patients were included. The methodological quality was poor in all trials except one trial. No serious adverse events were reported in the included studies. With the lack of trials comparing CHM with no treatment or placebo, it is impossible to accurately evaluate the efficacy of CHM. However, CHM in these studies seem to show an encouraging comparative effectiveness with CWM. More RCTs with a higher quality are required.     

中医药在脑血管支架置入后防治并发症中的作用

目的:评价中医药在脑血管支架置入后并发症中的作用效果.方法:应用计算机检索Science Direct 数据库、Ei数据库1960-01/2009-10期间的相关文章,检索词为"traditional Chinese medicine,stent placement,complication",并限定文章语言种类为English.同时计算机检索中国期刊全文数据库、中国生物医学文献数据库等1994-01/2009-10期间的相关文章,检索词为"中医药,脑血管,支架置入,并发症",并限定文章语言种类为中文.此外还手工查阅相关专著数部.纳入有关中医药防治脑血管支架置入后并发症的基础与临床实验.结果:脑血管支架置入后的中医药干预方法以益气、活血、涤痰为基本治法,亦可佐以疏肝理气、安神利水、凉血止血之品.常用的中药复方有生脉散、补阳还五汤、血府逐瘀汤加减、四逆汤及抵挡汤加减等.现代药理学研究表明,大量益气活血化瘀涤痰的中药及复方,通过多组分、多靶点、多途径的整合调节作用,有效地干预脑血管支架置入后并发症的发生.结论:对脑血管支架置入围手术期进行中医药干预,发挥中医药特色,对于提高手术成功率,防治、减少围手术期及远期并发症具有重要意义.     

Systematic Review and Meta-Analysis of Antimicrobial Treatment Effect Estimation in Complicated Urinary Tract Infection

Noninferiority trial design and analyses are commonly used to establish the effectiveness of a new antimicrobial drug for treatment of serious infections such as complicated urinary tract infection (cUTI). A systematic review and meta-analysis were conducted to estimate the treatment effects of three potential active comparator drugs for the design of a noninferiority trial. The systematic review identified no placebo trials of cUTI, four clinical trials of cUTI with uncomplicated urinary tract infection as a proxy for placebo, and nine trials with reports of treatment effect estimates for doripenem, levofloxacin, or imipenem-cilastatin. In the meta-analysis, the primary efficacy endpoint of interest was the microbiological eradication rate at the test-of-cure visit in the microbiological intent-to-treat population. The estimated eradication rates and corresponding 95% confidence intervals (CI) were 31.8% (26.5% to 37.2%) for placebo, 81% (77.7% to 84.2%) for doripenem, 79% (75.9% to 82.2%) for levofloxacin, and 80.5% (71.9% to 89.1%) for imipenem-cilastatin. The treatment effect estimates were 40.5% for doripenem, 38.7% for levofloxacin, 34.7% for imipenem-cilastatin, and 40.8% overall. These treatment effect estimates can be used to inform the design and analysis of future noninferiority trials in cUTI study populations.     

Chinese medicinal herbs for influenza: a systematic review

BACKGROUND: Influenza is an acute respiratory communicable disease which can cause high morbidity and mortality in an epidemic. Traditional Chinese medicinal herbs following a particular theory may be a potential medicine of choice. OBJECTIVES: We aim to assess the therapeutic effect and adverse reaction of traditional Chinese medicinal herbs in the treatment of uncomplicated influenza. SEARCH STRATEGY: We searched the Cochrane Library, MEDLINE, EMBASE, CBM, and handsearched the relevant Chinese journals. SELECTION CRITERIA: Randomised and quasi-randomised trials compared with placebo, or with other chemical drugs normally used in care, or various other Chinese medicinal herbs amd chemical drugs with herbal preparations compared with simple chemical drugs were also included. DATA COLLECTION AND ANALYSIS: At least two reviewers extracted data and assessed trial quality. MAIN RESULTS: We included 8 relevant studies, most of which were of low quality. Because of the clinical heterogeneity, we did not perform a summary meta-analysis. Some of the studies showed positive results favouring Traditional Chinese medicinal herb treatment compared to antiviral or antipyretic-analgesic drugs or the combination of them. Only three studies mentioned adverse reactions but no detailed data were acquired in the included studies. REVIEWERS' CONCLUSIONS: The small number of included studies and participants, as well as the low quality of most studies, made the evidence far from conclusive for clinical decision making. More high quality randomised controlled trials (RCTs) with similar interventions are required to strengthen the evidence for the efficacy and safety of certain herbal preparations.     

利奈唑胺和糖肽类抗生素对复杂性皮肤及软组织感染治疗效果的荟萃分析

目的 对现已发表的利奈唑胺和糖肽类抗生素治疗革兰阳性球菌复杂性皮肤及软组织感染的文献进行综合分析,评价利奈唑胺的疗效及安全性是否优于糖肽类抗生素.方法 计算机检索Medline数据库、Embase数据库、Ovid数据库、Cochrane 图书馆及中文生物医学期刊数据库等网络资源,并查阅所有纳入的参考文献,进行荟萃分析....     

The use of moist wound-healing dressings in the management of split-thickness skin graft donor sites: a systematic review

The aim of this systematic review was to determine the best available evidence related to the post-harvest management of split-thickness skin graft (STSG) donor sites. Studies included in the review were those involving patients of any age examining interventions relating to the post-harvest management of STSG donors and were intra-individual or randomized controlled trials. All studies were checked for methodological quality, and data were extracted using a data extraction tool. Many studies were combined in meta-analysis. The present report concerns studies examining moist and non-moist wound-healing dressings. Broad comparisons of moist wound-healing dressings against traditional non-moist dressings favoured moist wound-healing approaches in terms of healing rates, pain and infection. In comparing dressings within and between moist wound-healing dressing groups, the lack of studies of sufficient quality prevented determining a 'best dressing' for STSG donors. Moist wound-healing products have distinct clinical advantages over non-moist products in the management of STSG donors. There is a strong case for further head-to-head studies comparing products within the moist wound-healing group.     

The potential role of HMG-CoA reductase inhibitors in pediatric nephrotic syndrome

OBJECTIVE: To evaluate the safety and efficacy of the hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) as a potential treatment option for the dyslipidemia associated with childhood nephrotic syndrome. DATA SOURCES: Searches of MEDLINE (1966-April 2004), Cochrane Library, International Pharmaceutical Abstracts (1977-April 2004), and an extensive manual review of journals were performed using the key search terms nephrotic syndrome, familial hypercholesterolemia, dyslipidemia, and HMG-CoA reductase inhibitor. STUDY SELECTION AND DATA EXTRACTION: Two prospective uncontrolled studies evaluating the safety and efficacy of statin therapy in pediatric nephrotic syndrome were included. DATA SYNTHESIS: While an extensive amount of data is available in adult nephrotic syndrome in which statin therapy decreases total plasma cholesterol 22-39%, low-density lipoprotein cholesterol (LDL-C) 27-47%, and total plasma triglycerides 13-38%, only 2 small uncontrolled studies have been conducted evaluating the utility of these agents in pediatric nephrotic syndrome. These studies indicate that statins are capable of safely reducing total cholesterol up to 42%, LDL-C up to 46%, and triglyceride levels up to 44%. CONCLUSIONS: Lowering cholesterol levels during childhood may reduce the risk for atherosclerotic changes and may thus be of benefit in certain patients with nephrotic syndrome. Statins have demonstrated short-term safety and efficacy in the pediatric nephrotic syndrome population. Implementing pharmacologic therapy with statins in children with nephrotic syndrome must be done with care until controlled studies are conducted in this population.     

Applying the science to the prevention of catheter-related infections

BACKGROUND: Catheter-related bloodstream infection (CR-BSI) remains a leading cause of nososcomial infection, despite the fact that many CR-BSIs are preventable. Simple principles of infection control and the use of novel devices to reduce these infections are not uniformly implemented. OBJECTIVE: To review and summarize the evidence that promotes strategies to prevent CR-BSIs. DATA SOURCES: The Medline database and bibliographies of review articles and book chapters were searched for relevant articles. STUDIES INCLUDED: In vitro and in vivo laboratory-based studies, controlled clinical trials, prospective interventional trials, and epidemiologic investigations. OUTCOME MEASURES: Reduction in CR-BSI, catheter colonization, tunnel infection, or local site infection. SYNTHESIS: The recommended prevention strategies with strong supportive evidence include educating and training of health care providers who insert and maintain catheters; using full barrier precautions during central venous catheter insertion; using a 2% chlorhexidine preparation for skin antisepsis; eliminating the practice of scheduled replacement of central venous catheters for prevention of infection; and using antiseptic/antibiotic impregnated short-term central venous catheters. CONCLUSION: Simple interventions can reduce the risk for serious catheter-related infection. Health care provider awareness and adherence to these prevention strategies is critical to reducing the risk for CR-BSI, improving patient safety, and promoting quality health care.