中医药及中西医结合治疗乳腺癌研究文献的质量评价

目的 对近二十年来有关乳腺癌中医药及中西医结合的治疗性文献进行系统性评价，了解研究质量的总体水平及中医药及中西医结合治疗乳腺癌的有效性。方法 按照临床流行病学及循证医学的原则和方法，对1981-2001年CBMdisc与TCMLRS两库公开发表的、研究中医药及中西医结合治疗乳腺癌方面的临床文献进行质量评价。结果 共对11篇中医药及中西医结合治疗乳腺癌的临床对照文献进行了质量评价。关于随机化的质量：11篇文献中，提到“随机”字样的文献(RCT)为8篇(有6篇考虑为随机的可信性不足)；均没有提到随机分配方法的隐匿。关于盲法：11篇文献均未提及设盲。对不良事件或不良反应的报告与分析：82％的试验中未对不良反应进行观察；只有1篇报告未观察到不良事什及反应发生，1篇试验报告了不良反应的观察，但未说明用何种方法。结论 从评价的文献质量来看，近二十年来国内期刊发表的有关乳腺癌中医药及中西医结合治疗性的文献．普遍处于低质量的水平，高质量的义献很少。中医药及中心医结合治疗乳腺癌的疗效尚待根据高质量的大样本随机对照临床试验的结果进一步证实。     

提高中草药随机对照试验的质量Ⅰ:临床试验设计和方法学

目的:通过对中草药临床随机对照试验的设计及方法学进行质量评价,探讨如何提高中草药临床试验的质量。方法:文献检索2005年7月前发表于Cochrane图书馆的中草药系统评价共11篇,包含167个中草药临床随机对照试验。质量评价方法采用修订版CONSORT声明9项指标以及中草药剂型及质量控制标准指标。结果:所有167个临床试验都含有试验目的、方法、第1结局指标、统计学方法及中药剂型;其中163(97.6%)个临床试验说明了研究对象的纳入标准,只有26(15.6%)个临床试验说明了研究对象的排除标准;只有14(8.4%)个临床试验详细说明了随机序列的产生方法;4(2.4%)个临床试验提及了随机分配隐藏;绝大部分的临床试验(86.8%)属于开放性的,只有13.2%的临床试验采用了盲法设计;只有1个临床试验在试验前进行了样本含量的计算;在中草药剂型方面,45.5%的临床试验使用的是汤剂或中药茶包,只有1个临床试验提及了制剂的质量控制。在167个临床试验中,所有质量评价指标的涉及率只有36.0%。结论:现阶段中草药临床随机对照试验的质量还很低。建议:(1)试验设计者及实施者必须接受正规的临床试验基础知识的培训;(2)推荐采用临床试验设计流程图,逐一解决临床试验过程中的关键问题;(3)在方案正式实施前进行预试验,并根据预试验的结果对临床试验设计方案进行调整;(4)对临床试验设计的最终方案进行注册登记,并预先发表(最好是网上发表)临床试验设计方案;(5)广泛开展国际合作,特别是与对中医药研究感兴趣的国际知名学术研究机构进行合作,以提高中草药临床研究的质量。     

中医药治疗子宫肌瘤的系统评价

目的评价中医药治疗子宫肌瘤的临床疗效与安全性。方法通过检索1989～2006年发表的有关中医药治疗子宫肌瘤的临床研究文献,比较中医药与西药、安慰荆、空白组,以及中药加用某种疗法与单用这种疗法治疗的随机对照试验或半随机对照试验,从文献的一般情况、诊断纳入排除标准、疗效判定标准、研究方案设计四个方面进行质量评价,利用Cochrane协作网专用软件Review Manager（Revman4．2）进行Meta分析。结果共纳入临床研究文献293篇,可进行系统评价的文献31篇。结果显示部分中医药治疗子宫肌瘤在缩小子宫体积方面优于西药[效应值——加权均数差值（weighted mean differences,WMD）=-46．02,95％可信区间（-82．32,-9．72）];调节雌孕激素水平优于西药[效应值分别为WMD=-201．34,95％可信区间（-208．83,-193．85）和WMD=-0．20,95％可信区间（-0．26,-0．14）];改善贫血优于西药[效应值WMD=2．87,95％可信区间（1．42,4．32）];闭经的发生率低于西药[效应值RR=0．26,95％可信区间（0．09,0．71）]。部分中药联合西药在缩小肌瘤体积方面有增效作用[效应值WMD=-1．02,95％可信区间（-1．42,-0．63））。结论结果表明,部分中医药治疗子宫肌瘤有一定疗效。但由于在严格随机、双盲等方面还有欠缺,纳入研究的文献很少,其疗效目前尚无充分的证据,在以后的研究中尚需要设计良好的随机、双盲、多中心治疗子宫肌瘤的随机对照临床研究文献,以对本研究的结果能更进一步地证实。     

中医药治疗支气管哮喘缓解期的系统评价

目的:系统评价中医药治疗支气管哮喘缓解期的疗效与安全性。方法:计算机检索Cochrane图书馆、Medline、中国生物医学文献数据库(CBM)、中国学术期刊全文数据库(CNKI)和中国中医文献检索系统数据库,采用Cochrane Handbook评价体系对文献进行分析,采用Revman 5.0软件进行Meta分析。结果:纳入3项随机对照试验,包括2项中医药与西医药对照的试验和1项中西医结合与西医药对照的试验。合并后,中医治疗组临床疗效优于西医对照组(P<0.0001),中西医结合组未见明显优势(P=0.17);中医药治疗组中医证候疗效优于对照组(P=0.02);中医药组喘息、咳嗽和哮鸣音疗效与对照组无显著差异(P=0.12,P=0.25,P=0.91);中医药治疗可以显著提高FEV1%(P=0.001),对PEF25无明显影响(P=0.13);中医药治疗可以显著降低嗜酸性粒细胞(EOS)(P<0.00001);中医药治疗未见明显不良反应报道。结论:中医药单用或与西医药联合应用治疗支气管哮喘缓解期有一定的疗效,亦无明显的毒副作用报道。但由于所纳入试验方法学质量低下等原因,其潜在的疗效及安全性还需严格设计的高质...     

The case for randomized controlled trials to assess the impact of clinical information systems

There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit.     

Toward Evidence-Based Chinese Medicine: Status Quo, Opportunities and Challenges

How to test the treatments of Chinese medicine(CM) and make them more widely accepted by practitioners of Western medicine and the international healthcare community is a major concern for practitioners and researchers of CM.For centuries,various approaches have been used to identify and measure the efficacy and safety of CM.However,the high-quality evidence related to CM that produced in China is still rare.Over the recent years,evidence-based medicine(EBM) has been increasingly applied to CM,strengthening its theoretical basis.This paper reviews the past and present state of CM,analyzes the status quo,challenges and opportunities of basic research,clinical trials,systematic reviews,clinical practice guidelines and clinical pathways and evidence-based education developed or conducted in China,pointing out how EBM can help to make CM more widely used and recognized worldwide.     

16例结直肠癌骨转移患者的循证治疗

目的查找循证医学证据,为16例结直肠癌骨转移患者制定合理的治疗方案。方法针对患者的临床问题,以metastatic colorectal cancer,RCT,human,systematic review,meta-analysis等为检索词,电子检索Cochrane图书馆（2010年第1期）、EMBASE（2005,1-2010,12）和Black Well electronic journals（2005,1-2010,12）查找相关的系统评价、随机对照试验等,并对所获得证据进行质量评价。结果从Cochrane临床试验中心登记库查到临床对照15篇,从EMBASE及Black Well electronic journals检索到Meta分析10篇,随机对照试验8篇,结果显示对转移性结直肠患者进行化疗可延缓病情的发展,提高患者的生存率,据此,结合医生经验及患者意愿,对该16例患者进行化疗及其他支持治疗,患者临床症状好转,生活质量提高。结论我们运用循证医学证据为16例结直肠癌骨转移患者选择了合理的治疗方案,但化疗的毒性、对患者生活质量的影响及病情症状的控制程度还需要进一步的高质量、大样本的随机对照试验研究。     

中医药治疗阳痿随机对照研究文献的质量评价

目的对中医药治疗阳痿随机对照试验文献进行分析,以期系统地衡量中医药治疗阳痿的临床研究质量,从而客观地评价中医药治疗阳痿的临床疗效。方法按照临床流行病学/DME和循证医学的原则,采用统一编制的《中医药治疗性文献系统质量评价及信息采集表》,对1989～2008年发表的阳痿中医药治疗性文献进行质量评价。结果检索到符合标准的随机对照试验文献共72篇,虽均有提及随机、random、随机分组等字样,但只有7篇说明了具体的随机分配方法;8篇采用盲法。72篇文献均未说明样本含量的估算及失访、退出病例;有不良反应观察的共11篇;有随访的1篇。在组间均衡性分析及疗效评价、结论推导等方面还存在很大的不足。结论中医药治疗阳痿的临床研究在科研设计和实施方面仍存在着很多问题,其研究的方法学设计有待加强。     

Review of the Regulations for Clinical Research in Herbal Medicines in USA

In 2012,USA Food and Drug Administration（FDA） approved 39 new drugs,however,there are only two botanical drugs（one topical and one oral）approved by FDA since the publication of the FDA＇s industry guidelines for the botanical drug product in June 2004.The approval shows the Western guideline can be used for herbal medicines,authors investigate current regulation on herbal medicine clinical research,identify challenges conducting clinical trials,and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area.Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials.Authors critically explore case study of the 1st FDA approved botanical drugs,Veregen（sinecatechins）,green tea leaves extract,a topical cream for perianal and genital condyloma.In consideration of current regulation environment in USA,based on the findings and analysis through the literature review and Veregen case study,authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considerina in a herbal medicine clinical trial.     

A Summary and Evaluation of Current Evidence for Myocardial Infarction with Chinese Medicine

Objective: To provide evidence-based recommendations for clinical application and provoke thoughts for future researchers by conducting a comprehensive summary and evaluation of the current evidence profile for the role of Chinese medicine(CM) in treating myocardial infarction(MI). Methods: Online databases including Pub Med, EMBase, Cochrane Library, Chinese National Knowledge Infrastructure(CNKI), Chinese Biomedical Medicine(CBM), VIP Journal Integration Platform, and Wanfang database were systematically searched for literatures on CM in treating MI. After screening, studies were categorized into 5 types, i.e. systematic review(SR), randomized controlled trial(RCT), observational study, case report and basic research. General information was abstracted, and the quality levels of these studies and their conclusions were summarized and assessed. Results: A total of 452 studies including 10 SRs, 123 RCTs, 47 observational studies, 28 case reports, and 244 basic researches were selected. Clinical studies centered primarily on herbal decoction and mostly were not rigorously performed. High-quality studies were predominantly on Chinese patent medicines(CPMs) such as Danshen Injection(丹参注射液), Shenmai Injection(参麦注射液), Shengmai Injection(生脉注射液) and Qishen Yiqi Dripping Pills(芪参益气滴丸). The most frequently observed pattern of drug combination was decoction plus injection. Results of SRs and clinical studies showed that CM may reduce mortality, decrease risk of complication, reduce myocardial injury, improve cardiac function and inhibit ventricular remodeling. Findings from basic researches also supported the positive role of CM in reducing infarct size and myocardial injury, promoting angiogenesis, preventing ventricular remodeling and improving cardiac function. According to the current evidence body, CM has proven effects in the prevention and treatment of MI. It is also found that the effects of CPMs vary with indications. For instance, Shenmai Injection has been found to be especially effective for reducing the incidence of acute clinical events, while CPMs with qi-nourishing and bloodcirculating properties have been proven to be effective in inhibiting ventricular remodeling. High quality evidence supports the use of CM injection for acute MI and CPM for secondary prevention. Reports on adverse events and other safety outcomes associated with CM for MI are scarce. Conclusions: Sufficient evidence supported the use of CM as an adjuvant to Western medicine for preventing and treating MI. The choice of drug use varies with disease stage and treatment objective. However, the quality of the evidence body remains to be enhanced.     

中草药临床研究的评价

补充替代医学正被广泛应用,并呈现出良好的增长趋势。随着寻求补充替代医学疗法的人口比例的增长,无论是补充替代医学被单独使用,还是与传统的对抗疗法联合应用,对补充替代医学临床报告质量的研究变得日益迫切。大部分这种质量研究是针对那些主要目的在于为临床医师提供参考的临床研究报告,我们发现,在解释临床研究的结果及其意义时,人们不得不面对其方法学质量低劣的问题。如何解决这个问题,将是我们面临的巨大挑战。临床医师要有效地利用这些科学研究的文献,就必须熟悉循证医学的基本原则。本文的目的在于向临床医师介绍临床研究评价的概念,使他们在阅读研究论文时能带着评判的眼光,以便更好地评价论文中的研究结果,并将其合理地运用到自己的日常医疗实践中去。本文主要讨论了以下六个方面的问题:(1)循证医学的基本原理;(2)临床研究的类型;(3)证据的分级;(4)应用临床试验报告统一标准评价随机对照试验报告的质量;(5)随机对照试验方法学质量的评分;(6)中草药临床研究质量评价的有关问题。     

循证医学与临床医学教育观念的更新

循证医学（Ｅｖｉｄｅｎｃｅ－ＢａｓｅｄＭｅｄｉｃｉｎｅ,ＥＢＭ）是诞生于２０世纪９０年代的一门新兴医学科学,其核心思想是将临床医学研究结果进行系统全面的综合评价,为临床医疗实践,科研、卫生决策和医学教育提供可靠的科学依据,传统的临床医学教育观念已不适应ＥＢＭ时代的要求,以问题为基础的循证医学的临床教育观念和教学模式,是当今临床医学发展的必然趋势。它将对临床教学和临床实践产生重大而深远的影响。     

中西医结合治疗糖尿病肾病疗效的系统评价

目的:运用循证医学的方法,评价中西医结合治疗糖尿病肾病(DN)的疗效。方法:收集中西医结合与单纯西医药治疗DN的随机对照试验(RCT)和半随机对照试验(CCT),评价纳入试验的质量,采用Revman4.2.2软件进行Meta分析。结果:纳入69篇RCT和1篇CCT,全部论文被评为C级。Meta分析结果显示:与单纯西医药治疗相比,中西医结合治疗可进一步减少DN的尿白蛋白排泄率、24h尿白蛋白排泄量、24h尿蛋白定量、尿素氮、血清肌酐,提高内生肌酐清除率和总有效率。结论:中西医结合治疗优于单纯西医药治疗,但由于本系统评价所纳入研究存在方法学上的缺陷,加之评价的主要是DN相关的实验室指标,而非终点指标,所以中西医结合治疗DN的疗效尚需进一步研究。     

清开灵注射液治疗急性中风的Meta分析

背景：中医药学几千年来各界了许多治疗中风有产的疗法和方药,如清开灵注射液（）简称清开灵）等,但因临床研究对方法学的重视仍不够,影响了研究结论的推广和国外医学界的承认。循证医学及系统分析的方法和结果日益得到了国际医学界和卫生决策部门的认可与重视,利用循证医学,系统分析的方法,拿出Ｍｅｔａ分析等数据,将极寺地促进中医药走向世界。目的：在严格的质量评价的基础上,对清开灵的临床疗与安全性进行系统评价。     

痰热清注射液治疗急性气管-支气管炎随机对照试验的系统综述及文献质量评价

目的：系统综述痰热清注射液治疗急性气管-支气管炎的临床疗效及安全性,分析随机对照试验报告的质量。方法：采用系统综述的方法,利用Jadad计分表及CONSORT for TCM评价纳入文献的质量;纳入的文献按不同治疗策略进行分层,评价其临床结果。结果：符合纳入标准的文献共10篇。其中2篇有纳入标准,4篇有排除标准,无1篇文献对样本量估算以及随机化相关细节进行说明,无1篇文献应用盲法设计。仅报道2例与痰热清注射液可能有关的不良事件。结论：①纳入的随机对照试验文献存在未充分说明随机方法、纳入标准、排除标准,未进行样本量估算及盲法设计等不足,尚不能对痰热清注射液治疗急性气管-支气管炎的临床疗效提供确切的循证依据。②痰热清注射液有可能引发变态反应的风险,需加以防范,过敏体质者应慎用。     

A Reflection on the 2017 Nobel Prize for Physiology and Chinese Medicine

Research on the molecular mechanisms controlling circadian rhythm in Western medicine is comparable to the study of a day-night rhythm in Chinese medicine (CM), as also focus on the same life phenomenon. By comparing the two, this paper elaborates on the differences between them in their respective issues of consciousness, ways of thinking, research methods and research results. Relatively speaking, Nobel Prize research has a stronger sense of the problems and concerns about the essence of "what", while CM focuses on "how a thing functions". The former mainly adopts experimental and mathematical methods, while the latter primarily depends on observation and understanding. The natural philosophy and natural science eventually lead to the results and the inevitable, quantitative and qualitative differences. Research on the life rhythm in CM should be proposed, scientific problems should be fully grasped, and research should be carried out with the aid of multidisciplinary new knowledge and new achievements through cross-disciplinary studies. On the basis of clinical epidemiological research and experimental research, a systematic review should be made of the human physiology of CM and the pathological rhythm model to explore the regulatory mechanism of time rhythm and create a new theory of time medicine.     

Recent Highlights of Experimental Research for Inhibiting Tumor Growth by Using Chinese Medicine

To give an overview of contemporary experimental research using Chinese medicine (CM) for the treatment of cancer. As an integral part of mainstream medicine in the People''s Republic of China, CM emphasizes improvements in holistic physical condition instead of merely killing tumor cells, which is consistent with the current medical model that advocates patient-oriented treatment. Great progress has been made in experimental research, and the principle aspects include anti-tumor angiogenesis, inducing apoptosis and differentiation, reversing multidrug resistance, and improving immune function. As a current hot topic in cancer research, tumor microenvironment (TME) highlights the mutual and interdependent interaction between tumor cells and their surrounding tissues, and the CM treatment concept bears a striking resemblance to it. To date, primary points of TME include extracellular matrix remodeling, inflammation, hypoxia, and angiogenesis, but trials using CM with a focus on TME are rare. Despite considerable recent development, experimental research on CM for solving cancer issues appears insufficient. Greater efforts in this field are urgently needed.     

Individual Patient Data Meta-Analysis Is Needed in Chinese Medical Research

Publication biases and collection limitations are the main disadvantages of a traditional meta-analysis based on aggregate patient data（APD）from published articles.Individual patient data（IPD）meta-analysis,as the gold standard of systematic review,is a possible alternative in this context.However,the publications relative to IPD meta-analyses are still rare compared with the traditional ones,especially in the research oriented to Chinese medicine（CM）.In this article,the strengths and detailed functioning of IPD meta-analysis are described.Furthermore,the need for IPD meta-analysis to assess the treatments based on CM was also discussed.Compared with the traditional APD meta-analysis,the IPD meta-analysis might give a more accurate and unbiased assessment and is worth to be recommended to CM researchers.     

特发性膜性肾病中医临床实践指南（2021）

特发性膜性肾病占我国肾小球疾病的24.9%，已跃居第二位且比例有逐年增高趋势。中医药治疗已广泛应用于特发性膜性肾病的临床实践中，然而目前尚无中医治疗膜性肾病的循证实践指南。本指南按照国际指南制订方法与步骤，证据质量及推荐意见强度使用GRADE方法，通过访谈国医大师以及广东省名中医，确定指南范围、形成临床问题提纲；基于访谈结果和现有中西医肾病指南、权威教材以及临床研究文献的系统梳理和回顾的结果拟定临床问题、膜性肾病临床疗效评价指标以及中医证型的调查清单，在全国范围内进行专家调查；然后针对临床问题检索到的证据进行质量评价，并举行专家共识会议，最终形成关于中医治疗特发性膜性肾病的10条推荐意见。本指南聚焦于中医治疗特发性膜性肾病的临床实践，适用于各级中医/中西医结合医疗机构以及开展中医药服务的医疗机构及医务工作者。     

循证医学对临床医学教育观念的影响

循证医学是 2 0世纪末期医学领域的一门新兴科学 ,其核心内容是将当今所能获得的最好的研究证据、医生个人专业技能和多年的临床经验以及病人的价值和愿望 ,进行系统全面地综合评价 ,为临床医疗、科研、卫生决策和医学教育提供可靠的科学依据。现代医学模式已经从经验医学向循证医学转化 ,临床医学教育也应该适应现代医学模式的需要从根本上转变教育观念