大样本随机临床试验与循证医学

近二十年来,国际临床医疗模式发生了重大变化,由过去以经验为基础的医疗模式逐渐转变为以证据为基础的医疗模式。以证据为基础的医疗模式也称为循证医学或求证医学（ｅｖｉｄｅｎｃｅｂａｓｅｄｍｅｄｉｃｉｎｅ）。循证医学要求客观公正地评估某种治疗药物对患者生活质量的远期影响和生存率的影响。评估某种治疗药物好坏的标准有若干条,但最主要的是对病人生存率的影响及长期生活质量的影响。新药上市之前,要经过严格的Ⅰ,Ⅱ期临床试验,以观察药物对患者的数周或数月的治疗效果,观察指标往往是某种疾病的一种或几种临床表现（症状、…     

发挥优势开拓创新——试析循证医学中的内分泌临床试验

循证医学具有完整的临床试验体系，有系统综述和荟萃分析，其中随机、对照、双盲的临床试验在循证医学中处于核心地位。发挥我国临床试验的优势，积极参与国际临床合作研究。     

循证卒中医学

临床真实性与临床对照试验的方法相互影响的持续存在是很理想的。一项良好的试验设计应能反映医生、特别是患者的观点，相反，熟悉临床试验也能改进日常工作方法。换句话说，每种方法学原理都源于临床实践。例如：随机化(建设性的怀疑作为其实践的对象)、独立性(对医药公司善意的不信任)、知情同意(让患者了解不确定性)、I类错误(在一项试验后不错误的乐观)、Ⅱ类错误(在一项试验后不错误的悲观)、选择正确的转归指标(恰当性比准确性更重要)、意向处理原则(注重实效的分析)以及亚组分析的危险性(“我的最后一例患者综合征”)。     

循证卒中医学

临床真实性与临床对照试验的方法相互影响的持续存在是很理想的。一项良好的试验设计应能反映医生、特别是患者的观点,相反,熟悉临床试验也能改进日常工作方法。换句话说,每种方法学原理都源于临床实践。例如:随机化(建设性的怀疑作为其实践的对象)、独立性(对医药公司善意的不信任)、知情同意(让患者了解不确定性)、Ⅰ类错误(在一项试验后不错误的乐观)、Ⅱ类错误(在一项试验后不错误的悲观)、选择正确的转归指标(恰当性比准确性更重要)、意向处理原则(注重实效的分析)以及亚组分析的危险性(“我的最后一例患者综合征”)。     

循证心血管医学——从临床试验到临床实践

传统的临床医学模式以经验和推理为基础。它评价药物或非药物治疗手段所用的指标是临床替代终点 (ｃｌｉｎｉｃａｌｓｕｒｒｏｇａｔｅ)或替代终点 (ｓｕｒｒｏｇａｔｅｅｎｄ ｐｏｉｎｔ) ,例如血压、血流动力学、血液生化指标 (血糖、血脂等 )、心律失常 (室性早搏、非持续性室性心动过速、心房颤动等 )。但近年来 ,国际上许多大规模多中心前瞻性双盲安慰剂对照的临床试验的结果表明 ,不少治疗手段对临床替代终点的影响与该手段对病人预后终点 (ｏｕｔｃｏｍｅｅｎｄ ｐｏｉｎｔ)的影响并不平行 ,并且一些对临床替代指标有明显“治疗效果…     

我国糖尿病合并高血压治疗临床试验文献的循证医学分析

目的分析国内开展糖尿病合并高血压治疗临床试验研究文献的质量,为今后开展临床试验研究提供建议和方向。方法查阅我国1978年～2009年有关糖尿病合并高血压治疗的临床试验研究文献,利用循证医学的原理,对这些临床试验研究文献进行定性、定量评价。结果130篇糖尿病合并高血压治疗临床试验研究文献被选为研究对象。结论我国越来越重视糖尿病合并高血压治疗的临床试验研究,有关这方面的文献逐年增多,尤其降压药物联合治疗糖尿病合并高血压的文献更多,研究质量逐渐提高,但临床研究中简单临床结局报告过多,创新性研究少,绝大部分都没有严格按照随机、双盲、对照、多中心的原则进行实验设计,更没有统一的疗效标准,使得结果与结论不够客观、可靠,并且缺乏可比性,影响了国内外学术交流。我国糖尿病合并高血压治疗临床试验研究文献的质量有待提高。     

注重临床试验向临床实践的转化

美国心脏病协会 (AHA)主席RobertRonow在 2 0 0 2年第 2 5届美国心脏病学年会开幕式致辞中提出一个崭新的理念 ,指出现代医生的两大任务是探索新的知识 ,并注重将其转化为临床实践 (Todiscovernewknowledgeandtransferittoclinicalpracticeandtothecommunity) ,使大众受益。现就以下 3方面加以阐述。1　循证医学模式的重要性目前的医学模式已经从以经验和推理为基础的传统医学模式转化为以证据为基础的循证医学模式。所谓循证医学 ,即应用最多的有关信息 (最佳的证据 ) ,通过谨慎、明确和明智的确认和评估 ,作出医学方面决策的实践活动 (…     

治疗心力衰竭的循证医学进展

心力衰竭(心衰)至今仍是心血管疾病重要致死的终极病变,为了让读者能了解这方面近年的进展,我们在2005年美国和欧洲的心衰治疗指南基础上,回顾关于心衰的临床试验和相关循证医学治疗概况.     

循证医学与心血管康复医学

1992年正式诞生循证医学 (EBM,evidence- basedmedicine) [1 ] 。在随后的岁月中它对医学模式的转变 ,医学实践的指导 ,以及预防、临床和康复医学的理念更新起到了重要的作用 ,并且正以其特有的优势日益受大重视。在心血管预防和临床医学领域已有大量事实证明循证医学的优越性。心血康复医学在我国作为一个新的医学领域也将在循证医学的指导下 ,快速发展 ,造福人类。1　循证医学与传统的医学模式传统的临床医学模式以经验和推理为基础 ,认为来自非系统观察的临床经验是判断患者预后、疗效及评价诊疗方法的可靠途径 ,只需掌握疾病的发病机…     

循证医学在心胸外科临床教学中的应用

目的探讨在心胸外科本科临床教学中使用循证医学(EBM)方法教学对学生临床和研究能力的影响。方法教学中根据所选病例提出问题,让学生查找书本、专著和文献资料并讨论分析出最佳临床处理方案。结果大部分学生通过EBM教学,临床、研究能力和考试(考核)成绩都得到显著提高。结论 EBM应用于临床教学有利于培养学生的1临床思维和科研能力,值得推广。     

重视循证医学在消化系疾病中的应用

循证医学（Evidence—based medicine，EBM）即遵循证据的医学，是一门新兴交叉临床医学基础学科。著名临床流行病学家，循证医学创始人之一David Sackett教授在2001年，重新修订循证医学的定义为“慎重、准确和明智地应用当前所能获得的最佳研究依据；同时结合医生的个人专业技能和临床经验；考虑患者的价值和愿望，将三者完美地结合制定出患者的治疗措施”。     

循证医学对糖尿病诊断的贡献及目前存在的分歧

主要根据几项探讨负荷后血糖水平与糖尿病特征性视网膜病变发生率之间关系的前瞻性流行病学研究，美国国家糖尿病数据组（NDDG）/世界卫生组织（WHO）（1979/1980）提出了以口服葡萄糖耐量试验（OGTT）2h血糖水平作为糖尿病诊断的依据。得到全球的公认。美国糖尿病学会（ADA）/WHO（1997/1999）根据20世纪80年代初以后多项OGTT2h血糖与空腹血糖（FPG）水平之间相互关系的流行病学研究，将糖尿病FPG诊断标准下调至7.0mmol/L，但对是否应用OGTT于糖尿病的诊断存在分歧，有待更多的循证医学研究予以解决。     

Teaching residents evidence-based medicine skills

OBJECTIVES: To measure the effectiveness of an educational intervention designed to teach residents four essential evidence-based medicine (EBM) skills: question formulation, literature searching, understanding quantitative outcomes, and critical appraisal. DESIGN: Firm-based, controlled trial. SETTING: Urban public hospital. PARTICIPANTS: Fifty-five first-year internal medicine residents: 18 in the experimental group and 37 in the control group. INTERVENTION: An EBM course, taught 2 hours per week for 7 consecutive weeks by senior faculty and chief residents focusing on the four essential EBM skills. MEASUREMENTS AND MAIN RESULTS: The main outcome measure was performance on an EBM skills test that was administered four times over 11 months: at baseline and at three time points postcourse. Postcourse test 1 assessed the effectiveness of the intervention in the experimental group (primary outcome); postcourse test 2 assessed the control group after it crossed over to receive the intervention; and postcourse test 3 assessed durability. Baseline EBM skills were similar in the two groups. After receiving the EBM course, the experimental group achieved significantly higher postcourse test scores (adjusted mean difference, 21%; 95% confidence interval, 13% to 28%; P<.001). Postcourse improvements were noted in three of the four EBM skill domains (formulating questions, searching, and quantitative understanding [P<.005 for all], but not in critical appraisal skills [P=.4]). After crossing over to receive the educational intervention, the control group achieved similar improvements. Both groups sustained these improvements over 6 to 9 months of follow-up. CONCLUSIONS: A brief structured educational intervention produced substantial and durable improvements in residents’ cognitive and technical EBM skills. Presented in part at the annual meeting of the Society of General Internal Medicine, San Francisco, Calif, April 30, 1999. The Department of Medicine of Cook County Hospital provided all funding and support for this project.     

肠易激综合征药物治疗的循证医学评价

肠易激综合征是肠道动力和感觉异常的功能性肠病,人群患病率较高,但发病机制仍然不明,目前认为与胃肠动力异常、内脏感觉过敏、脑一肠轴改变、精神心理异常等多种因素有关。治疗IBS的药物种类较多,但主要是缓解症状,改善患者生活质量。目前评价治疗肠易激综合征药物疗效的临床试验越来越多,本文从循证医学的角度总结了近期有关6种主要药物（包括解痉剂、导泻药、止泻剂、肠道动力感觉调节剂、微生态制剂和抗抑郁药）的临床试验和综述,评价其疗效和安全性。     

The use of evidence-based medicine in the practice of consultant physicians. Results of a questionnaire survey

Abstract Background: Information is lacking about the extent to which Australasian physicians apply methods of evidence‐based medicine (EBM) in routine practice. Aims: To assess the frequency and predictors of use of EBM methods in a sample of consultant physicians in adult medicine. Methods: Self‐administered questionnaires were distributed to a convenience sample of 545 physicians from October 1998 to January 1999. Results: One hundred and eleven questionnaires were returned (20% response rate). Ninety‐eight (88%) respondents formulated five or less clinical questions per week; 69 (62%) undertook five or more evidence searches per week, the majority as MEDLINE searches involving therapeutic topics. Respondents identified insufficient time (74%), limited search skills (41%), and limited access to evidence (43%) as search impediments. In determining evidence quality, 37% frequently relied on global impressions, while 22% frequently applied explicit critical appraisal (p=0.008). Efficiency of literature searches was rated on average as good/very good by 18%, fair by 52% and poor by 30%. As a result of EBM, 47% frequently had confidence in pre‐existing decisions increased, 39% gained improved knowledge, and 5% altered clinical decisions. Frequently encountered inhibitors to changing practice were personal conservatism (40%), organisational constraints (40%), and interdisciplinary tensions (39%). Perceived weaknesses of EBM included: limited applicability to individual patients (26%); evidence deficiencies (25%); and too time consuming (13%). In making EBM more attractive, one third requested reliable evidence sources at the point of care. Conclusions: The application of EBM to routine practice by physicians is constrained by deficient EBM skills, limited access to evidence, lack of time, and cognitive and environmental factors. Targeted education in EBM and systems that quickly deliver high‐quality evidence at the point of care are needed in realising the full potential of EBM to improve care.     

从科学证据到临床实践

从1992年加拿大McMaster大学循证医学工作组第一次提出“循证医学”这一名词和概念至今只有短短十五年时间，循证医学已经在世界各地蓬勃发展，其原理内容的阐述以及方法学的探索一直在日新月异的完善和发展，它对医疗实践和卫生决策产生了积极重大的影响，得到了卫生工作者的普遍认同。     

Irritable bowel syndrome: Pathogenesis,diagnosis, treatment,and evidence-based medicine

Irritable bowel syndrome(IBS)is a chronic and debilitating functional gastrointestinal disorder that affects9%-23%of the population across the world.The percentage of patients seeking health care related to IBS approaches 12%in primary care practices and is by far the largest subgroup seen in gastroenterology clinics.It has been well documented that these patients exhibit a poorer quality of life and utilize the health care system to a greater degree than patients without this diagnosis.The pathophysiology of IBS is not clear.Many theories have been put forward,but the exact cause of IBS is still uncertain.According to the updated ROMEⅢcriteria,IBS is a clinical diagnosis and presents as one of the three predominant subtypes:(1)IBS with constipation(IBS-C);(2)IBS with diarrhea(IBS-D);and(3)mixed IBS(IBS-M);former ROME definitions refer to IBS-M as alternating IBS(IBS-A).Across the IBS subtypes,the presentation of symptoms may vary among patients and change over time.Patients report the most distressing symptoms to be abdominal pain,straining,myalgias,urgency,bloating and feelings of serious illness.The complexity and diversity of IBS presentation makes treatment difficult.Although there are reviews and guidelines for treating IBS,they focus on the efficacy of medications for IBS symptoms usinghigh-priority endpoints,leaving those of lower priority largely unreported.Therefore,the aim of this review is to provide a comprehensive evidence-based review of the diagnosis,pathogenesis and treatment to guide clinicians diagnosing and treating their patients.