2000―2006年《中国针灸》杂志中RCT报告质量评价.doc

2000―2006年《中国针灸》杂志中RCT报告质量评价文章编号：0255-2930(2008)06-0439-04 中图分类号：R 245-0 文献标志码：A [摘 要] 评价《中国针灸》杂志中随机临床试验(RCT)报告的质量。 手工检索2000―2006 年《中国针灸》，筛选RCT文章，并对其采用《针灸随机临床试验报告资料提取表》进行质量评估。 共纳入686篇RCT文章，其方法学质量和国际标准相比有较大差距。仅有1篇RCT对试验流程进行描述；对其他影响RCT报告质量的内容报告也较少，如医师资历(3.06%)、不良反应(4.23%)、盲法(5.98%)、随访(14.43%)。结果表明针灸RCT在试验设计、实施过程和报告方面有待改进。 [关键词] 随机对照试验；期刊/统计学和数值数据；针灸学；@中国针灸 Critical appraisal of randomized clinical trials in Chinese Acupuncture and Moxibustion from 2000 to 2006 GENG Ling-ling1，LIN Ren-sheng1，SUN Xia-yun1，WU Li1，ZHONG Ming-ming1，ZHAO Bin1，ZHENG Jun1，Director： LIU Jian-ping2 (1.Faculty of Humanity and Social Sciences，2.College of Basic Medicine，Beijing University of CM，Beijing 100029，China) ABSTRACT：to assess the quality of randomized controlled trials (RCTs) published in Chinese Acupuncture and Moxibustion.Manually retrieve RCT papers published in Chinese Acupuncture and Moxibustion from 2000 to 2006 and use “the extraction form of acupuncture and moxibustion randomized clinical trial report data” to evaluate the quality of RCTs.Six hundred and eighty-six RCTs were enrolled.The methodological quality was lower than the international standard and only one RCT paper described the trial technological process.And there were a less reports about influencing RCT quality，such as acupuncturist′s qualification and education background (3.06%)，adverse reaction (4.23%)，blind method (5.98%) and follow-up (14.43%).RCTs on acupuncture and moxibustion published in Chinese Acupuncture and Moxibustion need to be improved in trial design，conduction and report. KEY WORDS：Randomized Controlled Trials；Periodicals/statist；Acup Mox Science；@Chinese Acupuncture and Moxibustion 循证医学强调医疗卫生决策要建立在科学证据的基础之上，强调从系统评价中获取依据，以使研究结论建立在具有说服力的、充足的证据基础上，从而使诊疗手段、方法更具有效性和安全性。近年来随着循证医学的普及，人们强调临床观察证据的可靠性，在临床试验中采用随机对照试验(RCT)设计逐渐增多。RCT是评价干预措施疗效的标准设计方案，对其报告质量的评价有助于改进研究设计，可以帮助我国的针灸临床研究提高试验的可信度，也是传播有效针灸疗法的方法。 《中国针灸》杂志是国内针灸杂志中最具有权威性的专业期刊，发表的文章能够代表国内针灸临床研究的水平。为了解近年来国内针灸RCT的实施及报告情况，笔者检索鉴定了