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目的评价《中国中西医结合杂志》刊登的中医药临床随机对照试验(RCT)的质量,并分析其变化。方法计算机检索CNKI数据库,查找《中国中西医结合杂志》2014年刊载的RCT。以CONSORT 2010清单评价纳入RCT的报告质量,同时分析其方法学质量及伦理学要求执行情况,并与2004年同类研究对比。结果共纳入80个RCT。干预措施排前3位的依次为中成药、汤剂、针灸。纳入RCT的条目报告符合率>80%的条目有摘要、受试者、随机序列、知情同意;条目报告符合率50%~80%的有引言、干预措施、危害、资助;其余条目报告符合率<50%。其中,文题、试验设计、结局指标、样本量、随机方法类型、分配隐藏、盲法、纳入分析的例数、结局与估计值、推广性、解释、试验注册与试验方案13个条目的报告符合率<10%。与2004年对比,报告质量、方法学质量、伦理学报告均有提高。在摘要结构化、背景和目的阐释、受试者纳入、不良反应、中医药干预措施质量控制标准、中医药诊断评估标准、随访、资助、伦理审批和知情同意方面进步显著;在随机设计类型、分配隐藏、随机化实施、样本量计算、盲法、意向性分析方面进步较小。但是,流程图的使用一直缺如。结论《中国中西医结合杂志》临床随机对照试验报告质量、方法学质量及伦理学要求执行较以往有进步,但试验设计、结局指标、样本量、随机化、盲法、试验注册及流程图的使用仍需进一步提高。
Objective To evaluate the quality of clinical randomized controlled trials (RCTs) published in Chinese Journal of Integrated Traditional and Western Medicine and analyze the changes. Methods The CNKI database was searched by computer to find out the RCT published in 2014 of China Integrative Medicine. Assess the quality of the RCTs included in the CONSORT 2010 checklist and analyze their methodological quality and ethical requirements, in comparison with similar studies of 2004. Results A total of 80 RCTs were included. The top 3 interventions followed by proprietary Chinese medicines, decoction, acupuncture. Entries included in the RCT have abstracts, subjects, randomized sequences, and informed consent for items meeting the rate of> 80%; introductions, interventions, endangerments, grants for articles meeting the 50% to 80% compliance report; <50%. Among them, the number of articles, experimental designs, outcome measures, sample sizes, types of randomization methods, distribution hiding, blinding, number of cases included, outcomes and estimates, generalizations, interpretations, reports of 13 trials of pilot registrations and trials The coincidence rate <10%. Compared with 2004, the report quality, methodology quality and ethics report all improved. Significant progress was made in summary structure, background and purpose interpretation, subject inclusion, adverse reactions, quality control standards for Chinese medicine interventions, diagnostic evaluation criteria of TCM, follow-up, funding, ethical approval and informed consent. In terms of randomized design type, Hidden distribution, randomized implementation, sample size calculation, blinding, intentions analysis of small progress. However, the use of flow charts has always been absent. Conclusion The quality of clinical randomized controlled trials, the quality of methodological and ethical requirements of the Chinese Journal of Integrated Traditional and Western Medicine have been improved over the past years. However, the experimental design, outcome measures, sample size, randomization, blinding, trial registration and flow chart Use still need to be further improved.