黄芪注射液治疗慢性心力衰竭“随机”对照试验报告质量评价  

Reporting Quality Assessment of Huangqi Injection for Chronic Heart Failure Randomized Clinical trials

作　　者：付姝菲[1] 张俊华[1] 刘洋[1] 王小莹[1] 

机构地区：[1]天津中医药大学中医药研究院方剂学重点实验室临床评价中心,天津300193

出　　处：《辽宁中医杂志》2009年第10期1713-1715,共3页Liaoning Journal of Traditional Chinese Medicine

基　　金：国家科技支撑计划资助项目(2007BAI47B01);天津市科技创新专项资金资助项目(07FDZDSH01011)

摘　　要：目的:评价黄芪注射液治疗慢性心力衰竭的随机对照试验报告质量。方法:检索包括PubMed,Cochrane Central Register of Controlled Trials,EMBASE,中国生物医学文献数据库,中国期刊全文数据库等电子文献数据库同时配合手工检索,广泛收集黄芪注射液治疗慢性心力衰竭的随机对照研究。根据《中医药临床随机对照试验报告规范(征求意见稿)》制定黄芪注射液治疗慢性心力衰竭的报告质量评价表,对符合纳入标准的文献进行描述性分析。结果:共有107篇报道为"随机"对照试验的文献被纳入评价。根据评价表的22项原则逐一进行评估。全部文献文题表述均不完整,54篇(50.5%)文献有摘要,仅有26篇(24.3%)文献有引言。77篇(72.0%)文献没有明确的纳入及排除标准,11篇(10.3%)文献未提及诊断标准,无1篇文献记录知情同意书签署及伦理委员会审批情况,所有研究均未提及确定样本量的依据和终止试验的原则。91个(85.0%)研究没有说明随机序列产生的方法。32个(29.9%)研究未说明采用何种统计学方法。79个(73.8%)研究从性别、年龄、心功能等方面描述了基线情况。54个(50.5%)研究对试验中的不良反应进行了报道。30个(28.0%)研究提出了试验结果具有可推广性。所有研究均未提及研究者与试验的相关利益冲突。结论:通过对纳入的107篇文献评估发现,大部分研究者对临床试验方案的设计及实施报道不明确,特别是在方法学方面存在较多问题。Objective： To assess the reporting quality cf Huangqi Injection for chronic heart failure randomized clinical trials. Methods ： An extensive search including PubMed, Cochrane Central Register of Controlled Trials, EMBASE and other Chinese literature databases was performed up to July 2008. Clinical trials about Huangqi injection for the treatment of chronic heart failure were searched. The reporting quality of each trial was assessed according to the Consolidated Standards for Reporting Trials of Traditional Chinese Medicine （CONSORT for TCM） （For Solicitation of Comments）. Results：There are 107 reports included in the assessment according to the 22 items of the CONSORT for TCM. All the statements of the titles were not complete. 54 （50. 5% ） reports included abstracts. Only 26（24. 3% ） reports included introduction. There were not clearly statements of the inclusion and exclusion criteria in 77（72.0% ） studies. The diagnostic criteria of the disease were not mentioned in 11 （ 10. 3% ） reports. All the studies reported without the informed consent and ethics committee approval of the situation. None of the studies explain the rationale of sample size determined and the principle of study termination. The methods used to generate the random allocation sequence were not mentioned in 91 （85.0%） studies. 32（29. 9% ） studies did not report the statistical methods. Baseline demographic and clinical characteristics were reported in 79（73. 8% ） studies. All important adverse events and side effects were mentioned in the 54 （50. 5% ） studies. 30 （28. 0% ） studies reported the external validity. The conflict of interest between investigators and study were not mentioned in all of the studies. ConciSion：Through the assessment of 107 reports it indicated that most of the study design and implement were not clear especially the methodology.

关 键 词：黄芪注射液 慢性心力衰竭 CONSORT for TCM 报告规范 

分 类 号：R720.597[医药卫生—急诊医学]