黄芪注射液治疗糖尿病肾病随机对照试验报告质量评价  

Quality Evaluation of the Report for Randomized Controlled Trials of HuangQi Injection in Treating Diabetic Nephropathy

作　　者：任芳[1,2] 徐厚谦[1] 

机构地区：[1]甘肃中医学院,甘肃兰州730000 [2]金昌市第一人民医院内科

出　　处：《西部中医药》2013年第12期1-4,共4页Western Journal of Traditional Chinese Medicine

摘　　要：目的:应用CONSORT标准评价Jadad评分≥3分的有关黄芪注射液治疗糖尿病肾病的RCT报告质量。方法:按照Cochrane协作网制定的检索策略检索出2013年1月以前的所有有关黄芪注射液治疗糖尿病肾病的随机和半随机对照临床试验。应用CONSORT声明和一些中医药评价指标对Jadad评分≥3分的RCT文献的报告质量进行综合评价。数据提取和文献方法学质量评价由2名评价人员独立完成,如有争议通过讨论或由主要研究者解决。结果:共检出480篇文献,只有16篇RCT符合纳入标准。在纳入的16篇RCT中,含诊断标准的有16篇,占100.0%;说明详细用药方案及疗程的有14篇,占87.5%;正确地说明随机分配方法的有11篇,占68.75%;说明统计学方法的有15篇,占93.75%;描述对象纳入期间的有12篇,占75.0%;描述各组基线资料的有14篇,占87.5%;提及退出/失访例数的有5篇,占31.25%;提及不良反应的有9篇,占56.25%;描述中医证型的只有1篇,占6.25%。没有1篇文献提及样本含量的估计、分配方案的隐藏和实施、受试对象流程图,意向性治疗分析和终点指标观察。结论:大部分RCT的方法学及结果部分报告不够详细,建议尽量按照CONSORT标准来报告RCT以提高RCT的报告质量和真实性。Objective： To evaluate the quality of randomized controlled trial （RCT） report about HuangQi in- jection in treating diabetic nephropathy （DN） with Jadad scales 〉 three points by CONSORT standard. Method： All the papers of randomized and semi-randomized controlled clinical trials about HuangQi injection in treating DN were searched before January, 2013, quality of RCT report with Jadad scales ≥ three points was assessed comprehen- sively by CONSORT statement and some TCM indexes. Data extraction and quality evaluation of literature method- ology were performed by two judges independently. If there was the dispute, it should be solved through discussion or main investigators. Result： Altogether 480 articles were detected, and only 16 pieces met the standard. Among 16 included articles, there were 16 articles with diagnostic criteria, which accounted for 100.0%; 14 ones with detailed medication plan and the course of the treatment, which reached 87.5%; 11 ones with right demonstration of random- ized distribution method, and 68.75%; 15 with the presentation of statistical method, and 93.75%; 12 pieces with the description of the included objects and 75.0%; 14 ones describing baseline information in different groups and 87.5%; five pieces referring to the number of the cases quit or dropped, and 31.25%; nine articles talking about ad- verse reactions and 56.25%; only one piece discussing TCM patterns and 6.25%. There was no article mentioning the estimate of samples contents, the hide and implementation of distribution plan, flowchart of the objects, inten- tion-to-treat analysis and observation of endpoint indexes. Conclusion： Since methodology and results for most of the RCT are not reported in detail, we suggest that RCT should be reported according to CONSORT standard to improve the quality and the authenticity of RCT.

关 键 词：黄芪注射液 糖尿病肾病 随机对照试验 CONSORT声明 报告质量评价 

分 类 号：R587.1[医药卫生—内分泌]