生脉注射液治疗扩张型心肌病的临床随机对照试验质量评价

Quality assessment of randomized controlled trials on Shengmai injection in treating dilated cardiomyopathy

关键词:  生脉注射液  扩张型心肌病  随机对照试验  质量评价

Key words:  Shengmai injection  dilated cardiomyopathy  randomized controlled trial  quality assessment

摘要:

[目的] 调查生脉注射液治疗扩张型心肌病随机对照试验（RCT）文献质量。[方法] 采用 Jadad 评分量表与中医药临床随机对照试验报告规范（CONSORT for TCM）标准进行评价。[结果] 共检索到符合纳入标准的 RCT 文献16 篇。采用 Jadad 量表评分，其中1 分 14篇，0分 2 篇。无文章描述采用的随机序列方法，无 1 例报道如何执行分配隐藏，无1 篇文章提及盲法，无1篇文章提及退出与撤出情况。按照 CONSORT for TCM标准，仅 9 篇（56.30%） 描述了诊断标准， 1篇（6.25%） 提供了中医标准，1篇（6.25%）文章描述了终点指标，5 篇（31.30%） 描写了不良事件，均未进行样本含量计算、意向性分析和分层分析，均未报道伦理审查和知情同意情况。[结论] 目前生脉注射液治疗扩张型心肌病的临床研究中，在研究设计方法、文章报告全面性、质量等方面有待提高。

Abstract:

[Objective] To assess the quality of randomized controlled trial (RCT) reports of Shengmai injection in the treatment of dilated cardiomyopathy. [Methods] Using the Jadad scale and the CONSORT for TCM standard, the evaluation was performed. [Results] There were 16 articles of RCT met with the inclusion criteria. When the Jadad score was used 14 articles have 1 points and 2 articles have 0 points. There wasn't any article, in which the method using random sequence was described. No one report described how to perform the random concealment. There wasn't any article, in which the blind method was mentioned. There wasn't also any one, in which the withdrawal and withdrawal conditions were described. According to the standard of CONSORT for TCM, only 9 articles(56.30%) have described the diagnostic criteria. There was 1 article (6.25%), which has provided the standard of TCM. Only 1 article (6.25%), in which the standard of endpoint was described. Five articles (31.30%) have described the adverse events. All of them haven't performed the sample content calculation, the intentionality analysis and hierarchical analysis. All of them have not reported the ethics review and the condition of informed consent. [Conclusion] In the clinical study of dilated cardiomyopathy by the Shengmai injection, the method of research design, the comprehensive respects and quality of the reported article are needed to be improved