对“丹参”增加急性心力衰竭患者出血风险研究的商榷

Discussion on Higher Bleeding Risk with Salvia Miltiorrhiza for Acute Heart Failure

因近期国外期刊发表了1篇有关“中药治疗急性心力衰竭的临床研究”文章,发现丹参与院内出血及死亡增加存在相关性,一时引起医学界对中药安全性的广泛讨论。笔者研读原文后发现,该研究为横断面研究,无法得出因果关系推断;文中的“丹参”并不是某一种药物或成分,而是包含多种产品,甚至人参、红参皆归入“丹参”之属;定义的“死亡”将治疗撤出与院内死亡合二为一。鉴于该研究的研究类型及方法学缺陷,笔者认为该文无法得出丹参增加急性心力衰竭患者院内出血及死亡的结论。

Recently a research paper focusing on treatment of acute heart failure(AHF) by Chinese materia medica(CMM) published abroad found that inpatients bleeding and mortality were highly related with Salvia Miltiorrhiza(SM). After controversial results published, general concerns have been raised about the safety of CMM. However, this research belongs to cross-sectional study, which can′t be used for causality deduction. Moreover, there were sharply different products in SM group, even including ginseng and ginseng rubra. In addition, withdrawal of care and in-hospital mortality were defined as the composite outcomes. Given the research type and methodological weakness, authors believe that this paper is far from enough to demonstrate unsafety of SM.