杞菊地黄丸治疗原发性高血压临床疗效与安全性系统评价

Systematic review of clinical efficacy and safety of Qiju Dihuang pills in treating essential hypertension

目的:系统评价杞菊地黄丸(汤)治疗原发性高血压的有效性和安全性。方法:搜集杞菊地黄丸治疗原发性高血压的随机对照试验,按照Cochrane协作网推荐的方法评价纳入研究的方法学质量,运用RevMan 5.1软件完成异质性检验,Meta-分析,敏感性分析,倒漏斗图分析等相关统计分析。结果:共纳入10项合格研究,共计1 033例患者,纳入研究方法学质量普遍较低,Meta-分析结果显示杞菊地黄丸与西药常规治疗相比降压疗效总有效率RR=1.09,95%CI[1.00,1.18],无显著性差异;改善中医证候表现总有效率RR=1.51,95%CI[1.15,1.98],有显著性差异;未见关于杞菊地黄丸不良反应的报道;倒漏斗图分析显示不对称。结论:现有证据尚不能证实杞菊地黄丸可提高降压疗效,但可显著改善患者中医证候表现,且较为安全,低质量的原始研究和研究间异质性影响了本系统评价的可靠性,有必要开展高质量、多中心、大样本的随机对照试验进一步评价。

Objective：To systematically assess the clinical efficacy and safety of Qiju Dihuang pills（QDP） in treating essential hypertension（EH）. Methods：Randomized controlled trials（RCT） of QDP in the treatment of EH were retrieved. The methodologi- cal quality of trials were assessed according to the criteria recommended by the Cochrane Handbook for Systematic Reviews of interventions, heterogeneity test,meta-analyses,sensitivity analyses and funnel plot analyses were performed by the Review Man- ager 5.1.2 software. Results：Ten qualified trials involving 1 033 patients were included. The methodological quality of these tri- als was low. Meta-analyses indicated that there was no statistical significance between QDP and western medicine in antihyper- tensive efficacy（relative risk（RR）l.09,95% confidence interval（C/）[1.00,1.181） and there was statistical significance in im- proving the syndrome of TCM（RR=l.51,95%CI[1.15,1.98]）. No adverse reaction was reported about QDP. Funnel plot was asymmetry. Conclusion ：Existing evidences fail to confirm that QDP can enhance the antihypertensive efficacy,yet it can signifi- cantly improve the syndrome of TCM. The reliability of systematic review is affected by the low quality of primary studies and heterogeneous. Further reasonably designed,multi-center and large-scale RCT should be carried out.