降压0号治疗原发性高血压有效性和安全性的系统评价

Compound anti-hypertensive tablets (No.0) for primary hypertension:a systematic review

目的评价降压0号治疗原发性高血压的有效性和安全性。方法制定严格的纳入和排除标准,全面检索相关数据库(CBMDISC,CNKI,维普,万方,Cochrane Library,MEDLINE,OVID,PubMed Central),并配合数据库外检索保证文献的查全率。由两名独立的摘录员对原始研究进行质量评价和信息摘录。利用Rev Man 4.2软件进行Meta分析,根据各原始研究间异质性大小选择随机/固定效应模型,并进行敏感性分析和亚组分析。结果共检索到相关文献649篇,经评价后19个研究包含2 434例患者符合研究的纳入标准,其中4篇为中等质量的研究,其余均为低质量的研究。有效性结果:降压0号组与常规药物组合并总有效率之比及其95%可信区间为1.02(0.98,1.05),两组差异无统计学意义(P=0.39);安全性结果:降压0号组与常规药物组合并不良事件发生率之差及其95%可信区间为-0.01(-0.03,0.02),两组差异无统计学意义(P=0.65)。结论根据目前研究证据,降压0号与其他常规降压药物相比疗效相近、不良事件的发生情况与其他常规降压药差异不明显,有较为可靠的疗效和安全性。为得到更加可靠的结论,开展更多设计严谨,大样本、多中心的随机对照实验进行验证和补充是必要的。

Objective To systematically review the efficacy and safety of Compound Anti-Hypertensive Tablets （No. 0） for primary hypertension. Methods The following databases were searched from their inception： Cochrane Library, MEDLINE, OVID, PubMed Central, CBMDISC, CNKI, VIP information and Wanfang Data Info Site. Experts were contracted for unpublished data. Two independent investigators extracted the detailed data and assessed study quality using pre-established criteria for different kinds of studies. Meta analysis was performed using Rev Man 4.2 software. Random or fixed effect models were used according to degree of heterogeneity. Sensitivity analyses and subgroup analyses were performed too. Results 649 related articles were collected following the searching strategies and 19 studies were eligible for inclusion. 1. As to the efficacy, there was no statistical significant difference between Compound Anti-Hypertensive Tablets （ No. 0） and other anti-hypertensive drugs （RR = 1.02, 95 % CI 0. 98 to 1.05, P = 0.39）. 2. For the safety, there was also no statistical significant difference between the research drug and the control （RD= -0.01, 95 % CI -0. 03 to 0.02, P = 0.65）. Conclusions Based on current evidence, Compound Anti-Hypertensive Tablets （No. 0） appears to have the same effect as other anti-hypertensive drugs without having more adverse events. However, multi-center large-scale randomized conrolled trials of higher quality are needed to to enrich current evidence.