Zhang Dan, Wu Jiarui, Liu Shi, Zhang Xiaomeng, Zhang Bing
Department of Clinical Pharmacology of Traditional Chinese Medicine, School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Medicine (Baltimore). 2016 Dec;95(51):e5692. doi: 10.1097/MD.0000000000005692.
To systematically evaluate the clinical efficacy and safety of Salvianolate injection in the treatment of unstable angina pectoris (UAP).
Using literature databases, we conducted a thorough and systematic retrieval of randomized controlled trials (RCTs) that using Salvianolate injection for treating UAP. The Cochrane Risk of Bias Assessment Tool was used to evaluate the methodological quality of the RCTs, and then the data were extracted and meta-analyzed by RevMan5.2 software.
A total of 22 RCTs with 2050 participants were included. The meta-analysis indicated that the combined use of Salvianolate injection and western medicine (WM) in the treatment of UAP can achieve a superior effect in angina pectoris total effective rate (risk ratio [RR] = 1.22, 95% confidence interval [CI] (1.17, 1.27), Z = 10.15, P < 0.00001], and the total effectiveness rate of electrocardiogram [RR = 1.26, 95% CI (1.19,1.34), Z = 7.77, P < 0.00001]. In addition, Salvianolate injection can improve the nitroglycerin withdrawal rate and the serum level of NO, decrease high-sensitivity C-reactive protein. Adverse drug reactions (ADRs) or adverse drug events (ADEs) were reported in 6 RCTs involving 15 cases; however, there were no serious ADRs/ADEs.
Based on the systematic review, the combined use of Salvianolate injection and WM in the treatment of UAP can achieve a better effect; however, there was no definitive conclusion about its safety. More the large-sample and multicenter RCTs are needed to support its clinical usage.
系统评价注射用丹参多酚酸盐治疗不稳定型心绞痛(UAP)的临床疗效和安全性。
利用文献数据库,全面、系统地检索使用注射用丹参多酚酸盐治疗UAP的随机对照试验(RCT)。采用Cochrane偏倚风险评估工具评价RCT的方法学质量,然后提取数据并使用RevMan5.2软件进行荟萃分析。
共纳入22项RCT,涉及2050名参与者。荟萃分析表明,注射用丹参多酚酸盐联合西药治疗UAP在心绞痛总有效率方面效果更佳(风险比[RR]=1.22,95%置信区间CI,Z=10.15,P<0.00001),心电图总有效率方面(RR=1.26,95%CI(1.19,1.34),Z=7.77,P<0.00001)。此外,注射用丹参多酚酸盐可提高硝酸甘油停减率及血清NO水平,降低高敏C反应蛋白。6项RCT报道了15例药物不良反应(ADR)或药物不良事件(ADE),但均无严重ADR/ADE。
基于系统评价,注射用丹参多酚酸盐联合西药治疗UAP疗效更佳;但其安全性尚无定论。需要更多大样本、多中心RCT支持其临床应用。