苦碟子注射液治疗不稳定型心绞痛的系统评价

Systematic Review of Kudiezi Injection in Treatment of Unstable Angina Pectoris

目的:系统评价苦碟子射液治疗不稳定型心绞痛的疗效和安全性。方法:计算机检索VIP,CBM,CNKI,Wanfang以及Pub Med,查找有关苦碟子射液治疗不稳定型心绞痛的临床随机对照试验。根据纳入及排除标准筛选文献,按照Jadad质量评价标准进行评价,采用Revman 5.3软件进行Meta分析。结果:共10个临床随机对照试验纳入系统评价,均为Jadad评分<3分的低质量研究,Meta分析结果显示:苦碟子注射液治疗不稳定型心绞痛在临床心绞痛总有效率[OR=3.31,95%CI(2.23,4.92),P<0.000 01],显效率[OR=1.67,95%CI(1.28,2.18),P=0.000 1]以及心电图疗效[OR=2.70,95%CI(1.95,3.74),P<0.000 01]方面优于对照组,其差异有统计学意义。结论:苦碟子注射液治疗不稳定型心绞痛可显著提高总有效率、显效率以及心电图疗效,且具有较好的安全性。但现有小样本的临床随机对照试验方法学和报告质量偏低,还需要大样本、高质量的临床研究进一步证实。

Objective： To systematically review the efficacy and safety of Kudiezi injection in the treatment of unstable angina pectoris. Method： VIP,CBM,CNKI,Wanfang and Pub Med were searched to find the clinical randomized controlled trials on Kudiezi injection treatment for unstable angina. The literature were screened according to inclusion and exclusion criteria, and evaluated according to Jadad quality assessment criteria; Revman 5. 3 software was used for Meta-analysis. Result： A total of 10 randomized controlled trials were included in the systematic review,all of which were low-quality studies with Jadad score 3 points. Meta analysis showed that Kudiezi injection was better than the control group in total effective rate [OR = 3. 31,95% CI（ 2. 23,4. 92）,P〈0. 000 01 ], markedly effective rate [OR = 1. 67,95% CI（ 1. 28,2. 18）, P = 0. 000 1] and electrocardiogram efficacy [OR = 2. 70,95% CI（ 1. 95,3. 74）,P〈0. 000 01] for the treatment of unstable angina pectoris, with statistically significant differences. Conclusion： Kudiezi injection in the treatment of unstable angina can significantly improve the total effective rate,markedly effective rate and electrocardiogram efficacy with satisfactory safety. However, the existing small-sample randomized controlled trials are of low methodological and reporting quality, so large-sample high-quality clinical studies are required for further verification.