丹参酮ⅡA磺酸钠注射液治疗不稳定型心绞痛疗效和安全性的Meta分析

Meta-analysis on Effectiveness and Safety of Tanshinone Ⅱ A Sulfonate Sodium Injection in Treatment of Unstable Angina Pectoris

目的:研究丹参酮ⅡA磺酸钠注射液治疗不稳定型心绞痛疗效和安全性。方法:检索策略:以冠状动脉粥样硬化性心脏病、冠心病、不稳定型心绞痛、胸痹、心痛、丹参酮IIA磺酸钠注射液、丹参酮注射液、tanshinoneⅡA sulfonate、unstable angina、randomized controlled trial、clinical trials为主题词,检索中国知网(CNKI)、维普全文期刊数据库(VIP)、万方数据库、Pubmed从建库-2014年10月31日的相关文献;纳入标准:随机对照试验且病例资料完整,各文献研究假设及研究方法相似,组间均衡性较好。采用Jadad评分法进行文献质量评价,运用Rev Man 5.2软件进行Meta分析。计数资料用比值比(OR),计量资料用加权均数差(WMD),计算95%可信区间(CI)。纳入文献异质性检验结果P>0.05,采用固定效应模型进行Meta分析;反之,采用随机效应模型;对≥10篇分析结果,采用漏斗图分析发表偏倚。结果:纳入34篇文献,常规治疗加丹参酮ⅡA磺酸钠注射液对不稳定型心绞痛总有效率[OR=3.83,95%CI(3.11,4.71),P<0.000 01];心电图改善率[OR=3.34,95%CI(2.61,4.28),P<0.000 01];血浆粘度改善[WMD=-0.20,95%CI(-0.38,-0.03),P=0.03];全血高切粘度改善[WMD=-0.67,95%CI(-0.85,-0.50),P<0.000 01];C反应蛋白改善[WMD=-2.66,95%CI(-3.31,-2.00),P<0.000 01]。结论:常规治疗加丹参酮ⅡA磺酸钠注射液治疗不稳定型心绞痛能取得一定的临床疗效且无明显不良反应。但由于现有文献研究质量较差,尚有待于大量的高质量随机对照试验进一步予以证实。

This paper was aimed to study the effectiveness and safety of Tanshinone Ⅱ A Sulfonate Sodium Injection in the treatment of unstable angina pectoris（UAP）. Keywords such as coronary atherosclerotic heart disease, coronary heart disease, unstable angina, chest impediment, cardialgia, Tanshinone Ⅱ A Sulfonate Sodium Injection, tanshinone injection, tanshinone Ⅱ A sulfonate, unstable, angina, randomized controlled trial（RCT）, and clinical trials were searched in CNKI, VIP, Wanfang and Pubmed from the construction of database until October 31 st, 2014. The inclusion criteria were RCT with clinical data integrity, similar literature research methods, and good balance between groups. The Jadad score method was used to carry out quality assessment. Meta-analysis was conducted by Rev Man5.2 software. Count data was processed by odds ratio（OR）. Measurement data was processed with the weighted mean differences（WMD）. The 95% confidence interval（CI） was also calculated. The heterogeneity test result of included literatures was P〉0.05. The fixed effects model was used in the meta-analysis. On the other hand, random effect model was used. For the analysis results of more than 10 papers, the funnel plot was used in the analysis of publication bias. The results showed that a total of 34 studies were included. The results of meta-analysis suggested that the total efficiency of conventional treatment plus Tanshinone Ⅱ A Sulfonate Sodium Injection for UAP was [OR = 3.83, 95%CI（3.11, 4.71）, P〈0.000 01]. The electrocardiogram improvement rate was [OR = 3.34, 95%CI（2.61,4.28）, P〈0.000 01]; plasma viscosity improvement was [WMD =-0.20, 95%CI（-0.38,-0.03）, P = 0.03]; high shear viscosity of whole blood improvement was [WMD =-0.67, 95%CI（-0.85,-0.50）, P〈0.000 01]; C-reactive protein improvement was [WMD =-2.66, 95%CI（-3.31,-2.00）, P〈0.000 01]. It was concluded that the conventional treatment plus Tanshinone Ⅱ A Sulfonate Sodium Injection for UAP had certain clinical effect with no obvious adverse reaction. However, due to the poor quality of the existing research literatures, the results should be further verified by large amount of high quality RCTs.