黄芪注射液治疗病毒性心肌炎随机对照试验的系统评价

Systematic review of randomized controlled trials of astragalus injection in treatment of viral myocarditis

目的评价黄芪注射液辅助治疗病毒性心肌炎的临床疗效及安全性。方法计算机检索Pudmed、CNKI、VIP及万方医学网中关于黄芪注射液联合常规西医疗法治疗病毒性心肌炎的随机对照试验,对符合标准的随机对照试验进行系统评价。结果根据标准共纳入11篇随机对照试验,共966名患者。分析结果显示,与对照组比较,治疗组在治疗病毒性心肌炎的临床总有效率[OR=4. 90,95%CI(3. 19,7. 52),P <0. 01]、降低心肌酶谱指标[CK:WMD=-50. 18,95%CI(-89. 66,-10. 71),P=0. 01、CK-MB:WMD=-8. 59,95%CI(-11. 46,-5. 72),P <0. 01]等方面差异有统计学意义。临床总有效率漏斗图近似对称,发表偏倚不大。纳入的研究中未发现不良反应。结论在常规西医治疗基础上,联合应用黄芪注射液能明显改善病毒性心肌炎的临床症状及疗效,且临床安全性良好。但由于纳入研究文献质量普遍较低,影响研究结果的可靠性,故尚需更多的多中心、设计合理、大样本、随机双盲对照实验来进一步验证。

Objective To evaluate the clinical therapeutic effects and safety of astragalus injection in the assistant treatment of viral myocarditis. Methods The randomized controlled trials(RCTs) on viral myocarditis treated with astragalus injection and routine Western medicine were retrieved from Pubmed,CNKI,VIP and Wanfang databases. The systematic review was conducted on the eligible RCTs. Results According to the criteria,11 RCTs were included,including 966 patients. The results showed that compared with the control group,the total effective rate[OR = 4. 90,95% CI(3. 19,7. 52),P< 0. 01]and the reducing of myocardial zymogram indicators[CK: WMD =-50. 18,95% CI(-89. 66,-10. 71),P =0. 01; CK-MB: WMD =-8. 59,95% CI(-11. 46,-5. 72),P < 0. 01]were significantly different in the treatment group. The funnel plot of the clinical total effective rate indicated the approximate symmetry and less publication bias. The adverse reactions were not found in the included RCTs. Conclusion On the base of the routine treatment with Western medicine,astragalus injection adopted as the assistant treatment obviously relieves the clinical symptoms and improves the therapeutic effects on viral myocarditis. The clinical safety is satisfactory. But,the low quality of literature affects the reliability of research results. Hence,it needs more multi-central,rational designed,large sample-size and double-blind RCTs for the further verification.