参松养心胶囊治疗心脏神经官能症疗效性及安全性的Meta分析

摘要

目的：系统评价参松养心胶囊治疗心脏神经官能症的临床疗效和安全性。方法计算机辅以手工检索，采用RevMan 5.2软件进行Meta分析。结果纳入17篇随机对照试验，总计1663例患者。Meta分析结果提示，参松养心胶囊或联用常规西药临床疗效优于常规西药治疗（RR=1.29，95%CI：1.23~1.35），单纯中药治疗的总有效性亦优于常规西药对照组（RR=1.34，95%CI：1.23~1.46）。6个研究报道了不良反应，胃肠道不适是中药组主要不良反应（3.93%），血压心律异常是常规治疗组主要不良反应（17.04%），其中两组发生的胃肠道不适（RR=1.81，95%CI：0.68~4.83）、头昏面红（RR=2.81，95%CI：0.30~26.38）、头痛（RR=0.17，95%CI：0.02~1.30）和疲乏（RR=0.08，95%CI：0.00~1.31）等不良反应均无统计学差异，但在诱发血压过低、心动过缓等不良反应方面中药组较常规西药对照组更加安全（RR=0.08，95%CI：0.02~0.32）。单纯中药治疗的安全性亦优于常规西药对照组（RR=0.26，95%CI：0.08~0.82）。结论参松养心胶囊能安全有效地改善心脏神经官能症患者临床症状。受纳入研究质量限制以上结论有待开展更多高质量随机对照试验予以验证。%Objective To evaluate the efficacy and safety of Shen Song Yang Xin Capsule for cardiac neurosis.Methods After searching by computer and manual work, the meta-analysis was performed using RevMan 5.2 software.Results There were 17 randomized controlled trials (RCTs) included, involving 1663 cardiac neurosis patients. The results of meta-analysis showed that, Shen Song Yang Xin Capsule combined with/without conventional western medicine (WM) could make a better efficacy (RR=1.29, 95%CI: 1.23~1.35) when compared with the conventional treatment. The total efficacy caused by treatment only with traditional Chinese medicine (TCM) was also superior to conventional WM (RR=1.34, 95%CI: 1.23~1.46). Gastrointestinal discomfort (3.93%) was the main adverse drug reaction (ADR) in TCM treatment, and abnormal blood pressure and heart rates (17.04%) were the main ADRs in conventional treatment based on reports of 6 studies. No significant difference was found in gastrointestinal discomfort (RR=1.81, 95%CI: 0.68~4.83), dizziness and flushing (RR=2.81, 95%CI: 0.30~26.38), headache (RR=0.17, 95%CI: 0.02~1.30) and fatigue (RR=0.08, 95%CI: 0.00~1.31) between two groups. But TCM treatment was superior to conventional treatment with respect to hypotension and bradycardia (RR=0.08, 95%CI:0.02~0.32). Treatment only with TCM was safer than conventional WM treatment (RR=0.26, 95%CI: 0.08~0.82). Conclusion Shen Song Yang Xin Capsule could improve the clinic symptom of cardiac neurosis safely and effectively. Further high-quality and large-scale RCTs are needed to confirm these results.