基于荟萃分析的参仙升脉口服液治疗缓慢性心律失常药物经济学研究

Pharmaceutical economics research of Shen Xian Sheng Mai oral liquid in the treatment of slow arrhythmia based on Meta analysis

目的全面评价参仙升脉口服液治疗缓慢性心律失常的临床疗效、安全性及经济性。方法检索中国知网(CNKI)、万方和维普、The Cochrane Library、Pub Med、Springer、Pro Quest 7个中外数据库(2000年1月~2016年10月),筛选参仙升脉口服液治疗缓慢性心律失常的随机对照研究。使用Rev Man 5.3软件进行Meta分析,结合成本-效果分析进行经济性评价。结果研究纳入文献8篇,共666例患者。Meta分析结果显示,参仙升脉口服液治疗缓慢性心律失常临床疗效优于心宝丸组(OR=4.71,95%CI:2.96~7.50,P<0.001),参仙升脉口服液组对缓慢性心律失常患者最高心率的影响程度优于心宝丸组(SMD=10.51,95%CI:6.37~14.64,P<0.001),参仙升脉口服液组对缓慢性心律失常患者最低心率的影响程度优于心宝丸组(SMD=6.54,95%CI:4.82~8.26,P<0.001),参仙升脉口服液组对缓慢性心律失常患者平均心率的影响程度优于心宝丸组(SMD=6.00,95%CI:3.72~8.28,P<0.001),参仙升脉口服液组对缓慢性心律失常患者24 h总心搏数的影响程度优于心宝丸组,且差异具有统计学意义(P<0.05),参仙升脉口服液组与心宝丸组治疗缓慢性心律失常患者的不良反应发生率无统计学差异(OR=0.49,95%CI:0.13~1.85,P=0.29)。药物经济学分析结果显示,参仙升脉口服液治疗缓慢性心律失常每增加一个疗效单位,疗程内日均成本增加1.05~1.06元。根据WHO关于药物经济学评价的推荐意见,参仙升脉口服液治疗缓慢性心律失常增量成本效果比小于人均GDP,因疗效增加而增加的成本完全值得。结论参仙升脉口服液治疗缓慢性心律失常有较好的临床疗效,但结果需更多高质量、大样本的随机对照试验加以验证。

Objective To evaluate the efficacy, safety and economy of Shen Xian Sheng Mai oral liquid in the treatment of slow arrhythmia. Methods Literature databases（2000.1~2016.10） including Pub Med, CNKI and so on were searched. Random control trials of Shen Xian Sheng Mai oral liquid published at home and abroad were collected. Meta-analysis was conducted using Rev Man 5.3 software and economic evaluation was used costeffectiveness analysis. Results 8 literatures were included, invovling 666 patients. Meta analysis results showed that Shen Xian Sheng Mai oral liquid group is better than that of Xin Bao Wan group in the treatment of slow arrhythmia effect（OR=4.71, 95%CI： 2.96~7.50, P0.001）, the fastest heart rate（SMD=10.51, 95%CI： 6.37~14.64, P0.001）, the slowest heart rate（SMD=6.54, 95%CI： 4.82~8.26, P0.001）, the mean heart rate（SMD=6.00, 95%CI： 3.72~8.28, P0.001） and the 24 h total heart rate（P〈0.05）. There is no significant difference of adverse reactions between Shen Xian Sheng Mai oral liquid group and Xin Bao Wan group（OR=0.49, 95%CI： 0.13~1.85, P=0.29）. Pharmacoeconomic analysis results showed that Shen Xian Sheng Mai oral liquid group in the treatment of slow arrhythmia, periods of daily cost were increased 1.05~1.06 yuan. The incremental cost effectiveness of each disease is less than the per capital GDP, which shows that the cost of the increase in effectiveness is worth. Conclusion Shen Xian Sheng Mai oral liquid in the treatment of slow arrhythmia has better clinical efficacy and cost-effectiveness, more high quality and large sample randomized controlled trials are needed.