脉络宁注射液与复方丹参注射液治疗缺血性脑卒中的成本-效果分析

Cost-effectiveness Analysis of Mailuoning Injection and Compound Danshen Injection in the Treatment of Ischemic Stroke

目的:评价脉络宁注射液与复方丹参注射液治疗缺血性脑卒中的有效性和经济性。方法:以"脉络宁注射液""复方丹参注射液""注射用复方丹参""脑梗塞""脑梗死""缺血性脑卒中"中文检索词,"Mailuoning injection""Mompound danshen injection""Compound salvia miltiorrhiza injection""cerebral infarction""cerebral ischemic stroke"为英文检索词,运用逻辑运算符检索,并辅以文献追溯和手工检索等方法,检索中国知网、万方数据、维普网、PubMed中从建库起至2018年2月公开发表的脉络宁注射液与复方丹参注射液治疗缺血性脑卒中的随机对照试验(RCT)研究,通过RevMan 5.3软件对两种治疗方案的临床总有效率进行Meta分析,采用决策树模型进行药物经济学分析,计算两种治疗方案的成本-效果比(CER)、增量成本-效果比(ICER),通过下调药品成本20%和临床总有效率上下变动5%进行敏感性分析。结果:共纳入文献7篇,累计510例患者,Meta分析结果显示,脉络宁注射液的临床总有效率优于复方丹参注射液[OR=5.14,95%C(I2.83,9.34),P<0.001];决策树模型分析结果显示,复方丹参注射液的成本低于脉络宁注射液(168元vs. 394元),脉络宁注射液和复方丹参注射液的CER分别为4.18、2.21,脉络宁注射液较复方丹参注射液的ICER为12.4,且ICER小于2016年人均国内生产总值(53 935元)。敏感性分析结果未对结论造成影响。结论:与复方丹参注射液比较,脉络宁注射液治疗缺血性脑卒中的疗效更好,经济性更佳。

OBJECTIVE:To evaluate the effectiveness and economical efficiency of Mailuoning injection and Compound danshen injection in the treatment of ischemic stroke.METHODS:Using“Mailuoning injection”“Compound danshen injection”“Compound danshen for injection”“cerebral infarction”and“ischemic stroke”as Chinese keywords,“Mailuoning injection”“Compound danshen injection”“Compound salvia miltiorrhiza injection”“cerebral infarction”and“cerebral ischemic stroke”as English keywords,RCTs about Mailuoning injection and Compound danshen injection in the treatment of ischemic stroke were retrieved from CNKI,Wanfang database,VIP and PubMed by means of logical operator combined with literature tracing and manual retrieval during the date of database establishment to Feb.2018.RevMan 5.3 software was used for Meta-analysis of total response rate of 2 kinds of therapy plans.The decision tree model was used for pharmacoeconomics analysis.Cost-effectiveness ratio(CER)and incremental cost-effectiveness ratio(ICER)of two therapy plans were calculated.Sensitivity analysis was conducted by reducing 20%cost of drugs and fluctuating by 5%up and down of effectiveness.RESULTS:A total of 7 RCTs were included,involving 510 patients.The results of Meta-analysis showed that the total response rate of Mailuoning injection was better than that of Compound danshen injection[OR=5.14,95%CI(2.83,9.34),P<0.001].Results of decision tree model analysis showed that the cost of Compound danshen injection was lower than that of Mailuoning injection(168 yuan vs.394 yuan);CER of Mailuoning injection and Compound danshen injection were 4.18 and 2.21;ICER of Mailuoning injection was 12.4,compared with Compound danshen injection.ICER was lower than GDP per capita in 2016(53 935 yuan).The results of sensitivity analysis did not affect the conclusion.CONCLUSIONS:Compared with Compound danshen injection,Mailuoning injection is more effective for ischemic stroke and more economical.