胆舒胶囊治疗慢性胆囊炎的系统评价和药物经济学评价  

Systematic and pharmacoeconomic evaluation of Danshu Capsule on treatment of chronic cholecystitis

作　　者：魏嘉茵 周平达 徐龙辰 朱文涛[1] 王婷 WEI Jiayin;ZHOU Pingda;XU Longchen;ZHU Wentao;WANG Ting(School of Management,Beijing University of Traditional Chinese Medicine,Beijing 100029,China;School of Public Administration,Renmin University of China,Beijing 100872,China)

机构地区：[1]北京中医药大学管理学院,北京100029 [2]中国人民大学公共管理学院,北京100872

出　　处：《药物评价研究》2023年第5期1092-1104,共13页Drug Evaluation Research

基　　金：中央高校基本科研业务专项(2020-JYB-ZDGG-072)。

摘　　要：目的基于系统评价对胆舒胶囊治疗慢性胆囊炎的有效性、安全性和经济性进行成本-效果评价。方法检索中国学术期刊全文数据库(CNKI)、万方数据库(Wanfang Data)、维普中文科技期刊数据库(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、The Cochrane Library和Web of Science数据库中,关于胆舒胶囊的随机对照试验(RCT),检索时间为自建库起至2022年11月。使用RevMan 5.4软件对胆舒胶囊的有效性进行Meta分析,采用成本-效果分析法进行药物经济学评价,使用Treeage Pro软件对其经济性结果进行敏感性分析。结果共纳入23项RCTs,其中8项RCTs为慢性胆囊炎,15项RCTs为慢性结石性胆囊炎。系统评价分析结果,胆舒胶囊比金胆片[RR=1.26,95%CI(1.10,1.45),P=0.0009]、消炎利胆片[RR=1.26,95%CI(1.10,1.45),P=0.0009]和熊去氧胆酸片[RR=1.29,95%CI(1.08,1.55),P=0.006]治疗慢性胆囊炎的总有效率更高;胆舒胶囊比消炎利胆片[RR=1.33,95%CI(1.24,1.42),P<0.00001]和胆宁片[RR=1.24,95%CI(1.06,1.44),P=0.006]治疗慢性结石性胆囊炎的总有效率更高。胆舒胶囊比消炎利胆片治疗慢性结石性胆囊炎的不良反应发生率更低[RR=0.24,95%CI(0.15,0.39),P<0.00001]。成本-效果分析结果,胆舒胶囊与消炎利胆片、金胆片和熊去氧胆酸片相比治疗慢性胆囊炎的增量成本-效果比(ICER)分别是−0.64、0.31、−41.75;胆舒胶囊与消炎利胆片和胆宁片相比治疗慢性结石性胆囊炎的ICER分别是−43.96和−0.97。胆舒胶囊治疗慢性胆囊炎较对照药相比增加的成本完全值得,敏感性分析证实了结果的稳定性。结论胆舒胶囊粒治疗慢性胆囊炎具有较好的有效性、安全性和经济性,可进一步通过开展前瞻性临床试验佐证研究结论。Objective Evaluate the effectiveness and economy about Danshu Capsule on the treatment of chronic cholecystitis.Methods CNKI,Wanfang Data,VIP,SinoMed,PubMed,The Cochrane Library,and Web of Science databases were searched for randomized controlled trials(RCT)on Danshu Capsule from database establishment to November 2022.RevMan 5.4 software was used for meta-analysis of the effectiveness of Danshu Capsule,cost-effectiveness analysis was used for pharmacoeconomic evaluation,and Treeage Pro software was used for sensitivity analysis of their economic results.Results A total of 23 RCTs were included,eight of chronic cholecystitis,15 of chronic calculous cholecystitis.The results of systematic review and analysis showed that Danshu Capsule had higher overall response rate in the treatment of chronic cholecystitis than Jindan Tablet[RR=1.26,95%CI(1.10,1.45),P=0.0009],Xiaoyanlidan Tablet[RR=1.29,95%CI(1.08,1.55),P=0.006],Danshu Capsule had higher overall response rate than Xiaoyanlidan Tablet[RR=1.33,95%CI(1.24,1.42),P<0.00001]and Danning Tablet[RR=1.24,95%CI(1.06,1.44),P=0.006].Danshu Capsule had a lower incidence of adverse reactions than Xiaoyanlidan Tablet in the treatment of chronic calculous cholecystitis[RR=0.24,95%CI(0.15,0.39),P<0.00001].Cost-effectiveness analysis showed that the ICERs of Danshu Capsule in the treatment of chronic cholecystitis were−0.64,0.31 and−41.75 compared with Xiaoyanlidan Tablet,Jindan Tablet and Ursodeoxycholic Acid Tablet,respectively.The ICERs of Danshu Capsule in the treatment of chronic calculous cholecystitis were−43.96 and−0.97 compared with Xiaoyanlidan Tablet and Danning Tablet,respectively.Cost-effectiveness analysis showed that the additional cost of Danshu Capsule on the treatment of chronic cholecystitis was worth it.Sensitivity analysis supported the stability of results.Conclusion Danshu Capsule has good efficacy,safety and economy in the treatment of chronic cholecystitis,which can be further confirmed by carrying out prospective clinical trials.

关 键 词：胆舒胶囊 慢性胆囊炎 慢性结石性胆囊炎 系统评价 药物经济学评价 

分 类 号：R287.5[医药卫生—中药学] R969.3[医药卫生—中医学]