目的 基于系統(tǒng)評價對膽舒膠囊治療慢性膽囊炎的有效性、安全性和經(jīng)濟性進行成本-效果評價。方法 檢索中國學術(shù)期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)庫（Wanfang Data）、維普中文科技期刊數(shù)據(jù)庫（VIP）、中國生物醫(yī)學文獻服務(wù)系統(tǒng)（SinoMed）、PubMed、The Cochrane Library和Web of Science數(shù)據(jù)庫中，關(guān)于膽舒膠囊的隨機對照試驗（RCT），檢索時間為自建庫起至2022年11月。使用RevMan 5.4軟件對膽舒膠囊的有效性進行Meta分析，采用成本-效果分析法進行藥物經(jīng)濟學評價，使用Treeage Pro軟件對其經(jīng)濟性結(jié)果進行敏感性分析。結(jié)果 共納入23項RCTs，其中8項RCTs為慢性膽囊炎，15項RCTs為慢性結(jié)石性膽囊炎。系統(tǒng)評價分析結(jié)果，膽舒膠囊比金膽片［RR＝1.26，95%CI（1.10，1.45），P＝0.000 9］、消炎利膽片 ［RR＝1.26，95%CI（1.10，1.45），P＝0.000 9］和熊去氧膽酸片［RR＝1.29，95%CI（1.08，1.55），P＝0.006］治療慢性膽囊炎的總有效率更高；膽舒膠囊比消炎利膽片［RR＝1.33，95%CI（1.24，1.42），P＜0.000 01］和膽寧片［RR＝1.24，95%CI（1.06，1.44），P＝0.006］治療慢性結(jié)石性膽囊炎的總有效率更高。膽舒膠囊比消炎利膽片治療慢性結(jié)石性膽囊炎的不良反應(yīng)發(fā)生率更低［RR＝0.24，95%CI（0.15，0.39），P＜0.000 01］。成本-效果分析結(jié)果，膽舒膠囊與消炎利膽片、金膽片和熊去氧膽酸片相比治療慢性膽囊炎的增量成本-效果比（ICER）分別是-0.64、0.31、-41.75；膽舒膠囊與消炎利膽片和膽寧片相比治療慢性結(jié)石性膽囊炎的ICER分別是-43.96和-0.97。膽舒膠囊治療慢性膽囊炎較對照藥相比增加的成本完全值得，敏感性分析證實了結(jié)果的穩(wěn)定性。結(jié)論 膽舒膠囊粒治療慢性膽囊炎具有較好的有效性、安全性和經(jīng)濟性，可進一步通過開展前瞻性臨床試驗佐證研究結(jié)論。

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 = 0.000 9], 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 < 0.000 01] 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 < 0.000 01]. 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.

R287.5；R969.3

中央高?；究蒲袠I(yè)務(wù)專項（2020-JYB-ZDGG-072）