伏诺拉生治疗胃食管反流病有效性、安全性及经济性的快速卫生技术评估  

Rapid health technology assessment of efficacy,safety and cost-effectiveness of vonoprazan in the treatment of gastroesophageal reflux disease

作　　者：王栓 黄灿[1] 齐腊梅[1] WANG Shuan;HUANG Can;QI Lamei(Dept.of Pharmaceutical Administration,Anqing Municipal Hospital,Anhui Anqing 246000,China)

机构地区：[1]安庆市立医院药事管理科,安徽安庆246000

出　　处：《中国药房》2025年第7期794-800,共7页China Pharmacy

基　　金：中华国际医学交流基金会临床药学科研基金项目(No.Z-2021-46-2101)。

摘　　要：目的采用快速卫生技术评估方法,评价伏诺拉生(VPZ)治疗胃食管反流病的有效性、安全性和经济性,为临床决策提供依据。方法计算机检索PubMed、Medline、Cochrane Library、中国知网、维普、万方等中英文数据库,以及国内外卫生技术评估机构官网,检索时限从建库起至2024年8月,由2位研究者独立筛选文献、提取资料并评价纳入研究的质量后,对结果进行定性描述与分析。结果共纳入21篇文献,包括系统评价/Meta分析15篇和药物经济学研究6篇。有效性方面,与对照方案(不同剂量VPZ、安慰剂、其他阳性对照药或联合治疗)相比,VPZ(主要为20 mg/d VPZ)显著提高了治疗总有效率、第2周的黏膜愈合率、症状缓解率和愈合后第12、24周的维持率(P<0.05);当内镜下洛杉矶分级为C/D时,VPZ有效率显著高于对照方案(P<0.05)。安全性方面,VPZ与对照方案治疗GERD的不良事件发生率无显著差异(P>0.05),但长期使用VPZ导致血清胃泌素升高及肝功能异常的风险较对照方案更高(P<0.05)。经济性方面,与雷贝拉唑、兰索拉唑、艾司奥美拉唑相比,VPZ更具有成本-效用/成本-效果优势。结论VPZ治疗胃食管反流病具有良好的有效性、安全性、经济性。OBJECTIVE To evaluate the efficacy,safety and cost-effectiveness of vonoprazan(VPZ)in the treatment of gastroesophageal reflux disease(GERD)by rapid health technology assessment,and provide evidence for clinical decision-making.METHODS English and Chinese databases including PubMed,Medline,Cochrane Library,CNKI,VIP,and Wanfang data as well as the official websites of domestic and international health technology assessment agencies were searched by computer from the database establishment to August 2024.After literature screening,data extraction and quality evaluation of included studies were conducted by two researchers,the results were described and analyzed qualitatively.RESULTS A total of 21 pieces of literature were included,involving 15 systematic reviews/meta-analyses and 6 pharmacoeconomic studies.In terms of efficacy,compared with the control regimen(different doses of VPZ,placebo,other positive controls or combination therapy),VPZ(mainly 20 mg/d VPZ)significantly improved the total response rate,mucosal healing rate at 2nd week,symptom remission rate,and maintenance rate at 12th and 24th week after mucosal healing(P<0.05);when the endoscopic Los Angeles classification was C/D,the effective rate of VPZ was significantly higher than that of the control regimen(P<0.05).In terms of safety,there was no significant difference in the incidence of adverse events between VPZ and the control regimen for GERD treatment(P>0.05),but the risk of elevated serum gastrin and abnormal liver function caused by long-term use of VPZ was higher than that of the control regimen(P<0.05).In terms of cost-effectiveness,compared with rabeprazole,lansoprazole and esomeprazole,VPZ had a cost-effectiveness/cost-utility advantage.CONCLUSIONS VPZ is effective,safe and cost-effective in the treatment of GERD.

关 键 词：伏诺拉生 胃食管反流病 有效性 安全性 经济性 卫生技术评估 

分 类 号：R975[医药卫生—药品] R571[医药卫生—药学]