伏诺拉生治疗内镜下黏膜剥离术后相关溃疡的快速卫生技术评估  

Vonoprazan for ulcers associated with endoscopic submucosal dissection:a rapid health technology assessment

作　　者：王威 柯义君 程畅 方崇文 潘力生[3] 金涌 张焰平[1] WANG Wei;KE Yijun;CHENG Chang;FANG Chongwen;PAN Lisheng;JIN Yong;ZHANG Yanping(Department of Gastroenterology,Anqing Municipal Hospital,Anqing 246000,Anhui Province,China;Department of Pharmaceutical Administration,Anqing Municipal Hospital,Anqing 246000,Anhui Province,China;Department of Vascular Surgery,Anqing Municipal Hospital,Anqing 246000,Anhui Province,China;School Hospital,Anhui Medical University,Hefei 230000,China)

机构地区：[1]安庆市立医院消化内科,安徽安庆246000 [2]安庆市立医院药事管理科,安徽安庆246000 [3]安庆市立医院血管外科,安徽安庆246000 [4]安徽医科大学校医院,合肥230000

出　　处：《药物流行病学杂志》2025年第3期306-313,共8页Chinese Journal of Pharmacoepidemiology

基　　金：安徽省重点研究与开发计划项目(2022e07020040);皖南医学院校级科研项目(WK2023JXYY029)。

摘　　要：目的对伏诺拉生治疗内镜下黏膜剥离(ESD)术后相关溃疡的有效性、安全性和经济性进行快速卫生技术评估,为临床治疗决策提供参考依据。方法计算机检索PubMed、Cochrane Library、Embase、ScienceDirect、CNKI、WanFang Data数据库及国内外卫生技术评估(HTA)机构官方网站,搜集伏诺拉生治疗ESD术后相关溃疡的HTA报告、系统评价/Meta分析和药物经济学研究文献,检索时限均为从建库至2024年7月31日。由2位研究人员独立筛选文献、提取资料及评价文献的质量后,对纳入文献的结果进行综合分析。结果共纳入文献8篇,均为系统评价/Meta分析。有效性方面,与质子泵抑制剂(PPI)相比,伏诺拉生可显著提高ESD术后总溃疡愈合率、更迅速地缩小溃疡面积(P<0.05);亚组分析显示,伏诺拉生与PPI治疗ESD术后4周或8周溃疡愈合率差异均无统计学意义(P>0.05);与PPI相比,伏诺拉生可显著提高幽门螺杆菌阳性患者ESD术后溃疡的缩小率(P<0.05)。安全性方面,与PPI相比,伏诺拉生可显著降低总不良事件发生率(P<0.05);伏诺拉生与PPI致迟发性出血、溃疡穿孔发生率的差异无统计学意义(P>0.05)。结论伏诺拉生治疗ESD术后相关溃疡具有较好的有效性和安全性,未来需进一步开展经济学研究。Objective To evaluate the efficacy,safety and economy of vonoprazan in the treatment of post-endoscopic submucosal dissection(ESD)ulcer by rapid health technology assessment method,and to provide reference for clinical treatment decision.Methods PubMed,Cochrane Library,Embase,ScienceDirect,CNKI,WanFang Data databases and the official website of health technology assessment(HTA)agency were electronically searched to collect HTA reports,systematic reviews/Meta-analysis and pharmacoeconomic studies of vonoprazan in the treatment of post-ESD ulcer from inception to July 31,2024.Two researchers independently screened literature,extracted data,and comprehensively analyzed the results of the included literature on the basis of literature quality evaluation.Results A total of 8 studies were included,all were systematic reviews/Meta-analysis.In terms of effectiveness,compared with proton pump inhibitors(PPI),vonoprazan significantly increased the overall ulcer healing rate after ESD and more rapid reduction of ulcer area(P<0.05).The results of subgroup analysis showed that there was no significant difference in ulcer healing rate between vonoprazan and PPI treatment at 4 or 8 weeks after ESD(P>0.05).Vonoprazan significantly increased the rate of postoperative ulcer reduction in H.pylori positive patients compared with PPI(P<0.05).In terms of safety,compared with PPI,vonoprazan reduced the incidence of overall adverse events rate(P<0.05).The difference in the incidence of delayed bleeding and ulcer perforation between vonoprazan and PPIs showed no statistically significant difference.(P>0.05).Conclusion Vonoprazan demonstrated favorable efficacy and safety in the treatment of ESD ulcers,and further economic studies are warranted.

关 键 词：伏诺拉生 内镜下黏膜剥离术 溃疡 快速卫生技术评估 

分 类 号：R975.2[医药卫生—药品]