伏诺拉生治疗内镜下黏膜剥离术后人工溃疡的循证分析

Evidence-based analysis of vonoprazan in the treatment of artificial ulcers after endoscopic submucosal dissectionWEI Na1, ZHENG Bin1, Cai Hongfu1, Yang Jing1, LIU Maobai1*( 1.The pharmacy of Fujian Medical University Union Hospital, Fujian Fuzhou 350001, China)

关键词:  伏诺拉生  质子泵抑制剂  内镜下黏膜剥离术后  Meta分析  最小成本分析

Key words:  vonoprazan  proton pump inhibitors  after endoscopic submucosal dissection  Meta-analysis  cost minimization analysis

摘要:

目的 内镜下黏膜剥离术(endoscopic submucosal dissection, ESD)后人工溃疡治疗首选质子泵抑制剂(proton pump inhibitors, PPIs)，近年钾离子竞争性酸阻滞剂伏诺拉生(vonoprazan, VPZ)也被广泛应用于ESD术后人工溃疡。本研究旨在评估VPZ与PPIs应用于ESD术后人工溃疡的有效性与安全性，并进一步评价其经济性。方法 通过数据库检索VPZ与PPIs应用于ESD术后人工溃疡的有效性、安全性的相关研究进行系统评价，并进行经济性分析。结果 最终纳入9篇随机对照研究与6篇队列研究，共3644例患者。Meta分析结果显示：胃ESD术后，VPZ组与PPIs组在以下几方面差异不具有统计学意义：4周溃疡愈合率[RR=0.93,95%CI(0.69,1.25),P=0.63]、8周溃疡愈合率[RR=1.00,95%CI(0.95,1.06),P=0.93]、4周溃疡收缩率[MD=0.42,95%CI(-0.71,1.54),P=0.47]、术后8周内迟发性出血发生率[RR=0.55,95%CI(0.27,1.12),P=0.1; RR=0.82,95%CI(0.68,1.00),P=0.05]；在药物相关不良反应发生方面，除腹痛外二者差异无统计学意义。由于二者疗效相似，应用最小成本分析，结果显示，不同干预措施下VPZ 组患者的治疗成本均高于PPIs组。敏感性分析显示结果稳定。结论 现有证据表明，胃ESD术后，VPZ治疗人工溃疡并不优于PPIs，按照目前药品定价，从患者经济性考虑，使用PPIs更具经济性。

Abstract:

OBJECTIVE Proton pump inhibitors (PPIs) is the preferred treatment for artificial ulcers after endoscopic mucosal dissection (ESD), and in recent years, potassium-competitive acid blocker vonoprazan (VPZ) has also been widely used in the treatment of artificial ulcers after ESD. The aim of this study is to evaluate the effectiveness and safety of VPZ and PPIs in the treatment of artificial ulcers after ESD, and further evaluate their economics. METHODS A systematic evaluation of the effectiveness and safety of VPZ and PPIs in the application of artificial ulcers after ESD was conducted through database retrieval, and economic analysis was performed. RESULTS A total of 9 randomized control trial studies and 6 cohort studies involving 3644 patients were included. The meta-analysis results showed that there was no statistically significant difference between the VPZ group and the PPIs group in the following aspects after ESD: 4-week ulcer healing rate [RR=0.93, 95% CI (0.69,1.25), P=0.63], 8-week ulcer healing rate [RR=1.00, 95% CI (0.95,1.06), P=0.93], 4-week ulcer shrinkage rate[MD=0.42,95%CI(-0.71,1.54),P=0.47] and incidence of delayed bleeding within 8 weeks of different strategies after surgery [RR=0.55,95%CI(0.27,1.12),P=0.1; RR=0.82,95%CI(0.68,1.00),P=0.05]. There was no statistically significant difference in the occurrence of drug-related adverse reactions between the two groups, except for abdominal pain. Due to the two groups had similar therapeutic effects, cost minimization analysis was applied. The results showed that the treatment costs of patients in the VPZ group were higher than those in the PPIs group under different intervention treatments. Sensitivity analysis showed stable results. CONCLUSION Current evidence suggests that VPZ is not superior to PPIs in the treatment of artificial ulcers after ESD. Based on current drug pricing and patient economic considerations, PPIs is considered to be more cost-effective.