[关键词]
[摘要]
目的 将新型抑酸药富马酸伏诺拉生与经典治疗胃食管反流的口服质子泵抑制剂(PPI)类药物(奥美拉唑、雷贝拉唑钠、泮托拉唑钠等)进行临床综合评价,以期为医疗机构的安全、合理用药提供参考及循证依据。方法 基于《中国医疗机构药品评价与遴选快速指南(第二版)》,制定百分制评估体系,通过查阅万方数据库(Wanfang Data)、维普生物医学数据库(VIP)、中国学术期刊全文数据库(CNKI)、PubMed、Embase、Cochrane Library等数据库相关文献,以及参考药品说明书、临床指南,从有效性、药学特性、安全性、经济性、国家医保、基本药物情况、全球使用情况及药品生产企业状况等方面对富马酸伏诺拉生片、奥美拉唑肠溶胶囊2种、艾司奥美拉唑镁肠溶胶囊2种、雷贝拉唑钠肠溶片2种、泮托拉唑钠肠溶片2种、艾普拉唑肠溶片共10个品种进行量化评分,并根据评分结果划分推荐级别。结果 评价结果显示在胃食管反流的治疗方面,所评价药物的综合得分分别为富马酸伏诺拉生片80.1分,奥美拉唑肠溶胶囊(10 mg)83.8分,奥美拉唑肠溶胶囊(20 mg)80.3分,艾司奥美拉唑镁肠溶胶囊(石药)79.8分,艾司奥美拉唑镁肠溶胶囊(东阳光)79.6分,雷贝拉唑钠肠溶片(卫材)77.2分,雷贝拉唑钠肠溶片(晋城)74.8分,泮托拉唑钠肠溶片(武田)80.8分,泮托拉唑钠肠溶片(华纳)81分,艾普拉唑肠溶片73.6分。结论 所有品种得分均在70分以上,均建议为强推荐,且其中奥美拉唑肠溶胶囊、泮托拉唑钠肠溶片及富马酸伏诺拉生片作为胃食管反流治疗的优选药物。
[Key word]
[Abstract]
Objective To conduct a clinical comprehensive evaluation comparing the novel acid-suppressing drug Vonoprazan Fumarate with classic oral PPI drugs(e.g., Omeprazole, Rabeprazole, Pantoprazole) for the treatment of gastroesophageal reflux, aiming to provide evidence-based references for safe and rational drug use in medical institutions. Methods Based on the Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions(Second Edition), a 100-point evaluation system was established. Relevant literature was reviewed from databases including Wanfang Data, VIP Database, CNKI, PubMed, Embase, and Cochrane Library, supplemented by drug instructions and clinical guidelines. Ten drug varieties were quantitatively assessed across multiple dimensions: efficacy, pharmacological properties, safety, cost-effectiveness, national medical insurance(health insurance) coverage, essential drug status, global usage, and manufacturer reputation. The evaluated drugs included Vonoprazan Fumarate Tablets, two types of Omeprazole Enteric-Coated Capsules, two types of Esomeprazole Enteric-Coated Capsules, two types of Rabeprazole EntericCoated Tablets, two types of Pantoprazole Enteric-Coated Tablets, and Ilaprazole Enteric-Coated Tablets. Results The comprehensive scores for gastroesophageal reflux treatment were as follows: Vonoprazan Fumarate Tablets(80.1), Omeprazole Enteric-Coated Capsules 10 mg(83.8), Omeprazole Enteric-Coated Capsules 20 mg(80.3), Esomeprazole Enteric-Coated Capsules(Shiyao, 79.8), Esomeprazole Enteric-Coated Capsules(Dongyangguang, 79.6), Rabeprazole Enteric-Coated Tablets(Weicai, 77.2), Rabeprazole Enteric-Coated Tablets(Jincheng, 74.8), Pantoprazole Enteric-Coated Tablets(Takeda, 80.8), Pantoprazole Enteric-Coated Tablets(Huana, 81), and Ilaprazole Enteric-Coated Tablets(73.6). Conclusion All evaluated drugs scored above 70 points and were strongly recommended. Among them, Omeprazole Enteric-Coated Capsules, Pantoprazole Enteric-Coated Tablets, and Vonoprazan Fumarate Tablets are preferred options for gastroesophageal reflux treatment.
[中图分类号]
R975
[基金项目]
国家自然科学基金资助项目(82003878);河北省医学科学研究课题计划资助项目(20250654)