目的 快速评估艾普拉唑肠溶片治疗十二指肠溃疡的有效性、安全性和经济性,为临床和决策者提供参考。方法 计算机检索PubMed、Embase、the Cochrane Library、中国知网(CNKI)、万方数据库和国内外卫生技术评估(HTA)机构官方网站,纳入艾普拉唑对比其他药物治疗十二指肠溃疡的HTA报告、系统评价/Meta分析和药物经济学研究,采用定性描述的方法汇总纳入研究的结论。结果 共纳入10篇文献,其中系统评价/Meta分析5篇、经济学研究6篇(有1篇系统评价/Meta分析同时也进行了经济性研究)。在治疗十二指肠溃疡的有效性方面,艾普拉唑(10 mg·d-1)与其他PPIs方案的疗效相当,且艾普拉唑(10 mg·d-1)和艾普拉唑(5 mg·d-1)的疗效并无统计学差异;与H2受体拮抗剂相比,艾普拉唑(10 mg·d-1)治疗十二指肠溃疡的疗效显著优于雷尼替丁和法莫替丁。安全性方面,艾普拉唑(10 mg·d-1)与其他PPIs或H2受体拮抗剂方案的不良反应发生率无统计学差异。在治疗十二指肠溃疡的经济性方面,艾普拉唑(10 mg·d-1)相较于艾司奥美拉唑(40 mg·d-1)不具有经济性,而艾普拉唑(5 mg·d-1)比雷贝拉唑(10 mg·d-1)更具经济性。结论 艾普拉唑肠溶片在治疗十二指肠溃疡方面安全有效,不劣于其他PPIs,且相比雷贝拉唑具有一定的经济性。因艾普拉唑(10 mg·d-1)和艾普拉唑(5 mg·d-1)疗效相当,临床上可考虑采用低剂量方案以进一步提高其安全性和经济性。同时,有必要进一步开展低剂量艾普拉唑治疗十二指肠溃疡的临床研究,以完善相关证据。
Abstract
OBJECTIVE To rapidly evaluate the efficacy, safety and economical efficiency of ilaprazole enteric-coated tablets in the treatment of duodenal ulcer, so as to provide evidence-based evidence for clinical rational drug use. METHODS PubMed, Embase, the Cochrane Library, CNKI, WanFang database and health technology assessment (HTA) organization websites were searched systematically. HTA reports, systematic reviews/Meta-analysis and pharmacoeconomic studies comparing ilaprazole with other drugs for duodenal ulcer treatment were included. Qualitative and descriptive analysis were performed on the included studies. RESULTS A total of 10 literatures were included, including five systematic reviews/Meta-analysis and six pharmacoeconomic research (one systematic reviews/Meta-analysis also carried out pharmacoeconomic research). The efficacy of ilaprazole (10 mg·d-1) was comparable to other PPIs regimens in the treatment of duodenal ulcer, and there was no statistically significant difference in the efficacy of ilaprazole (10 mg·d-1) and ilaprazole (5 mg·d-1). Compared with H2 receptor antagonists, ilaprazole (10 mg·d-1) was significantly better than ranitidine and famotidine in the treatment of duodenal ulcer. In terms of safety, there was no statistical difference in the incidence of adverse reactions between ilaprazole (10 mg·d-1) and other PPIs or H2 receptor antagonists. In terms of the economics of treating duodenal ulcer, ilaprazole (10 mg·d-1) was not economical compared to esmeprazole (40 mg·d-1), while ilaprazole (5 mg·d-1) was more economical than rabeprazole (10 mg·d-1). CONCLUSION Ilaprazole enteric-coated tablets are safe and effective in the treatment of duodenal ulcer, not inferior to other PPIs, and have economic advantages compared with rabeprazole. Because ilaprazole (10 mg·d-1) and ilaprazole (5 mg·d-1) have comparable efficacy, a low-dose regimen could be considered clinically to further improve its safety and cost performance. At the same time, it is necessary to further carry out clinical and pharmacoeconomic studies of low-dose ilaprazole in the treatment of duodenal ulcer to improve the relevant evidence.
关键词
艾普拉唑 /
十二指肠溃疡 /
快速卫生技术评估
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Key words
ilaprazole /
duodenal ulcer /
rapid health technology assessment
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中图分类号：
R975.6
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参考文献
[1] EDITORIAL BOARD OF CHINESE DIGESTIVE JOURNAL. Diagnosis and treatment of peptic ulcer (2016, Xi′an)[J]. Chin J Dig(中华消化杂志), 2016, 36(8):508-513.
[2] LIN K J, GARCIA RODRIGUEZ L A, HERNANDEZ-DIAZ S. Systematic review of peptic ulcer disease incidence rates:do studies without validation provide reliable estimates[J]. Pharmacoepidemiol Drug Saf, 2011, 20(7):718-728.
[3] LIU W Z. Diagnosis and treatment of peptic ulcer[J]. Chin J Gastroenter(胃肠病学), 2016, 21(3):129-137.
[4] LIU T, XU C M, ZHAO Z G. Diagnosis and treatment of peptic ulcer[J]. Drug Eval(药品评价), 2016, 13(22):8-12.
[5] TANG H L, MEN P, ZHAI S D. Introducing and exploring the method of rapid review on drugs[J]. Clin Med J(临床药物治疗杂志), 2016, 14(2):1-4.
[6] ZHANG J, GE L, HILL M, et al. Standard-dose proton pump inhibitors in the initial non-eradication treatment of duodenal ulcer: systematic review, network Meta-analysis, and cost-effectiveness analysis[J]. Front Pharmacol, 2019,7(9):1512.
[7] HU Z H, SHI A M, HU D M, et al. Efficacy of proton pump inhibitors for patients with duodenal ulcers: a pairwise and network Meta-analysis of randomized controlled trials[J]. Saudi J Gastroenterol, 2017, 23(1):11-19.
[8] JI X Q, DU J F, CHEN G, et al. Efficacy of ilaprazole in the treatment of duodenal ulcers:a Meta-analysis[J]. World J Gastroenterol, 2014, 20(17):5119-5123.
[9] BOHIDAR N P. Ilaprazole: is this a superior proton pump inhibitor for duodenal ulcer?[J]. Trop Gastroenterol: Off J Dig Dis Found, 2013, 34(2):95-98.
[10] YU L J, HUANG W P, HAN J L. Ilaprazole in the treatment of duodenal ulcer:a Meta-analysis[J]. Cin J Postgrad Med, 2011, 34(31):15-17.
[11] DONG S C, ZHOU P. Cost-effectiveness analysis of epprazole and esomeprazole in treatment of helicobacter pylori positive duodenal ulcer[J]. J Beihua Univ(Natural Sci)(北华大学学报:自然科学版), 2019(6):778-782.
[12] ZENG X Z. Clinical observation on the treatment of duodenal ulcer with positive helicobacter pylori by esomeprazole[J]. Mod Diagn Treat(现代诊断与治疗), 2019(9):1411-1413.
[13] JIANG C Y, MU Y, JIN W M. Cost-effectiveness analysis of ilaprazole and esomeprazole in the treatment of helicobacter pylori positive duodenal ulcer[J]. Mod Dig Interv (现代消化及介入诊疗), 2017, 22(6):837-839.
[14] XUAN J W, SONG R L, XU G X, et al. Modeling the cost-effectiveness of ilaprazole versus omeprazole for the treatment of newly diagnosed duodenal ulcer patients in China[J]. J Med Econ, 2016, 19(11):1056-1060.
[15] YANG C, HUANG H, YUAN J, et al. Pharmacoeconomic evaluation of ilaprazole and rabeprazole for duodenal ulcer[J]. Chin J Pharmacoepidemiol(药物流行病学杂志), 2012(11):555-557.
[16] SEO K A, LEE S J, KIM K B, et al. Ilaprazole, a new proton pump inhibitor, is primarily metabolized to ilaprazole sulfone by CYP3A4 and 3A5[J]. Xenobiotica, 2012, 42(3):278-284.
[17] PU Q H, LV Q J. Meta-analysis of the influence of CYP2C19 genetic polymorphisms on the efficacy of proton pump inhibitors in the treatment of peptic ulcer in Chinese subjects[J]. China Pharm(中国药师), 2017, 20(9):1596-1600.
[18] CHEN M H, HOU X H, XIAO Y L, et al. 2014 expert consensus on gastroesophageal reflux disease in China[J]. Chin J Dig(中华消化杂志), 2014, 34(10):649-661.
[19] WANG Z H, WU J M, HU Z W, et al. Consensus on multidisciplinary diagnosis and treatment of gastroesophageal reflux disease in China[J]. Chin J Front Med (Electron Vers)(中国医学前沿杂志:电子版), 2019, 9:30-56.
[20] SUN S W. Effect of ilaprazole on the antiplatelet action of clopidogrel[J]. J Clin Psychosom Disord(临床心身疾病杂志), 2015, 21(1):59-60.
[21] QIN S M, TAN J R, ZHONG W Y, et al. The clinical application of iprazole enteric-coated tablets in the prevention of gastric mucosal injury caused by long-term use of low-dose aspirin[J]. Hebei Med (河北医学), 2014, 20(12):2041-2044.
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脚注
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基金
“国家重大新药创制”科技重大专项资助项目(2017zx09101001002002)
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