摘要
目的评价含盐酸小檗碱四联疗法对幽门螺杆菌(Hp)阳性功能性消化不良(FD)的疗效。方法选择258例Hp阳性FD患者,按治疗方法不同分为对照组和观察组,对照组给予标准四联疗法(埃索美拉唑肠溶片+阿莫西林+克拉霉素+枸橼酸铋钾颗粒),观察组将克拉霉素更换为盐酸小檗碱,利用意向性分析(ITT)数据集和符合方案(PP)数据集分别比较2组Hp根除率、症状缓解率、不良反应发生率。结果ITT与PP分析结果均一致,观察组Hp根除率(ITT:91.3% vs.79.0%,χ^2=7.422,P=0.006。PP:91.2%vs.82.4%,χ^2=4.285,P=0.038)、症状缓解率(ITT:65.1%vs.48.4%,χ^2=7.097,P=0.008。PP:65.1%vs.50.4%,χ^2=5.397,P=0.020)均高于对照组;观察组不良反应发生率低于对照组(ITT:8.7%vs.19.4%,χ^2=5.859,P=0.015。PP:8.7%vs.20.2%,χ^2=6.539,P=0.011)。结论含盐酸小檗碱四联疗法疗效显著,值得临床应用。
Objective To evaluate the clinical efficacy of the quadruple therapy containing berberine hydrochloride in the treatment of Helicobacter pylori(Hp)-positive functional dyspepsy(FD). Methods A total of 258 FD patients with positive Hp were recruited and divided into the control and observation groups according to different treatment methods. In the control group, standard quadruple therapy was given(esomeopram magnesium enteric-coated tablets + bismuth potassium cirtrate + amoxicillin + clarithromycin).In the observation group, clarithromycin was replaced by berberine hydrochloride. The eradication rate of Hp, remission rate of the symptoms and incidence rate of adverse reactions were statistically compared between two groups by using intention-to-treat and per-protocol analyses. Results ITT and PP analyses yielded consistent results. The eradication rate of Hp(ITT: 91.3% vs. 79.0%, χ~2 = 7.422, P = 0.006. PP: 91.2% vs. 82.4%,χ~2= 4.285, P = 0.038), and the remission rate of symptoms(ITT: 65.1% vs. 48.4%,χ~2 = 7.097, P = 0.008. PP: 65.1% vs. 50.4%, χ~2 = 5.397, P = 0.020) in the observation group were significantly higher than those in the control group. The incidence rate of adverse reactions in the observation group was remarkably lower than that in the control group(ITT: 8.7% vs. 19.4%,χ~2 = 5.859, P = 0.015. PP: 8.7% vs. 20.2%, χ~2 = 6.539, P = 0.011).Conclusion The quadruple therapy containing berberine hydrochlorideis yields high clinical efficacy in treating FD, which is worthy of clinical application.
作者
杨丽清
陈平湖
李嘉莉
叶伟智
Yang Liqing;Chen Pinghu;Li Jiali;Ye Weizhi(Department of Gastroenterology, Central People’s Hospital of Zhanjiang, Zhanjiang 524000, China)
出处
《新医学》
2019年第6期453-456,共4页
Journal of New Medicine
基金
2018年度湛江市科技发展专项资金竞争性分配项目(2018A01030)
关键词
幽门螺杆菌
功能性消化不良
盐酸小檗碱
疗效
Helicobacter pylori
Functional dyspepsia
Berberine hydrochloride
Clinical efficacy
