徐小青 周帆 吴小溪

[摘要] 目的 探討黄连素联合四联疗法作为幽门螺杆菌（Hp）一线治疗的效果和安全性。 方法 收集上海中医药大学附属普陀医院2018年11月～2019年11月Hp阳性的慢性胃炎患者100例，采用随机数字表法将其分为试验组和对照组，每组50例。对照组采用四联疗法，试验组在对照组的基础上加用黄连素，评估两组根除率、临床疗效和不良反应发生率。琼脂稀释法对Hp临床分离株行三种常用抗生素的药敏试验，分析耐药性及对两组根除率的影响。 结果 试验组按意向治疗分析，Hp根除率高于对照组，差异有统计学意义（P < 0.05）;按方案分析，两组Hp根除率比较，差异无统计学意义（P > 0.05）。两组临床疗效比较，差异无统计学意义（P > 0.05）。两组不良反应总发生率比较，差异无统计学意义（P > 0.05），其中试验组恶心、腹泻的发生率明显低于对照组，差异有统计学意义（P < 0.05）。Hp对克拉霉素、甲硝唑和阿莫西林的耐药率分别为32.0%、64.0%、0.0%。在克拉霉素耐药菌株中，试验组根除率明显高于对照组，差异有统计学意义（P < 0.05）。 结论 黄连素联合四联疗法可提高Hp根除率，且安全性高，可作为Hp克拉霉素高耐药地区一线治疗的可选方案。

[关键词] 幽门螺杆菌;四联疗法;黄连素;克拉霉素;耐药性

[中图分类号] R573          [文献标识码] A          [文章编号] 1673-7210（2020）07（a）-0078-04

[Abstract] Objective To investigate the efficacy and safety of Berberine combined with Quadruple therapy as a primary therapy for Helicobacter pylori（Hp） eradication. Methods A total of 100 Hp infected patients with chronic gastritis diagnosed by gastroscopy were enrolled in Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from November 2018 to November 2019. They were divided into the experimental group and the control group by random number table method， with 50 cases in each group. The control group was treated with Quadruple therapy，while the experimental group was treated with Berberine on the basis of the control group. The curative effect， eradication rate and adverse reactions of two groups were assessed. The drug resistance of Hp were tested for three common antibiotics by the agar dilution method， and the effect of antibiotic resistance on the eradication rate of the two groups was analyzed. Results According to the treatment intention analysis， the Hp eradication rate in the experimental group was higher than that in the control group， and the difference was statistically significant （P < 0.05）; according to the per-protocol analysis， there was no statistically significant difference in Hp eradication rate between the two groups （P > 0.05）. There was no statistically significant difference in the total incidence of adverse reactions between the two groups （P > 0.05）， and the incidence of nausea and diarrhea in the experimental group was significantly lower than that in the control group （P < 0.05）. The resistant rates of Hp to Clarithromycin， Metronidazole and Amoxicillin were 32.0%， 64.0%， 0.0%， respectively. The eradication rate of the experimental group was significantly higher than that in the control group in patients with clarithromycin-resistant strains （P < 0.05）. Conclusion Berberine combined with Quadruple therapy can increase the eradication rate of Hp and has high safety. It can be used as an option for first-line treatment in areas with high resistance to Hp Clarithromycin.

[Key words] Helicobacter pylori; Quadruple therapy; Berberine; Clarithromycin; Drug resistance

幽门螺杆菌（Helicobacter pylori，Hp）对常用抗生素耐药逐年增高是其根除失败的主要原因[1]。中医作为我国的传统医学，探寻中药用于Hp治疗深受中国学者的重视，已有研究证实[2]多种中药如黄连、黄芪、大黄等均有抗Hp作用。小檗碱是黄连的主要成分，又名黄连素，抗菌谱广，因其疗效好、毒副作用小、价廉等优点多用于肠道感染。研究显示[3]黄连对Hp抑菌效果最强。故本研究设计了开放、平行、随机对照研究，比较2周经典四联方案与黄连素联合四联疗法对Hp根除的差异，探讨黄连素的抗Hp作用，评价黄连素用于Hp根除的疗效和安全性，为中西医结合应用于Hp感染探索新的高效根除方案。