四联疗法联合黄芪颗粒根除幽门螺杆菌的临床研究

Efficacy of Quadruple Therapy Combined with Astragalus Membranaceus for Eradication of Helicobacter pylori

背景:根除幽门螺杆菌(Hp)是治疗多种胃病的一个重要环节。然而,随着Hp对抗菌药物的耐药性不断升高,传统三联、四联根除疗法的有效率不断下降。目的:探讨四联疗法联合黄芪颗粒根除Hp感染的有效性和安全性。方法:纳入395例经胃镜诊断为慢性胃炎伴消化不良、消化性溃疡并经快速尿素酶试验证实Hp感染的患者,其中慢性胃炎伴消化不良组185例,消化性溃疡组210例,将两种疾病的患者再分别分为试验组和对照组,试验组给予四联疗法+黄芪颗粒,对照组给予四联疗法,疗程均为14 d。治疗结束后4周复查13C-尿素呼气试验以评估根除疗效。结果:358例(90.6%)患者按方案完成治疗。慢性胃炎伴消化不良组中,试验组PP根除率显著高于对照组(P<0.05),ITT根除率差异无统计学意义(P>0.05)。消化性溃疡组中,试验组PP和ITT根除率与对照组相比差异均无统计学意义(P>0.05)。对照组中,消化性溃疡组的PP和ITT根除率显著高于慢性胃炎伴消化不良组(P<0.01)。试验组中,慢性胃炎伴消化不良组与消化性溃疡组的PP和ITT根除率差异无统计学意义(P>0.05)。慢性胃炎伴消化不良组与消化性溃疡组间以及对照组与试验组间不良反应发生率差异均无统计学意义(P>0.05)。结论:四联疗法联合黄芪颗粒能有效提高慢性胃炎伴消化不良患者的Hp根除率,且具有良好的安全性。

Background:In the treatment of many gastric diseases,eradication of Helicobacter pylori( Hp)is important. With the increasing in antibiotic resistance of Hp,the eradication efficacy of conventional triple and quadruple therapy for Hp is decreasing in recent years. Aims:To assess the efficacy and safety of quadruple therapy combined with astragalus membranaceus for Hp eradication. Methods:A total of 395 Hp-infected patients with chronic gastritis/dyspepsia and peptic ulcer diagnosed by gastroscopy were enrolled,of them 185 patients were of chronic gastritis/dyspepsia group and 210 patients were of peptic ulcer group. Patients in the two groups were subdivided into trial group and control group. Patients in trial group were given quadruple therapy combined with astragalus membranaceus for 14 days,and patients in control group were given quadruple therapy only for 14 days. Hp eradication was assessed by 13 C-urea breath test 4 weeks after treatment. Results:A total of 358 patients(90. 6%)completed the study. In chronic gastritis/dyspepsia group,the eradication rate was significantly higher in trial group than in control group by PP analysis(P<0. 05),but no significant difference was found by ITT analysis(P>0. 05). In peptic ulcer group,the eradication rates by PP and ITT analysis showed no significant differences between trial group and control group(P>0. 05). In control group,the eradication rates by PP and ITT analysis were significantly higher in peptic ulcer group than in chronic gastritis/dyspepsia group( P <0. 01). In trial group,the eradication rates by PP and ITT analysis were not significantly different between chronic gastritis/dyspepsia group and peptic ulcer group( P >0. 05 ). The incidence of adverse effects was not significantly different between chronic gastritis/dyspepsia group and peptic ulcer group as well as trial group and control group( P>0. 05). Conclusions:Quadruple therapy combined with astragalus membranaceus could increase the eradication rate of Hp in chronic gastritis/dyspepsia group safely.