黄连素四联方案补救治疗幽门螺杆菌感染的有效性和安全性

Efficacy and Safety of Berberine-containing Quadruple Regimen as Rescue Therapy for Helicobacter pylori Eradication

目的:探索黄连素四联方案用于幽门螺杆菌感染根除失败患者补救治疗的有效性及安全性。方法:将经四联方案初次根除治疗失败并自愿接受补救治疗的130例患者按纳入顺序,以1:1的比例分配治疗,随机接受14天黄连素四联(埃索美拉唑20mg+胶体果胶铋200 mg+阿莫西林1000 mg,2/d+黄连素300 mg 3/d)或四环素四联(埃索美拉唑20 mg+胶体果胶铋200 mg+四环素750 mg+呋喃唑酮100 mg,2/d)方案的治疗。所有患者均于治疗14天及治疗结束至少28天后随诊,详细记录患者症状及不良反应情况。治疗结束至少28天后进行13C尿素呼气试验来判断幽门螺杆菌根除情况。结果:65例接受黄连素四联根除治疗,65例接受四环素四联方案治疗。两组分别有6例和4例患者因不良反应服药依从性小于80%,其余患者均完成了14天的治疗。黄连素组和四环素组的幽门螺杆菌根除率ITT分析分别为76.9%(50/65)和81.5%(53/65),P=0.520;PP分析分别为84.7%(50/59)和86.9%(53/61),P=0.739。黄连素组和四环素组不良事件总体发生率分别为49.2%和41.5%,P=0.370。结论:黄连素四联疗法用于幽门螺杆菌感染的二次根除治疗,根除率较高,未明显增加不良事件发生率,是有效及安全的补救治疗方案。

Objective： To explore the efficacy and safety of berberine-containing quadruple regimen as rescue therapy in H. pylori infected subjects. Methods： Totally 130 patients with H. pylori infection who failed previous first-line eradication therapy were enrolled in this study. The patients were randomly assigned（1：1） 14 d berberine-containing quadruple therapy（berberine 300 mg tid ＋ amoxicillin1000 mg bid ＋ colloidal bismuth tartrate 220 mg bid ＋ esomeprazole 20 mg bid） or 14 d tetracycline-containing quadruple therapy（tetracycline 750 mg bid ＋ furazolidone 100 mg bid ＋ colloidal bismuth tartrate 220 mg bid ＋ esomeprazole 20 mg bid） as second-line rescue treatment. The regularity views were arranged at 14 d and 28 d after treatment,and the symptoms and adverse events were recorded. The eradication status was evaluated by ^13C-urea breath test which was performed at least 4 weeks after the end of treatment. Results： Sixty-five patients were assigned to berberine-containing quadruple therapy and 65 patients to tetracycline-containing quadruple therapy. Six patients in berberine-containing quadruple therapy and 4 patients in tetracycline-containing quadruple therapy did not complete treatment because of adverse events. The eradication rates of berberine-containing quadruple therapy and tetracycline- containing quadruple therapy were 76.9 %（50/65） versus 81.5 %（53/65） in intention-to-treat（ITT） analysis（P=0.520） and 84.7 %（50/59） versus 86.9 %（53/61） in per-protocol（PP） analysis（P=0.739）,respectively. The overall incidence of adverse events was 49.2 % and 41.5 %（P=0.370）,respectively.Conclusions： The 14- day berberine-containing quadruple regimen for Helicobacter pylori infection as second-line therapy can obtain high eradication rate and doesn＇t increase adverse events obviously,so it is an effective and safe rescue treatment.