两种含铋剂四联方案补救治疗幽门螺杆菌感染的临床研究

Clinical study of two different bismuth-containing quadruple rescue therapies for Helicobacter pylori eradication

目的评价两种不同的含铋剂四联方案补救治疗幽门螺杆菌(Helicobacter pylori,H.pylori)感染的临床疗效和安全性。方法将160例H.pylori感染的初始治疗失败患者随机分配至左氧氟沙星组和呋喃唑酮组。左氧氟沙星组给予雷贝拉唑10mg 2次/d+胶体果胶铋200mg 2次/d+阿莫西林1 000mg 2次/d+左氧氟沙星500mg 1次/d,疗程14d;呋喃唑酮组给予雷贝拉唑10mg 2次/d+胶体果胶铋200mg 2次/d+阿莫西林1 000mg 2次/d+呋喃唑酮100mg 2次/d,疗程14d。治疗结束6周后行13C-尿素呼气试验检查以确定H.pylori根除情况,通过按意向性分析(Intention-to-treat,ITT)和按符合方案分析(Per Protocol,PP)来评估两种治疗方案的H.pylori根除率。同时观察治疗过程中的不良反应与依从性。结果按ITT分析时,左氧氟沙星组和呋喃唑酮组对H.pylori的根除率分别为73.8%、87.5%,差异有统计学意义(P=0.028);按PP分析时,左氧氟沙星组和呋喃唑酮组对H.pylori的根除率分别为79.7%、93.3%,差异有统计学意义(P=0.015)。治疗过程中左氧氟沙星组和呋喃唑酮组的总体不良反应发生率分别为11.3%、17.5%,差异无统计学意义(P=0.260)。两组患者的依从性良好,均为97.5%。结论含呋喃唑酮的铋剂四联14天疗法是一种高效、安全的根除H.Pylori的补救治疗方案,在本地区其疗效明显优于含左氧氟沙星的铋剂四联14天疗法,是一种可供选择的治疗方案。

Objective To evaluate the efficacy and safety of two different bismuth-containing quadruple rescue therapies for the eradication of Helicobacter pylori. Methods 160 patients whose previous H.pylori eradication treatment failed were randomly assigned into two groups:patients in the levofloxacin group were given rabeprazole(10mg,b.i.d),colloidal bismuth pectin(200mg,b.i.d),amoxicillin(1 000 mg,b.i.d),levofloxacin(500mg,q.d)for 14 days,patients in the furazolidone group were given rabeprazole(10mg,b.i.d),colloidal bismuth pectin(200mg,b.i.d),amoxicillin(1 000 mg,b.i.d),furazolidone(100mg,b.i.d)for 14 days. H.pylori status was assessed by 13C-urea breath test at six weeks after the end of treatment.The eradication rates were determined by intention-to-treat(ITT)and per-protocol(PP)analyses.The eradication rate,incidence of adverse events and compliance were compared between the two groups. Results The eradication rates of the levofloxacin group and the furazolidone group were 73.8% and 87.5% in the ITT analysis respectively,and were 79.7% and 93.3% in the PP analysis respectively.The H.pylori eradication rates in the furazolidone group were significantly higher than those in the the levofloxacin group according to both ITT(P=0.028)and PP analysis(P=0.015). Adverse event rates were 11.3% and 17.5% in the levofloxacin group and the furazolidone group,respectively.There were no significant differences between the two groups(P=0.260).Compliance was similar in both groups(97.5%). Conclusion Fourteen-day furazolidone and bismuth-containing quadruple therapy is an effective and safe second-line rescue strategy. It showes a higher eradication rate than fourteen-day levofloxacin and bismuth-containing quadruple therapy in our area.