不含铋剂四联疗法与标准三联疗法根除幽门螺杆菌的效果分析

Non-bismuth quadruple therapy versus standard triple therapy for Helicobacter pylori eradication： a randomized controlled study

目的 比较基于质子泵抑制剂的7 d不含铋剂四联疗法与标准三联疗法7 d和10 d用于幽门螺杆菌（H.pylori）初次根除的效果.方法 开放性研究纳入2010年8月至2012年7月北京大学第一医院经13C-尿素呼气试验确诊、且从未接受过H.pylori根除治疗的246例H.pylori阳性无并发症的消化性溃疡及慢性胃炎患者,年龄18～75岁,其中男110例,女136例.按计算机随机分配为7 d不含铋剂四联治疗组（埃索美拉唑20 mg ＋阿莫西林1 000 mg ＋ 克拉霉素500 mg ＋ 替硝唑500 mg,2次/d）81例,标准三联（埃索美拉唑20 mg ＋阿莫西林1 000 mg ＋ 克拉霉素500 mg,2次/d）7 d组82例,标准三联10 d组83例.疗程结束后4周行13C-尿素呼气试验检测H.pylori根除效果,并记录药物不良反应发生率.结果 246例患者中242例完成随访,基线各组患者临床资料具可比性（均P〉0.05）.按意向性治疗（ITT）分析,7 d不含铋剂四联治疗组、标准三联7 d和10 d组H.pylori根除率分别为91.4%（74/81）,79.3%（65/82）和79.5%（66/83）;按符合方案（PP）分析分别为92.5%（74/80）,81.3%（65/80）和80.5%（66/82）.7 d不含铋剂四联治疗组均明显高于标准三联7 d组（P=0.029、0.035）和10 d组（P=0.032、0.026）;后两组之间差异无统计学意义（P=0.968、0.902）.7 d不含铋剂四联治疗组、标准三联7 d和10 d组不良反应发生率分别为8.8%（7/80）,7.5%（6/80）和9.8%（8/82）,各组之间差异无统计学意义（P=0.872）.结论 7 d不含铋剂四联疗法H.pylori根除率高,患者药物耐受性好,可用于H.pylori的初次根除治疗.

Objective To compare the efficacies of non-bismuth quadruple therapy for 7 days versus standard triple therapy for 7 or 10 days in initial treatment of Helicobacter pylori（ H. pylori）. Methods A randomized, open-labeled, controlled trial comparing non-bismuth quadruple therapy with standard triple therapy was performed at Peking University First Hospital from August 2010 to July 2012. A total of 246 patients with a diagnosis of tl. pylori infection by 13C-urea breath test and receiving no eradication therapy were randomly divided into non-bismuth quadruple therapy and standard triple therapy for 7 or 10 days. There were 110 males and 136 females with an age range of 18 -75 years. Among them,81 patients received non- bismuth quadruple therapy （esomeprazole 20 rag, amoxicillin 1 000 rag, clarithromycin 500 mg and tinidazole 500 mg given twice daily for 7 days） ; 82 standard triple therapy（ esomeprazole 20 mg,amoxicillin 1 000 mg and clarithrnmycin 500 mg given twice daily） for 7 days and 83 standard triple therapy for 10 days. The efficacies were examined at Week 4 post-therapy by 23 C-urea breath test. The incidence of adverse drug reactions was recorded. Results Among them, 242 patients completed the follow-up. The eradication rates for non-bismuth quadruple therapy and standard triple therapy for 7 or 10 days were 91.4% （74/81）, 79. 3 % （65/82） and 79. 5% （66/83） as determined by intention-to-treat analysis （ITT）. The eradication rates were 92. 5% （74/80）,81.3% （65/80） and 80. 5% （66/82） respectively as determined by per- protocol analysis （PP）. Non-bismuth quadruple therapy was superior to standard triple therapy for 7 days （ITY analysis P =0. 029,PP analysis P =0. 035） and 10 days （ITI＂ analysis P =0. 032,PP analysis P = 0. 026）. The differences for the eradication rates between standard triple therapy for 7 days and for 10 days were insignificant （ ITY analysis P = 0. 968, PP analysis P = 0. 902） ： Adverse reaction rates for non-bismuth quadruple therapy （ 8.8%, 7/80） and standard triple therapy for 7 days （ 7.5%, 6/80 ） and 10 days （9.8% ,8/82） were not significantly different （P = 0. 872）. Conclusion Non-bismuth quadruple therapy for 7 days is both effective and safe for the first-line eradication of H. pylori.