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
王淑君 1王蔚虹 1褚云香 1滕贵根 1胡伏莲1
作者信息
- 1. 100034,北京大学第一医院消化内科
- 折叠
摘要
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.
Abstract
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 Helicobacterpylori(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 H. pylori infection by C-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 mg,amoxicillin 1 000 mg,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 clarithromycin 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 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 (ITT analysis P = 0. 029, PP analysis P = 0. 035 ) and 10 days (ITT 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 (ITT 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.
关键词
螺杆菌,幽门/药物疗法/不良反应Key words
Helicobacter pylori/Drug therapy/Side effects引用本文复制引用
出版年
2014
NETL
NSTL
维普
万方数据