含呋喃唑酮三联和四联方案根除幽门螺杆菌感染的疗效观察  

Efficacy of triple versus quadruple furazolidone-based eradication regimens for Helicobacter pylori infection

作　　者：吕志发[1] 谢勇[1] 吕农华[1] 周虹[1] 刘志坚[1] 朱萱[1] 陈幼祥[1] 何星星[1] 刘东升[1] 马久红[1] 

机构地区：[1]南昌大学第一附属医院消化科,330006

出　　处：《中华医学杂志》2014年第8期572-575,共4页National Medical Journal of China

摘　　要：目的 观察含呋喃唑酮的三联和四联方案对幽门螺杆菌（H.pylori）感染根除治疗的效果及不良反应.方法 2010年6至12月,以南昌大学附属第一医院因上胃肠道症状而接受胃镜检查确诊为H.pylori感染阳性的十二指肠溃疡患者为研究对象,将符合入选标准的357例初治患者[男200例、女157例,年龄（42±12）岁]按计算机随机数字表随机分成4组：三联7 d组89例,给予阿莫西林1 000 mg＋呋喃唑酮100 mg＋雷贝拉唑10 mg,2次/d,疗程7 d;三联10 d组91例,与三联7 d组相同方案,疗程10 d;四联7 d组88例,给予阿莫西林1 000 mg,呋喃唑酮100 mg,雷贝拉唑10 mg,枸橼酸铋钾220 mg,2次/d,疗程7 d;四联10 d组89例,方案与四联7 d组相同,疗程10 d.各组疗程结束4周后,复查14C-尿素呼气试验,结果阴性者判断为H.pylori根除成功.结果 323例患者按方案完成了治疗（其中三联7 d和10 d组各有7例未完成,四联7 d和10 d组分别有9和11例未完成）.按意向性分析（ITT分析）,三联7 d、三联10 d、四联7 d、四联10 d组的根除率分别为71.91%（64/89）、81.32%（74/91）、78.41%（69/88）、83.15%（74/89）,总体差异无统计学意义（P〉0.05）.按符合方案分析（PP分析）,各组的根除率分别为78.05%（64/82）、88.10%（74/84）、87.34%（69/79）、94.87%（74/78）,总体差异有统计学意义（P=0.017）;四联10 d组的根除率明显高于三联7 d组（P=0.002）,其他各组两两相比,差异均无统计学意义（均P〉0.05）.总的不良反应发生率为7.00%（25/357）,各组之间比较不良反应发生率差异无统计学意义（P〉0.05）.结论 含呋喃唑酮四联10 d疗法较三联7 d疗法具有更高的根除率;10 d疗程与7 d疗程的根除率相似;含呋喃唑酮三联或者四联,疗程7 d还是10 d不良反应发生率相似.Objective To explore the eradication efficacies of triple versus quadruple furazolidone- based regimens for Helicobacter pylori （H. pylori） infection. Methods A total of 357 outpatients with H. pylori infection were enrolled from June to December 2010. There were 200 males and 157 females with an average age of （42 _＋ 12 ） years. A diagnosis of duodenal ulcer was made according to their endoscopic examination results. They were randomly assigned into 4 treatment groups ~ 7-day triple （ n = 89 ） and 10-day triple （n =91 ） , rabeprazole 10 rag, amoxicillin 1 000 mg and furazolidone 100 mg twice daily for 7 and 10 days respectively. 7-day quadruple （ n = 88 ） and 10-day quadruple （ n = 89 ） , rabeprazole 10 rag, bismuth 220 rag, amoxicillin 1 000 mg and furazolidone 100 mg twice daily for 7 and 10 days respectively. H. pylori status was re-assessed with 14 C-urea breath test after 4-week therapy. Results Among them, 323 cases completed the study. According to the analysis of intention-to-treat （ITT） , the 1t. pylpori eradication rates were 71.91% （64/89） in 7-day triple, 81.32% （74/91） in 10-day triple, 78.41% （69/88） in 7-day quadruple and 83.15% （74/89） in 10-day quadruple groups. No significant deviation existed among all groups （P 〉 0. 05 ）. According the per-protocol （PP） analysis, 1t. pylori eradication rates were 78.05% （64/82）in 7-day triple, 88.10% （74/84） in 10-day triple, 87.34% （69/79） in 7-day quadruple and 94. 87% （74/78） in 10-day quadruple groups. Significant deviation existed among all groups （P = 0. 017 ）. The H. pylori eradication rate in 10-day quadruple group was significantly higher than that in 7-day triple group （P = 0. 002 ）. The total adverse reaction rate was 7. 00% （25/357）. No significant difference existed among all groups （ P 〉 0. 05 ）. Conclusions Quadruple treatments provide higher H. pylori eradication rates than triple therapies. A 10-day treatment may improve H. pylori eradication rate. And 1

关 键 词：螺杆菌 幽门 十二指肠溃疡 呋喃唑酮 随机对照试验 根除率 

分 类 号：R57[医药卫生—消化系统]