复方嗜酸乳杆菌片在提高首次根治失败的幽门螺杆菌感染的再次根治率中的作用

Efficacy of compound eosinophil-lactobacillus tablets combined with triple therapy in the treatment of Helicobacter pylori infection after failed standard triple therapy

目的 观察复方嗜酸乳杆菌片联合三联疗法在提高首次根治失败的幽门螺杆菌（H.pylori）感染的再次根治率中的作用.方法 选取2011年1月-2012年6月在江苏省江阴市人民医院门诊诊断H.pylori阳性的消化性溃疡（胃溃疡、十二指肠球部溃疡、复合溃疡）、慢性胃炎（非萎缩/萎缩）经过标准三联方案首次根治失败的患者共180例.按实验组：对照组=1：1设计随机表,按随机区组设计进行随机分组,按照病例入选先后顺序分配随机号,每组90例.实验组：复方嗜酸乳杆菌片1 g（2片）/次,3次/d,餐后使用,疗程14 d（d1～14）,继续给予雷贝拉唑10 mg＋阿莫西林1.0g,2次/d,莫西沙星400 mg,1次/d,疗程10 d（d15～24）;对照组：给予雷贝拉唑10 mg＋阿莫西林1.0g,2次/d,莫西沙星400 mg,1次/d,疗程10 d（d1～10）.治疗结束至少4周后所有患者经13C尿素呼气试验（13C-UBT）或胃镜行病理学检查检测H.pylori,并对治疗中抗生素不良反应发生情况进行比较.结果 实验组及对照组的H.pylori根除率符合方案数据分析（PP）分别为：72.9％（62/85）、54.7％（47/86）（x2 =6.188,P=0.013）,而意向性分析（ITT）分别为：68.9％ （62/90）、52.2％（47/90）（x2 =5.233,P=0.022）,两组相比,差异有统计学意义（P＜0.05）.对照组在治疗中恶心呕吐、腹泻、便秘、口腔异味等不良反应发生率明显高于实验组（P＜0.05）.结论 复方嗜酸乳杆菌联合三联疗法对首次标准三联疗法根治失败的H.pylori感染患者,H.pylori根除率高于对照组,同时可以有效降低治疗过程中的不良反应.

Objective To evaluate the efficacy of compound eosinophil-lactobacillus tablets combined with 10 d triple therapy in the treatment of Helicobacter pylori （H. pylori） infection after failed standard triple therapy. Methods From Jan. 2011 to Jun. 2012, one hundred and eighty H. pylori infection patients in whom triple therapy failed were enrolled. These patients were randomly divided into experimental group and control group. The experimental group received a pretreatment with compound eosinophil-lactobacillus tablets 1 g （2 capsules） , three times a day, for 14 d （d1 ～ 14） , followed with rabeprazole 10 mg ＋ amoxicillin 1 000mg, twice a day, moxifloxacin 400 mg, one time a day, for 10 d （ d15 ～ 24） ; control group received rabeprazole 10 mg ＋ amoxicillin 1 000 mg, twice a day, moxifloxacin 400 mg, one time a day, for 10 d （d1～10）. For both groups, a 13C-urea breath test or gastroseope pathology examination were conducted after 4 weeks completion of the therapy to assess the outcome of residual H. pylori eradication and side-effects of anti-H, pylori treatment. Results The eradication rates of H. pylori in experimental group and control group were as follows： per-protocol （PP） ： （72.9%）62/85, （54.7%）47/86 （P =0.013） ; intention-to-treat （ITT） ： 68.9% （62/ 90）, 52.2% （47/90） （P = 0. 022）, there was statistical difference between two groups. The symptomatic improve- ments of nausea and vomiting, diarrhea, constipation and dysgeusia with a metallic taste in control group were higher than those in experimental group （P 〈 0.05 ）. Conclusion Compound eosinophil-lac-tobacillus tablets can reduce the occurrence of anti-H, pylori therapy related side-effects.