摘要目的 评价复方嗜酸乳杆菌片或布拉氏酵母菌散联合铋剂四联疗法根除幽门螺杆菌(H.pylori)的有效性和安全性.方法 将360例H.pylori感染者随机分为3组.四联组:埃索美拉唑镁肠溶片20 mg+枸橼酸铋钾220 mg+阿莫西林1 000 mg+呋喃唑酮100 mg2次/d,口服10 d;复方嗜酸乳杆菌组和布拉氏酵母菌组分别在四联组基础上,于服药第1天开始加用复方嗜酸乳杆菌片1 000 mg 3次/d或布拉氏酵母菌散500 mg 2次/d,口服14 d.治疗期间观察患者不良反应,治疗结束停药至少4周后行13C或14C-尿素呼气试验,结果阴性者判定为根除成功,比较3组间H.pylori根除率及不良反应发生率.结果 四联组、复方嗜酸乳杆菌组和布拉氏酵母菌组意向性(ITT)分析的根除率分别为81.7％(98/120)、84.2％(101/120)、85.0％(102/120),差异无统计学意义(P=0.768);3组方案(PP)分析的根除率分别为92.5％(98/106)、90.1％(101/111)、93.6％ (102/109),差异无统计学意义(P =0.770);复方嗜酸乳杆菌组不良反应的总体发生率(P =0.008)以及腹泻(P ＜0.001)的发生率均低于四联组,差异均有统计学意义,布拉氏酵母菌组不良反应的总体发生率(P =0.003)以及腹泻(P＜0.001)、腹胀(P =0.004)、便秘(P =0.002)的发生率均低于四联组,差异均有统计学意义,而两益生菌组不良反应发生率比较差异无统计学意义(P＞0.05).结论 复方嗜酸乳杆菌片和布拉氏酵母菌散均可降低铋剂四联方案中不良反应的总体发生率,前者可降低腹泻的发生率,后者可降低腹泻、腹胀、便秘的发生率.

abstractsObjective To investigate the efficacy and safety of Compound Lactobacillus Tablets or Saccharomyces boulardii Sachets combining with bismuth quadruple therapy for Helicobacter pylori (H.pylori) eradication.Methods A total of 360 H.pylori-infected patients were enrolled and randomly assigned into three groups.Group A received esomeprazole 20 mg bid + bismuth potassium citrate 220 mg bid + amoxicillin 1 000 mg bid + furazolidone 100 mg bid for 10 days.Group B or group C received the same quadruple therapy for 10 days as group A,as well as Compound Lactobacillus Tablets 1 000 mg tid or Saccharomyces boulardii Sachets 500 mg bid for 14 days.Drug-related side effects and adverse reactions were collected during the therapy,and H.pylori eradication results were confirmed by 13C/14C-UBT at least 4 weeks after cessation of therapy.Results The H.wlori eradication rates in group A,B and C were 81.7％,84.2％ and 85.0％ by ITT analysis (P =0.768) and 92.5％,90.1％ and 93.6％ by PP analysis (P =0.770),respectively.The overall side effects and adverse reactions rates (P =0.008) and occurrence of diarrhea (P ＜0.001) were significantly lower in group B than group A.The overall side effect rates (P =0.003) and occurrence of diarrhea (P ＜ 0.001),abdominal distension (P =0.004) and constipation (P =0.002) were significantly lower in group C than group A.There was no significant difference in side effects and adverse reactions rates between the two probiotics groups.Conclusions Both Compound Lactobacillus Tablets and Saccharomyces boulardii Sachets,combining with bismuth quadruple therapy,reduced the overall side effects and adverse reactions rates for H.pylori eradication.Moreover,the former can reduce the incidence of diarrhea,and the latter can reduce the incidence of diarrhea,abdominal distension and constipation.