目的评价酪酸梭菌二联活菌(常乐康)联合标准三联疗法对儿童幽门螺杆菌(Helicobacter pylori,H.pylori)感染的治疗效果,探讨更优化的H.pylori根除方案。方法采用前瞻性、随机病例对照研究方法,纳入符合H.pylori感染诊断标准的患儿144例,完成120例,随机分为2组:A组(标准三联组):奥美拉唑0.8~1.0mg/kg·d,分2次,餐前30min口服;克拉霉素15mg/kg·d,分2次口服,总量<1 000mg/d;阿莫西林50 mg/kg·d,分2次口服,总量<2 000 mg/d,疗程10d。B组(常乐康组):在标准三联疗法基础上加用常乐康840mg,每天2次,与抗生素间隔2h以上服用,疗程14d。于治疗前及治疗后4周进行症状评分,治疗过程中由患儿家长记录不良反应,停药4周后复查13 C呼气试验。比较两组症状缓解率、H.pylori根除率及不良反应的发生率。结果治疗4周后,标准三联组的症状缓解率为74.1%,常乐康组为90.3%,两组比较差异有统计学意义(χ2=6.27,P=0.04);H.pylori根除率,标准三联组为58.6%,常乐康组为80.6%,P=0.009,差异有统计学意义;治疗期间不良反应主要表现为恶心、呕吐、腹泻、腹胀和食欲不振等,常乐康组较标准三联组发生率明显下降,分别为16.1%和25.8%,差异有统计学意义(P=0.03)。结论酪酸梭菌二联活菌辅助治疗儿童幽门螺杆菌感染可以提高临床症状缓解率,增加H.pylori根除率,减少不良反应发生率。 Objective To evaluate the therapeutic effect of Clostridium butyricum (Chang Lekang) combined with standard triple therapy on Helicobacter pylori (H.pylori) infection in children, and to explore a more optimized H.pylori eradication program. Methods A prospective and randomized case-control study was conducted in 144 children with H.pylori infection and 120 patients were randomly divided into two groups: group A (standard triple group): omeprazole 0.8-1.0 mg / kg · d, 2 times, oral 30min before meals; clarithromycin 15mg / kg · d, 2 times orally, the total <1 000mg / d; amoxicillin 50 mg / kg · d, Oral, total <2 000 mg / d, treatment 10d. Group B (Changlekang group): On the basis of standard triple therapy plus Chang Lok Hong 840mg, 2 times a day, with antibiotics over 2h interval, treatment 14d. Symptoms were scored before treatment and 4 weeks after treatment. Adverse reactions were recorded by parents of children during the course of treatment. After 13 weeks of withdrawal, the 13 C breath test was reviewed. The rate of symptom relief, eradication rate of H.pylori and the incidence of adverse reactions were compared between the two groups. Results After 4 weeks of treatment, the symptom relief rate was 74.1% in the standard triple group and 90.3% in the Changlekang group, with significant difference between the two groups (χ2 = 6.27, P = 0.04); H.pylori eradication rate, standard Triple therapy group was 58.6%, Chang Lek group was 80.6%, P = 0.009, the difference was statistically significant; adverse reactions during treatment mainly as nausea, vomiting, diarrhea, abdominal distension and loss of appetite, Changle Kang group than the standard triple Group incidence decreased significantly, respectively, 16.1% and 25.8%, the difference was statistically significant (P = 0.03). Conclusion Clostridium butyricum viable adjuvant treatment of Helicobacter pylori infection in children can improve the clinical symptom response rate, increase H. pylori eradication rate and reduce the incidence of adverse reactions.