益生菌辅助含铋剂四联疗法根除幽门螺杆菌的临床研究*

Clinical study on probiotics auxiliary bismush quadruple therapy for Helicobacter pylori eradication*

摘要:

目的 探讨益生菌联合铋剂四联疗法能否在一定程度上提高幽门螺杆菌根除率，同时缩短根治幽门 螺杆菌用药时间，降低抗菌药使用过程中的相关不良反应。方法 选取2018年1月1日—2019年4月30日在温州 医科大学附属第二医院消化内科就诊，并经证实存在幽门螺杆菌感染者600例，随机分为4组，每组150例。A组： 予阿莫西林胶囊1.0 g/次，2次/d，克拉霉素缓释片500 mg/次，2次/d，雷贝拉唑钠肠溶片20 mg/次，2次/d，胶 体果胶铋胶囊200 mg/次，2次/d，疗程10 d；B组：用药同A组，疗程14 d；C组：在A组用药基础上加用复方嗜 酸乳杆菌片1.0 g/次，3次/d，疗程10 d；D组：用药同C组，疗程14 d。治疗结束4～8周后行13C-尿素呼气试验， 结果阴性者判断为幽门螺杆菌根治成功。比较4组的幽门螺杆菌根除率及不良反应发生率。结果 按照意向性分 析，A 组与B 组、A 组与C 组、A 组与D 组、C 组与D 组间幽门螺杆菌根除率比较，差异有统计学意义（P < 0.007）；B组与C、D组比较差异无统计学意义（P >0.007）；按照符合方案集分析，A组与B组、A组与C组、A 组与D组、C组与D组间幽门螺杆菌根除率比较，差异有统计学意义（P <0.007）。B组与C、D组比较差异无统计 学意义（P >0.007）。A组腹胀、恶心、腹泻发生率高于C组（P <0.007）；B组腹胀、恶心、腹泻、便秘发生率高 于C组（P <0.007）；B组腹胀、纳差、腹泻发生率高于D组（P <0.007）；4组间皮疹、头痛、味觉异常发生率比 较，差异无统计学意义（P >0.05）。结论 益生菌辅助铋剂四联疗法能在一定程度上提高幽门螺杆菌根除率，对 于抗生素耐药率较低的地区有可能缩短用药时间；并且益生菌辅助治疗同时能降低抗菌药使用过程中发生的胃肠 道不良反应。

Abstract:

Objective To explore whether probiotics auxiliary bismuth quadruple therapy can effectively improve the eradication rate of H.pylori, and whether can shorten the medication time for H.pylori and reduce the related adverse reactions during the use of antibacterial drugs. Methods Six hundred H. pylori-infected patients were selected and randomly divided into four groups. Group A: the total course of treatment is 10 days, with amoxicillin capsule 1.0 g bid, clarithromycin sustained release tablets 500mg bid, rabeprazole sodium enteric-coated tablets 20 mg bid, olloidal pectin bismuth capsule 200 mg bid; group B: the total course of treatment is 14 days and the medication plan is the same as group A; group C: the total course of treatment is 10 days, and the compound Lactobacillus acidophilus tablets 1.0 g tid was added to the group A regimen; group D: The total course of treatment is 14 days, and the medication plan is the same as group C. After 4 to 8 weeks of treatment, 13C-UBT was performed, and the negative ones were judged to be successful in the radical treatment of H.pylori. Finally, the eradication rate of H.pylori and the incidence of adverse reactions among the four groups were compared. Results According to the intent-to-treat analysis (ITT analysis), the comparisons of eradication rate between group A and group B, group A and group C, group A and group D, group C and group D were statistically significant (P < 0.007), the differences between group B and group C, group B and group D were not statistically significant (P > 0.007). According to the perprotocol analysis (PP analysis) method, the differences of eradication rate between group A and group B, group A and group C, group A and group D, group C and group D were statistically significant (P < 0.007), but no significant difference was found between group B and group C, group D (P > 0.007). The incidences of abdominal distension, nausea, and diarrhea in group A were significantly higher than those in group C, and the differences were statistically significant (P < 0.007). Compared with group D, group B had a higher incidence of abdominal distension, anorexia, and diarrhea, and the difference was statistically significant (all P < 0.007). The incidences of bloating, nausea, diarrhea, and constipation were significantly higher in Group B than in group C, and the differences were statistically significant (P < 0.007). The difference was not statistically significant in the incidences of rash, headache, and taste abnormalities among the groups (P > 0.05). Conclusion Probiotics auxiliary bismuth quadruple therapy can effectively improve the eradication rate of H.pylori up to a point. For some areas with low resistance to antibiotics, it is also possible to effectively shorten the time of administration, and probiotics can also reduce the gastrointestinal side effects that occur during the use of antibacterials.