复方嗜酸乳杆菌片联合三联方案根除幽门螺杆菌的临床研究

目的探讨复方嗜酸乳杆菌片联合三联方案根除幽门螺杆菌(Helicobacter pylori,H.pylori)的疗效及不良反应。方法将143例H.pylori检测阳性的患者随机分为A1组(48例)、A2组(46例)和B组(49例)。B组给予三联方案(埃索美拉唑、阿莫西林、克拉霉素)根除H.pylori治疗,疗程10d。A1组、A2组分别在上述三联方案的基础上同时加用10d、20d的复方嗜酸乳杆菌片。治疗过程中观察并记录上述三组的不良反应发生情况,停药4周后查13 C呼气试验判别H.pylori根除是否成功。结果共133例患者完成治疗和随访,A1组、A2组、B组根除率按方案(PP)分析分别为65.9%、69.8%、63.0%,按意向性(ITT)分析分别为60.4%、65.2%、59.2%,无论按方案分析还是意向性分析三组根除率差异均无统计学意义(P0.05)。纳入三组的共143例患者均完成不良反应的随访,A1组、A2组、B组不良反应发生率分别为10.4%、8.7%、30.6%,三组相比差异有统计学意义(P0.05),其中A1组、A2组分别与B组相比差异有统计学意义(P0.05),A1组与A2组相比差异无统计学意义(P0.05)。结论三联方案加用10d、20d的复方嗜酸乳杆菌片未能提高H.pylori根除率,但可降低不良反应发生率。

The eradication of Helicobacter pylori using compound Lactobacillus acidophilus tablets combined with triple therapy

Abstract: Objecttve To investigate the clinical efficacy and adverse reactions of Compound Lactobacillus acidophilus combined with triple therapy in the eradication of Helicobacter pylori (H. pylori). Methods 143 H. pylori-infected patients were randomly divided into group A1 (n=48), group A2 (n=46) or group B (n=49). The group B was treated with the triple therapy (esomeprazole, amoxicillin and clarithromycin) for 10 days. The group A1 and A2 were additionally given Compound Lactobacillus acidophilus pills on the basis of standard triple therapy for 10 and 20 days respectively. The adverse reactions during treatment were observed and recorded. Four weeks after the course of treatment H.pylori eradication rates were assessed through the 13C urea breath test. Results A total of 133 patients completed the treatment and follow-up. The eradication rates of H.pylori in groups A1, A2 and B were 65.9%, 69.8% and 63.0% respectively by per-protocol (PP) analysis, and were 60.4%, 65.2% and 59.2% respectively by intention-to-treat (ITT) analysis. Whether by PP analysis or ITT analysis, the differences were not statistically significant (P>0.05). All the 143 patients completed the follow-up of adverse reactions. The incidence of adverse reactions in groups A1, A2 and B were 10.4%, 8.7% and 30.6% (P<0.05), respectively, and it was significantly higher in group B than in groups A1 and A2 (P<0.05), while there was no significant difference between groups A1 and A2 (P>0.05). Conclusion Compound Lactobacillus acidophilus 10 or 20 days combined with triple therapy can not increase the eradication rates of H. pylori, but reduce the incidence of adverse reactions significantly.