艾普拉唑四联疗法联合双歧杆菌在幽门螺杆菌补救方案中的疗效评价

Efficacy and safety of Bifidobacterium combined with ilaprazole-containning quadruple therapy in rescue eradication of Helicobacter pylori

目的评价不同给药时机及疗程的双歧杆菌(Bifidobacterium)联合艾普拉唑(Ilaprazole)四联疗法在根除幽门螺杆菌(Helicobacter pylori,H.pylori)补救治疗方案中的有效性及安全性.方法 280例H.pylori感染的初治失败患者随机分成4组.A组给予艾普拉唑、阿莫西林、呋喃唑酮、胶体果胶铋治疗14 d.B组在A组方案上联用双歧杆菌14 d.C、D组分别在A、B组方案前分别口服双歧杆菌28 d.所有患者治疗结束4 wk后行C13-尿素呼气试验(urea breath test,UBT)记录H.pylori根除率、不良反应发生率.结果 251例完成治疗和随访.意向性治疗(intention-totreat,ITT)分析A、B、C、D组H.pylori根除率依次为:62.85、71.43、75.71、77.14;符合方案集(per-protocol,PP)分析,各组根除率依次为:72.13、79.36、84.13、84.38.B、C、D组根除率显著高于A组(P<0.05);C、D组根除率显著高于B组(P<0.05);C、D组间根除率差异无统计学意义(P>0.05).A、B、C、D组患者治疗完成率分别为:87.14(61/70)、90.00(63/70)、90.00(63/70)、91.43(64/70).B、C、D组治疗完成率显著高于A组(P<0.05);D组治疗完成率略高于B、C组,差异无统计学意义(P>0.05).A、B、C、D组患者不良反应发生率分别为:14.92、10.61、7.46、6.06.B、C、D组不良反应发生率显著低于A组(P<0.05),C、D组不良反应发生率显著低于B组(P<0.05);C、D组间差异无统计学意义(P>0.05).结论双歧杆菌能有效提高补救治疗方案的H.pylori根除率,减少药物不良反应,增加患者治疗依从性.补救方案中在四联疗法前服用双歧杆菌28 d是最优选择.

AIM To evaluate the efficacy and safety of Bifidobacterium combined with ilaprazole-containning quadruple therapy in rescue eradication of Helicobacter pylori （H. pylori）. METHODS Two hundred and eighty H. pylori infected patients who failed initial treatment were randomly divided into four groups： A-D. Group A was treated with ilaprazole, amoxicillin, furazolidone, and colloidal bismuth pectin for 14 d. Group B was simultaneously given Bifidobacterium for 14 d on the basis of the therapy in group A. Groups C and D were, respectively, given Bifidobacterium for 28 d before the same therapy in groups A and B. H. pylori eradication was assessed by C13-urea breath test （C1CUBT）, and the incidence of adverse reactions was compared in the four groups at 4 wk after treatment. RESULTS In total, 251 patients completed the treatment and follow-up according to the experimental design. Intention-to-treat （1TT） analysis showed that the H. pylori eradication rates in groups A, B, C, and D were 62.85, 71.43, 75.71, and 77.14, respectively, and per-protocol （PP） analysis showed that the eradication rates in groups A, B, C, and D were 72.13, 79.36, 84.13, and 84.38, respectively. The eradication rates in groups B, C, and D were significantly higher than that in group A （P 〈 0.05）, and the eradication rates in groups C and D were significantly higher than that in group B （P 〈 0.05）, while no statistically significant difference was found between groups C and D （P 〉 0.05）. The completion rates in groups A, B, C, and D were 87.14 （61/70）, 90.00 （63/70）, 90.00 （63/70）, and 91.43 （64/70）, respectively. The completion rates in groups B, C, and D were significantly higher than that in group A （P 〈 0.05）, while there was no significant difference in the completion rates among group B, C, and D （P 〉 0.05）. The incidence of adverse reactions in groups A, B, C, and D was 14.92, 10.61, 7.46, and 6.06, respectively. The incidence of adverse reactions in groups B, C, and D was significantly lower than that in group A （P 〈 0.05）, and the incidence of adverse reactions in groups C and D was significantly lower than that in group B （P 〈 0.05）, while there was no significant difference in the incidence of adverse reactions between groups C and D （P 〉 0.05）. CONCLUSION Bifidobacterium can effectively improve the rescue eradication rates of H. pylori, decrease the incidence of adverse reactions, and improve the compliance with treatment. The optimal strategy for rescue eradication is 28 d of Bifidobacterium before the ilaprazole- containning quadruple therapy.