莫西沙星三联疗法联合瑞巴派特根除2型糖尿病患者幽门螺杆菌感染的疗效

Moxifloxacin-based triple therapy combined with rebamipide for Helicobacter pylori eradication in type 2 diabetic patients

目的观察莫西沙星三联疗法联合瑞巴派特根除2型糖尿病患者幽门螺杆菌（Hp）的疗效。方法200例有胃肠道症状的2型糖尿病Hp阳性患者，按年龄、性别分层随机分配入瑞巴派特组和安慰剂组各100例，两组均给予莫西沙星为基础的三联Hp根除治疗10d，瑞巴派特组和安慰剂组同时分别给予瑞巴派特和安慰剂治疗30d。所有患者分别于根除治疗前和治疗后第7～8周进行^14C-尿素呼气试验，计算并比较血糖指标、胃肠道症状评分和Hp根除率；两组根除成功者于12个月后再次进行^14C-尿素呼气试验，比较两组根除成功者的再感染率。结果治疗前后两组之间平均空腹血糖、餐后血糖、糖化血红蛋白以及治疗前胃肠道症状评分比较，差异均无统计学意义（均P〉0．05）。治疗后瑞巴派特组胃肠道症状（2．1±0．9）低于安慰剂组（4．4±0．7），差异有统计学意义（P〈0．01）。瑞巴派特组Ir丌和PPHp根除率高于安慰剂组[86％（86／100）比73％（73／100），92．5％（86／93）比76．8％（73／95）]，差异有统计学意义（P〈0．05或P〈0．01）。根除成功者瑞巴派特组的11Tr和PP再感染率低于安慰剂组[19．8％（17／86）比35．6％（26／73），20．5％（17／83）比36．6％（26／71）]，差异有统计学意义（均P〈0．05）。结论莫西沙星三联疗法联合瑞巴派特可提高2型糖尿病的Hp根除率，降低再感染率，改善Hp相关的胃肠道症状。

Objective To evaluate the efficacy of moxifloxacin-based triple therapy combined with rebamipide for Helicobacter pylori （Hp） eradication in type 2 diabetic patients. Methods Two-hundred age and sex matched type 2 diabetic patients with Hp infection and accompanied by gastrointestinal symptoms were assigned into rebamipide group （ n = 100 ） and placebo group （ n = 100 ）. Both groups received moxifloxacin-based triple therapy for 10 d to eradicate Hp. Rebamipide was administrated in rebamipide group and placebo was administrated in placebo group for 30 d. All patients proceeded 14C-urea breath test （14 C-UBT ） before and 7 - 8 weeks after eradication therapy. The blood sugar indices, gastrointestinal symptom scores and Hp eradication rates were measured and compared. Those who had gained successful Hp eradication in both groups proceeded 14 C-UBT again 12 months after eradication therapy, and the re-infection rates of both groups were compared. Results There were no significant differences in the average fasting glucose, postprandial glucose and HbA1 c levels between the rebamipide group and the placebo group before and after therapy （ P 〉 0.05 ） , the gastrointestinal symptoms of the rebamipide group were improved more markedly than those of the placebo group after therapy （ Rome ~ Criteria, 2. 1 -＋ 0.9 vs. 4.4 ±0. 7, P 〈 0. 01 ）. The Hp eradication rate with both intention-to-treat （1TT） and per protocol （PP） analysis of the rebamipide group were higher than that of the placebo group [ 86. 0% （86/100） vs. 73.0% （73/100）, P 〈0. 05 and 92. 5% （86/93） vs. 76. 8% （73/95）, P 〈0. 01 ]. The re-infection rates with both ITT and PP analysis of those who had successful eradication in rebamipide group were lower than that in placebo group [ 19. 8% （17/86） vs. 35.6% （26/73）, P 〈0. 05 and 20. 5% （17/83） vs. 36. 6% （26/71）, P 〈 0.05 ]. Conclusions Moxifloxacin-based triple therapy combined with rebamipide has a more beneficial effect on Hp related symptoms, a higher Hp eradication rate and a lower Hp re-infection rate for type 2 diabetic patients.