序贯疗法与标准三联疗法治疗幽门螺杆菌阳性功能性消化不良患者的疗效比较

Treatment outcomes of functional dyspepsia patients with Helicobacter pylori infection:a comparison between sequential treatment regimen and conventional triple therapy

目的:评价序贯疗法(sequential treatment regimen)与标准三联疗法对幽门螺杆菌(Helicobacter pylori,Hp)阳性功能性消化不良(functional dyspepsia,FD)患者根除Hp效果及症状改善情况。方法:Hp阳性的130例FD患者随机分为2组:S组给予奥美拉唑20 mg、阿莫西林1 000 mg口服5 d后再给予奥美拉唑20 mg、克拉霉素500 mg和替硝唑400 mg口服5 d,均2次/d;T组给予奥美拉唑20 mg、克拉霉素500 mg和阿莫西林1 000 mg口服7 d,均2次/d;治疗后4周及随访1年后行快速尿素酶试验和14C-尿素呼气试验,并对症状进行评分。结果:S组按意图治疗(ITT)Hp根除率为83.58%(56/67),按试验方案(PP)分析为91.80%(56/61);T组根除率按ITT分析为65.08%(41/63),按PP分析为69.49%(41/59),均显著低于S组(P<0.05)。Hp根除组患者治疗前症状评分为4.88±1.76,1年后为2.18±0.83,差异有统计学意义(P<0.05);Hp持续感染组患者治疗前症状评分为4.99±1.66,随访1年后为3.89±1.56,差异无统计学意义。结论:序贯疗法对Hp阳性FD患者Hp根除效果明显好于标准三联疗法,Hp根除后消化不良症状可显著改善。

Objective：To compare the eradication rates of H. pylori infection between a new sequential treatment regimen and conventional triple therapy in functional dyspepsia patients, and to assess the symptom improvement of functional dyspepsia. Methods： One hundred and thirty functional dyspeptic patients with H. pylori infection were randomly divided into 2 groups. Patients in sequential treatment group received 10-day sequential therapy：omeprazole （40 mg daily） plus amoxicillin （1 g twice daily） for the first 5 days, followed by omeprazole （20 mg） ,clarithromycin （500 mg） and tinidazole （500 mg） twice daily for the another 5 days; patients in triple therapy group received standard 7-day treatment： omeprazole （20 mg）, clarithromycin （500 mg） and amoxicillin （1 g） twice daily for 7 days. H. pylori statuses were assessed by rapid urease test and ;4 C-urea breath test at base line level 4 weeks and one year after treatment, and symptom scores in various H. pylori statuses were evaluated. Results： The eradication rates of H. pylori in the sequential treatment group was 83.58; （56/67）by intention-to-treat（TTI） analysis and 91.80; （56/61） by per-protocol（PP）analysis, and the numbers in the triple therapy group were 65.08; （41/63） and 69.49;（41/59）,respectively, which were significantly lower than those in the sequential treatment group （P〈0. 05）. The symptom scores of patients with H. pylori eradicated after treatment were 4. 88±1.76 before treatment and 2. 18±0.83 one year after treatment （P〈0. 05）; the scores of patients whose H. pylori was not eradicated after treatment was 4. 99± 1.66 before treatment and 3. 89 ± 1. 56 one year later; there was no significant difference between the 2 numbers. Conclusion： Sequential treatment regimen has a better H. pylori eradication effect for functional dyspepsia patients positive of H. pylori than standard triple therapy; the symptom of dyspepsia can be greatly improved after H. pylori eradication.