不同幽门螺杆菌根除方案对功能性消化不良影响的临床研究

Clinical Study on Effects of Different Eradication Therapies for Helicobacter pylori on Functional Dyspepsia

背景：功能性消化不良（FD）是常见的功能性胃肠病,幽门螺杆菌（H.pylori）是FD的重要致病因素之一.目的：探讨不同H. pylori根除方案对FD患者临床症状的疗效.方法：160例H. pylori（＋）FD患者随机分为10 d序贯治疗组（60例）、7 d三联治疗组（60例）和对照组（40例）.所有息者于停药4周后复查14C-尿素呼气试验以评估H. pylori根除率.患者于治疗前、治疗后第3、6、12个月评估FD症状.结果：10 d序贯治疗组、7 d三联治疗组和对照组的H.pylori根除率分别为93.2%、74.1%和48.6%（符合方案分析）以及91.7%、71.7%和42.5%（意向治疗分析）,各组相比差异有统计学意义（P〈0.05）.治疗后第6、12个月,10 d序贯治疗组和7 d三联治疗组中H. pylori根除者的FD症状改善率显著高于对照组（P〈0.05）,但两治疗组之间无明显差异.结论：10 d序贯治疗和7 d三联治疗的FD症状改善率无明显差异,但前者H. pylori根除率高于后者,临床可推荐10 d序贯疗法治疗H.pylori（＋）FD患者.

Background： Functional dyspepsia （FD） is a commonly seen functional gastrointestinal disorder, and Helicobacter pylori （H. pylort） is one of the important pathogenetie factors of FD. Aims： To investigate the therapeutic effects of different eradication therapies for H. pylori on clinical symptoms in FD patients. Methods： One hundred and sixty H. pylori positive FD patients were randomly allocated into 10-day sequential therapy group （60 cases）, 7-day triple therapy group （60 cases） and control group （40 cases）. H. pylori eradication rate was assessed 4 weeks after treatment by 14C-urea breath test. Symptom score of FD was evaluated before treatment and at the 3rd month, 6th month, as well as 12th month after treatment. Results： The H. pylori eradication rates of 10-day sequential therapy group, 7-day triple therapy group and control group were 93.2%, 74.1% and 48.6% （per-protocol analysis）, and 91.7%, 71.7% and 42.5% （intention-to-treat analysis）, respectively, with significant differences among these three groups （P〈O.05）. Six months and twelve months after treatment, FD symptom amelioration rate of H. pylori eradicated patients in lO-day sequential therapy and 7-day triple therapy groups was higher than that in control group （p〈0.05）, while the difference between 10-day sequential therapy group and 7-day triple therapy group was not significant. Conclusions： Although no difference is found in FD symptom amelioration rate between H. pylori eradicated patients in 10-day sequential therapy group and 7-day triple therapy group, the eradication rate of H. pylori in lO-day sequential therapy group is higher than that in 7-day triple therapy group. 10-day sequential therapy should be recommended to the treatment of H. pylori positive FD patients in clinical practice.