序贯疗法与三联疗法根除儿童幽门螺杆菌感染的临床研究

目的比较分析由奥美拉唑、克拉霉素、阿莫西林和甲硝唑组成的10 d序贯疗法与标准三联疗法根除儿童幽门螺杆菌（Hp）感染的临床疗效。方法将109例诊断为Hp感染的患儿按随机数字表法分为3组：10 d序贯疗法组（37例）、10 d三联疗法组（36例）和14 d三联疗法组（36例）。10 d序贯疗法组：前5 d给予奥美拉唑0.6-0.8 mg·kg^-1·次-1＋阿莫西林50 mg·kg^-1·d-1,口服,每日早晚各1次;后5 d改用奥美拉唑0.6-0.8 mg·kg^-1·次-1＋克拉霉素15-30 mg·kg^-1·d-1＋甲硝唑片25-30 mg·kg^-1·d-1,口服,每日早晚各1次。10 d和14 d三联疗法2组：奥美拉唑0.6-0.8 mg·kg^-1·次-1＋克拉霉素15-30 mg·kg^-1·d-1＋阿莫西林50 mg·kg^-1·d-1或甲硝唑片25-30 mg·kg^-1·d-1,口服,每日早晚各1次,疗程分别为10 d和14 d。所有患儿在停药后至少4周复查13C尿素呼气试验（13C-UBT）,观察Hp根除率、疗效及不良反应（食欲不振、恶心、呕吐、腹泻、便秘、头痛、皮疹等症状）的发生情况。结果 109例患儿中失访7例（6.4%,10 d序贯疗法组1例,10 d三联疗法组2例,14 d三联疗法组4例）。10 d序贯疗法组Hp根除率按意向治疗分析（ITT）及试验方案分析（PP）均明显高于10 d三联疗法组（χ^2=5.408,5.137,均P〈0.05）,与14 d三联疗法组比较差异均无统计学意义（χ^2=2.510,0.868,均P〉0.05）。3组患儿治疗后总有效率比较差异均无统计学意义（χ^2=0.320,P〉0.05）。3组患儿均未出现严重的不良反应。结论 10 d序贯疗法是一种安全、有效的儿童Hp根除方案。

Sequential Therapy and Standard Triple Therapy for Eradication of Helicobacter Pylori Infection in Children

Objective To comparatively analyze the clinical effectiveness of a 10-day sequential therapy consisting of omeprazole,clarithromycin,amoxicillin and metronidazole and standard triple therapy for the eradication of Helicobacter pylori（Hp） infection in children. Methods A total of 109 children diagnosed with Hp infection were randomly divided into three groups. In the 10-day sequential therapy group（n=37）, children were given omeprazole 0.6-0.8 mg·kg^-1, clarithromycin 15-30 mg·kg^-1·d^-1and metronidazole 25-30 mg·kg^-1·d^-1for 5 days after treatment with omeprazole 0.6-0.8 mg·kg^-1and amoxicillin 50 mg·kg^-1·d^-1 for 5 days.In the 10-day triple therapy group and 14-day triple therapy group, children were given omeprazole 0.6-0.8 mg·kg^-1, clarithromycin 15-30 mg·kg^-1·d^-1and amoxicillin 50 mg·kg^-1·d^-1or metronidazole 25-30 mg·kg^-1·d^-1for 10 and 14 days, respectively. All drugs were taken twice daily（morning and evening）.The Hp eradication rate was appraised by13C-UBT at least 4 weeks after completion of treatment. In addition, the curative effectiveness and adverse drug reactions（inappetence, nausea, vomiting, diarrhea, constipation, headache, rash, etc.） were compared among the three groups. Results Among the 109 children, 7 patients（6.4%） were lost to follow-up, including 1 patient in 10-day sequential therapy group, 2 patients in 10-day triple therapy group and 4patients in 14-day triple therapy group. By tent-to-treat（ITT） and per-protocol（PP） analyses, Hp eradication rates in 10-day sequential therapy group were significantly higher than those in 10-day triple therapy group（ χ^2=5.408 and χ^2=5.137, respectively; P0.05）, but not significantly different from those in 14-day triple therapy group（ χ^2=2.510 and χ^2=0.868, respectively; P 0.05）. There were no significant differences in the total effective rate among the three groups（ χ^2=0.320, P0.05）. No serious adverse reactions occurred in all children. Conclusion The 10-day sequential therapy is