摘要
目的探讨由奥美拉唑、克拉霉素、阿莫西林-克拉维酸钾、甲硝唑组成的10日序贯疗法根除儿童幽门螺杆菌（Hp）感染的临床疗效。方法经快速尿素酶反应、病理检查和Hp培养任意两项检查阳性确诊为Hp感染的腹痛患儿214例，单盲随机法分为4组。10日序贯疗法组（54例）治疗方案为前5d应用奥美拉唑0．8-1．0mg／（kg·d）＋阿莫西林-克拉维酸钾50mg／（kg·d），每日早晚2次口服，后5d应用奥美拉唑0．8-1．0mg/（kg·d）＋克拉霉素20mg／（kg·d）＋甲硝唑20mg／（kg·d），每日早晚2次口服。三联疗法7d组（53例）、10d组（55例）、14d组（52例）：奥美拉唑0．8-1．0mg／（kg·d）＋克拉霉素20mg／（kg·d）＋阿莫西林-克拉维酸钾50mg/（kg·d），每日早晚2次口服，疗程分别为7、10和14d。停药后4周复诊，复查^13C尿素呼气试验（^13C-UBT），按意图治疗分析（ITT）和按试验方案分析（PP）Hp根除率。记录有无恶心呕吐、腹泻、皮疹、头晕头痛不良反应及腹痛的缓解情况。结果214例入组患儿失访15例，总失访率为7．0％（15／214）。10日序贯组实际入组51例，7d、10d、14d三联疗法组实际入组分别为49例、49例和50例。10日序贯组Hp根除率ITT85．2％（46／54），PP90．2％（46／51）；7d三联疗法组Hp根除率ITT66．0％（35／53），PP71．4％（35／49）；10d三联疗法组Hp根除率ITT60．0％（33／55），PP67．3％（33／49）；14d三联疗法组Hp根除率ITT78．8％（41／52），PP82．0％（41／50）。按ITT分析，10日序贯疗法组与7d、10d三联疗法组Hp根除率比较差异有统计学意义（χ2=5．331、8．664，P均〈0．05），与14d三联疗法组Hp根除率比较差异无统计学意义（χ2=0．724，P〉0．05）；按PP分析，10日序贯疗法组与7d、10d三联疗法组Hp根除率比较差异有统计学意义（χ2=5．719、7．864，P均〈0．05），与14d三联疗法组Hp
Objective To evaluate the clinical effect of a 10-day sequential therapy which was made up of omeprazole, elarithromycin, amoxieillin-clavulanate and metronidazole for the eradication of Helicobacter pylori （Hp） infection in children. Method A total of 214 children with abdominal pain, who were confirmed to have Hp infection through endoscopy, biopsy, and Hp culture. The 214 cases were randomly divided into four groups. A 10-day sequential therapy group accepted omeprazole 0. 8 - 1.0 mg/（kg · d） plus amoxicillin-clavulanate 50 rag/（ kg · d） for five days and omeprazole 0. 8 - 1.0 mg/ （kg · d）, claritbromycin 20 mg/（ kg · d） and metronidazole 20 mg/（ kg· d） for the remaining five days.The 7-day triple therapy group, 10-day triple therapy group and 14-day triple therapy group received omeprazole 0. 8 - 1.0 mg/ （ kg· d） , amoxicillin-clavulanate 50 mg/ （ kg · d） and elaritbromycin 20 mg/ （kg. d） for 7 days, 10 days, 14 days, respectively. All drugs were given twice daily. All these patients received 13C urea breath test （13 C-UBT） four weeks after the treatment. Result Finally, 199 patients were followed up, and the total rate of loss to follow-up was 7.0% （15/＇214）. Hp eradication rate was 85.2% and 90. 2% in the 10-day sequential therapy group on intention to treat （ITT） and per protocol （PP） analyses, 66. 0% and 71.4% in the 7-day triple therapy group on ITY and PP analyses; 60. 0% and 67. 3% in 10-day triple therapy group on ITTand PP analyses, and 78. 8% and 82. 0% in patients who received the 10-day sequential regimen on ITY and PP analyses, respectively. By ITT analysis, there was significantly difference between the 10-day sequential therapy group and 7-day or 10-day triple therapy group （P 〈 0.05） , while no significant difference was found between the 10-day sequential therapy group and 14-day triple therapy group （P 〉 O. 05 ）. The results of the ITF analysis and the PP analysis were the same. The four groups had neither significant d
出处
《中华儿科杂志》
CAS
CSCD
北大核心
2012年第8期563-567,共5页
Chinese Journal of Pediatrics
基金
“十一五”国家科技支撑计划课题（2007BAl04802）
关键词
儿童
螺杆菌
幽门
序贯疗法
三联疗法
Child
Helicobacter pylori
Sequential therapy
Standard triple therapy
