序贯疗法根除儿童幽门螺杆菌感染的综合疗效评价

Comprehensive curative effect evaluation on sequential therapy for eradication of helicobacter pylori infection in children

目的：探讨序贯疗法根除儿童幽门螺杆菌（helicobacter pylori,Hp）感染的效果及安全性。方法：经尿素呼气试验（13C-UBT）、快速尿素酶试验（RUT）两项检查均阳性确诊为Hp感染的腹痛患儿100例,进行胃镜下胃黏膜糜烂程度评分,随机分为序贯疗法和三联疗法组。序贯疗法组前5 d予奥美拉唑0.8~1.0mg/（kg·d-1）＋阿莫西林/克拉维酸钾50mg/（kg·d-1）,后5 d予奥美拉唑0.8~1.0mg/（kg·d-1）＋克拉霉素20mg/（kg·d-1）＋甲硝唑20mg/（kg·d-1）,共10 d。对照组采用标准三联方案,予奥美拉唑0.8~1.0mg/（kg·d-1）＋阿莫西林克拉维酸钾50mg/（kg·d-1）＋克拉霉素20mg/（kg·d-1）,连续10 d。停药后4周复诊,复查胃镜、13C-UBT、RUT,再次进行胃镜下胃黏膜糜烂程度评分。比较两组Hp根除情况、胃黏膜糜烂程度变化及不良反应发生率。结果：100例入组患儿共失访8例（8.0%）,其中序贯疗法组5例,三联疗法3例。序贯疗法组患儿Hp根除率分别为88.0%（ITT）、97.8%（PP）,三联疗法患儿Hp根除率分别为66.0%（ITT）、70.2%（PP）,组间比较差异显著（P〈0.05）。序贯疗法组和三联疗法组胃黏膜糜烂治疗有效率分别为97.8%（44/45）、85.1%（40/47）,组间比较差异显著（P〈0.05）。两组不良反应发生率比较无统计学意义（P〉0.05）。结论：序贯疗法可有效根除儿童Hp,更有助于改善胃黏膜病变程度,其效果优于标准三联疗法。

Objective： To investigate the efficacy, and safety of sequential therapy for eradication the helicobacter pylori（helicobacter pylori, Hp） infection in child. Methods ： The enrolled criteria are diagnosis with Hp infection, urea breath test（13C- UBT） and rapid urease test（RUT） were both positive. 100 cases were included. The symptom of abdominal pain, gastric mucosa erosion rate were evaluated under gastroscope, then they were randomly divided into sequential therapy and triple therapy group（n = 50）. For sequential therapy group, the medication for the first 5 d is omeprazole 0.8 ~ 1.0 mg/（kg·d-1） ＋ amoxicillin clavulanic acid potassium 50 mg/（kg·d-1）, then for the last 5 d is omeprazole 0.8 ~ 1.0 mg/（kg·d-1） ＋ clarithromycin 20 mg/（kg·d-1）＋ metronidazole 20 mg/（kg·d-1）. The total treatment period is 10 d. For control group, adopts the standard triple therapy with omeprazole 0.8 ~ 1.0 mg/（kg·d-1） ＋ amoxicillin clavulanic acid potassium 50 mg/（kg·d-1）＋ clarithromycin 20 mg/（kg·d-1） for 10 d. 4 weeks after discontinuation, the patients were followed up. The gastroscope, 13C- UBT, RUT were test again, and erosion degree of gastric mucosa were scored under gastroscope. Hp eradication, extent of gastric mucosal erosion change and incidence of adverse reactions were compared between the two groups. Results： 8 cases（8.0%） were lost within 100 cases, 5 cases in sequential therapy group,and 3 cases in triple therapy. Hp eradicate rate in sequential therapy group were 88.0%（ITT）, 97.8%（PP）, Hp eradicate rate in triple therapy group were 66.0%（ITT）, 70.2%（PP）, there are significant difference between two groups（P〈0.05）. The gastric mucosal erosion treatment rate were 97.8%（44/45）, 85.1%（40/47） for sequential therapy group and triple therapy group respectively, there are also significant difference between groups（P〈0.05）. Incidence of adverse reactions between the two groups has no statistical significance（P〉0.05）. Conclusion： Sequential therapy can effectively eradicate the Hp infection in children, and improve the degree of gastric mucosa lesions. Its effect is better than the standard triple therapy.