Kato Seiichi, Konno Mutsuko, Maisawa Shun-Ichi, Tajiri Hitoshi, Yoshimura Norikazu, Shimizu Toshiaki, Toyoda Shigeru, Nakayama Yoshiko, Iinuma Kazuie
Department of Pediatrics, Tohoku University School of Medicine, 1-1 Seiryo-machi, Aoba-ku, 980-8574 Sendai, Japan.
J Gastroenterol. 2004 Sep;39(9):838-43. doi: 10.1007/s00535-004-1398-6.
Large-scale clinical trials in children are lacking concerning Helicobacter pylori eradication therapies. The purpose of this study was to assess the efficacy of proton pump inhibitor (PPI)-based triple therapies in Japanese children.
This was a retrospective analysis of the first- and second-line PPI-based triple therapies from pediatric gastrointestinal units between 1996 and 2003. Data collected included doses and duration of regimens, drug compliance, success or failure of eradication, ulcer healing, and symptom response of those with dyspepsia and no ulcers. The results of antibiotic susceptibility tests were also reported in cases where these were performed.
A total of 149 pediatric patients (mean age, 12.6 years) were studied, including 123 patients who received first-line therapy: 115 received a PPI plus amoxicillin and clarithromycin (PAC) and 8 received a PPI plus amoxicillin and metronidazole (PAM). Overall eradication rates of the first-line PAC and PAM therapies were 77.4% and 87.5%, respectively ( P = 0.68). All 14 patients with failed PAC therapy received the second-line PAM regimen, resulting in an eradication rate of 100%. Mild side effects were reported only in PAC regimens (13.8%). Primary resistance to amoxicillin, clarithromycin, and metronidazole was detected in 0%, 34.7%, and 12.5% of the strains, respectively. The PAC regimen showed a high eradication rate for clarithromycin-susceptible strains (91.7%), but was relatively ineffective for resistant strains (40.0%) ( P < 0.01). Eradication of H. pylori was associated with ulcer healing and symptomatic improvement among those with gastritis only (both; P < 0.001). Among 17 patients with iron-deficiency anemia, post-treatment hemoglobin levels were higher than the pretreatment levels ( P < 0.001).
The PAC regimen is effective in children. Clarithromycin resistance is associated with eradication failure. Metronidazole is a good substitute for clarithromycin as the second-line option for children.
关于幽门螺杆菌根除疗法，儿童大规模临床试验尚缺。本研究目的是评估基于质子泵抑制剂（PPI）的三联疗法对日本儿童的疗效。
这是一项对1996年至2003年间儿科胃肠病科室基于PPI的一线和二线三联疗法的回顾性分析。收集的数据包括治疗方案的剂量和疗程、药物依从性、根除成功或失败、溃疡愈合情况，以及消化不良且无溃疡患者的症状反应。若进行了抗生素敏感性试验，也报告其结果。
共研究了149例儿科患者（平均年龄12.6岁），其中123例接受一线治疗：115例接受PPI加阿莫西林和克拉霉素（PAC），8例接受PPI加阿莫西林和甲硝唑（PAM）。一线PAC和PAM疗法的总体根除率分别为77.4%和87.5%（P = 0.68）。所有14例PAC治疗失败的患者接受了二线PAM方案，根除率达100%。仅PAC方案报告有轻微副作用（13.8%）。阿莫西林、克拉霉素和甲硝唑的原发耐药率分别在0%、34.7%和12.5%的菌株中检测到。PAC方案对克拉霉素敏感菌株显示出高根除率（91.7%），但对耐药菌株相对无效（40.0%）（P < 0.01）。仅患胃炎的患者中，幽门螺杆菌的根除与溃疡愈合和症状改善相关（两者均P < 0.001）。17例缺铁性贫血患者中，治疗后血红蛋白水平高于治疗前水平（P < 0.001）。
PAC方案对儿童有效。克拉霉素耐药与根除失败相关。甲硝唑作为儿童二线选择是克拉霉素的良好替代药物。
