Boccia Gabriella, Manguso Francesco, Miele Erasmo, Buonavolontà Roberta, Staiano Annamaria
Department of Pediatrics, University Frederico II, Naples, Italy.
Am J Gastroenterol. 2007 Jun;102(6):1291-7. doi: 10.1111/j.1572-0241.2007.01152.x. Epub 2007 Feb 23.
To evaluate the efficacy of acid-suppressive maintenance therapy for gastroesophageal reflux disease (GERD) in children, after the healing of reflux esophagitis.
Forty-eight children (median age 105 months, range 32-170) with erosive reflux esophagitis were initially treated with omeprazole 1.4 mg/kg/day for 3 months. Patients in endoscopic remission were assigned in a randomized, blinded manner by means of a computer-generated list to three groups of 6-month maintenance treatment: group A (omeprazole at half the starting dose, once daily before breakfast), group B (ranitidine 10 mg/kg/day, divided in two doses), and group C (no treatment). Endoscopic, histological, and symptomatic scores were evaluated at: T0, enrollment; T1, assessment for remission at 3 months after enrollment (healing phase); T2, assessment for effective maintenance at 12 months after T0 (3 months after the completion of the maintenance phase). Relapse was defined as the recurrence of macroscopic esophageal lesions. After the completion of the maintenance phase, patients without macroscopic esophagitis relapse were followed up for GERD symptoms for a further period of 30 months.
Of 48 initially treated patients, 46 (94%) healed and entered the maintenance study. For all patients, in comparison to T0, the histological, endoscopic, and symptomatic scores were significantly reduced both at T1 and T2 (P<0.0001, for each). No significant difference was found in these three scores, comparing group A, B, and C at T1 and T2. A relapse occurred in one patient only, who presented with macroscopic esophageal lesions at T2. Three months after the completion of the maintenance phase, 12 (26%) patients complained of symptoms sufficiently mild to discontinue GERD therapy, excluding the patient who showed macroscopic esophagitis relapse. Three of 44 (6.8%) patients reported very mild GERD symptoms within a period of 30 months after maintenance discontinuation.
Our pediatric population showed a low rate of erosive esophagitis relapse and GERD symptom recurrence long term after healing with omeprazole, irrespective of the maintenance therapy.
评估抑酸维持治疗对儿童反流性食管炎愈合后胃食管反流病（GERD）的疗效。
48例糜烂性反流性食管炎患儿（中位年龄105个月，范围32 - 170个月）初始接受奥美拉唑1.4 mg/kg/天治疗3个月。内镜检查缓解的患者通过计算机生成的列表以随机、盲法方式分为三组进行6个月的维持治疗：A组（奥美拉唑起始剂量减半，早餐前每日一次）、B组（雷尼替丁10 mg/kg/天，分两次给药）和C组（不治疗）。在内镜检查、组织学检查和症状评分方面进行评估的时间点为：T0，入组时；T1，入组后3个月评估缓解情况（愈合阶段）；T2，T0后12个月（维持阶段结束后3个月）评估维持治疗效果。复发定义为食管宏观病变的复发。维持阶段结束后，无食管宏观病变复发的患者针对GERD症状进行了为期30个月的随访。
48例初始治疗患者中，46例（94%）愈合并进入维持治疗研究。对于所有患者，与T0相比，T1和T2时组织学、内镜检查和症状评分均显著降低（每项P<0.0001）。在T1和T2时，比较A组、B组和C组，这三项评分无显著差异。仅1例患者出现复发，该患者在T2时出现食管宏观病变。维持阶段结束后3个月，12例（26%）患者抱怨症状足够轻微，可停止GERD治疗，不包括出现食管宏观病变复发的患者。44例患者中有3例（6.8%）在维持治疗停药后30个月内报告有非常轻微的GERD症状。
我们的儿科患者群体在使用奥美拉唑愈合后，无论维持治疗如何，长期来看糜烂性食管炎复发率和GERD症状复发率都较低。
