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儿童愈合性食管糜烂的奥美拉唑长期维持治疗:一项前瞻性研究。

Long-term maintenance treatment with omeprazole in children with healed erosive oesophagitis: a prospective study.

机构信息

Division of Gastroenterology, British Columbia Children's Hospital/University of British Columbia, Vancouver, Canada.

出版信息

Aliment Pharmacol Ther. 2012 Feb;35(3):368-79. doi: 10.1111/j.1365-2036.2011.04950.x. Epub 2011 Dec 18.

Abstract

BACKGROUND

Short-term studies show that PPIs heal erosive esophagitis in children. There are no prospective studies that examine long-term maintenance therapy of erosive esophagitis in children with and without underlying GERD-predisposing disorders.

AIM

To determine prospectively the dose of omeprazole needed to maintain remission of erosive oesophagitis and reflux symptoms in children.

METHODS

Patients aged 1-16 years with healed erosive reflux oesophagitis after omeprazole treatment (0.7-3.5 mg/kg/day) entered a 21-month maintenance phase where they initially received half the dose of omeprazole required to heal. Endoscopy was performed after 3, 12 and 21 months. The omeprazole dose was increased if erosive oesophagitis or reflux symptoms recurred.

RESULTS

A total of 46 patients entered the study and 32 completed it. Of these, 17 (53%) remained on the maintenance dose, 12 (38%) returned to their healing dose and 3 (9%) ended the study on a dose higher than their healing dose. Three-quarters of the completers (24/32) had no erosive oesophagitis relapse. Four patients (13%) had relapse of only erosive oesophagitis, 4 (13%) had relapse of erosive oesophagitis and symptoms, and 10 (31%) had only symptomatic relapse. Of the 46 patients, 48% had GERD-predisposing disorders (neurological impairment or oesophageal atresia). Overall, 62.5% (5/8) of patients who had an erosive oesophagitis relapse had a GERD-predisposing disorder versus 33.3% (8/24) of those who did not.

CONCLUSIONS

Remission of erosive oesophagitis is maintained with omeprazole treatment for at least 21 months in most children aged 1-16 years, and the drug is well tolerated. To maintain remission, some 60% of patients require more than half the dose required for healing. In children with GERD-predisposing conditions, GERD is often chronic and relapsing, and requires long-term management.

摘要

背景

短期研究表明质子泵抑制剂可治愈儿童的糜烂性食管炎。目前尚无前瞻性研究检查有或无潜在 GERD 易患疾病的儿童糜烂性食管炎的长期维持治疗。

目的

前瞻性确定维持儿童糜烂性食管炎缓解和反流症状所需的奥美拉唑剂量。

方法

接受奥美拉唑(0.7-3.5mg/kg/天)治疗后愈合的年龄在 1-16 岁的患有愈合性糜烂性反流性食管炎的患者进入 21 个月的维持阶段,最初接受治愈所需剂量的一半。在 3、12 和 21 个月后进行内镜检查。如果出现糜烂性食管炎或反流症状,增加奥美拉唑剂量。

结果

共有 46 名患者入组,32 名患者完成研究。其中,17 名(53%)继续维持剂量,12 名(38%)恢复到治愈剂量,3 名(9%)结束研究时剂量高于治愈剂量。完成研究的 32 名患者中,75%(24/32)无糜烂性食管炎复发。4 名患者(13%)仅出现糜烂性食管炎复发,4 名患者(13%)出现糜烂性食管炎和症状复发,10 名患者(31%)仅出现症状复发。46 名患者中,48%(22/46)有 GERD 易患疾病(神经损伤或食管闭锁)。总体而言,62.5%(5/8)出现糜烂性食管炎复发的患者有 GERD 易患疾病,而未出现糜烂性食管炎复发的患者中,这一比例为 33.3%(8/24)。

结论

在大多数 1-16 岁的儿童中,奥美拉唑治疗至少 21 个月可维持糜烂性食管炎缓解,且药物耐受性良好。为了维持缓解,约 60%的患者需要超过治愈所需剂量的一半。在有 GERD 易患疾病的儿童中,GERD 往往是慢性和复发性的,需要长期管理。

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