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生长激素治疗活动性小儿克罗恩病的随机对照试验。

A randomized controlled trial of growth hormone in active pediatric Crohn disease.

机构信息

Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and the University of Cincinnati College of Medicine, Cincinnati, OH, USA.

出版信息

J Pediatr Gastroenterol Nutr. 2010 Aug;51(2):130-9. doi: 10.1097/MPG.0b013e3181c992d6.

DOI:10.1097/MPG.0b013e3181c992d6
PMID:20453679
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2910806/
Abstract

OBJECTIVES

Growth hormone (GH) may reduce symptoms and improve growth in Crohn disease (CD). The effect on mucosal inflammation is not known. We hypothesized that GH would improve both clinical and mucosal disease activity and stimulate linear growth in pediatric CD.

PATIENTS AND METHODS

Twenty patients ages 7 to 18 receiving corticosteroids (CTX) for active CD were randomized to begin GH, 0.075 mg x kg(-1) x day(-1) (group A), or continue CTX alone (group B). Clinical and endoscopic disease activities were assessed after 12 weeks. Group B began GH at 12 weeks, and clinical disease activity was assessed at 24 weeks. Subjects who experienced a clinical response after 12 weeks of GH therapy continued treatment for an additional 52 weeks, and linear growth was assessed.

RESULTS

Sixty-five percent of patients receiving GH achieved clinical remission, compared with 20% treated with CTX alone (P = 0.03). Although endoscopic disease activity trended toward an improvement at week 12 in group A, this did not differ between the groups. Sixty-one percent of week 12 GH responders maintained their clinical response through week 64. Mean (95th confidence interval) height z score on GH increased from -1.1 (-1.6, -0.6) to -0.4 (-1, 0.2), P = 0.004 during this 52-week extension phase. GH was well tolerated with no unexpected safety signals.

CONCLUSIONS

The addition of GH to CTX therapy did not induce a reduction in mucosal inflammation, relative to CTX alone. However, GH was safe and effective as an adjunct to CTX for treatment of clinical disease activity and growth failure in pediatric CD.

摘要

目的

生长激素(GH)可能减轻克罗恩病(CD)的症状并促进生长。但 GH 对黏膜炎症的影响尚不清楚。我们假设 GH 不仅能改善临床和黏膜疾病活动,还能刺激儿科 CD 患者的线性生长。

患者和方法

20 名年龄 7 至 18 岁、正在接受皮质类固醇(CTX)治疗的 CD 活动期患者被随机分为 GH 组(A 组,0.075mg·kg-1·d-1)和 CTX 组(B 组)。12 周后评估临床和内镜疾病活动度。B 组于 12 周时开始使用 GH,24 周时评估临床疾病活动度。在 GH 治疗 12 周后出现临床应答的患者继续接受治疗 52 周,评估线性生长。

结果

接受 GH 治疗的患者中 65%达到临床缓解,而单独接受 CTX 治疗的患者中仅 20%达到临床缓解(P = 0.03)。尽管 A 组在第 12 周时内镜疾病活动度呈改善趋势,但两组间无差异。61%的第 12 周 GH 应答者在第 64 周时仍保持临床应答。在 52 周的延长阶段,GH 组的平均(95%置信区间)身高 z 评分从-1.1(-1.6,-0.6)增加至-0.4(-1,0.2),P = 0.004。GH 耐受性良好,无意外安全信号。

结论

与单独使用 CTX 相比,GH 联合 CTX 治疗并未导致黏膜炎症减轻。然而,GH 作为 CTX 的辅助治疗,对儿科 CD 的临床疾病活动和生长不良是安全有效的。

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