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重组人生长激素治疗慢性肾功能衰竭儿童的两种剂量方案——关于线性生长和不良反应的报告

Recombinant human growth hormone treatment, using two dose regimens in children with chronic renal failure--a report on linear growth and adverse effects.

作者信息

Hertel Niels Thomas, Holmberg Christer, Rönnholm Kai A R, Jacobsen Bendt Brock, Olgaard Klaus, Meeuwisse Gunnar W, Rix Mariane, Pedersen Fritz Bangsgaard

机构信息

Department of Growth and Reproduction, Righospitalet, University of Copenhagen, Denmark.

出版信息

J Pediatr Endocrinol Metab. 2002 May;15(5):577-88. doi: 10.1515/jpem.2002.15.5.577.

DOI:10.1515/jpem.2002.15.5.577
PMID:12014516
Abstract

The aim of this study was to study the efficiency and the adverse effects of 2 or 4 IU/m2/day of growth hormone (GH) in the first year and 4 IU/m2/day in the second. Of 29 growth-retarded children with chronic renal failure (CRF) (aged 3.4-15.1 years), 23 completed the first year of therapy, and 16 completed the second year. Height velocity SDS (HVSDS) increased in the first year in the low-dose group with 3.0, and 3.8 in the high-dose group. In the second year, HVSDS increased by 1.3 in the low-dose group and by 2.1 in high-dose group (p < 0.05). The IGF-I/IGFBP-3 ratio rose identically during the first year (p < 0.01). The retarded bone age did not advance inappropriately. The integrated insulin levels (AUC) increased significantly after 1 year of therapy in both groups. HbA1c, levels did not change. The number of adverse events was highest in the low-dose group, in which one patient developed overt insulin dependent diabetes mellitus. In conclusion, glucose metabolism should be monitored in children with CRF during rhGH-treatment. GH therapy in our patients resulted in a significant increase in height velocity with no inappropriate bone age progression and few serious adverse effects, all without relation to the dose of rhGH. The low start dose (2 IU/m2/ day) was of no advantage compared to the high dose.

摘要

本研究的目的是探讨第一年使用2或4IU/m²/天生长激素(GH)以及第二年使用4IU/m²/天生长激素的疗效和不良反应。29例慢性肾衰竭(CRF)导致生长迟缓的儿童(年龄3.4 - 15.1岁)中,23例完成了第一年治疗,16例完成了第二年治疗。第一年,低剂量组身高速度标准差得分(HVSDS)增加3.0,高剂量组增加3.8。第二年,低剂量组HVSDS增加1.3,高剂量组增加2.1(p < 0.05)。第一年期间,胰岛素样生长因子-I/胰岛素样生长因子结合蛋白-3(IGF-I/IGFBP-3)比值同样升高(p < 0.01)。发育迟缓的骨龄没有过度提前。两组治疗1年后,胰岛素总体水平(AUC)显著升高。糖化血红蛋白(HbA1c)水平未改变。低剂量组不良事件数量最多,其中1例患者发展为明显的胰岛素依赖型糖尿病。总之,rhGH治疗期间,CRF患儿的糖代谢应受到监测。我们的患者接受GH治疗后,身高速度显著增加,骨龄无过度进展,严重不良反应较少,且所有情况均与rhGH剂量无关。与高剂量相比,低起始剂量(2IU/m²/天)并无优势。

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