National Cooperative Growth Study: 25 Years of Growth Hormone Data, Insights, and Lessons for Future Registries.

4区 医学 Q2 Medicine
Jennifer J Bell, Barbara Lippe, Alicia A Romano, Joseph T Cernich, Rita D Swinford, Dalia Moawad
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引用次数: 12

Abstract

Background: The National Cooperative Growth Study (NCGS) data are reviewed from 1985-2010 to report on final demographic, efficacy, and safety findings, and to illustrate the value of long-term, real-world follow-up to physicians and patients.

Methods: The NCGS was a multicenter, open-label, observational, postmarketing surveillance study of Genentech growth hormone (GH) products for the treatment of children with growth failure in North America.

Findings: Data from 65,205 patients representing 240,951 patient-years of experience were collected. All etiological groups had clinically meaningful improvements in near-adult height SDS. Females and African Americans were under-represented in the NCGS with little change in accrual over time. The favorable safety profile of GH was validated through the registry.

Conclusions: Twenty-five years of monitoring GH use through the NCGS yielded extensive insight into the utility of GH in various underlying etiologies. Demographic disparities were clear and became evident by analyzing data collected through the registry.

国家合作生长研究:25年的生长激素数据、见解和未来登记的经验教训。
背景:回顾1985-2010年国家合作生长研究(NCGS)的数据,报告最终的人口统计学、疗效和安全性发现,并说明对医生和患者进行长期、现实世界随访的价值。方法:NCGS是一项多中心、开放标签、观察性、上市后监测的研究,研究基因泰克生长激素(GH)产品在北美治疗生长衰竭儿童。研究结果:收集了65,205例患者的数据,代表240,951例患者年的经验。所有病因组的近成人身高SDS均有临床意义的改善。女性和非裔美国人在NCGS中的代表性不足,随着时间的推移变化不大。通过注册验证了生长激素的良好安全性。结论:通过NCGS监测生长激素使用25年,对生长激素在各种潜在病因中的应用产生了广泛的见解。通过分析通过登记收集的数据,人口差异很明显。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Pediatric endocrinology reviews : PER
Pediatric endocrinology reviews : PER Medicine-Endocrinology, Diabetes and Metabolism
自引率
0.00%
发文量
1
期刊介绍: PEDIATRIC ENDOCRINOLOGY REVIEWS (PER) publishes scholarly review articles in all areas of clinical and experimental Endocrinology, Diabetes, Nutrition and Metabolism. PER is intended for practicing pediatricians, pediatric endocrinologists, pediatric diabetologists, pediatric gastroenterologists, neonatologists, pediatric gynecologists, nutritionists, sport physicians and pediatricians-in-training. PER will also publish topics on specific subjects or as proceedings of scientific meetings in the above fields of interest. All articles, whether invited or direct contributions, are peer-reviewed. PER publishes correspondence, book reviews, a meeting calendar and meeting reports.
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