Long-Acting Gonadotropin-Releasing Hormone Analogues for Central Precocious Puberty, Including 45-mg 6-month Subcutaneous Leuprolide Acetate: Use for Treatment and Treatment Monitoring.

IF 2.6 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM
Lawrence A. Silverman, Mitchell E. Geffner, Matthew Benson
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Abstract

INTRODUCTION Studies of gonadotropin-releasing hormone analogues [intramuscular (IM) leuprolide acetate (LA) and triptorelin] for treatment monitoring of central precocious puberty (CPP) demonstrate this approach is effective for confirming pubertal hormone suppression. Herein, we provide new data using subcutaneous LA (SC LA) suggesting similar efficacy for treatment monitoring. METHODS PubMed, Embase, and CINAHL were searched for studies of GnRHa use to monitor treatment of CPP. The titles and the abstracts were reviewed; five studies were selected. Additionally, new unpublished data for SC LA from the original phase 3 trial (primary data published by Klein et al.) were evaluated. Serum LH and leuprolide levels at screening, 1, 4, and 6 hours after the first dose SC LA were analyzed and plotted. RESULTS Data from 162 children (155 girls) were evaluated. SC and IM LA produced overlapping median LH concentration curves and peak LH concentrations after the first dose. For IM LA, subsequent doses yielded suppressed peak LH levels (2.7 IU/L [mean]). For SC LA, subsequent doses also resulted in significant suppressed peak LH levels (0.2±0.02 IU/L) and achieved sex-steroid hormone suppression in >98%. CONCLUSIONS Compared to IM LA and triptorelin, long-acting SC LA shows similar burst kinetics and rapid LH rise after the first dose, followed by similar suppression of LH and sex steroids after subsequent doses. Since IM LA and triptorelin have demonstrated usefulness that is comparable to that of traditional GnRH stimulation testing for monitoring CPP, we presume that SC LA may be similarly employed.
治疗中枢性性早熟的长效促性腺激素释放激素类似物,包括 45 毫克 6 个月皮下注射醋酸亮丙瑞林:用于治疗和治疗监测。
简介:对促性腺激素释放激素类似物[肌肉注射(IM)醋酸亮丙瑞林(LA)和曲普瑞林]进行中枢性性早熟(CPP)治疗监测的研究表明,这种方法能有效确认青春期激素抑制。在此,我们提供了使用皮下注射 LA(SC LA)进行治疗监测的新数据,表明这种方法也具有类似的疗效。方法检索了 SpubMed、Embase 和 CINAHL 中有关使用 GnRHa 监测 CPP 治疗的研究。对研究的标题和摘要进行了审阅,从中选出了五项研究。此外,还评估了原始 3 期试验中 SC LA 未发表的新数据(Klein 等人发表的主要数据)。分析并绘制了筛查、首次服用 SC LA 后 1、4 和 6 小时的血清 LH 和亮丙瑞林水平。在第一次给药后,SC LA 和 IM LA 的 LH 浓度曲线中位数和 LH 浓度峰值重叠。对于 IM LA,后续剂量会抑制 LH 峰值水平(2.7 IU/L [平均值])。结论与 IM LA 和曲普瑞林相比,长效 SC LA 表现出相似的爆发动力学和首剂后 LH 的快速上升,随后的剂量对 LH 和性类固醇有相似的抑制作用。由于 IM LA 和曲普瑞林在监测 CPP 方面的作用与传统的 GnRH 刺激试验相当,因此我们推测 SC LA 也可用于监测 CPP。
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来源期刊
Hormone Research in Paediatrics
Hormone Research in Paediatrics ENDOCRINOLOGY & METABOLISM-PEDIATRICS
CiteScore
4.90
自引率
6.20%
发文量
88
审稿时长
4-8 weeks
期刊介绍: The mission of ''Hormone Research in Paediatrics'' is to improve the care of children with endocrine disorders by promoting basic and clinical knowledge. The journal facilitates the dissemination of information through original papers, mini reviews, clinical guidelines and papers on novel insights from clinical practice. Periodic editorials from outstanding paediatric endocrinologists address the main published novelties by critically reviewing the major strengths and weaknesses of the studies.
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