在使用醋酸亮丙瑞林皮下注射 6 个月治疗中枢性性早熟期间,评估抑制情况时使用的未受刺激促黄体生成素:与临床反应的相关性。

IF 2.6 3区 医学 Q3 ENDOCRINOLOGY & METABOLISM
Karen O Klein, Bradley S Miller, Nelly Mauras
{"title":"在使用醋酸亮丙瑞林皮下注射 6 个月治疗中枢性性早熟期间,评估抑制情况时使用的未受刺激促黄体生成素:与临床反应的相关性。","authors":"Karen O Klein, Bradley S Miller, Nelly Mauras","doi":"10.1159/000539110","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Phase 3 trial of 6-month subcutaneous leuprolide acetate (SC-LA) in children with central precocious puberty (CPP) demonstrated efficacy and safety. The aims of this secondary analysis were to evaluate unstimulated luteinizing hormone (LH) as efficacy measure, assess clinical suppression metrics, and present biochemical and clinical data for subgroups not achieving hormone suppression.</p><p><strong>Methods: </strong>Sixty-two children with treatment-naïve CPP received 2 doses of 45 mg SC-LA at 24-week intervals. Unstimulated and GnRH-stimulated LH, E2, and T concentrations were measured. Clinical measures included bone age (BA) and predicted adult height (PAH).</p><p><strong>Results: </strong>Eighty-four percentage and 86% of children achieved unstimulated LH &lt;1 IU/L at weeks 24 and 48, respectively. Of 8 children not achieving unstimulated LH &lt;1 IU/L at week 24 that completed the study, all showed a lack of pubertal stage progression and stable/decreased BA to chronological age ratio (BA/CA). Received operating characteristic (ROC) analyses suggested unstimulated LH is a good diagnostic predictor of GnRH-stimulated LH &lt;4 IU/L at weeks 24 and 48 (AUC = 0.88). Across all children, mean BA/CA improved from 1.4 (screening) to 1.3 (week 48) and mean PAH increased by 3 cm. Of 7 girls not achieving stimulated LH &lt;4 IU/L at week 24, all achieved E2 &lt;10 pg/mL, showed a lack of pubertal stage progression, and had stable or decreased BA/CA by week 48. Additionally, 6/7 had increased PAH by week 48 and 4 had unstimulated LH &lt;1 IU/L.</p><p><strong>Conclusion: </strong>Unstimulated LH has value as an efficacy measure and concentrations &lt;1 IU/L may be an adequate surrogate of treatment response in children with CPP. All children who completed the study had evidence of pubertal suppression.</p>","PeriodicalId":13025,"journal":{"name":"Hormone Research in Paediatrics","volume":null,"pages":null},"PeriodicalIF":2.6000,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Unstimulated Luteinizing Hormone for Assessment of Suppression during Treatment of Central Precocious Puberty with 6-Month Subcutaneous Leuprolide Acetate: Correlations with Clinical Response.\",\"authors\":\"Karen O Klein, Bradley S Miller, Nelly Mauras\",\"doi\":\"10.1159/000539110\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Phase 3 trial of 6-month subcutaneous leuprolide acetate (SC-LA) in children with central precocious puberty (CPP) demonstrated efficacy and safety. The aims of this secondary analysis were to evaluate unstimulated luteinizing hormone (LH) as efficacy measure, assess clinical suppression metrics, and present biochemical and clinical data for subgroups not achieving hormone suppression.</p><p><strong>Methods: </strong>Sixty-two children with treatment-naïve CPP received 2 doses of 45 mg SC-LA at 24-week intervals. Unstimulated and GnRH-stimulated LH, E2, and T concentrations were measured. Clinical measures included bone age (BA) and predicted adult height (PAH).</p><p><strong>Results: </strong>Eighty-four percentage and 86% of children achieved unstimulated LH &lt;1 IU/L at weeks 24 and 48, respectively. Of 8 children not achieving unstimulated LH &lt;1 IU/L at week 24 that completed the study, all showed a lack of pubertal stage progression and stable/decreased BA to chronological age ratio (BA/CA). Received operating characteristic (ROC) analyses suggested unstimulated LH is a good diagnostic predictor of GnRH-stimulated LH &lt;4 IU/L at weeks 24 and 48 (AUC = 0.88). Across all children, mean BA/CA improved from 1.4 (screening) to 1.3 (week 48) and mean PAH increased by 3 cm. Of 7 girls not achieving stimulated LH &lt;4 IU/L at week 24, all achieved E2 &lt;10 pg/mL, showed a lack of pubertal stage progression, and had stable or decreased BA/CA by week 48. Additionally, 6/7 had increased PAH by week 48 and 4 had unstimulated LH &lt;1 IU/L.</p><p><strong>Conclusion: </strong>Unstimulated LH has value as an efficacy measure and concentrations &lt;1 IU/L may be an adequate surrogate of treatment response in children with CPP. All children who completed the study had evidence of pubertal suppression.</p>\",\"PeriodicalId\":13025,\"journal\":{\"name\":\"Hormone Research in Paediatrics\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2024-04-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Hormone Research in Paediatrics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000539110\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Hormone Research in Paediatrics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000539110","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
引用次数: 0

摘要

简介对中枢性性早熟(CPP)儿童进行的为期 6 个月的醋酸亮丙瑞林(SC-LA)皮下注射 3 期试验显示了有效性和安全性。该二次分析的目的是:评估作为疗效指标的非刺激黄体生成素(LH);评估临床抑制指标;并提供未达到激素抑制的亚组的生化和临床数据。测量未刺激和GnRH刺激下的LH、E2和T浓度。临床指标包括骨龄(BA)和预测成人身高(PAH):84%和86%的儿童在第24周和第48周分别达到了非刺激LH<1IU/L。在第24周未达到非刺激LH<1IU/L的8名完成研究的儿童中,所有儿童均未出现青春期进展,且BA与实际年龄比值(BA/CA)稳定/下降。接受操作特征(ROC)分析表明,在第24周和第48周,未刺激LH是GnRH刺激LH<4IU/L的良好诊断预测指标(AUC=0.88)。在所有儿童中,平均 BA/CA 从 1.4(筛查)提高到 1.3(第 48 周),平均 PAH 增加了 3 厘米。在第 24 周时,7 名女孩的促性腺激素 LH<4IU/L 未达标,但到第 48 周时,她们的 E2<10pg/mL 全部达标,青春期阶段没有进展,BA/CA 稳定或下降。此外,到第 48 周时,6/7 人的 PAH 增加,4 人的未受刺激 LH<1IU/L.Conclusion:结论:未受刺激的 LH 具有疗效测量的价值,其浓度为 1IU/L 可能是 CPP 儿童治疗反应的适当替代指标。所有完成研究的儿童都有青春期抑制的证据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Unstimulated Luteinizing Hormone for Assessment of Suppression during Treatment of Central Precocious Puberty with 6-Month Subcutaneous Leuprolide Acetate: Correlations with Clinical Response.

Introduction: Phase 3 trial of 6-month subcutaneous leuprolide acetate (SC-LA) in children with central precocious puberty (CPP) demonstrated efficacy and safety. The aims of this secondary analysis were to evaluate unstimulated luteinizing hormone (LH) as efficacy measure, assess clinical suppression metrics, and present biochemical and clinical data for subgroups not achieving hormone suppression.

Methods: Sixty-two children with treatment-naïve CPP received 2 doses of 45 mg SC-LA at 24-week intervals. Unstimulated and GnRH-stimulated LH, E2, and T concentrations were measured. Clinical measures included bone age (BA) and predicted adult height (PAH).

Results: Eighty-four percentage and 86% of children achieved unstimulated LH <1 IU/L at weeks 24 and 48, respectively. Of 8 children not achieving unstimulated LH <1 IU/L at week 24 that completed the study, all showed a lack of pubertal stage progression and stable/decreased BA to chronological age ratio (BA/CA). Received operating characteristic (ROC) analyses suggested unstimulated LH is a good diagnostic predictor of GnRH-stimulated LH <4 IU/L at weeks 24 and 48 (AUC = 0.88). Across all children, mean BA/CA improved from 1.4 (screening) to 1.3 (week 48) and mean PAH increased by 3 cm. Of 7 girls not achieving stimulated LH <4 IU/L at week 24, all achieved E2 <10 pg/mL, showed a lack of pubertal stage progression, and had stable or decreased BA/CA by week 48. Additionally, 6/7 had increased PAH by week 48 and 4 had unstimulated LH <1 IU/L.

Conclusion: Unstimulated LH has value as an efficacy measure and concentrations <1 IU/L may be an adequate surrogate of treatment response in children with CPP. All children who completed the study had evidence of pubertal suppression.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
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.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信