Article(id=1291404792329401253, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404791758975909, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.11.003, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1728662400000, receivedDateStr=2024-10-12, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824495632, onlineDateStr=2026-08-04, pubDate=1750089600000, pubDateStr=2025-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824495632, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824495632, creator=13701087609, updateTime=1785824495632, updator=13701087609, issue=Issue{id=1291404791758975909, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1750089600000', pubDateStr='2025-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824495496, creator='13701087609', updateTime=1785824495496, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1511, endPage=1516, ext={EN=ArticleExt(id=1291404792547505062, articleId=1291404792329401253, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of vitamin D combined with low-dose triptorelin acetate in the treatment of girls with central precocious puberty, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To observe the efficacy of low-dose triptorelin acetate injection combined with vitamin D drop in the treatment of central precocious puberty (CPP) in girls.
Methods CPP children were divided into treatment group and control group using a cohort method. The treatment group received a low-dose of triptorelin acetate injection at 50 μg·kg-1 via intramuscular injection every 4 weeks, along with oral vitamin D drop at 400 units. The control group received standard dose treatment, starting with an initial dose of 100 μg·kg-1 via intramuscular injection, followed by a maintenance dose of 80 μg·kg-1 every 4 weeks. Both groups were treated continuously for 12 months. The clinical efficacy, physical development, hormone levels, secretion levels of peptides and hormones related to the hypothalamic-pituitary-gonadal axis were compared between the two groups, along with safety evaluation.
Results During the trial, 42 cases were included in the treatment group and 37 cases in the control group. After treatment, the overall effective rates for the treatment and control groups were 90.48% (38 cases/42 cases) and 78.38% (29 cases/37 cases), respectively, with no statistically significant difference (P>0.05). After treatment, the predicted adult height for the treatment and control groups was (164.59±4.35) and (162.38±5.21) cm, respectively; the differences in bone age were (1.07±0.28) and (1.24±0.29) years; the growth rates were (5.35±1.17) and (5.93±1.24) cm·year-1; estradiol levels were (13.11±5.67) and (16.08±4.73) pg·mL-1; luteinizing hormone levels were (1.49±0.20) and (2.15±0.18) U·L-1; follicle-stimulating hormone levels were (4.95±0.74) and (6.14±0.87) pg·mL-1; neuropeptide kisspeptin levels were (1.02±0.19) and (1.20±0.40) μg·L-1; neurokinin B levels were (0.35±0.08) and (0.41±0.08) μg·L-1; anti-Müllerian hormone levels were (3.88±0.36) and (4.15±0.40) ng·L-1; insulin-like growth factor-1 levels were (216.91±25.43) and (231.64±30.87) ng·mL-1; 25-hydroxyvitamin D levels were (28.42±4.52) and (26.15±3.73) μg·L-1, with statistically significant difference (all P<0.05). The main adverse drug reactions in the treatment group included nausea and vomiting, as well as pain and swelling at the injection site. In the control group, the main adverse drug reactions included slight vaginal bleeding, nausea and vomiting, pain and swelling at the injection site and rashes near the injection site. The overall incidence of adverse drug reactions in the treatment group and control group were 7.14% (3 cases/42 cases) and 16.22% (6 cases/37 cases), without statistically significant difference (P>0.05).
Conclusion In children with CPP, the application of low-dose triptorelin combined with vitamin D drop can improve clinical efficacy, physical development, growth-related factors, hormone levels and the secretion levels of peptides and hormones associated with the hypothalamic-pituitary-gonadal axis. It can also slow the development of secondary sexual characteristics and inhibit gonadal development, while demonstrating good safety.
, authors=Xin WANG, Min LI, Qian DENG, Juan-juan WANG, authorsList=Xin WANG, Min LI, Qian DENG, Juan-juan WANG, authorCompany=null, correspAuthors=Juan-juan WANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291404792883049383, articleId=1291404792329401253, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=维生素D联合低剂量醋酸曲普瑞林治疗中枢性性早熟女童的临床研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的 观察低剂量醋酸曲普瑞林注射液结合维生素D滴剂治疗中枢性性早熟（CPP）女童的疗效。
方法 将CPP患儿按照队列法分为试验组与对照组。试验组患儿予以低剂量醋酸曲普瑞林注射液50 μg·kg-1肌内注射，每4周进行1次，同时每天予以维生素D滴剂400单位口服。对照组患儿予以常规剂量治疗，初始剂量100 μg·kg-1肌内注射，后续每4 周以80 μg·kg-1剂量维持治疗。2组患儿均持续治疗12个月。比较2组患儿的临床疗效、体格发育情况、性激素水平、下丘脑-垂体-性腺轴相关肽与激素分泌水平，并进行安全性评价。
结果 试验组入组42例，对照组入组37例。治疗后，试验组和对照组的总有效率分别为90.48%（38例/42例）和78.38%（29例/37例），在统计学上差异无统计学意义（P>0.05）。治疗后，试验组和对照组预计成年期终身高分别为（164.59±4.35）和（162.38±5.21）cm，骨龄差值分别为（1.07±0.28）和（1.24±0.29）岁，生长速率分别为（5.35±1.17）和（5.93±1.24）cm·year-1，雌二醇分别为（13.11±5.67）和（16.08±4.73）pg·mL-1，黄体生成素分别为（1.49±0.20）和（2.15±0.18）U·L-1，卵泡刺激素分别为（4.95±0.74）和（6.14±0.87）pg·mL-1，神经肽吻素分别为（1.02±0.19）和（1.20±0.40）μg·L-1，神经激肽B分别为（0.35±0.08）和（0.41±0.08）μg·L-1，抗米勒管激素分别为（3.88±0.36）和（4.15±0.40）ng·L-1，胰岛素样生长因子-1分别为（216.91±25.43）和（231.64±30.87）ng·mL-1，25-羟维生素D水平分别为（28.42±4.52）和（26.15±3.73）μg·L-1。试验组的上述指标与对照组比较，在统计学上差异均有统计学意义（均P<0.05）。试验组的药物不良反应主要有恶心呕吐、注射部位疼痛肿胀，对照组的药物不良反应主要有少量阴道出血、恶心呕吐、注射部位疼痛肿胀、注射部位附近红疹。试验组和对照组的药物不良反应总发生率分别为7.14%（3例/42例）和16.22%（6例/37例），在统计学上差异无统计学意义（P>0.05）。
结论 CPP患儿应用低剂量醋酸曲普瑞林注射液结合维生素D滴剂，能够改善临床疗效、体格发育情况、生长发育相关因子、性激素及下丘脑-垂体-性腺轴相关肽与激素分泌水平，减缓第二性征发育，抑制性腺发育，并且安全性较好。
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