Article(id=1291339013957345594, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291338935477724120, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.01.007, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1720540800000, receivedDateStr=2024-07-10, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808812845, onlineDateStr=2026-08-04, pubDate=1737043200000, pubDateStr=2025-01-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808812845, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808812845, creator=13041195026, updateTime=1785808812845, updator=13041195026, issue=Issue{id=1291338935477724120, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='1', pageStart='1', pageEnd='148', issueExtLink='null', onlineDate='null', pubDate='1737043200000', pubDateStr='2025-01-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808794022, creator='13041195026', updateTime=1785808794022, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=31, endPage=35, ext={EN=ArticleExt(id=1291339014225781051, articleId=1291339013957345594, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of recombinant human growth hormone in treatment of children with growth hormone deficiency, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To explore the clinical effects and influencing factors of recombinant human growth hormone (rhGH) treatment in pediatric patients with growth hormone deficiency.
Methods The study subjects were pediatric patients with growth hormone deficiency, all of whom received a combination therapy of stanozolol tablets 2 mg (qd) and 0.1 U·kg-1·d-1 of recombinant human growth hormone injection for a continuous period of one year. After one year, the patients were divided into active group and invalid group based on clinical outcomes. Comparisons were made between the two groups in terms of height, annual growth velocity (GV) and height standard deviation score (HtSDS) before and after treatment, and safety evaluations were conducted. Multivariate Logistic regression analysis was used to identify factors that influenced the treatment outcomes in pediatric patients with growth hormone deficiency.
Results After one year of treatment, a total of 93 cases pediatric patients were included in the analysis, with 62 cases in the active group and 31 cases in the invalid group. The heights of the patients before and after treatment were (119.40±2.48) and (129.08±2.37) cm, respectively; the GV were (3.08±0.39) and (7.34±1.02) cm·year-1, respectively; the HtSDS were -2.45±0.49 and -1.68±0.35, respectively, with statistically significant differences observed for all comparisons (all P<0.05). In the active and invalid groups, the proportions of patients with GV<3.0 cm·year-1 before treatment were 32.26% and 58.06%, respectively; the proportions of patients with peak growth hormone (GH) levels <5.0 ng·mL-1 before treatment were 30.65% and 54.84%, respectively; the average maternal heights were (158.83±5.76) and (155.48±6.58) cm, respectively, with statistically significant differences observed for all comparisons (all P<0.05). The results of the Logistic regression model showed that GV<3.0 cm·year-1 before treatment, peak GH levels <5.0 ng·mL-1 before treatment, and a shorter maternal height were independent risk factors for poor treatment outcomes with rhGH in pediatric patients with growth hormone deficiency (all P<0.05). No severe adverse reactions occurred during the treatment of any patient; seven patients experienced pain at the injection site, one patient had a slight increase in blood glucose, and five patients had mild decreased appetite. The total incidence of adverse drug reactions were 13.98% (13 cases/93 cases).
Conclusion Treatment with rhGH for pediatric patients with growth hormone deficiency can significantly improve height development and has good safety, but it is influenced by factors such as growth velocity, peak GH levels, and maternal height.
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目的 探讨重组人生长激素（rhGH）治疗生长激素缺乏症患儿的临床效果及其影响因素。
方法 研究对象为生长激素缺乏症患儿，所有患儿均接受司坦唑醇片2 mg（qd）+0.1 U·kg-1·d-1重组人生长激素注射液治疗，连续治疗1年。1年后根据临床疗效将患儿分为有效组和无效组。比较2组患儿治疗前后的身高、年生长速率（GV）、身高标准差（HtSDS），并进行安全性评价。用多元Logistic回归方法分析影响生长激素缺乏症患儿治疗效果的相关因素。
结果 治疗1年后，共有93例患儿纳入分析，有效组62例，无效组31例。治疗前与治疗后患儿的身高分别为（119.40±2.48）和（129.08±2.37）cm，GV分别为（3.08±0.39）和（7.34±1.02）cm·year-1，HtSDS测定值分别为-2.45±0.49和-1.68±0.35，在统计学上差异均有统计学意义（均P<0.05）。有效组和无效组患儿治疗前GV<3.0 cm·year-1占比分别为32.26%和58.06%，治疗前GH峰值<5.0 ng·mL-1占比分别为30.65%和54.84%，母亲平均身高分别为（158.83±5.76）和（155.48±6.58）cm，在统计学上差异均有统计学意义（均P<0.05）。Logistic回归模型结果显示：治疗前GV<3.0 cm·year-1、治疗前GH峰值<5.0 ng·mL-1、母亲平均身高低是rhGH治疗生长激素缺乏症患儿疗效不佳的独立危险因素（均P<0.05）。所有患儿治疗过程中均未出现严重的药物不良反应，7例患儿表现为注射部位疼痛、1例血糖轻微升高，5例患儿食欲轻度减退，药物不良反应发生率为13.98%（13例/93例）。
结论 rhGH治疗生长激素缺乏症患儿能显著改善身高发育情况，具有较好的安全性，但受到生长速率、GH峰值水平、母亲身高的影响。
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谭秋月（1983-），女，副主任医师，主要从事儿童生长发育及儿童保健方面的研究
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