两种剂型生长激素治疗儿童身材矮小症的网状 Meta 分析  

Network Meta-Analysis on Two Dosage Forms of Recombinant Human Growth Hormone in the Treatment of Short Stature in Children

作　　者：肖彤 王钰[3] 郝丽娜[3] 俞淑文 Xiao Tong;Wang Yu;Hao Lina;Yu Shuwen(College of Pharmacy,Cheeloo College of Medicine,Shandong University,Jinan 250012,China;Shandong Guoxin Yiyang Group Zaozhuang Central Hospital,Shandong Zaozhuang 277000,China;Affiliated Children’s Hospital,Shandong University,Jinan 250022,China;Phase I Clinical Trial Center,Qilu Hospital of Shandong University,Jinan 250012,China;National Medical Products Administration Key Laboratory for Clinical Research and Evaluation of Innovative Drug,Shandong University,Jinan 250012,China)

机构地区：[1]山东大学齐鲁医学院药学院,济南250012 [2]山东国欣颐养集团枣庄中心医院,山东枣庄277000 [3]山东大学附属儿童医院,济南250022 [4]山东大学齐鲁医院Ⅰ期药物临床试验中心,济南250012 [5]山东大学国家药品监督管理局创新药物临床研究与评价重点实验室,济南250012

出　　处：《儿科药学杂志》2025年第5期40-46,共7页Journal of Pediatric Pharmacy

基　　金：山东省卫生健康委员会第二批药品临床综合评价项目,编号2022YZ026。

摘　　要：目的:系统评价重组人生长激素粉针剂和注射液治疗儿童身材矮小症的有效性与安全性。方法:计算机检索中国知网(CNKI)、维普(VIP)、万方(Wanfang)、中国生物医学文献服务系统(SinoMed)、中国临床试验注册中心、PubMed、Web of Science、EMBase、the Cochrane Library数据库,检索时限均为建库至2024年11月,收集生长激素粉针剂和注射液治疗儿童身材矮小症的随机对照试验(RCT),根据Cochrane风险偏倚评估工具对纳入的文献进行质量评价,运用Stata 18.0软件进行网状Meta分析。结果:最终纳入18篇RCT,总样本量1768例,网状Meta分析显示,生长激素粉针剂与注射液对患儿骨龄、身高、胰岛素样生长因子1(IGF-1)、生长速度、胰岛素样生长因子结合蛋白3(IGFBP-3)及预测成年身高的影响比较差异无统计学意义。基于不良反应发生率进行网状Meta分析,以常规治疗为桥梁时,生长激素的两种剂型间的不良反应发生率比较差异无统计学意义。结论:生长激素注射液和粉针剂治疗特发性矮身材的有效性和安全性相当。由于相关文献数量较少且生长激素用法用量不一致,两种剂型生长激素对生长激素缺乏症的有效性和安全性有待验证。Objective:To systematically evaluate the efficacy and safety of recombinant human growth hormone(rhGH)injection versus powder for injection in the treatment of short stature in children.Methods:CNKI,VIP,Wanfang,SinoMed,the Chinese Clinical Trial Registry,PubMed,Web of Science,EMBase,and the Cochrane Library databases were retrieved to collect randomized controlled trial(RCT)of rhGH injection versus powder for injection in the treatment of short stature in children from database establishment to Nov.2024.The quality of the included studies was assessed by using the Cochrane risk of bias assessment tool and network Meta-analysis was performed by using Stata 18.0 software.Results:A total of 18 RCT were enrolled,including 1,768 patients.Network Meta-analysis revealed no statistically significant differences between the rhGH injection versus powder for injection in the effects on bone age,height,insulin-like growth factor 1(IGF-1)levels,growth velocity,insulin-like growth factor binding Protein 3(IGFBP-3)levels,and predicted adult height in children.Network Meta-analysis was performed based on the incidence of adverse drug reactions,when conventional treatment was used as a bridge,there was no statistically significant difference in the incidence of adverse drug reactions between the two dosage forms of growth hormone.Conclusion:The efficacy and safety of rhGH injection versus powder for injection in the treatment of idiopathic short stature are comparable.Due to the limited relevant literature and inconsistent usage and dosage of growth hormone,the efficacy and safety of the two dosage forms in the treatment of growth hormone deficiency need to be verified.

关 键 词：生长激素 儿童 身材矮小症 特发性矮身材 剂型 网状 META分析 

分 类 号：R725.8[医药卫生—儿科]