基因重组人生长激素治疗青春期前特发性矮小症的量效和时效关系研究  

Study on the Dose-effect and Time-effect Relationship of Recombinant Human Growth Hormone in the Treatment of the Preadolescent Idiopathic Short Stature

作　　者：徐雪梅[1] 庞军[2] 

机构地区：[1]衢州市人民医院基层卫生管理科,浙江衢州324000 [2]宁波大学医学院附属阳明医院内六科,浙江余姚315400

出　　处：《中国药房》2015年第17期2372-2375,共4页China Pharmacy

基　　金：余姚市科技计划项目(No.2007Y04)

摘　　要：目的:从量效与时效两个层次评价基因重组人生长激素(rh GH)治疗青春期前特发性矮小症(ISS)的疗效和安全性。方法:将120例ISS患儿按随机数字表法分为对照组和rh GH低、中、高剂量治疗组,每组30例。各组患儿每晚睡前皮下注射不同剂量的rh GH或安慰剂,治疗时间为2年。定期复查并记录患儿年龄、骨龄、骨龄/年龄、身高、体质量、生长速度、预测成年高度等生长参数,采用SPSS 13.0统计软件对结果进行分析。结果:rh GH可剂量和时间依赖性地促进青春期前ISS患儿生长,剂量0.18 u/(kg·d)治疗18个月时可达治疗峰值;超过该剂量或时间,疗效无明显增加,不良反应发生率却会增高。结论:rh GH可量效和时效性地促进青春期前ISS患儿生长,但应注意剂量和时间的选择,以使治疗效果最大化。OBJECTIVE： To evaluate the efficacy and safety of recombinant human growth hormone （rhGH） in the treatment of preadolescent idiopathic short stature （ISS） in aspects of dose-effect and time-effect. METHODS： 120 ISS children were random- ly divided into control group, rhGH low, medium and high dose groups by number, 30 for each. Children in all groups were inject- ed subcutaneously rhGH or placebo with difference doses before sleeping every evening for 2 years. The growth parameters of chil- dren were periodically checked and recorded, including age, bone age, bone age / age, height, body mass, growing velocity and predicted adult velocity, etc. The results were analyzed by SPSS 13.0. RESULTS： rhGH could promote the growth of preadolescent children with ISS in dose-dependent and time-dependent and the efficacy could reach the peak at the dose of 0.18 u/（kg· d） for 18 months; the efficacy had no obvious increase and the incidence of adverse reactions would increase with excessive dose or time. CONCLUSIONS： rhGH can promote the growth of preadolescent children with ISS in dose-dependent and time-dependent. However, the selection of dose and time should be paid more attention to achieve the maximum efficacy.

关 键 词：基因重组人生长激素 特发性矮小症 量效关系 时效关系 

分 类 号：R459.1[医药卫生—治疗学]