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背景:国外已有许多研究证实重组人生长激素治疗特发性矮身材安全有效,但国内尚未见此类长期系列研究。目的:观察重组人生长激素对特发性矮身材患儿的促生长效果,并与生长激素缺乏症患儿进行比较。设计:病例对比观察。单位:青岛大学医学院附属医院儿内科。对象:选择2004-12/2006-03于青岛大学医学院儿内科就诊的矮身材患儿98例,患儿监护人均知情同意。按病因分为2组,特发性矮身材组30例,生长激素缺乏症组68例。方法:特发性矮身材组及生长激素缺乏症组患儿均给予国产重组人生长激素(长春金赛药业有限责任公司生产)治疗,剂量分别为0.15IU/(kg·d),0.1IU/(kg·d),每晚睡前皮下注射,疗程6个月。治疗前及治疗后3,6个月分别测定患儿的身高、体质量、骨龄,观察注射部位局部反应,计算生长速度。骨龄按照GP图谱法测算,预测身高按BP法计算。主要观察指标:两组患儿治疗前及治疗3,6个月后身高、体质量、骨龄及生长速度的变化情况。结果:98例患儿全部进入结果分析,无脱落。①组内比较结果:治疗后3,6个月后两组患儿的身高、生长速度均显著高于治疗前[特发性矮身材组身高:(126.5±9.4),(129.1±8.6),(121.1±11.0)cm(P<0.01),生长速度:(7.3±2.9),(7.5±2.7),(3.5±2.1)cm/年(P<0.01);生长激素缺乏症组身高:(111.0±13.0),(114.0±13.0),(108.0±12.0)cm(P<0.01),生长速度:(13.2±3.5),(13.5±3.6),(4.0±2.9)cm/年(P<0.01)]。治疗6个月后,特发性矮身材组30例患儿中27例促进了身高增长,生长激素缺乏症组68例患儿全部促进了身高增长。②组间比较:治疗3,6个月后两组患儿同期的生长速度比较,生长激素缺乏症组高于特发性矮身材组(P<0.01)。③不良反应和副作用:2例患儿治疗1～3个月出现甲状腺功能减低现象,给予甲状腺素片口服治疗后未影响生长。1例注射局部红肿,1周后自行消失,未停药。结论:国产重组人生长激素治疗特发性矮身材儿童安全,总体有效,能明显提高患儿身高及生长速度,但疗效存在不均一性,且差于生长激素缺乏症儿童。
Background: There are many foreign studies have confirmed that recombinant human growth hormone treatment of idiopathic short stature safe and effective, but no such long-term series of studies in China. Objective: To observe the growth promoting effect of recombinant human growth hormone on children with idiopathic short stature, and to compare with growth hormone deficiency children. Design: Case comparison. Unit: Department of Pediatrics, Affiliated Hospital of Qingdao University Medical College. PARTICIPANTS: A total of 98 short stature infants admitted to Department of Internal Medicine, Medical College of Qingdao University from December 2004 to March 2006 were selected. The guardian of the child informed consent. According to the cause is divided into two groups, idiopathic short stature group of 30 cases, growth hormone deficiency group 68 cases. Methods: Idiopathic short stature group and growth hormone deficiency group were given domestic recombinant human growth hormone (Changchun Kinsey Pharmaceutical Co., Ltd. production) treatment, the dose was 0.15IU / (kg · d), 0.1IU / (kg · d), every night before bedtime injection, treatment of 6 months. Before treatment and 3, 6 months after treatment, the children’s height, body weight and bone age were measured respectively. The local reaction at the injection site was observed and the growth rate was calculated. Bone age in accordance with the GP spectrum calculation, prediction height by BP method. MAIN OUTCOME MEASURES: The changes of height, body weight, bone age and growth rate before and 3 and 6 months after treatment in both groups were compared. Results: All the 98 children entered the result analysis without falling off. (1) The intra-group comparison results: The height and growth rate of children in both groups after 3 and 6 months of treatment were significantly higher than those before treatment [height of idiopathic short stature group: (126.5 ± 9.4), (129.1 ± 8.6), (121.1 ± 11.0) cm (P <0.01), and the growth rate was (7.3 ± 2.9), (7.5 ± 2.7) and (3.5 ± 2.1) cm / (13 ± 3.5), (13.5 ± 3.6) and (4.0 ± 2.9) cm / year (P <0.01) ]. After 6 months of treatment, 27 of 30 children with idiopathic short stature promoted height growth, and 68 children with growth hormone deficiency all contributed to height growth. ②Comparison between groups: The growth rate of the two groups was higher than that of idiopathic short stature group (P <0.01) at 3 and 6 months after treatment. ③ adverse reactions and side effects: 2 cases of children with treatment for 1 to 3 months decreased thyroid function, giving thyroxin tablets did not affect the growth after oral treatment. One case of local injection of inflamed, one week after disappearing, did not stop. Conclusion: Domestic recombinant human growth hormone treatment of idiopathic short stature children safe, overall effective, can significantly improve the height and growth rate of children, but there is heterogeneity in efficacy, and poor growth hormone deficiency in children.