重组人生长激素治疗特发性矮小症患儿的临床研究  

Clinical trial of recombinant human growth hormone in the treatment of children with idiopathic short stature

作　　者：邹海英[1] 胡云[1] 熊婷[1] 杨利[1] ZOU Hai-ying;HU Yun;XIONG Ting;YANG Li(Department of Endocrine Genetics and Metabolism,Jiangxi Provincial Children's Hospital,Nanchang 330038,Jiangxi Province,China)

机构地区：[1]江西省儿童医院内分泌遗传代谢科,江西南昌330038

出　　处：《中国临床药理学杂志》2023年第19期2761-2765,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的探讨不同剂量重组人生长激素(rhGH)对特发性矮小症(ISS)患儿骨代谢、甲状腺功能和血清胰岛素样生长因子-1(IGF-1)、胰岛素样生长因子结合蛋白-3(IGFBP-3)、皮质醇水平的影响。方法将ISS患儿随机分为试验组和对照组。试验组皮下注射rhGH 0.15 U·kg^(-1)·d^(-1),对照组皮下注射rhGH 0.20 U·kg^(-1)·d^(-1)。比较2组ISS患儿的生长情况[身高、体质量、生长速度(GV)、身高标准积分(Ht SDS)、骨密度]、骨代谢[25羟维生素D[25(OH)D]、骨碱性磷酸酶(BAP)、骨钙素(OC)]、甲状腺功能[游离三碘甲腺原氨酸(FT_(3))、游离甲状腺素(FT_(4))、促甲状腺激素(TSH)]和血清IGF-1、IGFBP-3、皮质醇水平变化。结果试验过程中共脱落1例,最终试验组纳入42例、对照组纳入43例。治疗后,对照组和试验组的身高分别为(130.42±7.21)和(136.61±6.98)cm,体质量分别为(28.33±1.65)和(30.41±1.48)kg,GV分别为(9.04±0.71)和(11.87±0.84)cm·year^(-1),Ht SDS分别为-1.82±0.22和-1.41±0.23,骨密度分别为(89.12±4.36)%和(91.34±4.54)%,25(OH)D分别为(30.97±2.79)和(32.66±2.47)ng·mL^(-1),BAP分别为(136.07±11.34)和(177.37±12.65)U·L^(-1),OC分别为(71.82±6.74)和(80.33±7.84)μg·L^(-1),血清IGF-1分别为(319.32±18.33)和(291.01±17.44)ng·mL^(-1),血清IGFBP-3分别为(3.71±0.35)和(3.51±0.33)μg·mL^(-1),血清皮质醇分别为(146.99±10.27)和(153.31±9.34)mmol·L^(-1),差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的FT_(3)、FT_(4)、TSH水平相比,差异均无统计学意义(均P>0.05)。结论rhGH 0.20 U·kg^(-1)·d^(-1)对提高ISS患儿生长、调节骨代谢和IGF-1、IGFBP-3、皮质醇水平优于rhGH 0.15 U·kg^(-1)·d^(-1),且对ISS患儿甲状腺功能无明显影响。Objective To explore the effects of different doses of recombinant human growth hormone(rh GH)on bone metabolism,thyroid function,levels of serum insulin-like growth factor-1(IGF-1),insulin-like growth factor binding protein-3(IGFBP-3)and cortisol in children with idiopathic short stature(ISS).Methods Children with ISS were randomly divided into treatment group and control group.The treatment group was given subcutaneous injection 0.15 U·kg^(-1)·d^(-1)rh GH,while control group was given subcutaneous injection 0.20 U·kg^(-1)·d^(-1)rh GH.The changes in growth status[height,weight,growth velocity(GV),height standard points(Ht SDS),bone mineral density],bone metabolism indexes[25 hydroxyvitamin-D[25(OH)D],bone alkaline phosphatase(BAP),osteocalcin(OC)],thyroid function indexes[free triiodothyronine(FT_(3)),free thyroxine(FT_(4)),thyroid stimulating hormone(TSH)],serum IGF-1,IGFBP-3 and cortisol in the two groups were compared.Results There was 1 case lost during the trial,and there were 42 cases in treatment group and 43 cases in control group finally.In control group and treatment group after treatment,height were(130.42±7.21)cm and(136.61±6.98)cm,body weight were(28.33±1.65)and(30.41±1.48)kg,GV were(9.04±0.71)and(11.87±0.84)cm·year^(-1),Ht SDS were(-1.82±0.22)and(-1.41±0.23),bone mineral density were(89.12±4.36)%and(91.34±4.54)%,25(OH)D were(30.97±2.79)ng·m L^(-1)and(32.66±2.47)ng·mL^(-1),BAP were(136.07±11.34)and(177.37±12.65)U·L^(-1),OC were(71.82±6.74)and(80.33±7.84)μg·L^(-1),IGF-1 were(291.01±17.44)and(319.32±18.33)ng·m L^(-1),IGFBP-3 were(3.71±0.35)and(3.51±0.33)μg·m L^(-1),cortisol were(153.31±9.34)and(146.99±10.27)mmol·L^(-1)(P<0.05).After treatment,there was no significant difference in levels of FT_(3),FT_(4)and TSH between the two groups(P<0.05).Conclusion rh GH 0.20 U·kg^(-1)·d^(-1)is superior to rh GH 0.15 U·kg^(-1)·d^(-1)in improving growth,regulating bone metabolism,levels of IGF-1,IGFBP-3 and cortisol in ISS children,which has no significant effects on thyroid

关 键 词：重组人生长激素 特发性矮小症 骨代谢 甲状腺功能 胰岛素样生长因子-1 胰岛素样生长因子结合蛋白3 皮质醇 

分 类 号：R97[医药卫生—药品]