摘要
目的基于下丘脑-垂体-性腺轴(HPG)观察醋酸曲普瑞林联合重组人生长激素(rhGH)治疗大骨龄中枢性性早熟(CPP)女童的临床疗效和安全性。方法将CPP女童随机分为对照组和试验组。对照组肌内注射醋酸曲普瑞林85~100μg·kg^(-1),每4周1次,治疗1年;试验组肌内注射醋酸曲普瑞林联合皮下注射rhGH 0.12~0.20 U·d^(-1),每天1次,治疗1年。比较2组患儿的临床疗效、生长发育指标、乳房Tanner分期、子宫体积、卵巢体积、性激素水平及药物不良反应发生情况。结果试验组、对照组共脱落8例,最终对照组和试验组分别入组42例、40例。治疗1年后,试验组总有效率为90.00%(36例/40例),高于对照组的71.43%(30例/42例),差异有统计学意义(P<0.05)。试验组和对照组的身高分别为(139.15±6.35)和(132.85±6.29)cm,年平均生长速度(ΔGV)分别为(8.35±0.52)和(5.14±0.45)cm,预测成年终身高(PAH)分别为(159.74±4.61)和(157.39±4.22)cm,差异均有统计学意义(均P<0.05)。试验组和对照组的子宫体积分别为(2.39±0.59)和(3.51±0.68)cm^(3),卵巢体积分别为(1.11±0.25)和(1.43±0.55)cm^(3),雌二醇(E_(2))分别为(18.25±6.33)和(23.54±7.61)U·L^(-1),促黄体生成素(LH)分别为(1.07±0.26)和(1.93±0.38)U·L^(-1),促卵泡激素(FSH)分别为(0.66±0.12)和(1.07±0.34)pg·mL^(-1),差异均有统计学意义(均P<0.05)。试验组总药物不良反应发生率为15.00%(6例/40例),对照组为14.29%(6例/42例),差异无统计学意义(P>0.05)。结论醋酸曲普瑞林联合rhGH治疗大骨龄CPP女童疗效更佳,可以改善患儿生长发育情况,降低性激素水平,并抑制第二性征,且安全性良好。
Objective To investigate the clinical efficacy and safety of triptorelin acetate combined with recombinant human growth hormone(rhGH) in the treatment of girls with central precocious puberty(CPP)of high skeletal age based on the hypothalamic-pituitary-gonadal(HPG) axis.Methods Girls with CPP were randomly divided into control group and treatment group.Control group was treated with intramuscular injection of 85-100 μg·kg^(-1) triptorelin acetate,once every 4 weeks,for 1 year.Treatment group was treated with triptorelin acetate combined with rhGH(subcutaneous injection of 0.12-0.20 U·d^(-1),qd,for 1 year).Clinical efficacy,growth and development indicators,Tanner stage of breast,uterine volume,ovarian volume,sex hormone levels,and adverse drug reactions were compared between the two groups.Results Excluding 8 drop-out cases,finally there were 42cases in control group and 40 cases in treatment group.After 1 year of treatment,the total effective rate in treatment group was 90.00%(36 cases/40 cases),higher than 71.43%(30 cases/42 cases) in control group,with significant difference(P <0.05).The height in treatment group and control group were(139.15±6.35) and(132.85±6.29) cm;growth velocity(ΔGV) were(8.35±0.52) and(5.14±0.45)cm;predicting adult height(PAH) were(159.74±4.61) and(157.39±4.22) cm,all with significant difference(all P <0.05).The uterine volume in treatment group and control group were(2.39±0.59) and(3.51±0.68) cm;ovarian volume were(1.11±0.25) and(1.43±0.55) cm^(3);estradiol(E_2) levels were(18.25±6.33) and(23.54±7.61) U·L~(-1);lnteinizing hormone(LH) levels were(1.07±0.26) and(1.93±0.38) U·L^(-1);follicle-stimulating hormone(FSH) levels were(0.66±0.12) and(1.07±0.34)pg·mL^(-1),the above indexes were significantly different between control group and treatment group(all P<0.05).The total incidence rates of adverse drug reactions in treatment group and control group were 15.00%(6 cases/40 cases) and 14.29%(6 cases/42 cases),with no significant difference(P>0.05).Conclusion The effica
作者
袁意
余丽蓉
吴限
YUAN Yi;YU Li-rong;WU Xian(Department of Endocrinology,Genetics and Metabolism,Jiangxi Children's Hospital,Nanchang 330000,Jiangxi Province,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2023年第24期3547-3551,共5页
The Chinese Journal of Clinical Pharmacology
关键词
中枢性性早熟
基于下丘脑-垂体-性腺轴
醋酸曲普瑞林
重组人生长激素
生长发育
central precocious puberty
hypothalamic-pituitary-gonadal axis
triptorelin acetate
recombinant human growth hormone
growth and development
