Clinical trial of leuprorelin acetate in the treatment of children with sexual precocity
10.13699/j.cnki.1001-6821.2016.14.014
- VernacularTitle:醋酸亮丙瑞林治疗小儿性早熟的临床研究
- Author:
Man-Yan ZHANG
1
;
Ying HE
;
Hong SHEN
Author Information
1. 绍兴市第二医院儿科
- Keywords:
leuprorelin acetate for injection of microspheres;
sexual precocity;
uterine volume;
ovarian volume
- From:
The Chinese Journal of Clinical Pharmacology
2016;32(14):1296-1298
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the clinical effect and safety of leu-prorelin acetate in the treatment of children with sexual precocity . Methods Forty-two children with central precocious puberty were ran-domly divided into control group and treatment group , 21 cases in each group.The control group was orally given megestrol acetate 2 mg, 3 times a day. Treatment group was treated with leuprorelin acetate 90μg? kg-1 by subcutaneous injection ,1 time a month on the basis of control group.Two groups were treated for 1 year.Compared the serum estradiol ( E2 ) , luteotropic hormone ( LH ) and follicle stimulating hormone ( FSH) , volume of uterus and ovary , and adverse drug reactions in two groups before and after treatment .Results After treatment , the serum levels of E2, LH and FSH were(9.87 ±1.41)ng? L-1, (1.29 ±0.16) U? L-1 , ( 2.65 ±0.37 ) U? L-1 in treatment group , significantly lower than (15.22 ±2.11 ) ng? L-1 ,(2.74 ±0.37 ) U? L-1 ,(3.24 ±0.43 ) U? L-1 in control group ( P<0.05 ) .The volume of uterus , ovary and right ovary of children in treatment group were ( 2.69 ±0.35 ), (1.47 ±0.21), ( 1.41 ± 0.18 ) cm2, significantly lower than (3.48±0.43),(1.98 ±0.26),(2.03 ±0.25)cm2 in control group (P<0.05).The adverse symptoms were mainly dizziness and sweating . There was no significant difference in the incidence of adverse drug reactions between the two groups (P>0.05).Con-clusion The leuprorelin acetate for injection of microspheres can significantly reduce the serum levels of E2 , LH and FSH in children with central precocious puberty , control the abnormal development of secondary sexual characteristics , improve the clinical efficacy , and also safety.
