Multi-site Study of Comprehensive Treatment for Children Precocious Puberty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 740
- 主要终点
- Comparisons of the height SDS'changes between GnRHa group and traditional chinese medicines group in 6 months.
研究概览
简要总结
This is a prospective, multicentric, comparative, non-randomized interventional study in which subjects diagnosed with central precocious puberty (CPP) and early puberty (EP) were treated for 6 months to compare the effect with GnRHa and traditional Chinese medicines.
详细描述
740 girls with CPP and EP participated in this study, all participates were divided into GnRHa group, traditional chinese medicines group and blank group. After at least six months therapy with GnRHa or traditional Chinese medicines, the investigators compare clinical parameters, sex hormone, bone age and ovarian ultrasound in three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premature appearance of secondary sexual characteristics: girls present with development of secondary sexual characteristics before 8, with breast induration as the earliest manifestation.
- •Accelerated linear growth: the annual growth rate is higher than normal.
- •Advanced bone age: the bone age is 1 or years more than the actual age
- •Enlargement of sexual glands: B-mode ultrasonography of pelvic cavity indicates the volumes of the uterus and ovaries have increased, and multiple ovarian follicles with a diameter>4mm can be found in ovaries;
- •HPGA functions have been primed; serum gonadotropin and sexual hormone levels reach pubertal values.
- •Subjects should be willing and able to follow the study protocol during the study period.
- •Subjects should submit their parents' or guardians' written informed consent before initiation of the study procedure with non-normal medical care. They should understand that subjects or their parents/guardians may withdraw the consent at any time without impairing future medical care. If the child is old enough to read and write, she should submit a separate consent form.
排除标准
- •Patients with central nervous system diseases and thyroid diseases;
- •Patients with CHA-induced precocious puberty;
- •Patients with poor compliance.
研究组 & 干预措施
GnRHa(Triptorlin or Leuprorelin)
Triptorlin or Leuprelin 100ug/kg per 28 days
干预措施: Triptorlin or Leuprorelin (Drug)
Traditional Chinese Medicines
Zhibo dihuang pills: 8 tablets twice a day by mouth for 6 months and Dabu ying pills: 6g twice a day by mouth for 6 months
干预措施: Zhibo dihuang pills (Drug)
Traditional Chinese Medicines
Zhibo dihuang pills: 8 tablets twice a day by mouth for 6 months and Dabu ying pills: 6g twice a day by mouth for 6 months
干预措施: Dabu ying pills (Drug)
结局指标
主要结局
Comparisons of the height SDS'changes between GnRHa group and traditional chinese medicines group in 6 months.
时间窗: 6 months
The change levels of height SDS in the GnRHa group (n=202) is lower than in the traditional chinese medicines group (n=155) ,(P\<0.05).
次要结局
- Comparisons of the breast stages'changes between GnRHa group and traditional chinese medicines group in 6 months.(6 months)