Rapidly progressive central precocious puberty
Conditions
Interventions
GnRHa combined with rhGH group:NA
GnRHa combined with PEG-rhGH group:NA
Sponsors
Shanghai Children's Hospital
Eligibility
Sex/Gender
Female
Age
8 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosis according to CPP or fast forward EFP: (1) CPP: breast development before the age of 8 or menarche before the age of 10 in girls; The Tanner stage of linear growth and sexual development accelerated, and the bone age exceeded the actual age by >= 1 year; Pelvic B-ultrasound showed enlarged ovaries with ovarian volume (ovarian volume = length × width × thickness × 0.5233) >1ml or multiple follicles >= 4mm in diameter; The peak value of LH in GnRH provocation test >= 5.0 u/l and the ratio of peak value of LH to peak value of FSH >= 0.6; (2) EFP: breast development in girls after 8-10 years of age; Rapid progression type (rapid progress of sexual development in a short time, = 1 year; Pelvic B-ultrasound showed enlarged ovaries with ovarian volume (ovarian volume = length × width × thickness × 0.5233) >1ml or multiple follicles >= 4mm in diameter; The peak value of LH in GnRH provocation test >= 5.0 u/l and the ratio of peak value of LH to peak value of FSH >= 0.6; 2.It meets the indications of GnRHa combined with PEG rhGH / rhGH: if the PAH of children is less than P3 or the target height is -2sds at the beginning of GnRHa treatment; During GnRHa treatment, if the growth rate of children is less than 0.5cm/ month for 3 consecutive months; 3.Children and parents were informed and voluntarily participated in the study;
Exclusion criteria
Exclusion criteria: 1.Organic central precocious puberty, such as central precocious puberty caused by various intracranial tumors; 2.Peripheral precocious puberty transforms into central precocious puberty, such as McCune Albright syndrome, congenital adrenal sebaceous hyperplasia, etc; 3.Patients have contraindications to the use of growth hormone, such as acute proliferative or severe non proliferative diabetic retinopathy, previous history of malignant tumor, etc; 4.Combined with the causes of growth disorders or short stature, such as GHD, SGA, ISS, Turner syndrome, hypothyroidism and other serious chronic disease-related short stature (such as cardiac dysfunction, liver and kidney dysfunction, chronic inflammatory bowel disease), etc; 5.The patient had received any PEG-rhGH / rhGH treatment within 6 months before the baseline period; 6.Patients whose epiphyses have been completely closed; 7.Scoliosis > 15 °; 8.Patients who were not suitable for inclusion after assessment by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in PAH;The incidence of all adverse events (AE) and serious adverse events (SAE) during the study period, such as liver, kidney function, thyroid function, fasting blood glucose, IGF-1, etc; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in HtSDS_CA, HtSDS_BA, GV, BA/CA, BMI , HG (FAH-PAH(t the beginning of fah-pah)), uterine ovarian volume, and basal sex hormone levels (LH, FSH, E2, PRL, P, T)); | — |
Countries
China
Contacts
Public ContactPin Li
Shanghai Children's Hospital
Outcome results
None listed