Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

Our study used a randomized controlled trial to validate the clinical efficacy of a combination of traditional Chinese and Western medicine in the treatment of children with rapid progressive central precocious puberty.

In the research, 164 subjects diagnosed with rapid progressive idiopathic precocious puberty are randomly divided into Group Ziyinxiehuo Granules and Megestrol Acetate Tablet（82 cases）and Group Gonadotrophin ( 82 cases). Patients in Group Ziyinxiehuo Granules and Megestrol Acetate Tablet are treated with ziyinxiehuo Granules and megestrol acetate tablet , whereas the Group Gonadotrophin received with gonadotrophin releasing hormone agonist, and all the subjects in two groups are continuously treated for 6 months.

Inclusion Criteria:

• Girls are diagnosed as Idiopathic central precocious puberty by GnRH （gonadotrophin releasing hormone）Stimulation Test, and their age of onset ≤8 years;
• Tanner stages of breast in female patients ≥ Tanner III stage，diameter of mammillary nucleus ≥ 3cm;
• B-type ultrasonography: the volume of uterus≥3ml, the volume of ovary≥1.5ml, the diameter of follicle≥4mm;
• Bone age: compared the chronological age, the bone age is more than 1 year and the bone age <11.5 years old;
• It progresses rapidly, ratio of bone age difference to chronological age difference> 1;
• No GnRH analogs or sex hormones were administrated in the past;
• All above are needed at the same time.

Exclusion Criteria:

• Precocious precocity caused by the central nervous system organic diseases;
• Precocious precocity caused by congenital hypothyroidism, congenital adrenal hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as McCune-Albright syndrome, etc;
• Precocious precocity with a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematous;
• Pseudo sexual precocity and partial precocious puberty.