Clinical Study on Dabuyin Pills Combined with Leuprolide Acetate Microspheres for Girls with Idiopathic Precocious Puberty with Yin Deficiency Resulting in Vigorous Fire Syndrome
Abstract: Objective: To observe the clinical effect and safety of Dabuyin Pills combined with Leuprolide Acetate Microspheres on girls with idiopathic central precocious puberty (ICPP) with yin deficiency resulting in vigorous fire syndrome. Methods: A total of 102 cases of ICPP girls with yin deficiency resulting in vigorous fire syndrome were selected and divided into the control group and the treatment group according to the random number table method,with 51 cases in each group. The control group was treated with Leuprolide Acetate Microspheres, and the treatment group was treated with Dabuyin Pills combined with Leuprolide Acetate Microspheres. The clinical effects and the rate of side reactions in the two groups were observed;the changes in traditional Chinese medicine (TCM) syndrome scores,development indexes of secondary sex characteristics,and sex hormone levels [follicle stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) in serum] were compared before and after treatment in two groups. Results:The effective rate was 82.35% in control group and 96.08% in treatment group with significant difference(P<0.05). After treatment,the scores of TCM syndromes including breast development, tidal fever and night sweating, agitation and irascibility, and constipation in two groups were decreased(P<0.05), the above four scores in treatment group were lower compared with control group (P<0.05). After treatment, the indexes of uterine volume, follicle diameter, ovarian volume and breast size in two groups were decreased(P<0.05),and the indexes of uterine volume,follicle diameter, ovarian volume and breast size in the treatment group were lower compared with control group (P<0.05). After treatment,the levels of FSH,LH and E2 in the two groups were decreased(P<0.05),and the levels of FSH,LH and E2 in the treatment group were lower compared with control group (P<0.05). The incidence of adverse reactions was 11.76% in control group and 3.92% in treatment group with no significant difference(P>0.05). Conclusion: Dabuyin Pills combined with Leuprolide Acetate Microspheres for ICPP girls with yin deficiency resulting in vigorous fire syndrome can improve clinical symptoms, adjust the development process of secondary sexual characteristics and reduce the levels of sex hormones,with high safety.