| Objective:Through the changes of TCM syndrome,physical signs,basic level of serum sex hormone and breast B-ultrasound,the clinical efficacy of Shugan Xiehuo Sanjie recipe in the treatment of girls’ simple premature thelarche was preliminarily evaluated,and the safety of its clinical use was observed,to provide new ideas and new methods for the treatment of girls’ simple premature thelarche with traditional Chinese medicine.Methods:In this study,a self-control test was used to include 48 cases who met the diagnostic criteria,they were treated with Shugan Xiehuo Sanjie recipe for 8 weeks.The clinical symptoms,signs,ultrasound of breast,uterus and ovary,serum sex hormone levels and drug safety indexes such as blood and urine routine,liver function(ALT,AST)and renal function(BUN,Cr)were observed and recorded before and after treatment.Results:In this study,a total of 48 cases were collected,3 cases were dropped,and 45 cases were actually completed.The details are as follows:1.Efficacy evaluation: Disease efficacy evaluation: After 8 weeks of treatment,the total effective rate was 91.11%.Evaluation of the curative effect of TCM syndrome: after 8 weeks of treatment,the total effective rate was 86.67%.2.Comparison of syndrome scores: After treatment,the scores of TCM syndromes and total scores were lower than those before treatment,and the difference was statistically significant(P<0.01).3.Comparison of breast color ultrasound:The maximum length and diameter of hypoechoic nodules of the breast after treatment were significantly different from those before treatment(P<0.01).4.Comparison of uterus and ovary by color ultrasound:The ovarian volume after treatment was significantly different from that before treatment(P<0.01),and the difference in uterine volume after treatment was not statistically significant(P>0.05).5.Comparison of basic levels of serum sex hormones:There were significant differences in the levels of FSH,LH and E2 before and after treatment(P<0.01),and the levels of PRL after treatment were significantly different from those before treatment(P<0.05).There was no significant difference in T and P levels between before and after treatment(P>0.05).6.Safety evaluation: All children in this study had no adverse reactions,and blood,urine,and liver and kidney function tests were normal.7.Follow-up results: All children were followed up for 1 month after treatment.There was no recurrence of the disease.In the ineffective children,there was no pubic hair,axillary hair and linear growth acceleration except that the breast did not disappear completely.Accompanying symptoms such as chest tightness,irritability and irritability have been improved to varying degrees.Conclusion:1.Shugan Xiehuo Sanjie recipe is an effective prescription for the treatment of simple premature breast development of girls with liver depression and fire syndrome,which can effectively relieve breast pain,irritability and other clinical concomitant symptoms.At the same time,it can improve the results of color ultrasound of breast,uterus,ovary and the basic level of serum sex hormone.2.Shugan Xiehuo Sanjie recipe has no adverse reactions in clinical observation,and its clinical application is safe. |