Effects Of Modified Xiehuang San With Leuprolide Acetate Microspheres In Girls With Idiopathic Central Precocious Puberty(Latent Fire In The Spleen And Stomach)

Objective: In order to preliminarily observe the effectiveness and safety of modified Xiehuang San with leuprolide acetate microspheres in the treatment of idiopathic central precocious puberty(Latent Fire in the Spleen and Stomach)in girls.Methods: 72 girls with ICPP aged 4-10 years who met the inclusion and exclusion criteria from December 2019 to November 2020 in the Department of Pediatrics of Sichuan Provincial Hospital of traditional Chinese medicine were collected and randomly divided into experimental group and control group according to the ratio of 1:1,The control group used leuprorelin acetate microspheres,and the test group added Xiehuang San on the basis of the control group.The course of treatment was 3 months.The TCM syndrome score,LH,FSH,E2,uterine volume,left and right ovarian volume before and after treatment were collected the 0th day,1month,2 months,and 3 months respectively.Results:1.Baseline evaluation: There was no significant difference between the two groups of children in age,course of disease,height,weight,bone age,LH,FSH,E2,uterine volume,left and right ovarian volume,and TCM syndrome scores(P>0.05).2.Comparison of efficacy(1)Effectiveness of disease: The effective rate of disease in the test group was90.32%,and the effective rate of disease in the control group was 84.85%.The test group was better than the control group(P<0.01).(2)The effective rate of TCM syndromes: the total effective rate of the test group was 93.55%,and the total effective rate of the control group was 81.82%.The test group was better than the control group(P<0.01).(3)Comparison of TCM syndrome scores: Both groups were effective in improving TCM syndromes(P<0.01).After 1,2,and 3 months of treatment,the test group was better than the control group(P<0.01).(4)Comparison of scores of main symptoms of traditional Chinese medicine:The experimental group was effective in improving TCM main symptom score at each time observation node(P < 0.01),and the control group was effective in improving TCM syndrome score after 2 and 3 months of treatment(P < 0.01).The test group was better than the control group at 1 month,2 months,and 3 months after treatment(P<0.05).(5)Comparison of scores of secondary symptoms of TCM: Both groups were effective in improving secondary symptoms of TCM(P<0.05).After 1 month of treatment,the test group was better than the control group in improving dry stools(P<0.01).After 2 and 3 months of treatment,the improvement of dry thirst,bad breath,poor sleep,short yellow urine and dry stool in the experimental group was better than that in the control group(P<0.05).After 3 months of treatment,the improvement of the symptom of swift digestion with rapid hungering in the test group was better than that in the control group(P<0.01).(6)Test observation indicators: Both groups were effective in improving uterine volume,LH,FSH,E2,left and right ovarian volume(P<0.05).After 3 months of treatment,the test group improved in LH,FSH,E2,and left and right ovarian volume.Both were better than the control group(P<0.05).In terms of uterine volume,the two groups had the same curative effect(P>0.05).3.Safety evaluation: There were no adverse reactions in the two treatment programs.Conclusion:(1)After 3 months of treatment,the experimental group was better than the control group in improving the symptoms of precocious puberty.(2)After 1 month,2 months and 3 months of treatment,the improvement rate of TCM syndrome in the experimental group was better than that in the control group;After 2and 3 months of treatment,the scores of TCM syndromes in the experimental group were better than those in the control group.Xiehuang San could effectively improve the TCM Syndromes of Latent Fire in the Spleen and Stomach syndrome in ICPP girls.(3)There were no serious adverse reactions in the two groups during and after the treatment,which had good safety.