Xuandi Ziyin Mixture(玄地滋阴合剂)for Central Precocious Puberty in Girls with Syndrome of Yin Deficiency and Fire Exuberance:A Prospective Cohort Study
Objective To observe the clinical effectiveness and safety of Xuandi Ziyin Mixture(玄地滋阴合剂)for central precocious puberty(CPP)in girls with syndrome of yin deficiency and fire exuberance,and to analyse the effect of body mass index(BMI)on the effectiveness.Methods A total of 236 girls with CPP of yin deficiency and fire exuberance syndrome were included,and all of them were given Xuandi Ziyin Mixture,30 ml each time,twice a day,for a total treatment period of 6 months.Before and after treatment,children's weight,height and bone age were measured,BMI and BMI Z-score(BMI Z)and the difference between bone age and actual age were calculated;ultra-sound was used to detect uterine and ovarian sizes,and to calculate uterine volume(Vuterus),bilateral ovarian volume(Vleft ovary,Vright ovary),and bilateral maximal follicle diameters(rleft follicle and right fallicle);and serum sex hormones were mea-sured,including follicle-stimulating hormone(FSH),luteinising hormone(LH),prolactin(PRL),estradiol(E2),and testosterone(T),and were scored for traditional Chinese medicine(TCM)syndrome.Multiple linear regression was used to analyse the influence factors of the difference between bone age and actual age,and changes in uterine volume.The children were divided into the normal weight group and the overweight/obesity group according to base-line BMI,and the bone age,the difference between bone age and actual age,Vuterus and BMI Z scores before and after treatment were compared between the two groups.Results Finally,199 children entered the statistical analysis.Compared with pre-treatment,the bone age,BMI and BMI Z scores of the children increased after treatment,and the difference between bone age and actual age,TCM syndrome scores,Vuterus,Vleft ovary,Vright ovary,rleft follicle and rright follicle decreased;and the levels of serum FSH,LH,E2,and T significantly decreased(P＜0.05 or P＜0.01).The differ-ence between bone age and actual age was negatively correlated with LH and Vuterus(P＜0.05),and changes in uterine volume were positively correlated with LH(P＜0.01).Comparing between the groups before and after treatment,the bone age,difference between bone age and actual age,and BMI Z scores of children in the normal weight group(100 cases)were significantly smaller than those in the overweight/obesity group(99 cases)(P＜0.01).Compared with pre-treatment,the bone age of the children in both groups increased,but the difference between bone age and actual age and Vuterus were significantly smaller(P＜0.01).Further comparison of △ bone age and actual age difference and△Vuterus(△=post-treatment value-pre-treatment value)between the two groups showed no statistically significant difference(P＞0.05).Conclusions Xuandi Ziyin Mixture can reduce bone age,sex hormone level,ovary and uterus size,and improve clinical symptoms in girls with yin deficiency and fire exuberance syndrome of CPP.It is also effective in overweight/obese children,and the inhibitory effect on bone age in girls with CPP is not affected by BMI,with good safety.
central precocious pubertygirlssyndrome of yin deficiency and fire exuberanceXuandi Ziyin Mixture(玄地滋阴合剂)overweight and obesitybone agesex hormonesbody mass index
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