【摘要】 目的 观察玄地滋阴合剂治疗女童中枢性性早熟（CPP）阴虚火旺证的临床疗效和安全性，并分析身体质量指数（BMI）对疗效的影响。方法 纳入236例CPP阴虚火旺证女童，均给予玄地滋阴合剂口服治疗，每次30 ml，每天2次，共治疗6个月。治疗前后检测患儿体重、身高、骨龄，计算BMI和BMI标准化值（BMI Z值）、骨龄与实际年龄差值；B超检测子宫卵巢大小，计算子宫容积(V_子宫)、双侧卵巢容积(V_左卵巢，V_右卵巢)、双侧最大卵泡直径(r_左卵泡及r_右卵泡)；检测血清性激素水平，包括促卵泡激素（FSH）、促黄体生成素（LH）、泌乳素（PRL）、雌二醇（E₂）、睾酮（T），并进行中医证候评分。采用多元线性回归分析骨龄与实际年龄差值、子宫容积变化的影响因素。患儿根据基线BMI分为正常体重组及超重/肥胖组两组，比较两组患儿治疗前后骨龄、骨龄与实际年龄差值、V_子宫及BMI Z值。结果 最终199例患儿进入统计分析，与治疗前比较，治疗后患儿骨龄、BMI及BMI Z值增大，骨龄与实际年龄差值、中医证候积分、V_子宫、V_左卵巢、V_右卵巢、r_左卵泡、r_右卵泡减小，血清FSH、LH、E₂、T水平下降（P<0.05或P<0.01）。骨龄与实际年龄差值变化与LH、V_子宫呈负相关（P<0.05），子宫容积变化与LH呈正相关（P<0.01）。治疗前后组间比较，正常体重组（100例）患儿骨龄、骨龄与实际年龄差值、BMI Z值明显小于超重/肥胖组（99例）（P<0.01）。与本组治疗前比较，两组患儿骨龄增大，骨龄与实际年龄差值、V_子宫缩小（P<0.01）。进一步对两组患儿Δ骨龄与实际年龄差值、ΔV_子宫比较（Δ=治疗后值-治疗前值），差异无统计学意义（P>0.05）。结论 玄地滋阴合剂治疗CPP阴虚火旺证女童可降低患儿骨龄、性激素水平，减小卵巢和子宫体积，改善临床症状，对超重/肥胖儿童效果亦佳，对CPP女童骨龄的抑制作用不受BMI影响，且安全性好。更多还原

【Abstract】 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;ultrasound was used to detect uterine and ovarian sizes,and to calculate uterine volume(V_uterus),bilateral ovarian volume(V_{left ovary},V_{right ovary}),and bilateral maximal follicle diameters(r_{left follicle} and r_{right follicle});and serum sex hormones were measured,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 baseline BMI,and the bone age,the difference between bone age and actual age,V_uterus 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,V_uterus,V_{left ovary},V_{right ovary},r_{left follicle} and r_{right follicle} decreased;and the levels of serum FSH,LH,E₂,and T significantly decreased（P<0.05 or P<0.01）.The difference between bone age and actual age was negatively correlated with LH and V_uterus（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 V_uterus were significantly smaller（P<0.01）.Further comparison ofΔbone age and actual age difference and ΔV_uterus（Δ=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.更多还原