复方逍遥合剂治疗肝郁化火证及复方地黄合剂治疗阴虚火旺证女童特发性性早熟临床观察

Clinical Study on Treatment of Idiopathic Central Precocious Puberty of Girl with Compound Xiaoyao Oral and Compound Dihuang Oral

目的:观察中药复方逍遥合剂,复方地黄合剂治疗女童特发性性早熟的有效性和安全性,并探讨其作用机制。方法:选取2013年9月—2015年8月,于上海市儿童医院门诊治疗的中医证型为肝郁化火证、阴虚火旺证女童特发性性早熟患儿共140例,每组证型分别随机设治疗组,对照组,各70例。肝郁化火证组予复方逍遥合剂口服,对照组予逍遥丸口服;阴虚火旺证组予复方地黄合剂口服,对照组予知柏地黄丸口服。治疗3个月,B超观察治疗后乳核变化,子宫、卵巢体积变化,3个月后记录黄体生成素(luteinising hormone,LH),卵泡刺激素(follicle-stimulating hormone,FSH),雌二醇(estradiol,E_2),性激素结合球蛋白(sex hormone binding globulin,SHBG)水平变化,同时记录药物不良反应。结果:治疗组乳核直径、卵巢容积及子宫容积的减少均有明显缩小(P<0.05);SHBG值治疗后有明显升高(P<0.05);治疗过程中未发现不良反应。结论:复方逍遥合剂治疗肝郁化火证、复方地黄合剂治疗阴虚火旺证女童特发性性早熟临床疗效显著,且安全性可靠。

Objective： On evaluate the effectiveness and safety of compound Xiaoyao oral, compound Dihuang oral in the treatment of female precocious puberty patients. Method： The 140 girls who were were diagnosed with hyperactivity of liver-fire and Yin deficiency and Huo exuberance treated at out-patient of our hospital from Sep. 2013 to Aug. 2015. Hyperactivity of liver-fire group were randomly assigned to two groups, the control group was given to Xiaoyaowan, the experimental group was given to compound Xiaoyao oral which was our hospital self-made traditional Chinese medicine. Yin deficiency and Huo exuberance were also randomly assigned to two groups, the control group was given to Zhibai Dihuang Wan, the experimental group was given to compound Dihuang oral. After 3 months treated, all patients were observed the breast changes, uteruses, ovarians volume change and the level of luteinising hormone （LH）, follicle-stimulating hormone （FSH）, estradiol （E2） , sex hormone binding globulin （SHBG） to evaluate its efficacy. At the end day, recording side effect of drug events; blood routine, liver function, renal function to evaluate its safety. Result： The treatment group was better than control group, the breast diameter and the reduction of uterine and ovary volume were changed significantly （P 〈 0. 05）. In both of two groups the incidence of adverse reactions and no side effect of drug events were found. Conclusion： The compound Xiaoyao oral, compound Dihuang oral treatment of idiopathic true precocious puberty were significant clinical effect and safety reliable.