中医药治疗女童性早熟68例随机双盲对照试验

Randomized Double-Blind Controlled Clinical Trial of TCM Treatment for 68 Girls with Sexual Precocity

目的:比较滋阴泻火与疏肝理气中药方剂治疗女童性早熟的疗效。方法:采用随机、双盲、对照分组的方法,患儿分为治疗组(滋阴泻火方早熟Ⅱ号)、对照组(疏肝理气方逍遥丸);双盲、双模拟给药。随访比较用药前后两组患儿乳核指数、乳房Tanner 分期、中医证候积分、B 超检查(子宫、卵巢容积、最大卵泡直径)、骨龄的变化。132例患儿完成所有随访。结果:两组患儿用药前后比较,治疗组乳核指数、乳房 Tanner 分期、中医证候积分减少程度优于对照组(P<0.05或 P<0.01);B 超检查子宫、卵巢容积,卵泡大小,治疗组控制程度均优于对照组(P<0.05或 P<0.01);骨龄改变比较,两组差异无显著性(P>0.05)。结论:滋阴泻火中药早熟Ⅱ号治疗女童性早熟疗效优于疏肝理气中药逍遥丸。

Objective:To compare therapeutic effects of Chinese medicine prescriptions for nourishing Yin to purge pathogenic fire,and prescriptions for relieving the depressed liver in treatment of sexual precocity of girls.Methods:The girls with sexual precocity were divided with random,double blind and control methods into a treatment group treated with the prescription for nourishing Yin to purge pathogenic fire,Zaoshu No.Ⅱ,and a control group treated with the prescription for relieving the depressed liver, Xiaoyao Pill.The medicines were given with double blind and double simulated methods.The mammary nucleus index,mammary Tanner phasing,cumulative scores of TCM syndromes,B type ultrasonography(volume of the uterus,ovary,the biggest follicle diameter),change of bone age were followed up and compared before and after treatment in the two groups.Follow-up was completed in 132 cases.Results:The treatment group in the mammary nucleus index,mammary Tanner phasing,decrease of cumulative scores of TCM syndromes after treatment was better than the control group(P<0.05 or P<0.01);volume of the uterus,volume of ovary and follicle size in the treatment group were better than in the control group(P<0.01).There was no significant difference between the two groups in change of bone age(P>0.05).Conclusion:Chinese medicine for nourishing Yin to purge pathogenic fire,Zaoshu No.Ⅱ,in therapeutic effect for treatment of sexual precocity of girls is better than the Chinese medicine for relieving the depressed liver,Xiaoyao Pill.