探讨对儿童中枢性性早熟(CPP)患儿采用知柏地黄丸联合大补阴丸治疗的疗效。

选择2011年8月至2013年4月在本院接受知柏地黄丸联合大补阴丸治疗的56例CPP患儿为研究对象。CPP诊断标准参考符合2010卫生部《性早熟诊疗指南(试行)》。按照56例CPP患儿治疗方法，将其分为试验组[n＝28，<5岁患儿口服知柏地黄丸54 g/次(9 g/粒)×2次/d＋大补阴丸180 g/次(9 g/粒)×2次/d，≥5岁患儿口服知柏地黄丸(72～90)g/次×2次/d＋大补阴丸360 g/次×2次/d，连续治疗6个月]和对照组(n＝28，仅口服知柏地黄丸，剂量及治疗时间与治疗组相同) (本研究遵循的程序符合本院人体试验委员会制定的伦理学标准，得到该委员会批准，分组征得受试对象监护人的知情同意，并与其签署临床研究知情同意书)。两组患儿性别、年龄、病程、性早熟类型、促性腺激素水平等临床资料比较，差异无统计学意义(P>0.05)。

两组患者经过6个月治疗后，再进行为期6个月随访时的显效率、有效率、无效率及总有效率比较(78.5% vs. 57.1%, 14.3% vs. 17.9%, 7.2% vs.25.0%, 92.8% vs.75.0%)，差异均有统计学意义(χ²＝3.546，2.314，2.597，12.114；P<0.05)。

对儿童CPP患儿采用知柏地黄丸联合大补阴丸进行治疗，疗效较好，但是否值得临床推广应用，则尚需多中心、大样本的随机对照研究进一步证实。

To discuss effectiveness by zhibai dihuang pill combined dabuyin pill to children with central precocious puberty (CPP).

From August 2011 to April 2013, a total of 56 cases of children with CPP were recruited. According to different strategies for treatment they were divided into treatment group (n=28; age <5-year-old children taking zhibai dihuang pill 54 g (9 g/grain) bis in die + dabuyin pill 180 g (9 g/grain) bis in die; ≥5-year-old children taking zhibai dihuang pill (72-90)g bis in die+ dabuyin pill 360 g bis in die, 6 months continuous treatment) and control group (n=28; only taking zhibai dihuang pill, dosage and course of treatment the same as treatment group). The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Children's Hospital of Zhengzhou. Informed consent was obtained from the parents of each participating child. There were no significance difference between two groups among age, gender, course of disease, type of precocious puberty, gonadotropin levels etc.(P>0.05).

Follow-up 6 months after treatment, there were significance difference between two groups among efficiencies, effectivenesses, in efficiencies and total effective rates (78.5% vs. 57.1%, 14.3% vs 17.9%, 7.2% vs. 25.0%, 92.8% vs. 75.0%; χ²=3.546, 2.314, 2.597, 12.114; P<0.05).

Curative effect of zhibai dihuang pill combined dabuyin pill is good for treatment children with CPP in this study. But whether it is worthy of clinical application multi-center, large-sample randomized controlled trial will be needed to further confirm the safety and effectiveness, etc..