探讨中药制剂代替激素治疗小儿单纯性肾病综合征(nephrotic syndrome，NS)的可行性。

选择2002年2月至2008年2月在本院住院治疗，符合小儿单纯性肾病综合征诊断标准的患儿80例(排除各种原因引起的继发性肾病综合征)，按就诊顺序将其随机分为治疗组(中药治疗，n＝40)、对照组(激素治疗，n＝40)(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)。两组患儿年龄、性别、病程、病情等比较，差异无显著意义(P>0.05)。对两组患儿均进行常规抗炎、利尿、消肿、纠正酸碱平衡失调及水电解质紊乱治疗的同时，治疗组加用中药口服制剂(紫河车500 g、太子参500 g、丹参500 g、淮山500 g、黄芪500 g、甘草250 g、首乌500 g，按比例研成细末，每次1.5 g，每天3次温开水送服)，疗程为10个月；对照组加用强的松，2 mg/(kg·d)，分3次口服治疗，待尿蛋白转阴2周后，逐渐减量，每日1次，疗程为10个月。完善相关检查，临床观察两组患儿水肿消退、尿量增加、尿蛋白转阴情况及血清蛋白、胆固醇、尿蛋白定量差异。

治疗初期(10 d内)，治疗组患儿尿量明显增加，但水肿消退，尿蛋白转阴等明显差于对照组，两组比较，差异有显著意义(P>0.05)。治疗8周后，两组患儿血清蛋白，胆固醇、尿蛋白定量测定结果比较，差异无显著意义(P>0.05 )。但不良反应、病情反复方面比较，治疗组明显优于对照组，且差异有显著意义(P<0.01)。

中药制剂替代激素治疗小儿单纯性肾病综合征，疗效确切，不良反应少，病情反复次数明显减少。

To investigate the feasibility of traditional Chinese medicine (TCM) on simple nephrotic syndrome (NS) instead of hormone treatment in children.

From February 2002 to February 2008, a total of 80 children who were diagnosed as simple nephrotic syndrome were divided into treatment group (TCM group, n=40) and control group (hormone group, n=40). The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Pengpai Memorial Hospital of Haifeng County. Informed consent was obtained from all participants. There had no significant difference on age, gender, disease course and condition between two groups (P>0.05). Both groups were given conventional anti-inflammatory, diuresis, edema reduction, acid-base balance to correct electrolyte imbalance, and water and electrolyte disturbance. Treatment group were treated with conventional method plus oral TCM preparation for 10 months. Oral TCM preparation included placenta hominis 500 g, heterophylly falsestarwort root 500 g, salvia miltiorrhiza 500 g, yam 500 g, astragalus mongholicus 500 g, glycyrrhiza uralensis 500 g, gold theragran 500 g. Control group were treated with conventional method plus prednisone orally [2 mg/(kg·d)] for 10 months. When protein was negative for 2 weeks, prednisone reduced from three times a day to once a day. The following signs were observed: edema reduction, urine volume, negative situation of urine protein, serum protein, cholesterol, and urine protein quantitation.

During the first 10 days of treatment, urine volume increased significantly in treatment group than that of control group, but edema reduction and disappearance of urine protein in treatment group were worse than those of control group (P<0.05). After 8-week treatment, there had no significant difference of serum protein, cholesterol, urine protein quantitation between two groups. Side effects and relapse in treatment group were significantly better than those of control group (P<0.01).

The curative effects of TCM on simple nephrotic syndrome instead of hormone treatment in children is effective with fewer side effects and relapse frequency.