按照多中心临床试验的原则评价了茶多酚片治疗慢性肾小球肾炎（肺肾气虚症）的有效性和安全性,采用多中心、分层区组随机、双盲双模拟、阳性药物（肾炎四味片）平行对照,观察病例240例,治疗组和对照组各120例,观察周期为8周。治疗8周后,茶多酚片组的疾病疗效、证候疗效、尿蛋白疗效和尿红蛋白疗效的愈显率分别为：35.0%、38.5%、49.6%和59.7%;同时有效率分别为：71.8%、86.1%、80.0%和72.6%,与对照组（肾炎四味片）组间比较均无统计学差异。实验过程中均未见不良反应及严重不良事件发生,茶多酚片组与肾炎四味片组受试者均评价为安全性1级。结果表明,茶多酚片是治疗慢性肾小球肾炎（肺肾气虚症）安全有效的药物,其疗效不低于肾炎四味片。

To evaluate the efficiency and safety of tea polyphenol tablet on chronic glomerulonephritis in clinic, a multi-centre, prospective, double-blind and double-mimicry, positive control (shenyan siwei tablet) trial was conducted, and 240 patients (120 patients of treated group and 120 patients of control group) was observed for 8 weeks. After 8 weeks’ treatment, the efficacy in cured rate of relieving clinical symptoms of patiens, the scores of symptoms efficacy, urinary protein efficacy and urine erythrocyte efficacy were 35.0%, 38.5%, 49.6% and 59.7% respectively in tea polyphenol tablet group, and the total effective rate were 71.8%, 86.1%, 80.0% and 72.6% respectively. It showed no difference comparing with positive control group. No adverse effects appeared during the trial, both tea polyphenol tablet and shenyan siwei tablet were evaluated as first-level safety by the patients of trial group and positive control group. All results suggested that tea polyphenol tablet is an efficient and safe drug in treatment of chronic glomerulonephritis, and its efficacy is not less than shenyan siwei tablet.