茶多酚片治疗慢性肾小球肾炎的临床观察

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。

Clinical Observation of Tea Polyphenol Tablet on Chronic Glomerulonephritis

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 we...