益肾清利颗粒联合低剂量雷公藤多苷片治疗慢性原发性肾小球疾病肾虚湿热证疗效观察  

Treatment of Chronic Primary Glomerulopathy Patients of Shen Deficiency and Dampness Heat Syndrome by Yishen Qingli Granule Combined Low-dose Tripterygium Wilfordii Multiglycoside Tablet:a Clinical Efficacy Observation

作　　者：盛梅笑 孙伟[1] 邢昌赢[2] 袁发焕[3] 汤水福[4] 熊佩华[5] 马济佩[6] 周栋 高坤 江燕 陈继红 毛慧娟[2] 牟娇[3] 罗月中[4] 魏明刚[5] 刘彩香[6] 

机构地区：[1]南京中医药大学附属医院肾科,南京210029 [2]南京医科大学第一附属医院肾科,南京210029 [3]第三军医大学新桥医院肾科,重庆400037 [4]广州中医药大学第一附属医院内三科,广州510405 [5]苏州大学附属第一医院中西医结合科,江苏苏州215006 [6]南京中医药大学无锡附属医院肾科,江苏无锡214001

出　　处：《中国中西医结合杂志》2013年第12期1636-1641,共6页Chinese Journal of Integrated Traditional and Western Medicine

基　　金："十一五"国家科技支撑计划项目(No.2007BAI20B102)

摘　　要：目的 评价益肾清利颗粒联合低剂量雷公藤多苷片治疗慢性原发性肾小球疾病肾虚湿热证的疗效与安全性。方法 选择南京中医药大学附属医院（60例）、南京医科大学第一附属医院（58例）、第三军医大学新桥医院（46例）、广州中医药大学第一附属医院（35例）、苏州大学附属第一医院（14例）、南京中医药大学无锡附属医院（18例）共计231例慢性原发性肾小球疾病（隐匿性肾炎、慢性肾炎）肾虚湿热证患者，按区组随机方法分为试验组115例、对照组116例。安全性分析集217例（试验组109例，对照组108例），全分析集203例（试验组99例，对照组104例）。两组均予ACEI/ARB等基础治疗，试验组予益肾清利颗粒（生黄芪10 g、制首乌10 g、石苇10 g，1.5 g/袋，含生药10 g）各1袋，2次/d；雷公藤多苷片10 mg，2次/d，根据24 h尿蛋白定量（UTP）调整雷公藤剂量，对照组予益肾清利颗粒模拟剂与雷公藤多苷模拟片。疗程24周，随访24周。观察治疗后UTP、尿红细胞计数（URBC）、肾功能（BUN、SCr）的变化，以及血常规（WBC）、肝功能（SGPT、SGOT）、胃肠不适、皮疹、女性月经紊乱等不良反应。结果 试验组总有效率（82.8%，82/99）优于对照组（61.5%，64/104，P〈0.01），对UTP进行分层比较的结果显示试验组UTP为0.8~3.0 g/24 h的患者疗效更优（P〈0.01）；试验组UTP降低的效应发生在治疗第8周以后，作用持续稳定，与对照组比较，差异有统计学意义（P〈0.01）； 试验组 URBC减少，但波动较大，其变化与对照组比较，差异无统计学意义（P〉0.05）；两组患者治疗后血WBC、SGPT、SGOT等安全性指标变化差异无统计学意义（P〉0.05）。结论 在ACEI/ARB等基础治疗上，益肾清利颗粒联合低剂量雷公藤多苷片能较好地控制慢性原发性肾小球疾病蛋白尿，并且有助于稳定�Objective To evaluate the clinical efficacy and safety of treatment of chronic primary glomerulopathy （CPG） patients of Shen deficiency and dampness heat syndrome （SDDHS） by Yishen Qingli Granule （YQG） combined with low-dose Tripterygium Wilfordii multiglycoside Tablet （TWT）. Methods Totally 231 CPG patients of SDDHS were enrolled in this study （including 60 patients from First Affiliated Hospital of Nanjing University of Chinese Medicine, 58 from First Affiliated Hospital of Nanjing Medical University, 46 from Xinqiao Hospital of Third Military Medical University, 35 from First Affiliated Hospital of Guangzhou University of Chinese Medicine, 14 from First Affiliated Hospital of Soochow University, and 18 from Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine）. They were randomly assigned to the control group （116 cases） and the trial group （115 cases） according to block group method. There were 217 cases in the safety analysis set （109 cases in the trial group vs 108 cases in the control group）, and 203 cases in the full analysis set （99 cases in the trial group vs 104 cases in the control group）.AII patients received basic treatment such as ACEI/ARB. Furthermore, YQG （consisting of raw astragalus 10 g, prepared Polygonum Multiflorum 10 g, Pyrrosia 10 g, 1.5 g each package, containing 10 g of crude drugs） was additionally given to patients in the trial group, each package, twice daily. The TWT （10 mg） was given, twice a day. The TWT dose was adjusted according to 24 h urinary total protein （UTP）. The placebos of YQG and TWT were administered to those in the control group. The treatment course consisted of 24 weeks and the follow-up visit lasted for 24 weeks. The biochemical indices were observed before and after treat- ment including 24 h UTP, urine red cell count （URBC）, renal functions （BUN, SCr）, blood routine test （WBCI）, and liver functions （SGPT, SGOT）. Reverse reactions such as gastrointestinal discomfort, skin rash, and irre

关 键 词：慢性原发性肾小球疾病 肾虚湿热证 蛋白尿 益肾清利颗粒 雷公藤多苷片 

分 类 号：R277.5[医药卫生—中医学]