中国医学科学院学报2016，Vol.38Issue(6)：686-695,10.DOI:10.3881/j.issn.1000-503X.2016.06.010
健脾清化方治疗脾虚湿热型慢性肾脏病3期的多中心随机对照临床观察
A Clinical Multicenter Randomized Controlled Study on JianpiQinghua Decoction in Treating Stage 3 Chronic Kidney Disease with A Syndrome Type of Dampness-heat due to Spleen Deficiency
摘要
Abstract
Objective To evaluate the clinical effectiveness of JianpiQinghua decoction in treating stage 3 chronic kidney disease (CKD3) with syndrome type of dampness-heat due to spleen deficiency. Methods A multicenter, randomized, controlled, prospective, double-blind, and double-simulation study was undertaken. A total of 270 CKD3 patients with syndrome type of dampness-heat due to spleen deficiency from the outpatient departments of six general hospitals were randomly divided into telmisartan+analog traditional Chinese medicine (TA) group, traditional Chinese medicine+analog telmisartan (TCMA) group, and telmisartan+traditional Chinese medicine (TTCM) group, in which the corresponding treatment was applied in addition to basic treatment. Six months later, changes in the traditional Chinese medicine (TCM) clinical symptom scores and renal functions before and after treatment were compared among these three groups. Results Of these 270 CKD3 patients who had been enrolled in this study, 30 cases lost to follow-up. The baseline data were comparable among these three groups. After treatment, the TCM clinical symptom scores of both syndrome of spleen-qi deficiency and dampness-heat in TA group were significantly higher than those in TCMA group and TTCM group (P<0. 001) . With the treatment time prolonged, the TCM clinical symptom scores showed similar descending trends in TCMA group and TTCM group but were different from that in TA group. After treatment, abnormal creatinine rate decreased (P =0. 003), and these three treatments and their interactions with each visit had no effect on serum urea nitrogen value (P = 0. 270, P = 0. 520); with prolonged treatment, the estimated glomerular filtration rates in three groups tended to be relatively stable after the first rise. The liver function and abnormal serum potassium rate were not statistically significant before and after treatment (P>0. 05) . Conclusions JianpiQinghua decoction can improve clinical symptoms of TCM in CKD3 patients with syndrome type of dampness-heat due to spleen deficiency and thus improve the quality of life and prognosis. The clinical efficacy of JianpiQinghua decoction alone or combined with telmisartan is superior to telmisartan monotherapy.关键词
健脾清化方/脾虚湿热/慢性肾脏病Key words
JianpiQinghua decoction/dampness-heat due to spleen deficiency/chronic kidney disease分类
医药卫生引用本文复制引用
余柯娜,倪兆慧,汪年松,彭文,王怡,张长明,何立群..健脾清化方治疗脾虚湿热型慢性肾脏病3期的多中心随机对照临床观察[J].中国医学科学院学报,2016,38(6):686-695,10.基金项目
上海市科学技术委员会科研计划项目(11DZ1973100),国家临床重点专科和国家中医药管理局重点学科和重点专科 Supported by the Shanghai Science and Technology Committee (11DZ1973100), National Clinical Key Specialist, and Key Subjects, and Key Specialist of the State Administration of Traditional Chinese Medicine （11DZ1973100）
