清热化湿祛瘀法对慢性肾衰竭湿热证患者多中心随机对照的临床研究

目的研究清热化湿祛瘀中药清肾颗粒联合西医基础治疗与单纯西医基础治疗对慢性肾衰竭湿热证患者的临床疗效。方法对入组人群采用多中心、随机、对照研究的方法,将符合方案的282例患者分为试验组136例,对照组146例;试验组与对照组均采用西医基础治疗,试验组加用具有清热化湿袪瘀功效的清肾颗粒,每次1袋(10 g),口服每日3次,疗程均为12周,观察临床疗效。结果试验组临床疾病总有效率为79.41%,优于对照组67.12%(P0.05);试验组中医证候总有效率为86.76%,明显高于对照组59.59%(P0.01);试验组能降低24 h尿蛋白定量、肌酐水平、升高肾小球滤过率估算值,优于对照组(P0.05)。结论清肾颗粒联合西医基础治疗对慢性肾衰竭湿热证患者在改善症状、降低证候积分值、减少尿蛋白、保护肾功能方面,显示了良好的临床疗效。

Qingre Huashi Quyu therapy on chronic renal failure patients with damp-heat pattern:a multicenter randomized-controlled clinical trial

Objective This multicenter,randomized-controlled clinical trial was designed to study the clinical efficacy of Qingshen Granule,formulated by TCM therapy principle of clearing heat (qingre), eliminating dampness (huashi)and removing blood stasis (quyu),on chronic renal failure patients with damp-heat pattern.Methods A total of 282 patients eligible were divided into treatment group (n =136)and control group (n =146).All patients were treated with conventional therapy,in addition, patients of treatment group took orally Qingshen Granule at a dose of 10 g,three times daily for consecu-tive 12 weeks.Results The total clinical curative effective rate of the treatment group (79.41%)was significantly higher than that of the control group (67.12%),and there were significant differences between the two groups(P <0.05).The clinical effect of TCM pattern in the treated group(86.76%) was significantly higher than that in the control group (59.59%),and there were significant differences between the two groups (P <0.01 ).After treatment,the levels of U-pro /24h and Scr were obviously lower (P <0.01),while eGFR was obviously higher (P <0.01 ),superior to the control group (P <0.05).Conclusion On the basis of conventional therapy,the satisfactory clinical efficacy of Qingshen Granule on chronic renal failure patients with damp-heat pattern was proved by ameliorating clinical symptoms,decreasing TCMpattern scores,reducing urinary protein and protecting renal function.