肾康丸联合西医治疗难治性肾病综合征气虚血瘀夹湿证的临床研究

Clinical Observation of Shenkang Pills Combined with Western Medicine in Treating Qi Deficiency and Blood Stasis Type Refractory Nephritic Syndrome

目的:评价肾康丸治疗难治性肾病综合征(refractory nephritic syndrome,RNS)气虚血瘀夹湿证的临床疗效与安全性。方法:将60例辨证为气虚血瘀夹湿证的患者随机分为对照组(采用西医基础治疗)30例及治疗组(在对照组的基础上采用肾康丸治疗)30例,疗程为3个月,观察两组患者血浆白蛋白(Alb),24 h尿蛋白定量(24 h Upr),血脂[总胆固醇(TC),甘油三脂(TG)],凝血/纤溶指标[纤维蛋白原(Fg),D-二聚体(D-D),凝血酶时间(TT),部分凝血活酶时间(APTT)]及中医证候。结果:治疗组治疗前后24 h Upr比较均有显著性差异(P<0.01)。治疗后两组间比较均有显著性差异(P<0.01);治疗组治疗前后TC,Alb,TG比较均有显著性差异(P<0.01),对照组治疗前后TC,Alb比较有统计学意义(P<0.05),而TG比较无统计学意义,治疗后两组间比较均有显著性差异(P<0.01);治疗组治疗前后Fg,APTT,D-D,TT有显著差异(P<0.01),对照组治疗后FG,D-D,APTT变化有统计学意义(P<0.05),而TT变化无统计学意义,治疗后两组间比较有统计学意义(P<0.05);两组治疗前后中医证候疗效比较差异有统计学意义(P<0.01)。结论:肾康丸联合西医基础治疗能显著减少24 h Upr,升高Alb,改善中医证候、高凝状态,降低血脂,明显减少和缓解激素及免疫抑制剂的不良反应。

Objective： To evaluate the clinical efficacy and safety of Shenkang pills in treating Qi deficiency and blood stasis combining with dampness accumulation refractory nephritic syndrome（ RNS）. Method：Sixty patients of RNS with Qi deficiency and blood stasis combining with dampness accumulation,were randomly divided into two groups. 30 cases in the control group only received Western medicine treatment,and 30 cases in the treatment group were also treated with Shenkang pills based on Western medicine treatment. Patients in both groups were treated continuously for 3 months. The clinical effects were observed,including plasma albumin（ Alb）,24 hours urine protein quantity（ 24 h Upr）,blood lipids [total cholesterol（ TC）,triglyceride（ TG） ],coagulation / fibrinolysis [fibrinogen（ Fg）,D-dimer（ D-D）,thrombin time（ TT）,kaolin partial thromboplastin time（ APTT） ]and traditional Chinese medicine（ TCM） syndrome. Result： There was significant difference in 24 h Upr in treatment group before and after the treatment（ P 〈 0. 01）,and there was significant difference between the two groups after treatment（ P〈 0. 01）. There was significant difference in TC,Alb and TG in treatment group before and after the treatment（ P 〈 0. 01）. TC and Alb of the control group were statistically significant before and after treatment（ P〈 0. 05）,but TG had no statistical significance,and there was significant difference（ P〈 0. 01）between the two groups after treatment. There was significant difference in Fg,D-D,APTT and TT in treatment group before and after treatment（ P 〈 0. 01）; Fg,D-D and APTT of control group after treatment were statistically significant（ P〈 0. 05）,while change of TT had no statistical significance,and there was statistical significant difference between the two groups after treatment（ P 〈 0. 05）. There was statistically significant difference in efficacy of traditional Chinese medicine（ TCM） syndrom between two groups after treatment（ P〈 0. 01）.Conclusion： Shenkang pills combined with western medicine therapy can significantly reduce 24 h Upr,elevate Alb,improve the symptoms of TCM syndrom and state of high coagulation,decrease blood fat,and significantly reduce and relieve the adverse reaction of the hormone and immune inhibitors.