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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 pill in treating rheumatoid arthritis syndrome with refractory nephritic syndrome (RNS). Methods: Sixty patients with syndromes of qi deficiency and blood stasis syndrome were randomly divided into control group (30 cases treated with western medicine) and 30 cases treated with Shenkang Pills (on the basis of the control group), the course of treatment was 3 (Alb), 24 h urinary protein (24 h Upr), blood lipid [total cholesterol (TC) and triglyceride (TG)], coagulation / fibrinolysis index [fibrinogen (Fg), D-dimer (DD), thrombin time (TT), partial thromboplastin time (APTT)] and TCM syndromes. Results: There was a significant difference in Upr at 24 h before and after treatment in the treatment group (P <0.01). The levels of TC, Alb and TG in the treatment group before and after treatment were significantly different (P <0.01), and the levels of TC and Alb in the control group before and after treatment were significantly different (P <0.01) (P <0.05), but there was no significant difference in TG between the two groups after treatment (P <0.01). There were significant differences in Fg, APTT, DD and TT before and after treatment in the treatment group (P <0.01) , While the changes of FG, DD and APTT in the control group were statistically significant (P <0.05), but there was no significant difference in TT between the two groups after treatment (P <0.05) Syndromes were significantly different (P <0.01). Conclusion: Shenkangwan combined with western medicine can significantly reduce 24 h Upr, increase Alb, improve TCM syndrome, hypercoagulable state, lower blood fat, significantly reduce and relieve adverse effects of hormones and immunosuppressive agents.