排毒保肾丸治疗慢性肾脏病3～4期的临床研究

A Clinical Study of Treating Chronic Kidney Disease Stage 3 and 4 Patients Using Paidu Baoshen Pill

目的：观察排毒保肾丸（大黄丸加减）治疗慢性肾脏病（CKD）3~4期中医辨证兼血瘀证和湿浊证患者的疗效。方法：将符合入选标准的CKD3~4期辨证兼血瘀证和湿浊证患者284例随机分为治疗组和对照组各142例,治疗组和对照组在常规治疗的基础上分别给予排毒保肾丸和包醛氧淀粉胶囊治疗,疗程均为16周。观察两组患者血瘀证和湿浊证中医证候的变化,以及24 h尿蛋白定量（24 h UP）、血纤维蛋白原（Fg）、尿素氮（BUN）、肌酐（Scr）、估算肾小球滤过率（e GFR）的改变,判定疾病疗效,记录不良反应。结果：治疗组血瘀证和湿浊证主症、次症均得到改善（P〈0.05或P〈0.01）,中医证候总有效率分别为90.5%和58.9%（P〈0.01）;与治疗前比较,治疗组治疗后24 h UP减少、血Fg降低（P〈0.01）,血BUN、Scr降低（P〈0.01）,e GFR升高（P〈0.01）,对照组治疗后血BUN降低（P〈0.01）,Scr下降（P〈0.05）、e GFR升高（P〈0.05）;与对照组治疗后比较,治疗组治疗后24 h UP、Fg、Scr降低（P〈0.01）,e GFR升高（P〈0.01）,BUN差异无统计学意义（P〉0.05）;治疗组和对照组疾病总有效率分别为81.0%和69.0%（P〈0.01）。结论：排毒保肾丸能改善CKD3~4期中医辨证兼血瘀证和湿浊证患者中医证候,减少蛋白尿,降低血纤维蛋白原,降低血尿素氮和肌酐,改善肾功能。

Objective：To observe the effect of Paidu Baoshen Pill（modified Rhubarb Zhechong Pills）in the treatment of chronic kidney disease stage 3 and 4 patients whose syndrome differentiation were both with blood stasis and dampness syndrome. Methods：284 cases of chronic kidney disease stage 3 and 4 patients whose syndrome differentiation were both with blood stasis and dampness syndrome were ramdoly divided into treatment group 142 cases and control group 142 cases. On the basis of conventional therapy,the treatment group and control group were given Paidu Baoshen Pill and coated aldehyde oxystarch capsules respectively for 16 weeks. Then the changes of TCM blood stasis and dampness syndrome. Blood urea nitrogen,creatinine,estimated glomerular fil-tration rate,the 24 hours urinary protein quantitative,the fibrinogen and the adverse reactions were observed. Results：The primary and second symptoms of blood stasis and dampness in the treatment group were improved（P ﹤ 0. 05 or P ﹤ 0. 01）. The total efficiency of TCM syndromes were better in the treatment group than that of the control group（P ﹤ 0. 05）. Compare with the pretherapy stage, the 24 hUP reduced（P ﹤ 0. 01）,the Fg,BUN and Scr decreased（P ﹤ 0. 01）,the eGFR ascended（P ﹤ 0. 01）in the treatment group. The BUN decreased（P ﹤ 0. 01）,the Scr decreased（P ﹤ 0. 05）,the eGFR elevated in the control group（P ﹤ 0. 05）,when compared with the pretherapy. Compared with the posttreatment conroll group,the 24 uUP,Fb and Scr decreased,the eGFR in-creased,the BUN had no statistical significance（P ﹥ 0. 05）. The total effective rate of the treatment group and the control group were 81. 0% and 69. 0% respectively（P ﹤ 0. 01）. Conclusion：Paidu Baoshen Pill can improve the TCM syndrome of chronic kidney dis-ease stage 3 and 4 patients whose syndrome differentiation were both with blood stasis and dampness syndrome,decreased urine pro-tein,reduce the blood urea nitrogen and creatinine,reduced fibrinogen and improve renal function.