祛毒颗粒治疗慢性肾衰竭的多中心临床研究

摘要

目的 观察祛毒颗粒治疗慢性肾衰竭(CRF)的临床疗效.方法 采用前瞻性多中心临床研究方法,选择2008年3月至2011年8月山东省4所三级医院收治的CRF患者252例,按随机数字表法分为试验组和对照组;两组均给予一般对症治疗,试验组在西医综合治疗基础上给予祛毒颗粒,对照组给予尿毒清颗粒,均每次5 g,每日3次,连用3个月.观察两组治疗前后24 h尿蛋白、N-乙酰-β-氨基葡萄糖苷酶(NAG)、血红蛋白(Hb)、血浆白蛋白(Alb)、甲状旁腺激素(PTH)、纤维蛋白原(FIB)、血清肌酐(SCr)、尿素氮(BUN)、尿酸(UA)、β2-微球蛋白(β2-MG)、视黄醇结合蛋白(RBP)、内生肌酐清除率(CCr)及中医症状积分的变化,每个月观察记录1次.结果 剔除无效病例后,试验组122例,对照组121例.治疗后两组患者24 h尿蛋白、NAG、FIB、PTH、SCr、BUN、UA、β2-MG、RBP均较治疗前明显下降,Alb、Hb、CCr均较治疗前升高(P＜0.05或P<0.01);且试验组上述指标降低和升高程度较对照组明显[24 h尿蛋白(mg):1 810±920比2 370±1 120;NAG(U/L):20.68±5.38比24.46±6.94;FIB(g/L):4.01±0.98比4.96±1.07;PTH(ng/L):101.6±52.9比227.2±80.5;SCr(μmol/L):257.86±83.71比321.06±95.11;BUN(mmol/L):17.43±7.47比22.64±10.19;UA(±mol/L):424.74±46.67比458.64±63.53;β2-MG(μg/L):5 750±1 470比7 830±1 690;RBP(mg/L):54.5±6.8比74.4±10.2;Alb(g/L):36.37±5.96比32.67±6.53;CCr(ml/s):0.44±0.17比0.36±0.16,P＜0.05或P＜0.01].试验组中医症状积分(分)明显低于对照组(16.7±8.4比23.2±9.3,P<0.05),临床总有效率明显高于对照组(90.16%比66.94%,P＜0.01).结论 祛毒颗粒具有改善肾功能、减少尿蛋白、升高血浆Alb、纠正甲状旁腺功能亢进及凝血功能紊乱、改善临床症状等的作用.%Objective To observe the clinical effect of Qudu granules (祛毒颗粒)in treating patients with chronic renal failure(CRF). Methods A prospective multicenter method was adopted to study 252 cases of CRF chosen from the four first-class hospitals of the third level in Shandong Province from March 2008 to August 2011. According to digital table method, the patients were randomly divided into two groups. an experimental group and a control group. The patients in the two groups all took general symptomatic treatment, those in the experimental group were administered orally with Qudu granules on the basis of comprehensive treatment of western medicine, while those in the control group treated with uremic clearance granules (尿毒清颗粒), every time 5 g, 3 times a day in both groups. The total therapeutic course was 3 months for both groups. The changes of urinary protein in 24 hours, N-acetyl-β-glucosaminidase (NAG),hemoglobin (Hb), plasma albumin (Alb), parathyroid hormone (PTH), fibrinogen (FIB), serum creatinine (SCr), blood urea nitrogen (BUN), uric acid (UA), β2-microglobulin (β2-MG), retinol-binding protein (RBP), creatinine clearance rate (CCr), the accumulative scores of the syndrome of spleen and kidney deficiency, turbidity and blood stasis were observed before and after treatment in the two groups, and the therapeutic effects were compared. The observation records were registered once a month. Results The invalid cases were removed, 122 effective cases in the experimental group and 121 in the control group were observed. After the treatment, the levels of urinary protein in 24 hours, NAG, FIB, PTH, SCr, BUN, UA,β2-MG and RBP were significantly lower, while the levels of Alb, Hb, CCr were obviously higher than those before the treatment in the two groups (P＜0. 05 or P＜0. 01). The degrees of increase or decrease of these indicators in the experimental group were more significant than those in the control group [24-hour urine protein (mg): 1 810±920 vs. 2 370±1 120; NAG (U/L): 20.68±5.38 vs. 24.46±6.94; FIB (g/L):4.01±0.98vs. 4.96±1.07; PTH (ng/L): 101.6±52.9 vs. 227.2±80.5; SCr (μmol/L): 257.86±83.71 vs. 321.06±95.11; BUN (mmol/L): 17.43±7.47 vs. 22.64±10.19; UA (μmol/L): 424.74±46.67 vs.458. 64±63.53; β2-MG (μg/L): 5 750±1 470 vs. 7 830±1 690; RBP (mg/L): 54. 5±6. 8 vs. 74.4±10. 2;Alb (g/L): 36.37±5.96 vs. 32.67±6.53; CCr (ml/s): 0.44±0.17 vs. 0.36±0.16, P＜0.05 or P＜0. 01]. The accumulative score of traditional Chinese medicine (TCM) symptoms in the experimental group was obviously less than that in the control group (16.7±8.4 vs. 23.2±9.3, P＜0. 05), the total therapeutic effective rate of experimental group was more remarkable than that of the control group (90. 16％ vs.66.94％, P＜0. 01). Conclusion CRF can be effectively treated by Qudu granules. This medicine possesses the functions of improving renal function, correcting hyperparathyroidism and coagulative function disorder,improving clinical symptoms, etc.