祛毒颗粒干预慢性肾功能衰竭病程的临床观察

目的 观察祛毒颗粒对慢性肾功能衰竭(chronic renal failure，CRF)病程进展的干预作用，并探讨其机制。方法 166例慢性肾脏病(chronic kidney disease，CKD)3、4期脾肾两虚、浊瘀阻滞证患者随机分为试验组(83例，完成77例)和对照组(83例，完成75例)。在一般治疗基础上，试验组口服祛毒颗粒，对照组口服尿毒清颗粒，均每次5 g，每天3次，治疗时间为12个月以上。观察两组患者血清肌酐(serum creatinine，SCr)的变化，以血肌酐倒数(1/SCr)为纵坐标，以治疗时间为横坐标，做直线回归分析，比较各组斜率和回归系数(b)。同时观察两组患者血压、24 h尿蛋白定量、血浆白蛋白(Alb)和血红蛋白(hemoglobin，Hb)。结果 试验组平均治疗时间［(42.8±18.5)个月］较对照组［(34.2±12.7)个月］长，差异有统计学意义(P<0.01)。治疗第48个月试验组未达到观察终点比率(35/77，45.45%)大于对照组(24/75，32.00%)，差异有统计学意义(P<0.01)。试验组回归直线b值为－0.00258±0.00132，对照组b值为－0.00386±0.00167，试验组斜率绝对值明显小于对照组(P<0.01)。试验组治疗第48个月血压明显低于对照组，治疗第12、24、36、48个月24 h尿蛋白定量均明显低于对照组同期，血浆Alb均明显高于对照组同期，差异有统计学意义(P<0.05)。两组各时间点Hb比较，差异均无统计学意义(P>0.05)。结论 祛毒颗粒能延缓CRF病程进展，其机制可能与降低血压、减少尿蛋白排泄、升高血浆Alb等因素有关。

Clinical Observation on the Disease Course of Chronic Renal Failure Intervened by Qudu Granule

Objective To observe the disease course of chronic renal failure (CRF) intervened by Qudu Granule (QG) and to explore its possible mechanism. Methods Totally 166 phase 3 and 4 chronic kidney disease (CKD) patients of Pi-Shen deficiency and phlegm-turbidity obstruction syndrome were randomly assigned to two groups, the experimental group (83 cases, completed in 77 cases) and the control group (83 cases, completed in 75 cases). Based on the routine treatment, patients in the experimental group orally took QG, while those in the control group orally took Niaoduqing Granule (NG), 5 g each time, 3 times a day in both groups. The total therapeutic course was over 12 months for all. The changes of serum creatinine (SCr) were observed in the two groups. The reciprocal of SCr was taken as the vertical coordinate, and the course of disease (months) as the horizontal coordinate. The oblique rate and the return coefficient (value b) were compared between the two groups. Meanwhile, the changes of blood pressure, 24-h urinary protein quantitative amount, plasma albumin (Alb), and hemoglobin (Hb) were also observed. Results The average treatment time was longer in the experimental group [(42.8±18.5) months] than in the control group [(34.2±12.7) months, P<0.01]. In the experimental group 35 patients didn′t reach the endpoint at the 48th month, accounting for 45.45%, while 24 patients didn′t reach the endpoint in the control group, accounting for 32.00%, showing statistical difference (P<0.01). The b value was-0.00258±0.00132 in the experimental group and -0.00386±0.00167 in the control group. The absolute value of the slope rate was obviously smaller in the experimental group than in the control group (P<0.01). The 48-month blood pressure was obviously lower in the experimental group than in the control group. The 24-h urinary protein at the 12th, 24th, 36th, and 48th month were obviously lower in the experimental group than in the control group at the same time point (P<0.05). The plasma Alb was obviously higher in the experimental group than in the control group at the same time point with statistical difference (P<0.05). There was no statistical difference in the Hb level between the two groups at each time point (P>0.05). Conclusions The course of CRF could be postponed by QG. Its mechanisms might possibly be correlated with lowering blood pressure, reducing the excretion of urinary protein, and increasing plasma Alb.