基于一项“多中心、随机对照、双盲”的临床研究探讨影响肾功能进展的因素

Factors Affecting the Progression of Renal Function: A Multicenter, Randomized,Controlled, Double-blind Clinical Study

目的基于一项前瞻性、多中心、随机、安慰剂对照、双盲的临床试验结果,探索影响肾功能进展的因素。方法选择343例慢性肾脏病3期的患者,将入组的患者随机分为治疗组和对照组,治疗组给予中药颗粒剂口服,对照组给予安慰剂口服。两组患者均给予基础治疗,疗程24周。评估两组患者肾功能变化情况。治疗结束后,根据患者肾功能情况,以CKD3期为界限,将病情好转者定为A组,该组患者血肌酐下降至CKD2期或CKD1期;病情恶化者为B组,该组患者血肌酐上升至CKD4期或CKD5期;病情稳定者为C组,该组患者血肌酐稳定,仍处于CKD3期,分析各组患者指标的差异。结果经过24周观察,比较两组患者的血肌酐(Scr)水平,治疗组130.78±32.55μmol· L^(-1),对照组149.12±41.27μmol· L^(-1),两组比较,差异有统计学意义(P<0.05)。eGFR水平比较,治疗组55.74±50.82 mL/min/1.73 m^(-2),对照组44.46±12.60 mL/min/1.73 m^(-2),差异有统计学意义(P<0.05)。研究结束后,A组患者血尿酸水平明显低于B组和C组的患者,A组患者血红蛋白水平明显高于B组和C组的患者,A组患者的血磷水平明显低于B组和C组的患者。结论中药颗粒剂在24周内可以明显改善肾功能,患者的血尿酸水平、血红蛋白及血磷水平对肾功能有一定的影响。

Objective To explore the factors influencing the progression of renal function based on the results of a prospective,multi-center,randomized,placebo-controlled,double-blind clinical study.Methods 343 patients with stage 3 chronic kidney disease(CKD)from 9 hospitals in Jiangsu province were randomly divided into the treatment group and the control group.Patients in the treatment group were given traditional Chinese medicine(TCM)granules twice a day,and the control group was given placebo granules of the same specification.The treatment group and the control group received the same basic treatment according to the standard requirements,and the observation lasted for24 weeks.The changes of renal function in the 2 groups were evaluated.At the end of treatment,according to the renal function of the patients,the patients were divided into group A,whose serum creatinine decreased to CKD2 or CKD1;the patients with worsening condition were in group B,whose serum creatinine increased to CKD4 or CKD5;the patients with stable condition were in group C,whose serum creatinine was stable and still in ckd3 stage.The differences of indicators in each group were analyzed.Results After 24 weeks of observation,the level of serum creatinine(sCR)in the treatment group was lower than that in the control group(130.78±32.55μmol·L^(-1),versus 149.12±41.27μmol·L^(-1)).eGFR treatment group was higher than the control group,the difference was statistically significant(55.74±50.82 mL/min/1.73 m^(2),versus 44.46±12.60 mL/min/1.73 m^(2)).After treatment,the serum uric acid level of group A was significantly lower than that of group B and group C,the hemoglobin level of group A was significantly higher than that of group B and group C,and the blood phosphorus level of group A was significantly lower than that of group B and group C.Conclusion TCM granules can significantly improve renal function within 24 weeks.Serum uric acid level,hemoglobin and blood phosphorus level have certain effects on renal function.