益气养阴活血方对糖尿病肾病患者临床终点事件的影响

Effects of Yiqi Yangyin Huoxue Formula on Clinical Endpoints of Diabetic Nephropathy Patients

目的评价益气养阴活血方对糖尿病肾病(DN)患者临床终点事件的影响。方法回顾性采集并筛选2008年纳入观察周期6个月的DN临床随机对照研究的95例患者基线数据。试验组47例,长期采用益气养阴活血方为主的中西医综合干预方案进行治疗;对照组48例,长期采用单纯西医综合干预方案进行治疗。分别于2011、2012、2013、2014年进行4次随访,比较2组患者肾功能进展/死亡等终点事件的远期发生率。结果试验组死亡5例,其中1例为肾功能衰竭引起死亡;对照组死亡8例,其中5例因肾功能衰竭引发多脏器衰竭死亡。试验组进入终末期肾脏病、肾功能进展等终点事件的发生率明显低于对照组(P<0.05)。结论以益气养阴活血方为主的中西医综合干预方案具有良好的保护肾功能作用,可以延缓DN患者进入终末期肾脏病的进程,改善DN的预后,疗效优于单纯西医综合干预方案。

Objective To evaluate the effects of Yiqi Yangyin Huoxue Formula on clinical endpoints of diabetic nephropathy patients. Methods Totally 95 patients who were involved into the six-month DN clinical RCT for observation in 2008 were retrospectively collected and screened. There are 47 cases in the trial group, who were chronically treated by integrated traditional Chinese and Western medicine therapy which mainly adopting Yiqi Yangyin Huoxue Formula. There were 48 cases in the control group, who were chronically treated with Western medicine. Follow-up visits were conducted in 2011, 2012, 2013, and 2014 respectively. Long-term incidence rate of renal function progress/deaths were compared in the two groups. Results Five cases died in the trial group, among which one case died of renal failure. Eight cases died in the control group, among which five died of renal failure and multiple organ failure. The incidence of endpoints entering end-stage renal disease and renal function progress was much lower than that of control group. Conclusion Integrated traditional Chinese and Western medicine therapy dominated by Yiqi Yangyin Huoxue Formula has good clinical efficacy of kidney protection, and can slow the progress of DN patients entering end-stage renal disease, and better than single Western medicine intervention.