益气养阴活血方对糖尿病肾病患者临床终点事件的影响(1)
摘要：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。
关键词：糖尿病肾病；益气养阴活血方；终点事件
DOI：10.3969/j.issn.1005-5304.2015.10.008
中图分类号：R259.872 文献标识码：A 文章编号：1005-5304(2015)10-0025-03
Abstract：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.
Key words：diabetic nephropathy；Yiqi Yangyin Huoxue Formula；endpoint
糖尿病肾病(diabetic nephropathy，DN)是糖尿病最常见的慢性微血管并发症之一，也是糖尿病患者的主要死亡原因之一。DN一旦发生，若蛋白尿控制不良，进展至终末期肾病(end-stage renal disease， ESRD)的速度大约是其他肾小球疾病的14倍，已逐渐成为ESRD的首位致病原因[1]。目前对DN的西医治疗以降糖、降压、调脂、降蛋白尿等对症治疗为主，但收效并不显著。以往研究表明，益气养阴活血方能有效减少DN患者尿蛋白排泄率、保护肾功能、延缓病情进展[2]，但缺乏长期随访，缺少长疗程远期临床疗效的流行病学证据。本研究基于前期随机对照试验[2]的分组及干预方案，继续对患者进行管理和随访，对以益气养阴活血方为主的中西医综合方案干预DN患者远期终点事件进行评价。
1 资料与方法
1.1 病例来源
2008年参与我科DN临床随机对照试验研究的DN患者95例，试验结束后长期于我科门诊及病房治疗及随访。
1.2 西医诊断标准
①糖尿病诊断依据1999年WHO颁布的糖尿病诊断标准[3]，临床症状加随机静脉血浆血糖≥11.0 mmol/L，或空腹静脉血浆血糖≥7.0 mmol/L。无症状者需2次血糖值达到诊断标准才能确诊。②DN诊断依据Mogensen分期[4]，符合Ⅲ、Ⅳ期诊断标准。 (李同侠等)
关键词：糖尿病肾病；益气养阴活血方；终点事件
DOI：10.3969/j.issn.1005-5304.2015.10.008
中图分类号：R259.872 文献标识码：A 文章编号：1005-5304(2015)10-0025-03
Abstract：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.
Key words：diabetic nephropathy；Yiqi Yangyin Huoxue Formula；endpoint
糖尿病肾病(diabetic nephropathy，DN)是糖尿病最常见的慢性微血管并发症之一，也是糖尿病患者的主要死亡原因之一。DN一旦发生，若蛋白尿控制不良，进展至终末期肾病(end-stage renal disease， ESRD)的速度大约是其他肾小球疾病的14倍，已逐渐成为ESRD的首位致病原因[1]。目前对DN的西医治疗以降糖、降压、调脂、降蛋白尿等对症治疗为主，但收效并不显著。以往研究表明，益气养阴活血方能有效减少DN患者尿蛋白排泄率、保护肾功能、延缓病情进展[2]，但缺乏长期随访，缺少长疗程远期临床疗效的流行病学证据。本研究基于前期随机对照试验[2]的分组及干预方案，继续对患者进行管理和随访，对以益气养阴活血方为主的中西医综合方案干预DN患者远期终点事件进行评价。
1 资料与方法
1.1 病例来源
2008年参与我科DN临床随机对照试验研究的DN患者95例，试验结束后长期于我科门诊及病房治疗及随访。
1.2 西医诊断标准
①糖尿病诊断依据1999年WHO颁布的糖尿病诊断标准[3]，临床症状加随机静脉血浆血糖≥11.0 mmol/L，或空腹静脉血浆血糖≥7.0 mmol/L。无症状者需2次血糖值达到诊断标准才能确诊。②DN诊断依据Mogensen分期[4]，符合Ⅲ、Ⅳ期诊断标准。 (李同侠等)