达肝素钠治疗糖尿病下肢动脉疾病Fontaine Ⅲ期患者的临床研究

The Use of Daltparin Sodium in Diabetic Patients with Lower Extremity Atherosclerotic Disease(Fontaine Stage Ⅲ)

目的探讨达肝素钠短期皮下注射对2型糖尿病下肢动脉疾病FontaineⅢ期患者下肢动脉血流动力学及临床症状的影响,并评价其安全性。方法将78例2型糖尿病下肢动脉疾病FontaineⅢ期患者随机分配至治疗组和对照组,分别接受基础治疗+达肝素钠(5000 U q12h,n=39)或基础治疗+安慰剂(0.9%氯化钠注射液0.4 mL q12h,n=39)治疗14 d。结果治疗组对ABI、TBI、足背动脉及胫后动脉平均血流速度的改善显著优于对照组,两者差异有统计学意义。治疗组对下肢疼痛症状的改善显著优于对照组,两者差异有统计学意义。治疗组对跛行症状的改善优于对照组,但两者差异无统计学意义。在本研究中,两组总体不良事件的发生率,差异无统计学意义,尤其是出血事件的发生率相似。结论达肝素钠短期皮下注射可以改善2型糖尿病下肢动脉疾病FontaineⅢ期患者的下肢动脉血流动力学,减轻下肢缺血程度;改善患者缺血肢体的疼痛程度,但未能增加患者的跛行距离。其短期应用安全性较好。

OBJECTIVE To evaluate the short-term efficacy and safety of Daltparin sodium on treating of chronic lower limb ischemia in diabetic patients with peripheral arterial occlusive disease （ Fontaine stage Ⅲ ）. METHODS A total of 78 patients were randomized to treatment with subcutanenous injection of 5 000 U Dahparin （n = 39） twice daily for 14 d plus basic treatment（ aggressive risk factor modification,antiplatelet therapy） or only basic treatment （n = 39）. RESULTS There were significant difference in the ABI, TBI and mean flow velocity of dotal artery and posterior tibial artery between the therapeutic group and the control group after treatment （ P 〈 0. 05 ）. There were significant difference in the SF-MPQ score between the two groups after treatment （ P 〈 0. 05 ）. No significant difference was observed between the two groups for the maximum walking distance （MWD） at the end of the treatment （P 〉 0.05）. No significant difference was observed between the two groups for the incidence of adverse events. But, there was significant difference in ALT A-value between the two groups （P 〈 0.01 ）. CONCLUSION Daltparin sodium short-term treatment can improve hemodynamic parameters, release lower limb ischemia and symptoms in diabetic patients with peripheral arterial occlusive disease（ Fontaine stage Ul ）. But, can not improve claudication symptoms in the patients. Dahparin sodium short-term treatment is safe and reliable.