那屈肝素钙治疗糖尿病下肢动脉疾病FontaineⅡ期患者疗效

Efficacy of nadroparin calcium in diabetic patients with lower extremity atherosclerotic disease(Fontaine stage Ⅱ)

目的:探讨那屈肝素钙短期皮下注射对2型糖尿病合并下肢动脉疾病FontaineⅡ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118例2型糖尿病合并下肢动脉疾病Fon-taineⅡ期患者随机分配至治疗组和对照组,分别接受基础治疗+那屈肝素钙(4 000 IU,q12h,n=59)或基础治疗+安慰剂(0.9%氯化钠注射液0.4 mL,q12h,n=59)治疗10 d。结果:治疗组踝肱指数(ABI)、趾肱指数(TBI)、足背动脉平均血流速度的改善显著优于对照组(P<0.05)。两组的最大行走距离(MWD)和无痛行走距离(PFWD)较治疗前有所增加,但差异无统计学意义;两组间改善程度比较差异也无统计学意义。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,但治疗组血清谷丙转氨酶(ALT)较对照组显著升高(P<0.01)。结论:那屈肝素钙短期皮下注射可以提高2型糖尿病合并下肢动脉疾病FontaineⅡ期患者的ABI、TBI、足背动脉平均血流速度,减轻下肢缺血程度,但未能显著改善患者的跛行症状。其短期应用存在一定比例的不良反应,如肝酶升高。在年龄≥70岁,合并肝肾功能不全的患者中应监测其肝酶的变化。

Objective： To evaluate the short-term efficiency and safety of nadroparin calcium in treating chronic lower limb ischemia in diabetic patients with lower extremity atherosclerotic disease（Fontaine stage II）.Methods： A total of 118 patients were randomized to treatment with subcutanenous injection of nadroparin（n=59）,4000 units twice daily for 10 days plus basic treatment（aggressive risk factor modification,antiplatelet therapy）,or basic treatment alone（n=59,control）.Results： ABI,TBI and mean flow velocity of dorsal artery were significantly improved after treatment with nadroparin as compared to control group（P0.05）.No significant difference was observed between 2 groups in mean flow velocity of posterior tibial artery,maximum walking distance or pain-free walking distance at the end of the treatment（P0.05）.The incidence of adverse events was not significantly different in 2 groups,but ALT was significantly increased in nadroparin group（P0.01）.Conclusion： Nadroparin calcium short-term treatment may improve hemodynamic parameters and lower limb ischemia in diabetic patients with lower extremity atherosclerotic disease（Fontaine stage II）,but does not significantly improve clinical symptoms.Short-term nadroparin calcium has side effects,such as elevated liver enzymes,so it is necessary to monitor liver enzyme changes in elder patients who are more than 70-years-old with dysfunction of liver or kidney.