贝前列素钠治疗2型糖尿病下肢动脉病变的随机对照研究

目的 比较贝前列素钠和阿司匹林治疗糖尿病合并下肢动脉病变的疗效及安全性.方法 采用随机、对照研究方法将2009年11月至2010年8月30例糖尿病合并下肢动脉病变的患者按照2：1随机分为贝前列素钠组（A组,40μg每日3次,n=20）及阿司匹林组（B组,100 mg每日1次,n=10）,服药12周.随机分组后分别在0、12周及24周进行无痛行走距离、最大行走距离的测定;0、12周测量踝肱指数（ABI）及血常规、肝肾功能、血脂及心电图.整个研究过程中对不良反应进行了评价.组间比较采用t检验、X2检验或秩和检验.结果 2组在年龄、性别、糖尿病慢性并发症无明显差异.A组疼痛、麻木及冷感症状的改善显著优于B组（X2=5.96,P＜0.05）;与基线（0周）时（276、1000 m）比较,A组在12周及24周无痛行走距离中位数分别为350 m（Z=-2.94,P＜0.05）和315 m（Z=-2.88,P＜0.05）,最大行走距离分别为1713 m（Z=-3.73,P＜0.05）和1600 m（Z=-3.58,P＜0.05）,均显著增加;B组在12周时无痛及最大行走距离分别为400 m（Z=-2.13,P＜0.05）及1075 m（Z=-2.54,P＜0.05）,较0周时显著增加,但24周时无痛及最大行走距离分别为390 m（Z=-0.81,P＞0.05）和1025 m（Z=-0.21,P＞0.05）,较0周无显著变化.两组间行走距离比较在0、12、24周均无显著差异,但12周时A组和B组无痛行走距离增加值的中位数分别为125、30 m（Z=-2.87,P＜0.05）,24周时分别为82.5、0 m（Z=-3.31,P＜0.05）,差异均有统计学意义;12周时A组和B组最大行走距离增加值的中位数分别为500、50 m（Z=-3.20,P＜0.05）,24周时分别为300、10 m（Z=-3.02,P＜0.05）,差异均有统计学意义.两组肝功能、肾功能、血常规、ABI在治疗前后无明显差异.结论口服前列腺素钠可安全有效地用于糖尿病合并下肢动脉病变的治疗.

Effects of beraprost sodium in the treatment of diabetic peripheral artery disease

Objective To evaluate the efficacy of beraprost sodium in the treatment of diabetic peripheral artery disease.Methods Thirty diabetic patients with peripheral artery disease treated from November 2009 to August 2010 were randomized into two groups in the ratio of 2 to 1:the group A treated with beraprost sodium(40 μg tid, n =20) and the group B with aspirin ( 100 mg qd, n = 10)for 12 weeks.The pain-free walking distance (PFWD), maximum walking distance (MWD) were measured at 0 week (before treatment), 12 week (after treatment) and 24 week (12 weeks follow-up after treatment).Anklebrachial index (ABI) and metabolic data were evaluated at0 and 12 week.The t, X2 and rank test was used in the data analysis.Results No differences in age, gender and diabetic complications was found between two groups.Ischemic symptoms were significantly improved in group A than in group B (90.0% vs 50.0%,X2 =5.96, P ＜0.05 ).Compared with those at baseline(276 and 1000 meters), the PFWD was 350 meters ( Z = -2.94,P ＜0.05), 315 meters (Z = -2.88 ,P ＜ 0.05)and MWD was 1713 meters(Z = -3.73 ,P ＜0.05), 1600 meters (Z = -3.58, P ＜ 0.05 )at 12 weeks and 24 weeks respectively in group A; and it was 400 meters(Z = -2.13 ,P ＜0.05), 390 meters (Z = -0.81 ,P ＞0.05) and 1075 meters(Z = -2.54,P ＜ 0.05 ), 1025 meters ( Z = - 0.21, P ＞ 0.05 ) at 12 weeks, 24 weeks respectively in group B.No significant differences in the PFWD was found at baseline, 12 weeks and 24 weeks between two groups.But the absolute increased PFWD was 125 meters for group A and 30 meters for group B at 12 weeks(Z = -2.87,P ＜0.05); 82.5 and 0 meters at 24 weeks in group A and group B(Z = -3.31, P ＜0.05).The absolute increased MWD was 500, 50 meters ( Z = - 3.20, P ＜0.05 ) and 300, 10 meters ( Z = - 3.02, P ＜ 0.05 )at 24 weeks in the group A and B, respectively.No significant side reaction of the beraprost treatment in these two groups.Conclusion Beraprost can be used effectively and safely in the treatment of diabetic artery disease.