To evaluate the efficacy of beraprost sodium in the treatment of diabetic peripheral artery disease.

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). Ankle-brachial index (ABI) and metabolic data were evaluated at 0 and 12 week. The t, χ² and rank test was used in the data analysis.

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%, χ²=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.

Beraprost can be used effectively and safely in the treatment of diabetic artery disease.

Diabetes mellitus, type 2; Peripheral vascular diseases; Beraprost sodium