微粒化纯化黄酮制剂治疗下肢静脉性溃疡的临床研究

Clinical Study on Micronised Purified Flavonoid Fraction to Treat Ulcer of Chronic Venous Insufficiency

目的评价微粒化纯化的黄酮制剂(爱脉朗)治疗下肢静脉性溃疡的疗效。方法2003年5月-2003年11月,48例下肢静脉功能不全溃疡患者随机分为治疗组和对照组,观察腿部沉重感、夜间腿部痉挛及疼痛等各项症状,并测定溃疡最大径。结果6周和12周,治疗组腿部沉重感、夜间腿部痉挛及疼痛评分较治疗前明显降低(P<0.05);对照组症状与入组前无统计学差异(P>0.05)。治疗组6周后溃疡最大径平均缩小(0.53±0.94)cm,12周时缩小(1.02±0.96)cm,较治疗前明显减小(P<0.05),其中3例观察期内溃疡愈合;对照组则无明显变化(P>0.05)。结论微粒化黄酮制剂是治疗慢性下肢静脉功能不全肢体溃疡的安全、有效的药物。

Objective To evaluate the efficacy of micronised purified flavonoid fraction ( alvenor) to treat the ulcer of chronic venous insufficiency (CVI). Methods From May to November 2003, 48 patients with chronic venous insufficiency ulcer were randomized into therapy group and control group. The symptoms such as the limb heaviness, night cramp and pain, as well as the maximum diameter of ulcer were observed during 12 weeks. Results The symptoms of heaviness, night cramp and pain were significantly relieved at the 6th and 12th week after drug treatment (P<0.05). In therapy group, the decrease of ulcer diameter was (0.53±0.94) cm and (1.02±0.96) cm, respectively, at the 6th and 12th week (P <0.05) , and among them 3 ulcers were cured in 12 weeks. However, the control group didn't have any marked change after 6 and 12 weeks. Conclusion Micronised purified flavonoid fraction is a safe and effective drug in the treatment of CVI ulcer.