速碧林联合爱脉朗对下肢静脉曲张患者术后疗效和安全性的临床研究

Clinical study on efficacy and safety of nadroparin and alvenor used during postoperative period of varicose veins of lower limb

目的观察速碧林(低分子肝素钙)联合应用爱脉朗(地奥司明)减轻下肢静脉曲张患者术后症状,预防深静脉血栓的疗效和安全性。方法对入选的90例下肢静脉曲张患者采用单中心、随机、开放、对照的方法进行采集和统计分析。入选患者随机分为试验组(即速碧林联合爱脉朗组30例)和对照组(速碧林组和爱脉朗组,即对照Ⅰ组和对照Ⅱ组各30例)。观察术后肿胀、腿部沉重感及疼痛等各项症状,并行双下肢彩色多普勒超声检查评估下肢深静脉血栓(DVT)形成情况。安全性方面,观察患者术前和术后凝血酶原时间(PT)、血小板计数(PLT)及纤维蛋白原(Fib)等反映凝血功能变化指标及临床表现,比较组间、组内的差异。结果术后1周试验组患者腿部肿胀、沉重感及疼痛等症状均较治疗前明显好转(P<0.05);对照Ⅰ组症状与治疗前比较差异无统计学意义(P>0.05)。术后2周对照Ⅰ组、试验组患者无DVT等并发症,对照Ⅱ组则有5例出现肌间静脉血栓形成(P<0.05)。安全性方面,术前试验组和对照组患者PT、PLT及Fib的平均值均在正常值范围内,3组比较差异无统计学意义(P>0.05)。术后对照Ⅱ组患者PT延长,Fib升高,PLT术后第3天降低而术后第7天升高,与术前比较差异有统计学意义(P<0.05)。试验组患者PLT术后第3天降低,与术前比较差异有统计学意义(P<0.05)。术后对照Ⅱ组患者PT较试验组延长,Fib升高,差异有统计学意义(P<0.05)。对照Ⅰ组患者中出现血小板持续降低2例而被剔除。3组在治疗期间和术后均无严重出血,3组比较差异无统计学意义(P>0.05)。结论预防性使用速碧林及爱脉朗对改善下肢静脉曲张术后患者的临床症状和体征、减少深静脉栓塞有效且安全。

Objective To explore the efficacy and safety of combined use of nadroparin （low molecular weight heparin） and alvenor（diosmin） for alleviating the postoperative symptoms and preventing deep vein thrombosis （DVT） in the patients with varicose veins of lower limb. Methods A total of 90 patients with varicose veins of lowerlimb were enrolled and performed the statistical anlysis by the monocenter, randomized, open, control method. The selected patients were randomly allocated to three groups ：nadroparin group （group Ⅰ ）,alvenor group （group Ⅱ ） and nodroparin combine alvenorgroup （group Ⅲ ）. The symptoms such as swelling, heaviness and pain were observed. The occurrence of DVT was observed under color Doppler of lower limbs. Preoperative and postoperative changes in prothrombin time （PT）, platelet count （PLT） and fibrinogen （Fib） and clinical perfor- mances were observed and compared in intra-and inter-groups. Results In the efficacy respect,swelling,heaviness and pain were statistically improved at the first week after the operation in the group m （P〈0.01）. No DVT occurred at the second week after operation in the group Ⅰ and Ⅲ. In the group Ⅱ ,5 cases suffered venous thrombosis（P〈0.05）. In terms of safety, there was no significant difference in the average of preoperative PT, PLT and Fib among three groups （P〉0.05）. In the group II , PT was pro- longed and Fib was increased. PLT was reduced on 3 d ,but increased on 7 d after operation,with statistical difference in the comparison between pre-and post-operation （P〈0.05）. PLT was reduced on postoperative 3 d in the group Ⅲ as compared with those before operation（P〈0.05）. PT in the group 11 was longer than that in the group ,and Fib was increased,with statistical difference between two groups （P〈0.05）. There was no statistical difference in terms of intraoperative and postoperative bleeding among the three groups （P〈0.05）. Conclusion The preventive use of nadroparin and alvenor is effective and safe to improve the clinical symptoms and signs, and reduce DVT for the postoperative patients with varicose veins of lowerlimb.