Rizzi A, Radaelli F, Pisano M, Orro S, Nazzari M, Ratti G, Giobbe R, Maggi G
Minerva Med. 1987 Jun 15;78(11):745-50.
The effectiveness and tolerability of defibrotide in the prevention of post-surgery deep vein thrombosis (DVT) were compared with those of heparin in a multicentric randomized controlled study. One hundred-eight-four both sexes patients submitted to thoracic surgery were randomly allocated to defibrotide (400 mg b.i.d. by IV route, n = 94) or to calcium heparin (5000 I.U. t.i.d. s.c., n = 90); both treatments were started the day before the operation and withdrawn when patients were allowed to stand up (i.e., after 7 days). No patients developed DVT in the defibrotide group, while a single case of DVT was detected in the heparin group; furthermore, a more prominent bleeding was observed in the latter, in the early post-operative period (normal bleeding: 2nd day: defibrotide 70/92 pts, heparin 53/90 pts, p less than 0.02; 3rd day: defibrotide 87/92 pts, heparin 76/90 pts, p less than 0.05, chi 2 test), while the healing rate of surgical wounds was similar in the two groups. No relevant modifications in laboratory parameters were seen throughout the observation period. Thus, these preliminary data suggest that defibrotide is at least as effective as heparin in the prevention of post-thoracic surgery DVT and that the former drug has a possibly better tolerability profile, due to a lesser tendency to bleeding.
在一项多中心随机对照研究中，比较了去纤苷预防术后深静脉血栓形成（DVT）的有效性和耐受性与肝素的有效性和耐受性。184例接受胸外科手术的患者被随机分配至去纤苷组（静脉途径，400mg，每日两次，n = 94）或肝素钙组（皮下注射，5000IU，每日三次，n = 90）；两种治疗均在手术前一天开始，当患者可以站立时停药（即7天后）。去纤苷组无患者发生DVT，而肝素组检测到1例DVT；此外，在术后早期，肝素组观察到更明显的出血（正常出血：第2天：去纤苷组92例中的70例，肝素组90例中的53例，p＜0.02；第3天：去纤苷组92例中的87例，肝素组90例中的76例，p＜0.05，卡方检验），而两组手术伤口愈合率相似。在整个观察期内，实验室参数未见相关改变。因此，这些初步数据表明，去纤苷在预防胸外科手术后DVT方面至少与肝素一样有效，并且由于出血倾向较小，前一种药物可能具有更好的耐受性。
