Ferrari P A, Cornelli U, Dina F, Gerosa C, Nazzari M, Ratti G
Ricerca Clinica, CRINOS S.p.A., Villa Guardia, Como.
Minerva Med. 1988 Jul;79(7):551-61.
In an open multicenter comparative study aimed at the evaluation of the efficacy of defibrotide in the prophylaxis of postsurgical deep vein thromboses (DVT) an ad interim evaluation has been made on 2626 patients thus far enrolled. 1323 had received defibrotide (200 mg q.i.d. by IV route from day -1 to day +7th postoperative), 941 calcium heparin (5000 IU b.i.d. or t.i.d. by SC route from day 0 to day +7 postoperative) and 362 other treatments (antiaggregating agents, placebo or no therapy). This group has not been included in the final evaluation, due to its limited size. The diagnosis of DVT or pulmonary embolism (PE) was made according to clinical routinary criteria. The incidence of DTV has been 15/1323 (1.13%) in the defibrotide group and 21/941 (2.23%) in the heparin group (chi-square, p = 0.056) while the cases of suspected or ascertained PE have been respectively 3/1323 (0.22%) and 10/941 (1.06%) (p = 0.02). The incidence of adverse effects with defibrotide was less than 1%; occasional cases of increased serum transaminase levels were seen with heparin. These preliminary results supports the effectiveness of defibrotide in the prevention of post-surgery DVT, its effects being similar or more prominent than those of calcium heparin, currently regarded as the standard medication.
在一项旨在评估去纤苷预防术后深静脉血栓形成（DVT）疗效的开放性多中心对照研究中，对目前已入组的2626例患者进行了期中评估。1323例患者接受了去纤苷治疗（从术后第-1天至第+7天，静脉注射，每日4次，每次200mg），941例接受了钙肝素治疗（从术后第0天至第+7天，皮下注射，每日2次或3次，每次5000IU），362例接受了其他治疗（抗聚集剂、安慰剂或未治疗）。由于该组规模有限，未纳入最终评估。DVT或肺栓塞（PE）的诊断依据临床常规标准。去纤苷组DVT的发生率为15/1323（1.13%），肝素组为21/941（2.23%）（卡方检验，p = 0.056），而疑似或确诊PE的病例分别为3/1323（0.22%）和10/941（1.06%）（p = 0.02）。去纤苷的不良反应发生率低于1%；肝素治疗时偶见血清转氨酶水平升高的病例。这些初步结果支持去纤苷在预防术后DVT方面的有效性，其效果与目前被视为标准药物的钙肝素相似或更显著。
