Kakkar V V, Corrigan T P, Fossard D P, Sutherland I, Thirwell J
Lancet. 1977 Mar 12;1(8011):567-9.
The results of a multicentre trial, designed to assess the efficacy of low-dose heparin in preventing fatal postoperative pulmonary embolism, were published in July 1975. In view of inconsistencies which have now become apparent in the data from one of the twenty-eight centres which took part in the trial, the results of the trial have been re-examined, excluding the data from this centre. Of 4031 patients remaining after exclusion of these data, 2033 were in the control group and 1998 in the heparin group. 170 (4-2%) patients died during the postoperative period, 94 in the control group and 76 in the heparin group; 70-2% of deaths in the control group and 65-7% in the heparin group had necropsy examination. 15 patients in the control group and none in the heparin group were found at necropsy to have died due to acute massive fatal pulmonary embolism (P less than 0-001). Exclusion of data from the one centre did not alter already published significant differences in the total incidence of deep-vein thrombosis, nor in the frequency of operative and post-operative bleeding complications observed in the control group and the heparin group.
一项旨在评估小剂量肝素预防术后致命性肺栓塞疗效的多中心试验结果于1975年7月发表。鉴于参与该试验的28个中心之一的数据中现已明显出现的不一致情况,对该试验结果进行了重新审查,排除了该中心的数据。排除这些数据后剩下的4031例患者中,2033例在对照组,1998例在肝素组。170例(4.2%)患者在术后期间死亡,94例在对照组,76例在肝素组;对照组70.2%的死亡病例和肝素组65.7%的死亡病例进行了尸检。尸检发现对照组有15例患者死于急性大面积致命性肺栓塞,而肝素组无1例(P<0.001)。排除该中心的数据并未改变已发表的关于深静脉血栓形成总发生率以及对照组和肝素组观察到的手术和术后出血并发症发生率的显著差异。