One hundred and twenty three APC patients were randomised to receive either gemcitabine 1000 mg/m2 or the same with weight-adjusted dalteparin (WAD) for 12 weeks. Primary end-point was the reduction of all-type VTE during the study period. , ISRCTN: 76464767.
The incidence of all-type VTE during the WAD treatment period (<100 days from randomisation) was reduced from 23%to 3.4%(p = 0.002), with a risk ratio (RR)of 0.145, 95%confidence interval (CI) (0.035-0.612) and an 85%risk reduction. All-type VTE throughout the whole follow-up period was reduced from 28%to 12%(p = 0.039), RR = 0.419, 95%CI (0.187-0.935) and a 58%risk reduction. Lethal VTE <100 days was seen only in the control arm, 8.3%compared to 0%(p = 0.057), RR = 0.092, 95%CI (0.005-1.635).
Weight adjusted dalteparin used as primary prophylaxis for 12 weeks is safe and produces a highly significant reduction of all-type VTE during the prophylaxis period. The benefit is maintained after dalteparin withdrawal although decreases with time.
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