Division of Cancer Medicine Centre for Biostatistics & Clinical Trials, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia.
Br J Haematol. 2011 Sep;154(5):626-34. doi: 10.1111/j.1365-2141.2011.08787.x. Epub 2011 Jul 14.
Peri-procedural management of warfarin reflects an intricate balance between the restoration of haemostasis and appropriate thromboprophylaxis. This prospective single-arm study assessed the safety and efficacy of a convenient schedule, incorporating low-dose intravenous vitamin K (vitK(IV) ) for short-term warfarin reversal prior to elective surgery, as well as vitK-dependent factor levels (vitK-Factors) and International Normalized Ratio (INR) pre- and post-vitK(IV) . One seventy eight patients on long-term warfarin received 3mg vitK(IV) 12-18 h pre-procedure with no adverse reactions. 167/178 (94%) achieved an INR≤1·5 post-vitK(IV) on the day of surgery, while all achieved INR≤1·7. Four patients had procedure-associated major bleeding, but importantly had achieved a pre-procedure INR<1·5 and vitK-Factors >0·30iu/ml. No patient suffered a symptomatic thromboembolism during the 6-week follow-up. Median days to re-establish a therapeutic INR were 4 (range 2-11). VitK(IV) near normalized all vitK-Factors, with a uniform pattern of depletion and repletion in association with an increase and decrease in INR, respectively; and from the data, INR<1·5 correlated with vitK-Factors >0·30iu/ml. Low-dose vitK(IV) for short-term warfarin reversal was reliable and safe, and successfully lowered the INR to an acceptable level for planned surgery, with no excess of bleeding, thromboembolism, delayed discharge, or resistance to warfarin. The protocol was simple and convenient for both the patients and the healthcare institution.
华法林围手术期管理反映了止血和适当的血栓预防之间的复杂平衡。这项前瞻性单臂研究评估了在择期手术前,使用方便的方案,即短期静脉内给予低剂量维生素 K(vitK(IV))逆转华法林,以及术前和术后检测维生素 K 依赖性因子水平(vitK-Factors)和国际标准化比值(INR)的安全性和有效性。178 例长期服用华法林的患者在术前 12-18 小时给予 3mg vitK(IV),无不良反应。167/178(94%)患者在手术当天的 INR 低于 1.5,而所有患者的 INR 均低于 1.7。4 例患者发生与手术相关的大出血,但重要的是术前 INR 低于 1.5 且 vitK-Factors >0.30iu/ml。在 6 周的随访期间,没有患者发生有症状的血栓栓塞。重新建立治疗性 INR 的中位时间为 4 天(范围 2-11 天)。vitK(IV)几乎可使所有的 vitK-Factors 恢复正常,INR 分别升高和降低与 vitK-Factors 分别耗竭和补充的模式一致;并且数据显示 INR 低于 1.5 与 vitK-Factors 高于 0.30iu/ml 相关。短期华法林逆转的低剂量 vitK(IV)是可靠和安全的,成功地将 INR 降至可接受的手术水平,且没有出血过多、血栓栓塞、延迟出院或对华法林的耐药。该方案对患者和医疗机构来说都简单方便。