华法林在我国治疗静脉血栓栓塞性疾病的最优抗凝区间

目的 前瞻性研究我国静脉血栓栓塞性疾病(VTE)患者不同华法林抗凝强度区间的出血率和VTE复发率及寻找最优国际标准化比值(INR)区间.方法 将2006年10月至2007年7月间安贞医院收治的180例VTE患者作为研究对象,随机分成A、B、C 3组,每组各60例,分别对应INR目标区问是1.50～1.99(低强度抗凝组)、2.00～2.50(中等强度抗凝组)及2.51～3.00(高强度抗凝组).INR稳定在目标区间2周以上后,开始正式观察每组大、中、小量出血率及VTE复发率.研究者及观察对象均遵循盲法原则.结果 低强度组与中高强度组的复发率分别为8.3%、1.7%(P=0.042).低、中、高强度抗凝3组间少量出血率分别为8.3%、18.3%及6.7%(P=0.089);低与中高强度组中量出血率分别为3.3%、7.5%(P=0.341);低与中高强度组大量出血率分别为0%、3.3%(P=0.303).62岁以上人群,中低强度组大出血(1例)与高强度组(3例)相比(即INR从1.5～2.5增加到2.51～3.00),危险比为12.600(95%可信区间为1.183～134.238).结论 对于一般中国人.华法林抗凝INR在2.0～3.0之间既能减少VTE复发风险又不增加出血风险,故INR应推荐在2.0～3.0之间.对于年龄62岁以上的高龄人群,INR应推荐在2.0～2.5之间.

The study of Chinese optimal anticoagnlant range of warfarin for venous thromboembolism

Objective The ann of trial is to observe the Chinese bleeding frequency and frequency of recurrent VTE in different international normalized ratio (INR) range of warfarin for venous thromboembolism (VTE) including deep venous thrombosis (DVT) and pulmonary embolism (PE) ,and to search optimal INR range. Methods We conducted a randomized, double-blind cohort trial, in which 180 patients were assigned to apply warfarin in a target INR of 1.50 to 1.99 (group A), a target INR of 2. 00 to 2. 50(group B) or a target of INR of 2. 51 to 3.00 (group C). Every group had respectively 60 patients. After they had completed warfarin therapy to be stabilely kept with those target INR range for two or more weeks, this study would be begun to observe the bleeding frequency and frequency of recurrent VTE. Results There was significant difference in recurrent VTE frequency between Group A (8. 3%) and BC (1.7%, P=O. 042). The minor bleeding frequency of Group A, B and C is respectively 8.3%, 18. 3% and 6. 7% (P = 0. 089). The moderate bleeding frequency of Group A and BC is respectively 3. 3% and 7.5% (P =0. 341), and large bleeding frequency of them is respectively 0% and 3. 3% (P = 0. 303). To patients whose age above 62 year, major bleeding episode occurred respectively in I patient assigned to INR of 1.5- 2.5 and in three patients assigned to Group C (bazard ratio, 12.600; 95 percent confidence interval, 1.183-134.238). Conclusion Warfarin therapy in INR of 2. 0 - 3. 0 is more effective than INR of 1.5 - 1.99 for the long-term prevention of recurrent VTE. And warfarin regimen in INR of 2. 0 - 3.0 does not increase the risk of major bleeding either. So to general Chinese, INR ought to be reccmended in 2. 0 -3.0. To patients whose age above 62 year, INR ought to be recommended between 2. 0 to 2. 5.