TRIAL OF DIFFERENT INTENSITIES OF ANTICOAGULATION IN PATIENTS WITH PROSTHETIC HEART-VALVES
TRIAL OF DIFFERENT INTENSITIES OF ANTICOAGULATION IN PATIENTS WITH PROSTHETIC HEART-VALVES
复制标题
DOI：
10.1056/nejm199002153220703
复制
发表时间：
1990-02-15
影响因子：
158.5
通讯作者：
GALLUS, AS
中科院分区：
文献类型：
--
作者：
SAOUR, JN;SIECK, JO;GALLUS, AS
在一项前瞻性随机研究中，我们比较了258例接受“中等强度”(凝血酶原时间比率1.5；国际标准化比率2.65)或“高强度”(凝血酶原时间比率2.5；国际标准化比率9)方案治疗的人工心脏瓣膜患者的抗凝效果和并发症。两组患者分别随访421个病人年和436个病人年。11名患者失去了随访。血栓栓塞症在两组中的发生频率相似(分别为每百人年4次和3.7次)，但中等强度组每百人年出血总数为6.2次，而高强度组为12.1次(P<；0.002)。中等强度组每100人年有5.2次轻微出血，而高强度组为10.1次(P<；0.01)。大出血在高强度组中也更为常见(每100个患者年发生2.1次--包括仅两次致命出血--而中等强度组为0.95次)，但差异不具有统计学意义。我们的结论是，在使用机械瓣膜的患者中，适度的抗凝效果(凝血酶原时间比约为1.5)可提供与更强化治疗相同的保护，但风险显著降低。
We compared the efficacy and complications of anticoagulation with warfarin in 258 patients with prosthetic heart valves treated with regimens of "moderate intensity" (prothrombin-time ratio, 1.5; international normalized ratio, 2.65) or "high intensity" (prothrombin-time ratio, 2.5; international normalized ratio, 9) in a prospective, randomized study. The two patient groups were followed up for 421 patient-years and 436 patient-years, respectively. Eleven patients were lost to follow-up. Thromboembolism occured with similar frequency in the two groups (4.0 and 3.7 episodes per 100 patient-years, respectively), but there was a total of 6.2 bleeding episodes per 100 patient-years in the moderate-intensity group as compared with 12.1 episodes in the high-intensity group (P < 0.002). There were 5.2 episodes of minor bleeding per 100 patient-years in the moderate-intensity group, as compared with 10.1 episodes in the high-intensity group (P < 0.01). Major bleeding was also more common in the high-intensity group (2.1 episodes per 100 patient-years-including the only two fatal hemorrhages-as compared with 0.95 episode in the moderate-intensity group), but the difference was not statistically significant. We conclude that a moderate anticoagulant effect (prothrombin-time ratio, about 1.5) in patients with a mechanical prosthetic heart valve offers protection equivalent to that of more intensive therapy, but at a significantly lower risk.