Turpie A G, Gunstensen J, Hirsh J, Nelson H, Gent M
Department of Medicine, Hamilton General Hospital, Ontario, Canada.
Lancet. 1988 Jun 4;1(8597):1242-5. doi: 10.1016/s0140-6736(88)92070-3.
After tissue heart valve replacement 108 patients were randomised to standard anticoagulant control with rabbit brain thromboplastin (Dade C reagent, therapeutic range 18-24 s; international normalised ratio 2.5-40) and 102 to a less intensive regimen controlled with human brain thromboplastin (Manchester Comparative Reagent, therapeutic range 26-30 s; INR 2.0-2.25). Treatment was continued for three months, outcome measures being major or minor embolism or haemorrhage. 2 patients in each group had major embolic events and 11 in each group had minor embolic events. The 95% confidence intervals on the differences are -3.4% to 3.2% for major embolism and -9.3% to 8.2% for minor embolism. Haemorrhagic complications were significantly more frequent with standard treatment (15 patients) than with the less intensive regimen (6 patients); and of the 5 patients with major haemorrhagic complications, all were in the standard treatment group, again a significant difference. The less intensive regimen is thus no less effective and safer than standard anticoagulant therapy in patients with tissue heart valve replacement.
在进行组织心脏瓣膜置换术后，108例患者被随机分配至采用兔脑凝血活酶（达德C试剂，治疗范围18 - 24秒；国际标准化比值2.5 - 4.0）进行标准抗凝控制组，102例患者被随机分配至采用人脑凝血活酶（曼彻斯特比较试剂，治疗范围26 - 30秒；国际标准化比值2.0 - 2.25）进行强度较低治疗方案组。治疗持续三个月，观察指标为严重或轻微栓塞或出血。每组各有2例患者发生严重栓塞事件，每组各有11例患者发生轻微栓塞事件。严重栓塞差异的95%置信区间为 - 3.4%至3.2%，轻微栓塞差异的95%置信区间为 - 9.3%至8.2%。标准治疗组（15例患者）的出血并发症明显比强度较低治疗方案组（6例患者）更频繁；在5例发生严重出血并发症的患者中，均在标准治疗组，同样存在显著差异。因此，对于接受组织心脏瓣膜置换术的患者，强度较低的治疗方案在有效性和安全性方面并不亚于标准抗凝治疗。
