Schulman S, Stigendal L, Jansson J H, Brohult J
Department of Internal Medicine, Karolinska Hospital, Stockholm, Sweden.
Acta Med Scand. 1988;224(5):425-30. doi: 10.1111/j.0954-6820.1988.tb19606.x.
In order to assess the recommended therapeutic interval with the prothrombin complex analysis, using Stago Prothrombin-complex Assay (SPA) as the reagent, a retrospective multicentre study was performed to obtain clinical documentation. All thromboembolic and haemorrhagic complications during secondary prophylaxis after venous thromboembolism in 272 patients were recorded and related to the intensity of the oral anticoagulation. Six thromboembolic complications in patients without a malignant disease occurred at SPA levels greater than or equal to 28%, confirming that the limit of the therapeutic range, determined by the risk of thromboembolic recurrences, should be set at an SPA level of 25% (international normalized ratio, INR = 2.0), at least in venous disease. Major haemorrhages occurred mainly at SPA levels less than 10% (INR greater than 4.0), unless underlying risk factors were present, thus setting the other limit of the therapeutic range. However, an adjustment of this limit to SPA = 15% (INR approximately 3.0) is suggested, since it would lead to further reduction of haemorrhage and is advisable in most patients with venous thromboembolism.
为了通过凝血酶原复合物分析评估推荐的治疗间隔，以Stago凝血酶原复合物分析（SPA）作为试剂，进行了一项回顾性多中心研究以获取临床资料。记录了272例患者静脉血栓栓塞后继发性预防期间的所有血栓栓塞和出血并发症，并将其与口服抗凝强度相关联。在无恶性疾病的患者中，当SPA水平大于或等于28%时发生了6例血栓栓塞并发症，这证实由血栓栓塞复发风险确定的治疗范围上限应设定为SPA水平25%（国际标准化比值，INR = 2.0），至少在静脉疾病中如此。除非存在潜在风险因素，主要出血主要发生在SPA水平低于10%（INR大于4.0）时，从而设定了治疗范围的另一个下限。然而，建议将此下限调整为SPA = 15%（INR约为3.0），因为这将导致出血进一步减少，并且在大多数静脉血栓栓塞患者中是可取的。
