Califf R M, Topol E J, George B S, Boswick J M, Abbottsmith C, Sigmon K N, Candela R, Masek R, Kereiakes D, O'Neill W W
Department of Internal Medicine, Duke University Medical Center, Durham, North Carolina 27710.
Am J Med. 1988 Sep;85(3):353-9. doi: 10.1016/0002-9343(88)90586-4.
Little attention has been paid to the importance of clinical factors associated with bleeding complications caused by the use of thrombolytic agents. The goal of our study was to examine clinical and hematologic factors associated with an increased risk of bleeding in a prospectively observed population that received intravenous tissue plasminogen activator for acute myocardial infarction.
Bleeding complications were evaluated in 386 consecutive patients treated with 150 mg of tissue plasminogen activator over six to eight hours for acute myocardial infarction. All patients also underwent immediate cardiac catheterization.
Quantitation of blood loss during the patients' hospital stay included a median drop in hematocrit of 11.4 points, a median nadir hematocrit of 31.2, a 14 percent rate of significant clinically evident bleeding, and a 31 percent rate of transfusion of two or more units of blood. All of these parameters were much more severe in patients treated with coronary artery bypass surgery. Access site hematoma was the most common source of bleeding (45 percent of patients), whereas 8 percent had gastrointestinal bleeding, two patients had retroperitoneal bleeding, and two patients had intracranial bleeding. The median nadir fibrinogen was 1.3 g/liter. Multiple linear regression models were used to investigate the relationship between clinical variables, including multiple hematologic measurements, and measures of the amount of blood loss. The use of coronary artery bypass grafting was the variable most closely associated with hemorrhage. Other invasive procedures (angioplasty and intra-aortic balloon pumping) were also associated with increased bleeding. Among the patient descriptors examined, lighter weight, older age, female sex, and history of hypertension were associated with greater blood loss. Of laboratory coagulation parameters, only nadir fibrinogen levels were significantly associated with more bleeding.
Careful clinical evaluation may improve assessment of the risk/benefit ratio of thrombolytic therapy.
对于与使用溶栓药物所致出血并发症相关的临床因素的重要性，人们关注较少。我们研究的目的是在一组前瞻性观察的因急性心肌梗死接受静脉注射组织型纤溶酶原激活剂的人群中，检查与出血风险增加相关的临床和血液学因素。
对386例连续的因急性心肌梗死在6至8小时内接受150毫克组织型纤溶酶原激活剂治疗的患者的出血并发症进行评估。所有患者均接受了即时心脏导管插入术。
对患者住院期间的失血量进行定量分析，包括血细胞比容中位数下降11.4个百分点，血细胞比容最低值中位数为31.2，有临床明显出血的发生率为14%，输注两单位或更多单位血液的发生率为31%。所有这些参数在接受冠状动脉搭桥手术的患者中要严重得多。穿刺部位血肿是最常见的出血来源（45%的患者），而8%的患者有胃肠道出血，2例患者有腹膜后出血，2例患者有颅内出血。纤维蛋白原最低值中位数为1.3克/升。使用多元线性回归模型研究临床变量（包括多项血液学测量指标）与失血量指标之间的关系。冠状动脉搭桥术的使用是与出血最密切相关的变量。其他侵入性操作（血管成形术和主动脉内球囊反搏）也与出血增加有关。在所检查的患者特征中，体重较轻、年龄较大、女性以及有高血压病史与失血量较大有关。在实验室凝血参数中，只有纤维蛋白原最低值水平与更多出血有显著关联。
仔细的临床评估可能会改善对溶栓治疗风险/获益比的评估。
