Potential applicability of recombinant factor VIIa for intracerebral hemorrhage
Potential applicability of recombinant factor VIIa for intracerebral hemorrhage
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DOI：
10.1161/01.str.0000189634.08400.82
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发表时间：
2005-12-01
期刊：
影响因子：
8.3
通讯作者：
Broderick, JP
中科院分区：
文献类型：
--
作者：
Flaherty, ML;Woo, D;Broderick, JP
背景和目的-到目前为止，除了支持性医疗护理外，还没有经过验证的、有效的治疗脑出血(ICH)的方法。最近的一项随机、盲目、安慰剂对照的重组因子VIIa(RFVIIa)试验报告称，与安慰剂相比，在脑出血发病后4小时内静脉注射rFVIIa可降低发病率和死亡率。我们试图确定rFVIIa在以人群为基础的大规模脑出血患者队列中的潜在适用性。方法-所有年龄<18岁的非创伤性脑出血患者分别于1998年5月至2001年7月和2002年8月至2003年4月在大辛辛那提地区住院。患者的人口统计学与rFVIIa试验的纳入和排除标准进行了比较，以确定是否有资格接受治疗和排除的原因。在rFVIIa试验中，符合条件的患者组的死亡率与安慰剂组进行了比较。结果：在4个历年中，1018名脑出血患者被确认；其中133名(13.1%)没有排除，并在规定的时间窗口内出现。另有45名患者(4.4%)可能符合条件，但发病时间或计算机断层扫描时间不确定。排除的最常见原因(不相互排斥)是：出现晚(n=398)、血管闭塞性疾病(n=369)、深度昏迷(n=219)、国际标准化比率或部分凝血活酶时间延长(n=200)。在潜在符合条件的患者中，90天的死亡率与rFVIIa试验中的安慰剂组相同(29%对29%；P=0.99)。结论--在这个基于人群的大型脑出血队列中，根据试验标准，13.1%至17.5%的患者有资格接受rFVIIa治疗。
Background and Purpose - To date, there are no proven, effective treatments for intracerebral hemorrhage (ICH) beyond supportive medical care. A recent randomized, blinded, placebo-controlled trial of recombinant factor VIIa (rFVIIa) administered intravenously within 4 hours of ICH onset reported a reduction in morbidity and mortality compared with placebo. We sought to determine the potential applicability of rFVIIa in a large, population-based cohort of ICH patients.Methods - All of the patients age >= 18 years hospitalized with nontraumatic ICH in the Greater Cincinnati region were identified from May 1998 to July 2001 and August 2002 to April 2003. Patient demographics were compared with the inclusion and exclusion criteria from the rFVIIa trial to determine eligibility for treatment and reasons for exclusion. Mortality in the eligible patient group was compared with the placebo group in the rFVIIa trial.Results - Over 4 calendar years, 1018 ICH patients were identified; of these, 133 (13.1%) had no exclusions and presented within the prescribed time window. An additional 45 patients (4.4%) may have been eligible but had uncertain onset or computed tomography scan times. The most common reasons for exclusion (not mutually exclusive) were late presentation (n = 398), vaso-occlusive disease (n = 369), deep coma (n = 219), and prolonged international normalized ratio or partial thromboplastin time (n = 200). Mortality at 90 days among potentially eligible patients was the same as for the placebo group in the rFVIIa trial (29% versus 29%; P = 0.99).Conclusions - In this large, population-based ICH cohort, 13.1% to 17.5% of patients would have qualified for treatment with rFVIIa by trial criteria.