Doria Cataldo, Fischer Craig P, Wood Christopher G, Li P Mark, Marra Steven, Hart James
Thomas Jefferson University Hospital, Philadelphia, PA 19107, USA.
Curr Med Res Opin. 2008 Mar;24(3):785-94. doi: 10.1185/030079908X273426. Epub 2008 Jan 31.
To compare the effectiveness of plasma-derived human thrombin and bovine thrombin for achieving hemostasis during surgery.
Adults (N = 305) with > or = 1 mild or moderate bleeding site not manageable by conventional modalities during elective cardiovascular, neurologic, or general surgical procedures at multiple study centers were randomized to human (n = 153) or bovine (n = 152) thrombin, applied topically with an absorbable gelatin sponge. Bleeding was assessed 3, 6, and 10 min post-application. Other evaluations included laboratory assessments, vital signs, blood loss, blood transfusions, time in specialty-care units, procedure duration, and length of hospital stay. Blood samples for antibody assessment were collected at baseline and postoperative week 5.
The proportion of patients achieving hemostasis within 10 min (primary outcome) was equivalent for human and bovine thrombin (97.4 vs. 97.4%, respectively; ratio, 1.00; 95% CI, 0.96-1.05). The proportions of patients achieving hemostasis at 6 min (94.8 vs. 92.8%) and 3 min (73.2 vs. 72.4%) were also equivalent. No clinically meaningful differences were noted for other variables. The products had similar adverse event profiles. More patients (12.7%) who received bovine thrombin demonstrated seroconversion for > or = 1 of the 4 antibodies assayed than patients who received human thrombin (3.3%). No patients in the human thrombin group developed seroconversion for anti-human thrombin or anti-human factor V/Va antibodies. Limitations of this study include the lack of a placebo-control group, the potential for inter-surgeon variability, and the fact that antibody assessment was not evaluable in all patients.
Plasma-derived human thrombin and bovine thrombin were equivalent in achieving hemostasis within 10, 6, and 3 min and had comparable safety profiles. None of the patients receiving human thrombin developed seroconversion for antibodies to any of the human antigens.
比较血浆源性人凝血酶和牛凝血酶在手术中实现止血的效果。
在多个研究中心进行的择期心血管、神经或普通外科手术中，有1个或以上轻度或中度出血部位且无法通过传统方式处理的成人患者（N = 305）被随机分为人凝血酶组（n = 153）或牛凝血酶组（n = 152），将其与可吸收明胶海绵一起局部应用。在应用后3、6和10分钟评估出血情况。其他评估包括实验室评估、生命体征、失血量、输血情况、在专科护理病房的时间、手术持续时间和住院时间。在基线和术后第5周采集血样进行抗体评估。
人凝血酶和牛凝血酶在10分钟内实现止血的患者比例（主要结局）相当（分别为97.4%和97.4%；比值，1.00；95%可信区间，0.96 - 1.05）。在6分钟（94.8%对92.8%）和3分钟（73.2%对72.4%）实现止血的患者比例也相当。其他变量未观察到具有临床意义的差异。两种产品的不良事件谱相似。接受牛凝血酶的患者中，有更多患者（12.7%）检测的4种抗体中有1种或以上出现血清转化，而接受人凝血酶的患者为3.3%。人凝血酶组中没有患者出现抗人凝血酶或抗人因子V/Va抗体的血清转化。本研究的局限性包括缺乏安慰剂对照组、外科医生之间存在变异性的可能性以及并非所有患者都能进行抗体评估。
血浆源性人凝血酶和牛凝血酶在10分钟、6分钟和3分钟内实现止血的效果相当，且安全性相当。接受人凝血酶的患者中没有出现针对任何人类抗原的抗体血清转化。
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