蕲蛇酶在健康志愿者的Ⅰ期临床研究

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健康志愿者18人,男11人,女7人,除该药研制者2人年龄为65和66岁外,其余平均年龄为26±s6.2岁。分3组,分别一次静脉滴注蕲蛇酶注射液1U(150μg)、2U(300μg)、3U(450μg)。3种剂量均能使血小板明显抑制,血小板明显减少,部分凝血活酶时间明显延长,纤维蛋白原明显下降,血浆FDP含量明显增多,优球蛋白溶解时间(ELT)明显缩短,优球蛋白复钙时间明显延长,并大多呈量效关系。对凝血酶原时间无明显变化。3种剂量对血浆ALT、AST、ALP、总蛋白、白蛋白、球蛋白、总胆固醇及胆红素等的影响均在正常波动范围内,此说明对肝功能无损害作用。其中对胆固醇则反有降低效果。对尿素氮和肌酐的影响亦均在正常波动范围内。对血糖亦无明显影响。对白细胞和血红蛋白等血像的影响亦在正常波动范围内。上述结果说明蕲蛇酶在高达3U(450μg)剂量下,对肝、肾、血像无明显不良反应。呼吸、血压、脉搏及体温均无明显变化。大剂量组有2例在血压计袖套压迫处出现数个散在性瘀血点,24h后自然消失。小剂量组1例(原为过敏体质)用药后出现喉头水肿过敏反应,经用氢化可的松静脉滴注即恢复 18 healthy volunteers, 11 males and 7 females, with the exception of two people aged 65 and 66 who developed the drug, with an average age of 26 ± s and 6.2 years old. Divided into three groups, respectively, a intravenous infusion of Viridian enzyme 1U (150μg), 2U (300μg), 3U (450μg). All the three doses significantly inhibited platelets, reduced platelets, prolonged partial thromboplastin time, decreased fibrinogen, increased plasma FDP content, shortened the euglobulin lysis time (ELT) The time was significantly prolonged, and most of them were dose-effect relationship. No significant changes in prothrombin time. The effects of three doses on the plasma ALT, AST, ALP, total protein, albumin, globulin, total cholesterol and bilirubin were within the normal range of fluctuation, indicating no damage to liver function. One of the anti-cholesterol on the contrary have reduced the effect. The impact on urea nitrogen and creatinine are also within the normal range of fluctuations. No significant effect on blood glucose. The impact on white blood cells such as hemoglobin and hemoglobin also within the normal range of fluctuations. The above results show that viper enzyme in up to 3U (450μg) dose, no significant adverse reactions to liver, kidney, blood. Breathing, blood pressure, pulse and body temperature were no significant changes. In the high-dose group, there were 2 scattered blood stasis spots in the cuff oppression of the sphygmomanometer, which disappeared spontaneously after 24 hours. Small dose group 1 (formerly allergic) medication laryngeal edema after allergic reactions, by hydrocortisone intravenous infusion that is restored
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