摘要
目的 评价健康受试者对重组葡激酶（血栓溶解药）的安全性和耐受性.方法 27例健康受试者静脉滴注重组葡激酶（2.5,5,10,15 mg）.结果 用药前后,所有受试者用药前后血压、心率及呼吸无异常变化,与溶栓有关的血液学参数、血尿常规、肝肾功能及血糖均无显著性变化.有10例（37.0%）发生轻微过敏反应;9例（33.3%）发生轻微出血;6例仅有牙龈少量渗血;1例发现尿中红细胞;1例出现静脉穿刺部位小瘀斑;在15 mg剂量组中,1例同时具有上述3种出血表现.结论 在2.5～15 mg内,健康受试者均能较好地耐受重组葡萄酶,但有少数出现轻度药物不良反应.
Objective To evaluate the tolerability and safety of recombi- nant staphylokinase （r- SAK） in healthy subjects. Methods Twenty seven healthy subjects received different dose of r - SAK as intravenous injection in the four groups （2.5, 5, 10, 15 mg）. Results After administration of r - SAK, there were no significant changes in blood pressure, heart rate and respiration rate in all subjects. No significant differences were found in blood parameters related to thrombolysis, blood routine, urine routine, hepatic and renal functions, and fasting blood sugar. Mild allergic reactions were observed in 10 （37.0%） of the 27 subjects, which presented bulbar conjunctiva congestion, chest skin flush and tetter. Minor bleeding was found in 9 （33.3%） of the 27 subjects. Gum bleeding was observed in 6 subjects, red cells were found in urine in one subject, and bleeding in the site of vein puncture was found in one subject. Only one subject who received 15 mg of r - SAK had the above three bleeding manifestations. Conclusion Administration of r - SAK was well tolerated from the lowest dose （2.5 mg） to the highest dose （15 mg） in healthy subjects. However, mild adverse reactions observed a few of healthy subjects.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2006年第2期116-118,共3页
The Chinese Journal of Clinical Pharmacology
关键词
重组葡激酶
安全性
耐受性
recombinant staphylokinase
safety
tolerability
