多次注射血凝酶对健康受试者凝血功能的影响及其安全性评价

Evaluation of influence of multi-mainline Reptilase on blood coagulation and safety in healthy volunteers

目的:考察多次注射血凝酶对健康受试者凝血功能的影响并评价其安全性。方法:20名男性健康志愿受试者按随机化方法分配至1kU,2kU两个剂量组,试验期间密切监测受试者的生命体征、心电图、凝血功能;给药前、后检查受试者的血尿常规、血液流变学、肝肾功能、电解质、血脂等指标。结果:多次给药后,1kU剂量组使凝血功能中的PT、APTT轻微下降,2kU剂量组使凝血功能中的PTI、NR、Fib轻微下降,但改变无临床意义,对凝血功能其他指标无明显影响,对血尿常规等指标也无不良影响。结论:多次给予血凝酶是安全的。

OBJECTIVE To evaluate the influence of haemocoagulase by multi-mainline on the blood coagulation safety in healthy volunteers. METHODS The 20 male volunteers of 19 - 27 years old were selected in accordance with the parameters of physical examination and laboratory test. The vohmteers were randomly divided to receive 1 kU,2 kU of muhi mainline dose of haemocoagulase, and the blood coagulation and other special parameters were observed. RESULTS Blood coagulation and other parameters had not been significantly affected by multl-mainline of Reptilase. CONCLUSION Muhi-mainline of haemocoagu lase is safe.