参芪扶正注射液Ⅰ期健康志愿者的耐受性研究

Phase Ⅰ tolerance clinical trial of shenqifuzheng saline injections in healthy volunteers

目的评价健康受试者单次和多次连续注射参芪扶正注射液的耐受性和安全性,确定临床给药的安全范围。方法按单中心、随机、开放试验设计。34例健康受试者,男女各半,其中单次给药22例,多次给药12例。单次给药：随机分为2,4,6,6,4例5个剂量组,分别予以单次静脉滴注参芪扶正注射液125,250,410,625,750 mL。多次给药：随机分为2组,每组6例,分别予以静脉滴注参芪扶正注射液625,750 mL,qd,连续7 d。观察各组用药后的临床症状、生命体征、心电图、血尿常规、肝肾功能、凝血功能等。结果参芪扶正注射液经单次或连续给药后,神经系统、呼吸系统、心血管系统、消化系统、皮肤系统、注射部位局部等均未发现异常。单次给药组出现5例凝血酶原时间（PT）延长、7例部分活化凝血酶原时间（APTT）延长、1例肌酸激酶升高认为与用药无关。连续给药组出现5例PT延长、2例APTT延长。单次给药组和连续给药组的PT延长和APTT延长均为轻度,且无临床意义。结论中国健康受试者单次静脉滴注参芪扶正注射液125~750 mL及连续静脉滴注每日750 mL是安全的,且人体可以耐受。推荐临床选择的剂量范围为125~750 mL。

Objective To assess the safety and tolerance of single- dose and multiple- dose intravenous drip of Shenqifuzheng saline injections in Chinese volunteers, thus to establish the safe clinical dosage.Methods Twenty- two healthy volunteers were randomly divided into 5single- dose groups（ 125,250,410,625 and 700 mL） and twelve volunteers were randomized into 2 multiple- dose groups（ six for 625 mL,six for 750 mL,qd × 7 d）. Subjective symptoms,objective signs,vital signs including blood pressure, heart rate, respiration were observed,and routine blood tests,routine urine tests,hepatic function,renal function,clotting function,electrocardiogram were monitored after medication. Results There were no abnormal findings in the vital signs,subjective symptoms, objective signs, electrocardiograph and no significant changes were found in the lab examinations. There were 5subjects with prothrombin time（ PT） slightly prolonged and 7 subjects with activation of prothrombin time（ APTT） prolonged among single-dose groups. 5 subjects with PT prolonged and 2 subjects with partial APTT prolonged among multiple- dose groups. Creatine kinase rising in one volunteer of the 625 mL single- dose group had no association withthe Shenqifuzheng injection. It could subside after taking a one- week rest. Conclusion Shenqifuzheng saline injections is safe at a dose of 125- 750 mL in a single administration or at a dose of 750 mL once daily for 7 days in Chinese volunteers.