槐果碱注射液的I期临床耐受性研究  

Phase I tolerability trial of sophocarpine injection

作　　者：苗红[1] 叶龙彬[1] 沈金芳[2] 孙黎[2] 

机构地区：[1]上海医药集团股份有限公司中央研究院,上海201203 [2]上海交通大学医学院附属仁济医院,上海200001

出　　处：《上海医药》2013年第5期56-58,共3页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的：研究单次和多次静脉滴注槐果碱注射液在健康人体内的耐受性和安全性。方法：单次给药试验共入选42名健康志愿者，分为9个剂量组，由初始剂量0．4mg/kg开始，在耐受性较好的情况下，逐渐增加至0．8、1．5、2．5、4、5、6、7、8mg／kg。多次给药试验在单次给药试验结束后进行，共入选17名健康志愿者，分为7和8mg／kg两个剂量组，连续7d，qd。试验中多次进行生命体征、心电图、体格检查及实验室检查，并严密观察不良事件。结果：与研究药物有关的不良事件主要为部分实验室检查值异常，不良事件的程度均为轻度，均未经处理而恢复正常。试验中未发生严重不良事件。结论：中国健康受试者单次静脉滴注0．4-8mg/kg和连续7d，每天单次静脉滴注7～8mg／kg的槐果碱注射液是安全的，能耐受的。ABSTRACT Objective： To assess the tolerability and safety of single-dose and multiple-dose administration of sophocarpine injection in healthy volunteers. Methods： Forty two healthy subjects were enrolled to the single-dose study. They were divided into 9 dose steps （0.4, 0.8, 1.5, 2.5, 4, 5, 6, 7 and 8 mg/kg）, and the first dose step was 0.4 mg/kg. Safety and tolerability found at the previous dose level were used as a basis for the decision to proceed to the next higher dose level. Seventeen healthy subjects were enrolled to the multiple-dose study, and the escalated dose level were 7 and 8 mg/kg, qd for 7 consecutive days. The safety was assessed based on vital signs, electrocardiograms （ECGs）, physical examinations, clinical laboratory tests and adverse events. Results： The main adverse events related to sophocarpine injection were abnormal in some of clinical laboratory values. All adverse events were mild in severity and untreated. None of severe adverse events was observed in the trial. Conclusion： Sophocarpine injection is safe and well tolerated in Chinese healthy subjects after a single dose of 0.4-8 mg/kg and multiple doses of 7- 8 mg/kg, qd for 7 days. KEY WORDS sophocarpine injection; phase I clinical trial; tolerability

关 键 词：槐果碱注射液 I期临床试验 耐受性 

分 类 号：R286.0[医药卫生—中药学]