注射用重组人甲状旁腺素(1-34)的Ⅰ期临床耐受性研究  

Phase Ⅰ clinical trial of recombinant human parathyroid hormone(1-34) for injection

作　　者：毕琳琳[1] 文爱东[1] 罗晓星[2] 贾艳艳[1] 周敏[1] 吴寅[1] 

机构地区：[1]第四军医大学西京医院药剂科,西安710032 [2]第四军医大学药理教研室,西安710032

出　　处：《中国新药杂志》2007年第7期561-564,共4页Chinese Journal of New Drugs

摘　　要：目的:评价中国健康志愿者皮下注射重组人甲状旁腺素(1-34)的安全性和耐受性。方法:将40例18～40岁的健康受试者随机分为10,20和40μg 3个剂量组,腹部皮下注射,观察临床症状体征并严密观察记录试验期间发生的不良反应事件。结果:各组受试者体检及实验室检查各项指标均在正常范围,具较好的可比性。给药后生命体征和实验室检查均未见有临床意义的改变,试验中未见严重不良反应发生。结论:健康受试者皮下注射甲状旁腺素(1-34)40μg以内安全性和耐受性较好。Objective： To evaluate the safety and tolerance of recombinant human parathyroid hormone （ 1-34 ） [ rhPTH （ 1-34 ） ]. Methods ： 40 Chinese healthy volunteers at age of 18 - 40 years old were randomized subcutaneously to inject with rhPTH （1-34） 10, 20 and 40μg. The safety was assessed based on clinical symptoms before and after subcutaneous injection of rhPTH （1-34）. Results： No abnormal outcomes and values were found in the physical examination and blood lab tests after subcutaneous injections. No serious ADRs were reported. Conclusion ： The rhPTH （1-34） for injection were safe and tolerable at a dose of up to 40μg.

关 键 词：重组人甲状旁腺素(1-34) 皮下注射 Ⅰ期临床试验 

分 类 号：R582[医药卫生—内分泌] R977[医药卫生—内科学]