注射用重组人胸腺肽α1人体耐受性临床研究  

The Clinical Tolerance Study of Recombinant Human Thymosin Alpha-1 for Injection

作　　者：麦丽萍[1] 何国东[1] 王曦培[1] 孙涛 张雪涛 郭兰[1,3] 古良[1,3] 林秋雄[1] 杨敏[1] MAI Li-ping;HE Guo-dong;WANG Xi-pei;SUN Tao;ZHANG Xue-tao;GUO Lan;GU Liang;LIN Qiu-xiong;YANG Min(Research Department of Guangdong General Hospital,Guangdong Academy of Medical Sciences,Guangzhou 510080,China;Guangdong Provincial Cardiovascular Institute,Guangzhou 510080,China;Jiangsu Haiwang Biological Pharmaceutical Co. Ltd.,Jinngsu Taizhou 225300,China)

机构地区：[1]广东省人民医院医学研究部广东省医学科学院,广州510080 [2]江苏海王生物制药有限公司,江苏泰州225300 [3]广东省心血管病研究所,广州510080

出　　处：《循证医学》2017年第4期244-247,共4页The Journal of Evidence-Based Medicine

摘　　要：目的观察健康人体对注射用重组人胸腺肽α1皮下注射的耐受性与安全性,采用剂量递增方案,确定单次及连续给药的安全剂量范围。方法单次给药48例健康受试者入组试验,其中36例分别皮下注射0.3 mg/m^2、0.6 mg/m^2、0.9 mg/m^2、1.4 mg/m^2、2.0 mg/m^2、2.7 mg/m^2注射用重组人胸腺肽α1,12例注射相应剂量的注射用水作为安慰剂;连续给药12例健康受试者分别皮下注射2.0 mg/m^2、2.7 mg/m^2注射用重组人胸腺肽α1,每周给药2次,连续4周。用药后对受试者进行临床观察和实验室检查,评价试验药物在人体的安全性。结果单次给药48例健康受试者入组并完成试验,所有受试者均未出现不良事件。连续给药12例健康受试者入组并完成试验,其中,有5名受试者出现不良事件,其中3例出现大便潜血阳性,1例出现血红蛋白尿,1例受试者出现大便潜血阳性和血红蛋白尿。停药后于随访期复查恢复正常,均无特殊处理,自行好转。结论单次应用注射用重组人胸腺肽α1 0.3~2.7 mg/m^2是安全的,耐受性良好;连续使用4周,每周2次,剂量在2.7 mg/m^2内是基本安全的。Objective To evaluate the safety,tolerance and make sure the safe dose range of single dose and continuous hypodermic injection Recombinant Human Thymosin Alpha?1(rh?thymosinα1)in Chinese healthy volunteers.Methods48healthy volunteers were received a single dose group,including36subjects hypodermic injection of0.3mg/m2,0.6mg/m2,0.9mg/m2,1.4mg/m2,2.0mg/m2,2.7mg/m2rh?thymosinα1,12subjects hypodermic injection of the same dose water as placebo.12subjects in continuous dose group were hypodermic injected2.0mg/m2or2.7mg/m2rhthymosinα1,two times a week,continue for four weeks.Safety and tolerance were evaluated by monitoring adverse events and laboratory parameters.Results48healthy volunteers actual finished in a single dose group.There were no adverse events taken place in a single dose group.12healthy volunteers actual finished in a continuous dose group.There were5adverse events taken place in a continuous dose group,including3subjects fecal occult blood(FOB),1subject haemoglobinuria,1subject FOB and haemoglobinuria.All of them returned to normal after drug withdrawal in follow?up phase.Conclusion Rh?thymosinα1from0.3mg/m2to2.7mg/m2hypodermic injection of single dose was safe and well tolerance.Continuous using for four weeks,two times a week and the dose in2.7mg/m2were safe.

关 键 词：注射用重组人胸腺肽α1 安全性 耐受性 

分 类 号：R969[医药卫生—药理学]