注射用重组人甲状旁腺素(1-34)单次给药人体耐受性和安全性研究  

Clinical Tolerance and Safety of Single-dose Subcutaneous Administration of Recombinant Human Parathyroid Hormone(1-34) in Chinese Healthy Volunteers

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作  者:李忠芳 刘亚妮[2] 曾繁典[3] 师少军[2] Li Zhongfang;Lu Yani;Zeng Fandian;Shi Shaojun(Department of Obstetrics&Gynecology,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China;Department of Pharmacy,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology;Institute of Clinical Pharmacology,Tongji Medical College,Huazhong University of Science and Technology)

机构地区:[1]华中科技大学同济医学院附属协和医院妇产科,武汉430022 [2]华中科技大学同济医学院附属协和医院药剂科 [3]华中科技大学同济医学院临床药理研究所

出  处:《中国药师》2019年第1期87-90,共4页China Pharmacist

基  金:国家科技部十二五"重大新药创新"科技重大专项基金项目(编号:20112X09302-002-01)

摘  要:目的:评价中国健康受试者单次皮下注射重组人甲状旁腺素(1-34)[rhPTH(1-34)]后的人体耐受性和安全性。方法:以健康受试者为研究对象,从安全起始剂量开始,进行单次给药耐受性试验。采用随机单中心临床研究,统一餐后皮下注射给药。30例受试者随机分为6个剂量组:10μg(4例),20μg(6例),30μg(6例),40μg(6例),50μg(4例),60μg(4例)。在Ⅰ期临床病房进行耐受性和安全性评价,观察受试者用药前后症状、生命体征、十二导联心电图(ECG)、实验室检查变化(包括血尿常规、血电解质、血糖、肝肾功能等)、并记录药品不良反应。结果:单次给药耐受性试验的受试者用药前后生命体征和ECG无显著变化,实验室检查等表明无器质性损伤。单次给药耐受性试验有15例受试者出现药品不良反应,主要包括注射局部红斑、食欲不振、恶心、呕吐等,均未作处理,1~7 h内自行缓解和消失。结论:中国健康人体对注射用rhPTH(1-34)单次皮下注射给药(10~60μg)的安全性和耐受性良好,但临床应用中应密切监测患者个体差异及可能出现的药品不良反应(包括关节疼痛、消化道和神经系统症状等)。Objective:To evaluate the tolerance and safety of single-dose subcutaneous administration of recombinant human parathyroid hormone(1-34)[rhPTH(1-34)]in Chinese healthy volunteers.Methods:Starting from the security initial dose,a tolerance study was carried out after single-dose subcutaneous administration of rhPTH(1-34).A randomized single center clinical trial was performed with postprandial subcutaneous administration.Thirty healthy volunteers were randomly divided into six groups with the dose of 10μg(n=4),20μg(n=6),30μg(n=6),40μg(n=6),50μg(n=4)and 60μg(n=4),respectively.The safety profiles and tolerability were evaluated in the phaseⅠdrug clinical trial ward by observing the symptoms,vital sign,twelve-lead electrocardiograms(ECGs)and laboratory parameters(including blood and urine routine,blood electrolyte,blood glucose,liver and kidney function,)before and after the subcutaneous administration.At the same time,the adverse drug reactions(ADRs)were recorded.Results:There were no significant changes in the vital signs and ECGs,and the laboratory tests showed no organic damages before and after the single-dose subcutaneous administration.Totally 15 cases in the single-dose study occurred ADRs(including local erythema,inappetence,nausea and vomiting)after the subcutaneous administration,and all relieved and disappeared within 1-7 h without any treatment.Conclusion:Single-dose subcutaneous administration of rhPTH(1-34)is safe and well tolerated in healthy Chinese volunteers with a single dose of 10-60μg.However,individual differences and possible ADRs(e.g.joint pain,digestive tract and nervous system symptoms)should be closely monitored in clinical application.

关 键 词:注射用重组人甲状旁腺素(1-34) 健康受试者 耐受性 安全性 

分 类 号:R977.1[医药卫生—药品]

 

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