中国临床药理学杂志
中國臨床藥理學雜誌
중국림상약이학잡지
THE CHINESE JOURNAL OF CLINICAL PHARMACOLOGY
2014年
6期
511-513
,共3页
薛薇%史爱欣%李茹冰%杨向阳%万华印%董凡%曹国颖%李扬%李敏%严蓓%胡欣
薛薇%史愛訢%李茹冰%楊嚮暘%萬華印%董凡%曹國穎%李颺%李敏%嚴蓓%鬍訢
설미%사애흔%리여빙%양향양%만화인%동범%조국영%리양%리민%엄배%호흔
钙增敏剂%连续给药%耐受性%盐酸椒苯酮胺%不良事件
鈣增敏劑%連續給藥%耐受性%鹽痠椒苯酮胺%不良事件
개증민제%련속급약%내수성%염산초분동알%불량사건
calcium sensitizer%continuous intravenous infusion%tolera-bility%piperphentonamine hydrochloride%adverse event
目的：评价盐酸椒苯酮胺（ PPTA）在健康人体以负荷剂量及维持剂量连续静脉给药24 h的耐受性和安全性。方法随机、开放、单中心I期临床试验设计。11名健康受试者给予PPTA 0.1 mg· kg-1静脉推注20 min，再以0.9 mg· kg-1维持静脉滴注24 h，进行生命体征、动态心电图、体格、实验室、眼科等检查，记录不良事件，评价药物耐受性和安全性。结果所有受试者生命体征基本平稳，无QTc间期延长，未发生严重不良事件，无受试者因不良事件而退出试验。6例受试者发生与研究药物可能有关的不良事件13例次，其中9例次为椒苯酮胺药效学作用，且所有不良事件均自行缓解，未予治疗。结论注射用盐酸椒苯酮胺0.1 mg· kg-1静脉推注20 min后，0.9 mg· kg-1静脉滴注24 h安全耐受。
目的：評價鹽痠椒苯酮胺（ PPTA）在健康人體以負荷劑量及維持劑量連續靜脈給藥24 h的耐受性和安全性。方法隨機、開放、單中心I期臨床試驗設計。11名健康受試者給予PPTA 0.1 mg· kg-1靜脈推註20 min，再以0.9 mg· kg-1維持靜脈滴註24 h，進行生命體徵、動態心電圖、體格、實驗室、眼科等檢查，記錄不良事件，評價藥物耐受性和安全性。結果所有受試者生命體徵基本平穩，無QTc間期延長，未髮生嚴重不良事件，無受試者因不良事件而退齣試驗。6例受試者髮生與研究藥物可能有關的不良事件13例次，其中9例次為椒苯酮胺藥效學作用，且所有不良事件均自行緩解，未予治療。結論註射用鹽痠椒苯酮胺0.1 mg· kg-1靜脈推註20 min後，0.9 mg· kg-1靜脈滴註24 h安全耐受。
목적：평개염산초분동알（ PPTA）재건강인체이부하제량급유지제량련속정맥급약24 h적내수성화안전성。방법수궤、개방、단중심I기림상시험설계。11명건강수시자급여PPTA 0.1 mg· kg-1정맥추주20 min，재이0.9 mg· kg-1유지정맥적주24 h，진행생명체정、동태심전도、체격、실험실、안과등검사，기록불량사건，평개약물내수성화안전성。결과소유수시자생명체정기본평은，무QTc간기연장，미발생엄중불량사건，무수시자인불량사건이퇴출시험。6례수시자발생여연구약물가능유관적불량사건13례차，기중9례차위초분동알약효학작용，차소유불량사건균자행완해，미여치료。결론주사용염산초분동알0.1 mg· kg-1정맥추주20 min후，0.9 mg· kg-1정맥적주24 h안전내수。
Objective To evaluate the safety and tolerability of continu-ous intravenous infusion of innovative calcium sensitizer piperphent-onamin ( PPTA) at a loading dose and a maintenance dose in healthy vol-unteers.Methods A randomized, open, single-center, phase I clini-cal trial in 11 healthy male and female subjects was conducted.Each subject was intravenously administered with a single loading dose of 0.1 mg· kg -1 for 20 min, and then a maintenance dose of 0.9 mg· kg -1 for 24 h.Safety and tolerance of PPTA were assessed by vital sign , dynamic electrocardiogram monitoring , physical examination , laboratory tests and eye exams, according to which adverse events ( AEs) were identified and recorded.The safety and tolerability were evaluated.Results Vital signs of all subjects were stable , and no QTc interval prolongation was observed during the trial.A total of 13 AEs were reported in 6 subjects , among which 9 AEs were the reflections of the effects of PPTA and all AEs were all relieved without treatment.Conclusion The regimen of in-travenous PPTA loading dose for 20 min and then a maintenance dose for 24 h is safe and tolerable.
