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伊晓倩, 李蕊, 张文胜等. 注射用磷丙泊酚钠在Ⅰ期临床耐受性试验中对健康受试者QT间期的影响[J]. koko体育app 学报(医学版), 2012, 43(6): 868-872.
引用本文: 伊晓倩, 李蕊, 张文胜等. 针剂用磷丙泊酚钠在Ⅰ期临床检验接受性检测中对安全健康受试者QT间期的损害[J]. 贵州上大学学报(临床医学版), 2012, 43(6): 868-872.
YI Xiao-qian, LI Rui, ZHANG Wen-sheng. et al. Effect of Single Doses of HX0507 on QTc Intervals in Healthy People: a Phase Ⅰ Safety and Tolerability Study[J]. Journal of Sichuan University (Medical Sciences), 2012, 43(6): 868-872.
Citation: YI Xiao-qian, LI Rui, ZHANG Wen-sheng. et al. Effect of Single Doses of HX0507 on QTc Intervals in Healthy People: a Phase Ⅰ Safety and Tolerability Study[J]. Journal of Sichuan University (Medical Sciences), 2012, 43(6): 868-872.

注射用磷丙泊酚钠在Ⅰ期临床耐受性试验中对健康受试者QT间期的影响

Effect of Single Doses of HX0507 on QTc Intervals in Healthy People: a Phase Ⅰ Safety and Tolerability Study

  • 摘要: 【摘要】 目的 探讨注射用磷丙泊酚钠(HX0507)在Ⅰ期临床耐受性试验中对健康受试者心电图QT间期的影响,了解其临床应用可能存在的风险。方法 将80例健康受试者顺序分配到13个剂量组。给药前记录基础心电图,并于给药后24 h内33个时点记录心电图。求得使用Fridericia公式和Bazett公式校正的QT间期,即QTcF(QTcF=QT/RR0.33)与QTcB(QTcB=QT/RR0.5)。以QTcF与基线值的差值(ΔQTcF)为主要目标变量分析HX0507对健康受试者QT间期的影响。结果 注射用磷丙泊酚钠在可能的临床常用剂量(3 mg/kg)和更大剂量(8~40 mg/kg)组给药后ΔQTcF均值在5.61~32.24 ms间,双侧90%可信区间上限在10.30~53.90 ms间。32例受试者出现了8种心电图相关的不良反应。结论 注射用磷丙泊酚钠在3 mg/kg和8~40 mg/kg剂量组对健康受试者QT间期有剂量相关性延长的趋势。  
    Abstract: 【Abstract】 Objective To assess the effect of HX0507 on QTc interval in healthy people in a phaseⅠsafety and tolerability study. Methods Eighty healthy people were randomly assigned to one of the 13 dosage groups. Standard 12-lead ECGs data were collected before and after HX0507, a water soluble prodrug of propofol, was given intravenously to the participants (at 33 time points). The QT interval values were corrected for heart rate using Fridericia’s formula (QTcF=QT/RR0.33) and Bazett’s formula (QTcB=QT/RR0.5). The primary target variable was baseline-adjusted changes in QTcF (ΔQTcF). Results Prolongation of QT interval was induced by HX0507 administered at an anticipated clinical dosage (3 mg/kg) or at a stronger dosage (8 mg/kg )and above. The mean ΔQTcF ranged from 5.61 ms to 32.24 ms, with an upper limit of 90% CI ranging from 10.30 ms to 53.90 ms. There was a linear correlation between HX0507 dosage and its effect on QT interval. Eight types of ECG-related adverse events were detected in 32 subjects. Conclusion Single administration of HX0507 induces dose-related QT prolongation.  
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