在新药Ⅰ期临床试验中安慰剂引起的三酰甘油变化
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摘要
目的本文拟评估在新药Ⅰ期临床试验中,住院时间在5 d以上,健康志愿者经单次或多次服用安慰剂后引起的三酰甘油(TG)变化趋势。方法通过搜集近5年新药Ⅰ期临床试验,单次或多次服用安慰剂,住院时间为5 d及以上,试验期间多次检测三酰甘油实验室检查的研究,对三酰甘油检查结果进行汇总分析。结果共纳入7项新药Ⅰ期临床试验,涉及61名健康志愿者。各试验志愿者的三酰甘油水平随住院时间的延长均有上升趋势,给药后经住院多日离开中心时测得的三酰甘油水平较基线平均升高0.17～0.61 mmol·L~(-1),共上报7例次相关不良事件。结论对于住院时间长的新药Ⅰ期临床试验,在进行相关不良事件判断,应考虑非药物因素可能引起三酰甘油升高的情况,可根据具情况适当放宽不良事件的评判标准。
Objective To evaluate the prevalence of triglyceride(TG)changes on placebo during Phase Ⅰ trials in healthy volunteers hospitalized for more than 5 days.Methods Retrospective review of triglyceride data collected on placebo during recent 5 years Phase I trials,healthy volunteers were hospitalized for more than 5 days,the number of triglyceride determinations more than once during the search period.Triglyceride data were investigated and analyzed.Results A total of 7 Phase Ⅰ trials involving 61 healthy volunteers were included.The level of triglycerides increased with the length of hospitalization; the average level of triglycerides increased from 0.17 to 0.61 mmol·L~(-1) compared with the baseline before discharge; 7 cases of adverse events were reported.Conclusion Non-drug factors induced triglyceride increasing should be considered in Phase I trials with long hospital stay.Maybe the evaluation criteria can be properly broadened for adverse event reporting.
Objective To evaluate the prevalence of triglyceride(TG)changes on placebo during Phase Ⅰ trials in healthy volunteers hospitalized for more than 5 days.Methods Retrospective review of triglyceride data collected on placebo during recent 5 years Phase I trials,healthy volunteers were hospitalized for more than 5 days,the number of triglyceride determinations more than once during the search period.Triglyceride data were investigated and analyzed.Results A total of 7 Phase Ⅰ trials involving 61 healthy volunteers were included.The level of triglycerides increased with the length of hospitalization; the average level of triglycerides increased from 0.17 to 0.61 mmol·L~(-1) compared with the baseline before discharge; 7 cases of adverse events were reported.Conclusion Non-drug factors induced triglyceride increasing should be considered in Phase I trials with long hospital stay.Maybe the evaluation criteria can be properly broadened for adverse event reporting.
引文
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