文章摘要
重复测量方差分析在安全药理学研究中的应用探讨
Application of Repeated Measurement Analysis of Variance in Safety Pharmacology Studies
投稿时间：2024-06-18  修订日期：2024-07-11
DOI：
中文关键词: 安全药理学研究、单因素方差分析、重复测量方差分析、重复资料、统计分析
英文关键词: safety pharmacology study, one-way analysis of variance, repeated measures analysis of variance, repeated data, statistical analysis
基金项目:国家重点研发计划资助项目(No. 2021YFC2302505)
作者单位邮编
王庚莉 郑州大学公共卫生学院 450066
单晓蕾 国家药品监督管理局药品审评中心 
张素才* 郑州大学公共卫生学院 450066
杨进涛 北京昭衍新药研究中心股份有限公司 
冯斐斐 郑州大学公共卫生学院 
张巧 郑州大学公共卫生学院 
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中文摘要:
      目的：本研究将以新药ZY711安全药理学试验中测量的雄性QTc指标为案例，探讨重复测量方差分析在安全药理学研究中的必要性，为临床研究和应用提供更为可靠的依据。 方法：采用IBM SPSS Statistics 27.0进行统计分析，QTc间期采用均数±标准差（ms，Mean±SD）进行统计学描述，比较单因素方差分析和重复测量数据方差分析统计方法对试验结果的影响。结果：对于单因素方差分析结果在4和12 mg·kg-1剂量组药后1h QTc间期的延长有统计学意义，在40 mg·kg-1剂量组药后0.5 h、1 h、2 h、4 h QTc间期的延长有统计学意义；而重复测量方差分析在4和12 mg·kg-1剂量组药后1 h、2 h QTc间期的延长有统计学意义，在40 mg·kg-1剂量组药后0.5 h、1 h、2 h、4 h和6 h QTc间期的延长有统计学意义。结论：重复测量方差分析可用于非临床安全药理学试验结果的评估，它可以清楚了解药物的起效与持续时间，并且可以对药物不同剂量之间的显著性检验进行全面判断。
英文摘要:
      Objective: To explore the necessity of repeated measures analysis of variance in safety pharmacology study by using male QTc index measured in safety pharmacology test of new drug ZY711 as a case, and to provide a more reliable basis for clinical study and application. Methods: Statistical analysis was performed using IBM SPSS Statistics 27.0. QTc interval was statistically described using mean ± standard deviation (ms, Mean ± SD). The effects of one-way analysis of variance and repeated measures data analysis of variance statistical methods on the test results were compared. Results: For the results of one-way analysis of variance, the prolongation of QTc interval at 1 h after administration was statistically significant in 4 and 12 mg kg-1 dose groups, and the prolongation of QTc interval at 0.5 h, 1 h, 2 h and 4 h after administration was statistically significant in 40 mg kg-1 dose group; while the prolongation of QTc interval at 1 h and 2 h after administration was statistically significant in 4 and 12 mg kg-1 dose groups, and the prolongation of QTc interval at 0.5 h, 1 h, 2 h, 4 h and 6 h after administration was statistically significant in 40 mg kg-1 dose group. Conclusion: Repeated measures analysis of variance can be used to assess the results of nonclinical safety pharmacology trials, which can clearly understand the onset and duration of action of drugs, and can comprehensively judge the significance test between different doses of drugs.
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