| 王庚莉,杨进涛,冯斐斐,张巧,单晓蕾,张素才.重复测量方差分析在安全药理学研究中的应用探讨[J].中国药事,2024,38(8):891-898 |
| 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 Measures Analysis of Variance in Safety Pharmacology Study |
| 投稿时间：2024-06-18 |
| DOI：10.16153/j.1002-7777.20240482 |
| 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（编号 021YFC2302505） |
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| 中文摘要: |
| 目的：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 Statistics27.0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方差分析统计方法对试验结果的影响。结果：单因素方差分析结果在4 mg·kg-1和12mg·kg-1剂量组药后1 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 hQTc间期的延长有统计学意义；而重复测量方差分析结果在4 mg·kg-1和12 mg·kg-1剂量组药后1 h、2 hQTc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，其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 pharmacologystudy by using male QTc index measured in safety pharmacology test of new drug ZY711 as a case, and to providea more reliable basis for clinical study and application. Methods: Statistical analysis was performed by using IBMSPSS Statistics 27.0. QTc interval was statistically described by using mean ± standard deviation (ms, Mean ±SD). The effects of one-way analysis of variance and repeated measures analysis of variance statistical methodson 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 theprolongation 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 for the results of repeated measures analysis of variance, the prolongation of QTc interval at1 h and 2 h after administration was statistically significant in 4 and 12 mg·kg-1 dose groups, and the prolongationof QTc interval at 0.5 h, 1 h, 2 h, 4 h and 6 h after administration was statistically significant in 40 mg·kg-1dose group. Conclusion: Repeated measures analysis of variance can be used to assess the results of nonclinicalsafety pharmacology trials, which could clearly understand the onset and duration of action of drugs, andcomprehensively judge the significance test between different doses of drugs. |
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