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| 多中心临床试验中实验室数据的定性分析方法 | |
| 引用本文： | 丁红,于浩,赵杨,苏炳华,陈峰.多中心临床试验中实验室数据的定性分析方法[J].中国临床药理学与治疗学,2006,11(8):955-957. |
| 作者姓名： | 丁红 于浩 赵杨 苏炳华 陈峰 |
| 作者单位： | 1. 广东天普生化医药股份有限公司新药部,广州,510520,广东 2. 南京医科大学流行病与卫生统计学系,南京,210029,江苏 3. 上海第二医科大学生物统计学教研室,上海,200025 |
| 摘 要： | 目的：探讨多中心临床试验中实验室数据的定性分析方法.方法：通过计算疗前正常者疗后异常的发生率,判断药物对实验室指标的影响;计算疗后实验室检查结果高于疗前者的比例,检验试验结果的随机性.结果：多中心临床试验中实验室定性资料的分析可以抵消年龄、性别、中心间差异的影响,为判定药物的安全性提供重要线索.结论：多中心临床试验中实验室资料既要进行定性分析,又要进行定量分析. |
| 关 键 词： | 多中心临床试验 实验室资料 定性分析 似然比检验 确切概率 |
| 文章编号： | 1009-2501(2006)08-0955-03 |
| 收稿时间： | 04 13 2006 12:00AM |
| 修稿时间： | 07 5 2006 12:00AM |
Qualitative analysis of laboratory data in multi-center clinical trials |
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| DING Hong,YU Hao,ZHAO Yang,SU Bing-hua,CHEN Feng.Qualitative analysis of laboratory data in multi-center clinical trials[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2006,11(8):955-957. | |
| Authors: | DING Hong YU Hao ZHAO Yang SU Bing-hua CHEN Feng |
| Institution: | Department of New Drug, Gnangdong Techpoool Bio-Pharma Co. , Ltd, Gnangzhou 510520, Gnangdong , China ; 1 Department of Epidernology and Biostatistics, Nanjing Medical University, Nanjing 210009, Jiangsu, China ; 2 Department of Biostatistics, the Second Medical University of Shanghai, Shanghai 200025, China |
| Abstract: | AIM: To study the qualitative methods for analyzing laboratory variables from multi-center clinical trial. METHODS: Two methods were proposed. One is to compare the proportions of persons whose values are clinical abnormal after treatment but normal before treatment. The other is to test the randomness of the difference of the values before and after treatment. RESULTS: Both of the methods can eliminate the difference between centers, as well as the difference between age groups and gender. The likelihood ratio test or Fisher's exact probability method should be used for first method, and u test or exact method based on binomial distribution with rate 0.5 for second method. CONCLUSION: In multi-center clinical trial, both qualitative and quantitative methods should be used for laboratory variables to evaluate the safety and tolerability of the drug being tested. |
| Keywords: | muhi-center clinical trial laboratory data qualitative analysis likelihood ratio test exact method |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |