| 反向临床试验 |
| |
| 引用本文： | 王曙炎,秦定一,杨波,赵国龙. 反向临床试验[J]. 数理医药学杂志, 2006, 19(1): 10-13 |
| |
| 作者姓名： | 王曙炎 秦定一 杨波 赵国龙 |
| |
| 作者单位： | 河南省医学科学研究所,郑州,450052;河南省医学科学研究所,郑州,450052;河南省医学科学研究所,郑州,450052;河南省医学科学研究所,郑州,450052 |
| |
| 摘 要： | 目的:提出反向临床试验的基本原理和方法。方法:指定试药和所要治疗的疾病。按治疗效果将病人划分为成功组与可比的失败组,就试药服用比例在两组间进行比较。亦可选取成功病例,找出可比的失败病例,就曾否服用试药进行配对比较。结果:若成功组试药服用比例高于失败组并具有统计学意义,则有利于接受试药。结论:其操作方向与传统临床试验相反,两者为互补关系,结果相互印证。因此,反向临床试验可作为药物临床评价的方法之一。
|
| 关 键 词： | 临床试验 药物 样本量 统计学检验 疗效 |
| 文章编号： | 1004-4337（2006）01-0010-04 |
| 收稿时间： | 2005-04-25 |
| 修稿时间： | 2005-04-25 |
The Backward Clinical Trial |
| |
| Wang Shuyan, et al. The Backward Clinical Trial[J]. Journal of Mathematical Medicine, 2006, 19(1): 10-13 |
| |
| Authors: | Wang Shuyan et al |
| |
| Affiliation: | Henan Institute of Medical Sciences Zhengzhou , Zhengzhou 450052 |
| |
| Abstract: | Objective: This paper proposes the basic principles and methods of backward clinical trial.Methods: A tested drug and a treated disease are prescribed.Patients are divided into a winning group and a comparable losing one on the basis of therapeutic efficacy.The proportions of receiving the drug in the two groups are compared.Alternatively,the matched pairs are obtained by means of taking a winner and finding a comparable loser.The comparisons are aimed at whether the drug is received within the pairs.Results: It will be favring to accept the drug if the proportion in the winning group is higher than that in the losing one and the difference is statistically significant.Conclusion: Its operating orientation is reverse to that of the traditional clinical trial.They are complementary and can be mutually reconfirmed in results.The backward clinical trial can be a method for the clinical evaluation of drugs. |
| |
| Keywords: | clinical trial drug sample size statistical test therapeutic efficacy |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
|
