反向临床试验  

The Backward Clinical Trial

作　　者：王曙炎[1] 秦定一[1] 杨波[1] 赵国龙[1] 

机构地区：[1]河南省医学科学研究所,郑州450052

出　　处：《数理医药学杂志》2006年第1期10-13,共4页Journal of Mathematical Medicine

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。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.

关 键 词：临床试验 药物 样本量 统计学检验 疗效 

分 类 号：R969.4[医药卫生—药理学] R311[医药卫生—药学]