【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。更多还原

【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.更多还原