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Some problems in the interpretation of clinical trials: longterm parallel study of fenoprofen in rheumatoid arthritis.

作者信息

Fries J F, Britton M C

出版信息

J Rheumatol. 1976;2:61-5.

PMID:781232
Abstract

Fenoprofen calcium was compared with acetylsalicylic acid in the treatment of 27 patients with definite or classic rheumatoid arthritis, over a period of one year. Both drugs appeared efficacious, with a slight edge to fenoprofen in the doses employed. Fewer side effects were noted with fenoprofen. Effectiveness continued undiminished throughout the year, and mean values of most parameters continued to improve in both groups over the entire period. Three problems which influence extrapolation of results from this and similar studies to the general setting are discussed. (1) Individual patients show great variation from the mean and from one observation point to another. Thus, expectations developed from mean values will seldom be accurate in a particular patient. (2) The relative doses chosen for two drugs in the clinical trial can profoundly influence both efficacy and toxicity. The qualification "at the doses employed" is seldom emphasized in clinical reports. (3) Patient compliance in the general clinical setting is importantly different from that in a clinical trial, and this potential problem must be assessed by the physician choosing an appropriate medication for a particular patient.

摘要

相似文献

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引用本文的文献

1
ARAMIS (the American Rheumatism Association Medical Information System). A prototypical national chronic-disease data bank.ARAMIS(美国风湿病协会医学信息系统)。一个典型的国家级慢性病数据库。
West J Med. 1986 Dec;145(6):798-804.
2
Fenoprofen: a review of its pharmacological properties and therapeutic efficacy in rheumatic diseases.非诺洛芬:其药理特性及在风湿性疾病中治疗效果的综述
Drugs. 1977 Apr;13(4):241-65. doi: 10.2165/00003495-197713040-00001.