Rose M, McMahon F G
Genentech, Inc., Washington, D.C.
Am J Hypertens. 1990 Feb;3(2):151-5. doi: 10.1093/ajh/3.2.151.
A dose-response analysis establishes the efficacy of most drugs. The medical literature is replete with so-called "Dose-Responses" to antihypertensive agents. The majority of these have failed. The use of a placebo helps minimize bias, though most studies here simply compared a test drug with the old drug. Short-acting drugs can have their duration of effect prolonged by giving larger doses than necessary. In order to produce more meaningful data, the Food and Drug Administration gathered together a group of experts who collectively proposed a set of Guidelines for studying these drugs. Though the final version has not yet been issued, investigators and clinicians working with this class of drugs are vitally interested in these guidelines, and have already encountered several problems. We identify some of these problems and propose some solutions.
剂量反应分析可确定大多数药物的疗效。医学文献中充斥着对抗高血压药物的所谓“剂量反应”。其中大多数都失败了。使用安慰剂有助于将偏倚降至最低，不过这里的大多数研究只是将受试药物与旧药进行比较。通过给予比必要剂量更大的剂量，短效药物的作用持续时间可以延长。为了得出更有意义的数据，美国食品药品监督管理局召集了一组专家，他们共同提出了一套研究这类药物的指南。尽管最终版本尚未发布，但从事这类药物研究的调查人员和临床医生对这些指南极为关注，并且已经遇到了一些问题。我们找出了其中一些问题并提出了一些解决方案。
