Koch-Weser J, Sellers E M, Zacest R
Eur J Clin Pharmacol. 1977 Jan 3;11(2):75-8. doi: 10.1007/BF00562895.
Three clinical pharmacologists independently evaluated 500 untoward clinical events reported by physicians as adverse drug reactions (ADRs). They often disagreed with the reporting physicians and with each other. They judged 14.4-28.2% of the events to be definite, 26.4-38.0% probable, 21.4-31.0% possible and 15.8-28.2% of the events to be definite, 26.4-38.0% probable, 21.4-31.0% possible and 15.8-28.2% unlikely ADRs. In their opinion 19.1-32.4% of the drugs blamed were definitely, 29.8-34.4% probably, 24.9-36.7% possibly and 8.4-14.5% not responsible for the adverse reactions. Evaluators disagreed among themselves about the drug most likely to have been responsible in 36.4% of the events, about ADRs causing hospital admission in 56.8%, about severe ADR morbidity in 55.8%, about ADR prolongation of hospitalization in 67.3% and ADR prolongation of hospitalization in 67.3% and about ADR contribution to death in 71.0%. The divergence of judgements suggests that suspected ADRs are usually ambiguous clinical events, and that incidence, severity, medical consequences and cost of ADRs can only be estimated.
三位临床药理学家独立评估了医生报告的500起不良临床事件，这些事件被认定为药物不良反应（ADR）。他们常常与报告医生意见不一，彼此之间也存在分歧。他们判定14.4% - 28.2%的事件为肯定的药物不良反应，26.4% - 38.0%为很可能的，21.4% - 31.0%为可能的，15.8% - 28.2%为不太可能的药物不良反应。在他们看来，19.1% - 32.4%被归咎的药物肯定、29.8% - 34.4%很可能、24.9% - 36.7%可能、8.4% - 14.5%对不良反应不负有责任。评估者们在36.4%的事件中对最有可能导致不良反应的药物存在分歧，在56.8%导致住院的药物不良反应、55.8%严重药物不良反应发病率、67.3%药物不良反应导致住院时间延长以及71.0%药物不良反应导致死亡方面也存在分歧。判断的差异表明，疑似药物不良反应通常是模糊的临床事件，药物不良反应的发生率、严重程度、医学后果和成本只能进行估算。
