Mikhael N Z, Boggs M, Kacew S, Potvin D L
J Environ Pathol Toxicol Oncol. 1986 Mar-Apr;6(3-4):315-21.
Morphologic evaluation of tissue specimens from a hospital population was used to identify and classify adverse reactions to drugs. With the use of this novel technique, the incidence of adverse tissue reactions was found to be 3.6% out of which 1.5% were found to be definitely caused by a specific pharmacological agent. Adverse tissue reactions were both sex- and age-related occurring more often in women and more frequently between the ages of 51-60 years. Although adverse tissue reactions were noted less frequently in males, a definite causative agent was identified in over 50% of males in which a tissue reaction was observed. Endometrium and liver were the predominant tissues altered morphologically in our hospital population. Estrogenic preparations and alcohol were found to be most frequently implicated in the observed adverse tissue reactions. In comparison to the observation of symptoms associated with drug use, our study provides an alternate means of relating an adverse reaction to pharmacological agent employed in that subjective bias can successfully be removed. Although the present system described appears to be more rigorous in identification of adverse reactions, evidence indicates that tissue adverse reaction technique may be advantageous in determination of an unwanted response in patients under 60 years of age. It is hoped that the tissue adverse reaction evaluation may provide a more accurate prediction of possible adverse effects and perhaps may be a more reliable, sensitive system for estimation of adverse effects in hospitalized patients.
利用对医院人群组织标本的形态学评估来识别和分类药物不良反应。通过使用这种新技术,发现组织不良反应的发生率为3.6%,其中1.5%被确定是由特定药理剂明确引起的。组织不良反应与性别和年龄相关,在女性中更常见,在51至60岁之间更为频繁。虽然男性中组织不良反应的记录较少,但在观察到组织反应的男性中,超过50%确定了明确的致病因素。在我们的医院人群中,子宫内膜和肝脏是形态学上改变最主要的组织。雌激素制剂和酒精被发现最常与观察到的组织不良反应有关。与观察与药物使用相关的症状相比,我们的研究提供了另一种将不良反应与所用药理剂联系起来的方法,因为主观偏差可以成功消除。虽然所描述的现行系统在识别不良反应方面似乎更为严格,但有证据表明,组织不良反应技术在确定60岁以下患者的不良反应方面可能具有优势。希望组织不良反应评估能够对可能的不良反应提供更准确的预测,并且可能成为评估住院患者不良反应更可靠、更敏感的系统。