Heimpel H
Department of Internal Medicine (Haematology/Oncology), University of Ulm, Germany.
Eur J Haematol Suppl. 1996;60:11-5. doi: 10.1111/j.1600-0609.1996.tb01639.x.
Blood dyscrasias account for only a minor fraction of all adverse drug reactions (ADRs), but are relevant because of their relatively high morbidity and mortality. For the majority of drugs, the magnitude of risk is low enough to remain undetected until wider distribution of the drug takes place. Thus, only post-marketing studies, carried out with appropriate methodology and sufficient statistical power, will allow the risk of serious haematological side-effects of new drugs to be ascertained. Publication of carefully studied and thoroughly described single case studies and reports to registries are necessary to detect new associations between drugs and blood dyscrasias, while only large cohort or case-control studies are suited to quantify the risks. Physicians managing a newly detected blood dyscrasia should be aware that it may be drug-induced. They should assess the exact diagnosis, obtain and thoroughly document a detailed exposure history and follow the blood counts after withdrawal of all potentially relevant agents. The recognition and appropriate management of the problem in individual cases is the basis for both effective patient care and the quality of subsequent pharmaco-epidemiological evaluation.
血液系统异常仅占所有药物不良反应（ADR）的一小部分，但因其相对较高的发病率和死亡率而备受关注。对于大多数药物而言，风险程度较低，在药物广泛使用之前一直未被发现。因此，只有采用适当方法并具备足够统计效力的上市后研究，才能确定新药严重血液学副作用的风险。发表经过仔细研究和详尽描述的单病例研究以及向登记处报告，对于发现药物与血液系统异常之间的新关联至关重要，而只有大型队列研究或病例对照研究才适合对风险进行量化。处理新发现的血液系统异常的医生应意识到这可能是药物所致。他们应评估确切诊断，获取并详尽记录详细的用药史，并在停用所有潜在相关药物后跟踪血细胞计数。在个体病例中对该问题的识别和适当处理，是有效患者护理以及后续药物流行病学评估质量的基础。
