Sobotka J L, Alexander B, Cook B L
University of Iowa, College of Pharmacy, Iowa City 52242.
DICP. 1990 Dec;24(12):1166-8. doi: 10.1177/106002809002401203.
Early case reports of fatal hematologic effects associated with carbamazepine (CBZ) resulted in manufacturer recommendations for extensive laboratory monitoring. Several alternative monitoring protocols have been published, indicating disagreement with those recommendations. The manufacturer has removed specific monitoring guidelines allowing physicians to monitor CBZ during treatment based on their clinical judgment. This study was designed to determine the frequency of CBZ hematologic monitoring in one academic setting. Data on complete blood counts (CBCs) were retrospectively obtained and were compared with 1975-88 Physicians' Desk Reference recommendations for weekly CBCs during the first three months of treatment. Eighty-three patients were identified: 32 psychiatry, 37 neurology, and 14 from other clinics. Only one patient met guidelines for monitoring during the entire first three months of treatment. Comparisons between clinics demonstrated no statistically significant differences in monitoring rates. Prospective studies in academic and private practice settings are needed to provide more information on actual monitoring practices. Due to the removal of specific manufacturer recommendations, a standard approach is needed to establish consistent and adequate monitoring and to provide legal support to prescribers.
早期有与卡马西平(CBZ)相关的致命血液学效应的病例报告,这导致制造商建议进行广泛的实验室监测。已经发表了几种替代监测方案,表明与这些建议存在分歧。制造商已取消特定的监测指南,允许医生根据临床判断在治疗期间监测CBZ。本研究旨在确定在一种学术环境中CBZ血液学监测的频率。回顾性获取全血细胞计数(CBC)数据,并与1975 - 1988年《医师案头参考》中关于治疗前三个月每周进行CBC的建议进行比较。确定了83名患者:32名来自精神病科,37名来自神经科,14名来自其他诊所。在治疗的整个前三个月中,只有一名患者符合监测指南。各诊所之间的比较表明监测率没有统计学上的显著差异。需要在学术和私人执业环境中进行前瞻性研究,以提供更多关于实际监测做法的信息。由于制造商取消了特定建议,需要一种标准方法来建立一致且充分的监测,并为开处方者提供法律支持。