Alphs L D, Anand R
CNS Medical Affairs, Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA.
J Clin Psychiatry. 1999;60 Suppl 12:39-42.
Clozapine represents the "gold standard" therapy for treatment-resistant schizophrenia including use for symptom reduction and use in patients intolerant of extrapyramidal side effects associated with other antipsychotics. Despite its clear benefit in these areas, its use has been associated with a serious, and sometimes life-threatening, risk for agranulocytosis. Effective white blood cell monitoring systems have been developed by Novartis affiliates across the world to ensure its safe use and to meet local health standards. The goals of the monitoring programs include: (1) weekly white blood cell monitoring during the initial months of therapy for early detection of severe leukopenia; (2) immediate discontinuation of clozapine if severe leukopenia is observed; (3) exclusion from reexposure to clozapine if a patient experiences clozapine-induced agranulocytosis; and (4) early cessation of treatment if hematologic guidelines are not followed ("no blood, no drug" policy). Together, these systems have demonstrated a worldwide reduction in the observed rate of agranulocytosis and in fatalities related to the emergence of agranulocytosis when rigorous monitoring systems are in place.
氯氮平是难治性精神分裂症的“金标准”疗法，包括用于减轻症状以及用于对与其他抗精神病药物相关的锥体外系副作用不耐受的患者。尽管它在这些方面有明显益处，但其使用与严重的、有时甚至危及生命的粒细胞缺乏风险相关。诺华在全球的附属公司已开发出有效的白细胞监测系统，以确保其安全使用并符合当地卫生标准。监测计划的目标包括：（1）在治疗的最初几个月每周进行白细胞监测，以便早期发现严重白细胞减少症；（2）如果观察到严重白细胞减少症，立即停用氯氮平；（3）如果患者发生氯氮平引起的粒细胞缺乏症，则排除再次接触氯氮平；（4）如果不遵循血液学指导原则（“无血液检查，无药物治疗”政策），则尽早停止治疗。总体而言，当严格的监测系统到位时，这些系统已在全球范围内降低了观察到的粒细胞缺乏症发生率以及与粒细胞缺乏症出现相关的死亡率。
