McEwen John, Purcell Patrick M, Hill Richard L, Calcino Lisa J, Riley Cathy G
Department of Executive Office, Therapeutic Goods Administration, Woden, Australian Capital Territory, Australia.
Pharmacoepidemiol Drug Saf. 2007 Jan;16(1):65-73. doi: 10.1002/pds.1236.
To estimate the incidence of pancytopenia in patients taking leflunomide with or without methotrexate in Australia.
Review of spontaneous reports to the Australian Adverse Drug Reactions Advisory Committee (ADRAC); estimation of incidence using national prescription reimbursement data; concomitant exposure to methotrexate was estimated using three sources of information.
ADRAC received 11 reports of pancytopenia (meeting predefined criteria) associated with the use of leflunomide during its first 31 months of marketing. In nine reports, the patients were also taking methotrexate. Estimates of incidence in patients taking leflunomide alone ranged from 1 in 3698 to 1 in 4582 patients exposed; for patients also taking methotrexate the estimates ranged from 1 in 575 to 1 in 822.
Use of methotrexate with leflunomide increases the risk of pancytopenia compared with use of leflunomide alone. The haematological toxicity of the combination requires further study.
评估在澳大利亚服用来氟米特（无论是否联用甲氨蝶呤）的患者中全血细胞减少症的发生率。
回顾向澳大利亚药物不良反应咨询委员会（ADRAC）提交的自发报告；利用国家处方报销数据估算发生率；通过三种信息来源估算甲氨蝶呤的合并暴露情况。
在来氟米特上市的前31个月中，ADRAC收到11例（符合预定义标准）与使用来氟米特相关的全血细胞减少症报告。在9例报告中，患者同时服用了甲氨蝶呤。单独服用来氟米特患者的发生率估计为每3698至4582例暴露患者中有1例；同时服用甲氨蝶呤的患者发生率估计为每575至822例中有1例。
与单独使用来氟米特相比，来氟米特与甲氨蝶呤联用会增加全血细胞减少症的风险。该联合用药的血液学毒性需要进一步研究。
