Department of Pediatrics, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.
Mod Rheumatol. 2011 Oct;21(5):449-57. doi: 10.1007/s10165-011-0451-6. Epub 2011 Apr 16.
We created the final bill of "Intravenous cyclophosphamide (IVCY) for the treatment of rheumatic disease of children in general" in order to get approval for the off-label use of IVCY from the Study Group on Pediatric Drug Therapy. As a result, this study group approved IVCY's off-label use in children via public applications. We could create IVCY regimen specific for Japanese children independently of the efficacy, dosage, and administration applied in Germany, which at the time of application was the only country in Europe and the USA where IVCY was approved. Later, its use in adults was given approval through public applications after being fully reviewed by the Study Group on Unapproved and Off-label Drugs of High Medical Need. Consequently, IVCY is now available for the treatment of both childhood and adult rheumatic diseases in general.
我们制定了“静脉注射环磷酰胺（IVCY）治疗儿科风湿病的最终方案”，以便获得儿科药物治疗研究小组对 IVCY 超说明书使用的批准。结果，该研究小组通过公开申请批准了 IVCY 在儿童中的超说明书使用。我们可以独立于德国应用的疗效、剂量和管理方式，为日本儿童制定特定的 IVCY 方案，而当时德国是欧洲和美国唯一批准 IVCY 使用的国家。之后，在高医疗需求未批准和超说明书药物研究小组充分审查后，通过公开申请批准了其在成人中的使用。因此，IVCY 现在可用于治疗儿童和成人的一般风湿病。
