Gaines A R, Varricchio F
Division of Biostatistics and Epidemiology, Food and Drug Administration, Rockville, Maryland 20852-1448, USA.
Mult Scler. 1998 Apr;4(2):70-3. doi: 10.1177/135245859800400205.
We conducted a comprehensive review of selected adverse event reports that were submitted to the Food and Drug Administration (FDA) for interferon beta-1b during the first 30 months following licensure. The adverse events reviewed were injection site reactions, injection site necroses, and non-injection site necroses. These adverse events were selected because of the relative frequency of injection site reactions and because of the severity and sequelae of certain injection site and non-injection site necroses. Our review enabled us to characterize the clinical presentation and the treatment received, which were not described in the package insert or by the IFN beta (interferon beta-1b) Multiple Sclerosis Study Group publication. The time of onset of the adverse events ranged from 1-29 months after initiation of interferon beta-1b treatment, with a mean of 1 month. In general, the more clinically significant adverse events (i.e., injection site necrosis and non-injection site necrosis) developed more slowly than the injection site reactions. Greater than 85% of the adverse events presented with one or two signs/symptoms, although the number of signs/ symptoms ranged from 1-8. No predominance of treatments for the adverse events was observed. The most striking finding was that the overall sex ratio, which could be due to reporting artifacts, was 8.1:1 female:male.
我们对在许可后的头30个月内向美国食品药品监督管理局（FDA）提交的有关干扰素β-1b的选定不良事件报告进行了全面审查。审查的不良事件包括注射部位反应、注射部位坏死和非注射部位坏死。选择这些不良事件是因为注射部位反应的相对频率以及某些注射部位和非注射部位坏死的严重性和后遗症。我们的审查使我们能够描述临床症状和接受的治疗情况，这些在包装说明书或干扰素β（干扰素β-1b）多发性硬化症研究组的出版物中均未描述。不良事件的发病时间为开始使用干扰素β-1b治疗后的1至29个月，平均为1个月。一般来说，临床上更严重的不良事件（即注射部位坏死和非注射部位坏死）比注射部位反应发展得更慢。超过85%的不良事件表现为一两种体征/症状，尽管体征/症状的数量范围为1至8种。未观察到针对不良事件的治疗方法存在优势。最显著的发现是，总体性别比为女性:男性 = 8.1:1，这可能是由于报告偏差所致。
