Brochet B, Lemaire G, Beddiaf A
Département de Neurologie, Fédération des Neurosciences Cliniques du CHU de Bordeaux, Hôpital Pellegrin, Bordeaux.
Rev Neurol (Paris). 2006 Jun;162(6-7):735-40. doi: 10.1016/s0035-3787(06)75071-8.
To compare occurrence of injection site reactions (ISRs) in patients with relapsing remitting multiple sclerosis (RRMS) newly started on interferon beta 1b (Betaferon), using 3 delivery methods.
A randomized, multicenter, phase IV, open label cross-over study was performed in 82 sites in France on 294 patients with RRMS beginning a treatment with interferon beta 1b. For the first month all patients used a standard injection technique. They then used an autoinjector, Betaject or Betaject Light, for one month each, according to the cross-over design. Primary outcome was defined as the percentage of injections sites with ISR evaluated by the investigator. Secondary endpoints included graduation of ISR, using a five-point scale by both investigators and patients, injection related pain assessed by patients, percentage of patients without ISR and a global evaluation by patients of injection devices.
The percentage of ISRs were significantly reduced (p<0.0001) when using either Betaject or Betaject light (24.1 percent and 24.1 percent respectively) compared with the standard technique (35.9 percent). No significant difference was seen between the 2 autoinjectors. The mean ISR intensity scores according to physician or patient were significantly reduced (p<0.0001 for each) by the 2 autoinjectors compared to the standard injection technique. No significant difference on the pain scale comparing respectively the standard, Betaject and Betaject light techniques but the mean level of pain was less than 1.2/10. In addition, the percentage of ISR-free patients was significantly lower with the standard injection technique phase (52.4 percent) than with autoinjector use (respectively 68.1 and 66.7 percent). A non significant higher percentage of patients subjectively preferred Betaject (53.7 percent) than to Betaject light (46.3 percent). The main other adverse events reported were flu-like symptoms (30.7 percent), transient and moderate increase of transaminases (4.8 percent) and headache (4.4 percent).
We conclude that autoinjector use reduces the occurrence of ISR during IFNB-1b therapy in RRMS.
比较复发缓解型多发性硬化症（RRMS）患者新开始使用干扰素β-1b（倍泰龙）时，三种给药方式下注射部位反应（ISR）的发生率。
在法国的82个地点对294例开始使用干扰素β-1b治疗的RRMS患者进行了一项随机、多中心、IV期、开放标签交叉研究。第一个月所有患者采用标准注射技术。然后根据交叉设计，他们分别使用自动注射器（Betaject）或轻便型自动注射器（Betaject Light）各一个月。主要结局定义为研究者评估的发生ISR的注射部位的百分比。次要终点包括ISR的分级（研究者和患者均使用五点量表）、患者评估的注射相关疼痛、无ISR患者的百分比以及患者对注射装置的总体评价。
与标准技术（35.9%）相比，使用Betaject或Betaject Light时ISR的百分比显著降低（p<0.0001）（分别为24.1%和24.1%）。两种自动注射器之间未见显著差异。与标准注射技术相比，两种自动注射器使医生或患者评估的ISR平均强度评分显著降低（每种情况p<0.0001）。在疼痛量表上，标准技术、Betaject和Betaject Light技术之间无显著差异，但平均疼痛水平低于1.2/10。此外，标准注射技术阶段无ISR患者的百分比（52.4%）显著低于使用自动注射器时（分别为68.1%和66.7%）。主观上，更喜欢Betaject的患者百分比（53.7%）略高于Betaject Light（46.3%），但差异无统计学意义。报告的其他主要不良事件为流感样症状（30.7%）、转氨酶短暂中度升高（4.8%）和头痛（4.4%）。
我们得出结论，在RRMS患者的IFNB-1b治疗期间，使用自动注射器可减少ISR的发生。
