关键词: infusion reactions multiple sclerosis ocrelizumab patient reported outcomes pre-medication

Mesh : Humans Diphenhydramine / administration & dosage therapeutic use Cetirizine / adverse effects administration & dosage therapeutic use Female Male Adult Middle Aged Antibodies, Monoclonal, Humanized / adverse effects therapeutic use administration & dosage Infusions, Intravenous / adverse effects Multiple Sclerosis / drug therapy

来  源:   DOI:10.3390/medicina60040659   PDF(Pubmed)

Abstract:
Background: Ocrelizumab is an effective medication for multiple sclerosis. However, infusion-related reactions (IRRs) are a concern for patients and may lead to discontinuation of ocrelizumab. To minimize IRRs, pre-medications are administered. However, from our experience, these medications, especially diphenhydramine, can cause marked drowsiness. The primary objective of this study was to evaluate whether cetirizine is non-inferior to diphenhydramine in limiting the proportion and severity of reactions from ocrelizumab infusions. Methods: Twenty participants were serially randomized in a 1:1 ratio to receive 10 mg of cetirizine or 25 mg of diphenhydramine orally prior to their first three ocrelizumab infusions. Results: The rate of IRRs in this study was similar across both treatment groups with no increase in the risk of severity, and no grade 3 IRRs. Further, patients receiving cetirizine experienced a reduction in fatigue. While there was not a significant difference in global satisfaction, this score increased over time in the cetirizine arm while it remained unchanged in the diphenhydramine arm. Conclusions: Overall, our results suggest that cetirizine does not increase the risk of infusion-related reactions compared to diphenhydramine.
摘要:
背景:Ocrelizumab是治疗多发性硬化症的有效药物。然而,输注相关反应(IRRs)是患者关注的问题,可能导致奥克瑞珠单抗停药.为了最小化内部收益率,服用前药物。然而,根据我们的经验,这些药物,尤其是苯海拉明,会导致明显的困倦。这项研究的主要目的是评估西替利嗪在限制奥克瑞珠单抗输注反应的比例和严重程度方面是否不劣于苯海拉明。方法:20名参与者以1:1的比例连续随机接受10mg西替利嗪或25mg苯海拉明的口服,然后进行前3次ocrelizumab输注。结果:本研究中两个治疗组的IRR率相似,严重程度风险没有增加,没有3级IRR。Further,接受西替利嗪治疗的患者疲劳减轻.虽然全球满意度没有显著差异,西替利嗪组的这一评分随着时间的推移而增加,而苯海拉明组的这一评分保持不变.结论:总体而言,我们的结果表明,与苯海拉明相比,西替利嗪不会增加输液相关反应的风险.
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