PDF(Pubmed)
Abstract：
Background: Fingolimod is approved in relapsing-remitting multiple sclerosis (RRMS) with the recommended dose of 0.5 mg daily. To tackle possible adverse events, some clinicians may reduce the dose of fingolimod, mainly in the alternate-day form. We systematically reviewed the literature for efficacy measures of this method. Methods: PubMed (Medline®), Web of Science, Embase, Scopus, and the Cochrane Library databases were searched until April 9, 2021. Clinical studies (other than case reports and case series), in English, were included. Then, publications concerning alternate dose fingolimod (including every other day, every two or three days) were selected. Those studies concerning reduced daily dose (any daily dose less than 0.5 mg/day) were excluded to focus on alternate dosing. Results: Four observational studies were included. Data on Ohtani et al. study were limited. Three other studies were of good quality based on the Newcastle-Ottawa Scale. A total of 296 patients on the standard dose were compared to 276 patients on the alternate dosage. The most common reason for switching to the alternate dose was lymphopenia, followed by elevated liver enzymes. Two studies concluded that the alternate dosing could be a safe, yet effective strategy in patients with intolerable adverse effects of daily dose. However, Zecca et al. warned about the high possibility of disease reactivation. Due to the differences in outcome measures of the studies, meta-analysis was not applicable. Conclusion: This systematic review highlights the ambiguity of evidence on safety and efficacy of alternate dosing of fingolimod, encouraging further research on the subject.
摘要：
背景：芬戈莫德被批准用于复发缓解型多发性硬化症（RRMS），推荐剂量为每天0.5mg。为了解决可能的不良事件，一些临床医生可能会减少芬戈莫德的剂量，主要是隔日形式。我们系统地回顾了这种方法的疗效测量文献。方法：PubMed（Medline®），WebofScience,Embase,Scopus,和Cochrane图书馆数据库被搜索到2021年4月9日。临床研究（病例报告和病例系列除外）在英语中,包括在内。然后，关于交替剂量芬戈莫德的出版物(包括每隔一天，每两三天)选择一次。排除那些关于减少日剂量(任何日剂量小于0.5mg/天)的研究,以关注替代给药。结果：纳入4项观察性研究。Ohtani等人的数据。研究有限。根据纽卡斯尔-渥太华量表，其他三项研究质量良好。将总共296名标准剂量患者与276名替代剂量患者进行比较。转换为替代剂量的最常见原因是淋巴细胞减少，其次是肝酶升高。两项研究得出结论，交替给药可能是安全的，然而，对于每日剂量不可耐受的不良反应患者的有效策略。然而,Zecca等人。警告疾病重新激活的可能性很高。由于研究结果指标的差异，荟萃分析不适用。结论：本系统评价强调了芬戈莫德替代给药的安全性和有效性的证据的模糊性。鼓励对该主题进行进一步研究。
