特立氟米特与富马酸二甲酯治疗复发-缓解型多发性硬化的疗效和安全性比较

IF 1.7 Q4 NEUROSCIENCES Neurology Research International Pub Date : 2021-07-15 eCollection Date: 2021-01-01 DOI:10.1155/2021/6679197
Nasim Nehzat, Omid Mirmosayyeb, Mahdi Barzegar, Reza Vosoughi, Erfane Fazeli, Vahid Shaygannejad
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引用次数: 1

摘要

背景:本观察性研究的目的是调查两种已获批准的口腔疾病改善疗法(DMTs)在缓解复发性多发性硬化症(RRMS)患者中的疗效和安全性:富马酸二甲酯(DMF)和特立氟米特(TRF)。方法:共纳入159例RRMS患者,其中TRF组82例,DMF组77例。在我们的研究入组前的两年期间,对扩展残疾状态量表(EDSS)、确认残疾改善(CDI)、确认残疾进展(CDP)和年复发率(ARR)进行评估。记录药物相关不良反应(ae)。我们采用倾向匹配评分法比较TRF和DMF的疗效。结果:经混杂因素匹配后,TRF-与dmf -处理组EDSS (P值= 0.54)、CDI (P值= 0.80)、CDP (P值= 0.39)、ARR (P值>0.05)差异无统计学意义。2例(2.43%)患者因纵隔炎和肝功能障碍停药,1例(1.29%)患者因抑郁停药。trf治疗组不良事件发生率为81.4%,其中头发稀疏(脱发)(62.9%)、指甲脱落(20.9%)和转氨酶升高(14.8%)是最常见的不良事件;在dmf治疗的患者中,不良反应发生率为88.2%,主要表现为潮红(73.2%)、瘙痒(16.9%)和腹痛(16.9%)。结论:根据我们的研究结果,在我们的伊朗研究人群中,DMF与TRF治疗RRMS一样有效和安全。多中心研究需要在其他人群中证实这些发现。
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Comparable Efficacy and Safety of Teriflunomide versus Dimethyl Fumarate for the Treatment of Relapsing-Remitting Multiple Sclerosis.

Background: The aim of this observational study is to investigate the efficacy and safety of two approved oral disease-modifying therapies (DMTs) in patients with remitting-relapsing multiple sclerosis (RRMS): dimethyl fumarate (DMF) vs. teriflunomide (TRF).

Methods: A total of 159 RRMS patients (82 on TRF and 77 on DMF) were included. The expanded disability status scale (EDSS), confirmed disability improvement (CDI), confirmed disability progression (CDP), and annualized relapse rate (ARR) were evaluated for the two-year period prior to enrollment in our study. The drug-associated adverse effects (AEs) were recorded. We conducted propensity matching score to compare the efficacy between TRF and DMF.

Results: After matching for the confounders, TRF- and DMF-treated groups were not different in terms of EDSS (P value = 0.54), CDI (P value = 0.80), CDP (P value = 0.39), and ARR (P value >0.05). TRF discontinuation occurred in 2 patients (2.43%) due to mediastinitis and liver dysfunction, while a patient (1.29%) discontinued DMF due to depression. Incidence rate of AEs in the TRF-treated group was 81.4%: hair thinning (hair loss) (62.9%), nail loss (20.9%), and elevated aminotransferase (14.8%) were the most common AEs; in DMF-treated patients, AEs were 88.2% with predominance of flushing (73.2%), pruritus (16.9%), and abdominal pain (16.9%).

Conclusion: Based on our findings, DMF is as efficacious and safe as TRF for the treatment of RRMS in our Iranian study population. Multicentric studies need to corroborate these findings in other populations.

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来源期刊
CiteScore
3.50
自引率
0.00%
发文量
10
审稿时长
17 weeks
期刊介绍: Neurology Research International is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies focusing on diseases of the nervous system, as well as normal neurological functioning. The journal will consider basic, translational, and clinical research, including animal models and clinical trials.
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