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在使用克拉屈滨片治疗多发性硬化症的第一年中,早期出现的副作用:通俗易懂的总结。

Side effects that occurred early in people with multiple sclerosis during the first year of treatment with cladribine tablets: a plain language summary.

机构信息

Division of Neurology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Canada.

Department of Neurology, Duke University School of Medicine, Durham, NC, USA.

出版信息

Neurodegener Dis Manag. 2022 Feb 1;12(1):1-7. doi: 10.2217/nmt-2021-0041. Epub 2022 Jan 12.

DOI:10.2217/nmt-2021-0041
PMID:35019731
Abstract

People with multiple sclerosis (also shortened to MS) may have difficulties staying on treatment due to side effects. Cladribine tablets, approved for treating relapsing forms of MS, are given by mouth for four short periods over two years. The benefit of convenient dosing may be lost if side effects prevent people with MS from finishing their treatment. This is the summary of a study that examined side effects from cladribine tablets treatment in the first 12 weeks of two clinical studies called CLARITY and ORACLE-MS. Overall, 34.7% of participants who took cladribine tablets experienced drug-related side effects compared to 23.2% of participants who took placebo. Most side effects were mild and were seen in 54.8% of participants taking cladribine tablets and 59.1% taking the placebo. A low number of participants discontinued treatment due to side effects (1.6% of participants who took cladribine tablets; 1.4% of participants who took placebo). The researchers concluded that cladribine tablets are well-tolerated and people with MS are likely to complete the full treatment course. ClinicalTrials.gov NCT numbers: CLARITY study - NCT00213135 and ORACLE-MS study - NCT00725985.

摘要

多发性硬化症(简称 MS)患者可能会因副作用而难以坚持治疗。克拉屈滨片已获批准用于治疗复发型多发性硬化症,患者需在两年内分四个短周期口服给药。如果副作用使多发性硬化症患者无法完成治疗,那么这种方便的给药方式的益处可能会丧失。这是一项研究的总结,该研究在 CLARITY 和 ORACLE-MS 两项临床试验的前 12 周内检查了克拉屈滨片治疗的副作用。总体而言,与服用安慰剂的参与者(23.2%)相比,服用克拉屈滨片的参与者中有 34.7%出现了与药物相关的副作用。大多数副作用为轻度,服用克拉屈滨片的参与者中有 54.8%出现副作用,服用安慰剂的参与者中有 59.1%出现副作用。因副作用而停止治疗的参与者人数较少(服用克拉屈滨片的参与者中有 1.6%;服用安慰剂的参与者中有 1.4%)。研究人员得出结论,克拉屈滨片耐受性良好,多发性硬化症患者很可能会完成全部治疗疗程。ClinicalTrials.gov 注册号:CLARITY 研究-NCT00213135 和 ORACLE-MS 研究-NCT00725985。

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Side effects that occurred early in people with multiple sclerosis during the first year of treatment with cladribine tablets: a plain language summary.在使用克拉屈滨片治疗多发性硬化症的第一年中,早期出现的副作用:通俗易懂的总结。
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