Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial | |
McKee, Justin B.1,2; Cottriall, Charles L.3; Elston, John3; Epps, Simon4; Evangelou, Nikos5; Gerry, Stephen6; Kennard, Christopher7; Kong, Yazhuo8,9; Koelewyn, Abigail1; Kueker, Wilhelm10; Leite, Maria Isabel1; Palace, Jacqueline1; Craner, Matthew1 | |
第一作者 | McKee, Justin B. |
通讯作者邮箱 | m craner([email protected]) |
摘要 | Background: Recent basic and clinical evidence suggests amiloride may be neuroprotective in multiple sclerosis (MS) through the blockade of the acid sensing ion channel (ASIC). Objective: To examine the neuroprotective efficacy of amiloride in acute optic neuritis (ON). Methods: A total of 48 patients were recruited to a phase 2, double blind, single site, randomised controlled trial. Scanning laser polarimetry (GDx) at 6 months was the primary outcome measure and optical coherence tomography (OCT) and visual and electrophysiological measures were secondary outcome measures. Participants aged 18-55 years, <= 28 days of onset of first episode unilateral ON, were randomised to amiloride (10 mg daily for 5 months) or placebo (, NCT 01802489). Results: Intention-to-treat (ITT) cohort consisted of 43 patients; 23 placebo and 20 amiloride. No significant drug-related adverse events occurred. No significant differences were found in GDx (p = 0.840). Visual evoked potentials (VEP) were significantly prolonged in the amiloride group compared to placebo (p = 0.004). All other secondary outcome measures showed no significant difference. Baseline analysis of OCT data demonstrated a significant pre-randomisation thinning of ganglion cell layer. Conclusion: Amiloride has not demonstrated any neuroprotective benefit within this trial paradigm, but future neuroprotective trials in ON should target the window of opportunity to maximise potential neuroprotective benefit. |
关键词 | Clinical trial outcome measurement multiple sclerosis axonal loss |
2019-02-01 | |
语种 | 英语 |
DOI | 10.1177/1352458517742979 |
发表期刊 | MULTIPLE SCLEROSIS JOURNAL |
ISSN | 1352-4585 |
卷号 | 25期号:2页码:246-255 |
期刊论文类型 | article |
收录类别 | SCI |
资助项目 | Multiple Sclerosis Society in the UK[952/11] |
出版者 | SAGE PUBLICATIONS LTD |
WOS关键词 | MULTIPLE-SCLEROSIS ; NEUROPROTECTION ; BRAIN ; MECHANISMS ; INJURY ; RISK |
WOS研究方向 | Neurosciences & Neurology |
WOS类目 | Clinical Neurology ; Neurosciences |
WOS记录号 | WOS:000457648700012 |
引用统计 | |
文献类型 | 期刊论文 |
条目标识符 | http://ir.psych.ac.cn/handle/311026/28314 |
专题 | 认知与发展心理学研究室 |
通讯作者 | Craner, Matthew |
作者单位 | 1.Univ Oxford, John Radcliffe Hosp, Nuffield Dept Clin Neurosci, Div Clin Neurol, Oxford, England 2.NHS Lothian, Princess Alexandra Eye Pavil, Edinburgh, Midlothian, Scotland 3.Oxford Univ Hosp NHS Fdn Trust, Oxford Eye Hosp, Oxford, England 4.Univ Bristol, Sch Clin Sci, Ophthalmol, Bristol, Avon, England 5.Univ Nottingham, Fac Med & Hlth Sci, Nottingham, England 6.Univ Oxford, Ctr Stat Med, Oxford, England 7.Univ Oxford, John Radcliffe Hosp, Med Sci Div, Oxford, England 8.Univ Oxford, Nuffield Dept Clin Neurosci, Oxford Ctr Funct Magnet Resonance Imaging Brain F, Oxford, England 9.Chinese Acad Sci, Inst Psychol, Beijing, Peoples R China 10.Oxford Univ Hosp NHS Fdn Trust, John Radcliffe Hosp, Dept Neuroradiol, Oxford, England |
推荐引用方式 GB/T 7714 | McKee, Justin B.,Cottriall, Charles L.,Elston, John,et al. Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial[J]. MULTIPLE SCLEROSIS JOURNAL,2019,25(2):246-255. |
APA | McKee, Justin B..,Cottriall, Charles L..,Elston, John.,Epps, Simon.,Evangelou, Nikos.,...&Craner, Matthew.(2019).Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial.MULTIPLE SCLEROSIS JOURNAL,25(2),246-255. |
MLA | McKee, Justin B.,et al."Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial".MULTIPLE SCLEROSIS JOURNAL 25.2(2019):246-255. |
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