Faculty of Medicine, Al-Azhar University, Cairo, Egypt.
Department of Pharmacotherapy, College of Pharmacy, The University of Utah, Salt Lake City, UT, USA.
Neurol Sci. 2023 Oct;44(10):3429-3442. doi: 10.1007/s10072-023-06869-8. Epub 2023 May 30.
The study aims to increase understanding of edaravone's efficacy and safety as an amyotrophic lateral sclerosis (ALS) treatment and provide significant insights regarding this field's future research.
We conducted a comprehensive search of the Embase, PubMed, Cochrane Library, Web of Science, and Scopus databases for randomized controlled trials and observational studies up until September 2022. We evaluated the studies' quality using the Cochrane risk of bias tool and the National Institutes of Health tool.
We included 11 studies with 2845 ALS patients. We found that edaravone improved the survival rate at 18, 24, and 30 months (risk ratio (RR) = 1.03, 95% confidence interval (CI) [1.02 to 1.24], P = 0.02), (RR = 1.22, 95% CI [1.06 to 1.41], P = 0.007), and (RR = 1.17, 95% CI [1.01 to 1.34], P = 0.03), respectively. However, the administration of edaravone did not result in any significant difference in adverse effects or efficacy outcomes between the two groups, as indicated by a P value greater than 0.05.
Edaravone improves survival rates of ALS patients at 18, 24, and 30 months with no adverse effects. However, edaravone does not affect functional outcomes. In order to ensure the validity of our findings and assess the results in accordance with the disease stage, it is essential to carry out additional prospective, rigorous, and high-quality clinical trials. The current study offers preliminary indications regarding the effectiveness and safety of edaravone. However, further comprehensive research is required to establish the generalizability and sustainability of the findings.
本研究旨在提高对依达拉奉治疗肌萎缩侧索硬化症(ALS)疗效和安全性的认识,并为该领域的未来研究提供重要见解。
我们对截至 2022 年 9 月的 Embase、PubMed、Cochrane 图书馆、Web of Science 和 Scopus 数据库进行了全面检索,以纳入随机对照试验和观察性研究。我们使用 Cochrane 偏倚风险工具和美国国立卫生研究院工具评估研究质量。
我们纳入了 11 项研究,共 2845 例 ALS 患者。我们发现依达拉奉可改善 18、24 和 30 个月时的生存率(风险比(RR)=1.03,95%置信区间(CI)[1.02 至 1.24],P=0.02),(RR=1.22,95% CI [1.06 至 1.41],P=0.007)和(RR=1.17,95% CI [1.01 至 1.34],P=0.03)。然而,依达拉奉在两组之间的不良反应或疗效结果方面并没有导致任何显著差异,这表明 P 值大于 0.05。
依达拉奉可提高 ALS 患者 18、24 和 30 个月时的生存率,且无不良反应。然而,依达拉奉对功能结局没有影响。为了确保我们研究结果的有效性并根据疾病阶段评估结果,需要开展更多前瞻性、严格和高质量的临床试验。本研究提供了依达拉奉有效性和安全性的初步证据。然而,需要进一步的综合研究来确定这些发现的普遍性和可持续性。