Pacheco Rafael Leite, Latorraca Carolina de Oliveira Cruz, da Silva Luciana Di Giovanni Marques, Ferreira Daniel Barbuda Guimaraes de Meneses, Fernandes Cristiano de Abreu Amorim, Hosni Nicole Dittrich, Cabrera Martimbianco Ana Luiza, Vianna Pachito Daniela, Riera Rachel
Evidence Based Health Program at Universidade Federal de São Paulo, Sao Paulo, Brazil.
Cochrane Brazil, São Paulo, Brazil.
Int J Clin Pract. 2019 Feb;73(2):e13295. doi: 10.1111/ijcp.13295. Epub 2018 Dec 11.
Stroke is a major cause of death and disability worldwide. The use of modafinil, a wakefulness-promoting agent, is hypothesised to benefit stroke patients.
We performed a systematic review in accordance with the Cochrane Handbook for Systematic Reviews of Interventions recommendations to assess the efficacy and safety of modafinil in poststroke patients. We prospectively registered the review protocol in PROSPERO (CRD42017078465) and reported the systematic review following the PRISMA statement.
Two published studies (77 participants) and one ongoing randomised controlled trial, with limited methodological quality, assessed the effects of modafinil (200 mg or 400 mg) for adults from 14 days poststroke up to 3 months poststroke and fulfilled our inclusion criteria. The clinical and methodological variability between studies precluded meta-analyses. Overall, these studies showed some benefit of modafinil for fatigue, but no benefit for disability, cognition, and for subscores of stroke-specific quality of life. Data for adverse events were scarce and mortality was not considered by studies. Due to very low quality related to the evidence, we are uncertain about the effects of modafinil for all outcomes assessed by our systematic review.
Based on two small randomised controlled trial, which provided very low quality evidence, the effects (benefits and harms) of modafinil for stroke patients are unclear and do not support its routinely use in clinical practice for this clinical situation. Number of Protocol registration in PROSPERO database: CRD42017078465 (available from http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017078465).
中风是全球范围内导致死亡和残疾的主要原因。促觉醒药物莫达非尼的使用被认为可能对中风患者有益。
我们按照《Cochrane系统评价干预措施手册》的建议进行了一项系统评价，以评估莫达非尼对中风后患者的疗效和安全性。我们在PROSPERO（CRD42017078465）中前瞻性地注册了该评价方案，并按照PRISMA声明报告了系统评价结果。
两项已发表的研究（77名参与者）和一项正在进行的随机对照试验，方法学质量有限，评估了莫达非尼（200毫克或400毫克）对中风后14天至3个月的成年人的影响，符合我们的纳入标准。研究之间的临床和方法学差异使得无法进行荟萃分析。总体而言，这些研究显示莫达非尼对疲劳有一定益处，但对残疾、认知和中风特异性生活质量的子评分没有益处。不良事件的数据稀少，研究未考虑死亡率。由于证据质量极低，我们不确定莫达非尼对我们系统评价中评估的所有结局的影响。
基于两项小型随机对照试验，其提供的证据质量极低，莫达非尼对中风患者的影响（益处和危害）尚不清楚，不支持在这种临床情况下将其常规用于临床实践。PROSPERO数据库中的方案注册号：CRD42017078465（可从http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017078465获取）。
