Emergency Department, Chengdu University of Traditional Chinese Medicine Affiliated Hospital, Chengdu, China.
General Practice Department, Chengdu University of Traditional Chinese Medicine Affiliated Hospital, Chengdu, Sichuan, China.
BMJ Open. 2021 May 10;11(5):e043585. doi: 10.1136/bmjopen-2020-043585.
Despite the continuous improvement in modern medical treatment, stroke is still a leading cause of death and disability worldwide. How to effectively improve the survival rate and reduce disability in patients who had a stroke has become the focus of many investigations. Recent findings concerning the benefits of glibenclamide as a neuroprotective drug have initiated a new area for prospective studies on the effects of sulfonylureas. Given the high mortality and disability associated with stroke, it is essential to weigh the benefits of neuroprotective drugs against their safety. Therefore, the objective of the current study is to conduct a systematic review using meta-analysis to assess the benefits and safety of glibenclamide as a neuroprotective drug.
This study will analyse randomised clinical trials (RCTs) and observational studies published up to 31 December 2020 and include direct or indirect evidence. Studies will be retrieved by searching PubMed, EMBASE, Web of Science, the Cochrane Library and China National Knowledge Infrastructure (CNKI) and WanFang Databases. The outcomes of this study will be mortality, scores from the Modified Rankin Scale and the occurrence of hypoglycaemic events. The risk of bias will be assessed using the Cochrane risk of bias assessment instrument for RCTs. A random-effect/fixed-effect model will be used to summarise the estimates of the mean difference/risk ratio using a 95% CI.
This meta-analysis is a secondary research project, which is based on previously published data. Therefore, ethical approval and informed consent were not required for this meta-analysis. The results of this study will be submitted to a peer-reviewed journal for publication.
CRD42020144674.
尽管现代医学治疗不断进步,但中风仍然是全球范围内导致死亡和残疾的主要原因。如何有效提高中风患者的生存率并降低残疾程度已成为许多研究的焦点。最近关于格列本脲作为神经保护药物的益处的发现,为磺酰脲类药物的作用的前瞻性研究开辟了一个新领域。鉴于中风相关的高死亡率和残疾率,权衡神经保护药物的益处与安全性至关重要。因此,本研究的目的是通过系统评价和荟萃分析来评估格列本脲作为神经保护药物的益处和安全性。
本研究将分析截至 2020 年 12 月 31 日发表的随机临床试验 (RCT) 和观察性研究,并纳入直接或间接证据。研究将通过搜索 PubMed、EMBASE、Web of Science、Cochrane 图书馆和中国国家知识基础设施 (CNKI) 和万方数据库进行检索。本研究的结局指标为死亡率、改良 Rankin 量表评分和低血糖事件的发生。使用 Cochrane 偏倚风险评估工具评估 RCT 的偏倚风险。使用随机效应/固定效应模型,使用 95%置信区间总结均数差/风险比的估计值。
这项荟萃分析是一项二次研究项目,基于已发表的数据。因此,这项荟萃分析不需要伦理批准和知情同意。本研究的结果将提交给同行评审期刊发表。
PROSPERO 注册号:CRD42020144674。