Beijing University of Chinese Medicine.
Dongfang Hospital Beijing University of Chinese Medicine, No. 6 Fangxingyuan 1st Block, Fengtai District, Beijing City 100078, PR China.
Medicine (Baltimore). 2021 Mar 12;100(10):e25004. doi: 10.1097/MD.0000000000025004.
Acute ischemic stroke (AIS) is an important factor leading to adult death and disability globally. For AIS patients who meet certain conditions, recombinant tissue plasminogen activator (rt-PA) intravenous thrombolysis is an important method recommended by national guidelines to achieve vascular recanalization. However, complications such as hemorrhagic transformation and vascular reocclusion after thrombolysis are still unsolved problems in clinical. Several systematic reviews of clinical randomized controlled trials (RCTs) in the past have shown that Chinese herbal injections (CHIs) can improve the neurological function of patients, increase the tolerance of ischemic tissues to hypoxia, and inhibit platelet aggregation. Therefore, this study conducted a meta-analysis of AIS treatment with intravenous thrombolysis alone and compared it with the combined application of CHIs. To evaluate whether CHIs have a synergistic effect on thrombolytic therapy and provide a basis for clinical application.
The following databases will be searched until September 2020: ①English databases: PubMed, Cochrane Library, Embase; ②Chinese databases: CNKI, Wanfang database, Weipu database, SinoMed. RCTs will be included to compare the efficacy of thrombolysis combined with CHIs and thrombolysis alone in the treatment of AIS. Data extraction and risk of bias assessments will be carried out by 2 verifiers independently. The risk of bias will be evaluated through the Cochrane risk of bias tool. Review Manager software 5.3 will be used for statistical analysis.
This study will provide comprehensive evidence for the treatment of AIS by CHIs combined with intravenous thrombolysis from multiple aspects.
The conclusion of the meta-analysis will provide a basis for judging whether CHIs combined with intravenous thrombolysis is an effective measure for the treatment of AIS.
Ethical approval is not needed because this study will be based on data that already published. We will publish the findings of this study in a peer-reviewed journal and related conferences.
CRD42020215546.
急性缺血性脑卒中（AIS）是全球导致成人死亡和残疾的重要因素。对于符合一定条件的 AIS 患者，重组组织型纤溶酶原激活剂（rt-PA）静脉溶栓是指南推荐的实现血管再通的重要方法。然而，溶栓后出现的出血性转化和血管再闭塞等并发症仍然是临床尚未解决的问题。过去的几项关于临床随机对照试验（RCT）的系统评价表明，中药注射剂（CHIs）可以改善患者的神经功能，增加缺血组织对缺氧的耐受性，抑制血小板聚集。因此，本研究对单独静脉溶栓治疗 AIS 进行了荟萃分析，并与 CHIs 的联合应用进行了比较，以评估 CHIs 对溶栓治疗是否具有协同作用，为临床应用提供依据。
本研究将检索至 2020 年 9 月的以下数据库：①英文数据库：PubMed、Cochrane Library、Embase；②中文数据库：CNKI、万方数据库、维普数据库、中国生物医学文献数据库。纳入比较溶栓联合 CHIs 与单独溶栓治疗 AIS 疗效的 RCT。由 2 位评价员独立进行数据提取和偏倚风险评估。采用 Cochrane 偏倚风险工具进行风险评估。采用 Review Manager 5.3 软件进行统计分析。
本研究将从多个方面为 CHIs 联合静脉溶栓治疗 AIS 提供全面的证据。
荟萃分析的结论将为判断 CHIs 联合静脉溶栓是否是 AIS 治疗的有效措施提供依据。
由于本研究将基于已发表的数据，因此不需要伦理批准。我们将在同行评议的期刊和相关会议上发表这项研究的结果。
PROSPERO 注册号：CRD42020215546。
