血塞通注射液治疗中风的证据及评价

Evidence and evaluation of Xuesaitong injection in treating stroke

关键词:  血塞通注射液  中风  系统评价-Meta分析  AMSTAR量表  证据

Key words:  Xuesaitong injection  stroke  systematic evaluation and Meta-analysis  AMSTAR  evidence

摘要:

[目的] 评价血塞通注射液治疗中风的系统评价/Meta分析的证据。[方法] 检索CNKI、SinoMed、WanFang、PubMed、Cochrane library和EMbase数据库，查找血塞通注射液治疗中风的系统评价和Meta分析。以AMSTAR量表评价方法学质量，并分析研究结果的证据级别。[结果] 共纳入9个系统评价/Meta分析，包括7个结局指标。与其他药物或常规治疗相比，血塞通注射液治疗中风临床总疗效更好，3篇显示在改善中风后神经功能缺损程度上更有优势，1篇显示能明显降低恶化率与病死率，但证据质量不高。AMSTER量表评价显示方法学质量高（条目报告率>80%）的条目有3个：纳入标准、检索资源、纳入研究的科学性；质量中等（50%~80%）的条目有3个：排除标准、纳入研究特征、发表偏倚；其余12个条目质量较差（<50%）。其中研究问题、灰色文献与研究文献清单3个条目问题突出。[结论] 现有的证据提示血塞通注射液能够改善中风的神经功能缺损程度，且安全性较好。但由于纳入文献质量不高，影响证据的强度，需要严格设计的高质量临床研究进一步论证。

Abstract:

[Objective] To evaluate evidence from systematic evaluation or Meta-analysis of xuesaitong injection in the treatment of stroke. [Methods] CNKI, Sinomed, Wanfang, PubMed, Cochrane library and Embase to collect SRs of xuesaitong injection in treating stroke were searched. The methodology quality was evaluated by the AMSTAR scale. [Results] A total of 9 SRs involving 7 outcomes were included. Compared with other drug or conventional therapy, total clinical effect of Xuesaitong injection treating stroke was better. There were 3 studies showed advantages in improving neurologic impairment degree after stroke. One study showed it can decrease the aggravation rate and death rate obviously, but quality of evidence was low. There were 3 high-quality (>80%) items:inclusion criteria, data resources and the scientific quality of the included studies. There were 3 items with moderate quality (50%~80%):exclusion criteria, the characteristics of the included studies and publication bias; the remaining 12 items with poor quality (<50%). Among them, the quality of 3 items was very low, such as, pre-determined research objectives, grey literature and a list of studies. [Conclusion] The current published SRs suggest xuesaitong injection appears to be safe and effective to improve neurological deficits for stroke treatment in general. However, it lacks high evidence. Further well-designed RCTs are needed.