醒脑静注射液治疗高血压脑出血随机对照试验的证据图

Evidence Mapping of Randomized Controlled Trials of Xingnaojing Injection in the Treatment of Hypertensive Cerebral Hemorrhage

目的应用证据图方法,系统检索与梳理醒脑静注射液治疗高血压脑出血的随机对照试验,以了解研究现状,为临床及科研提供借鉴与指导。方法检索8大中英文数据库,时限从建库至2020年9月。纳入文献需为醒脑静注射液单用或者联合西医常规治疗高血压脑出血的随机对照试验。采用文字描述结合图表展示研究现状。结果最终纳入文献93篇,主要从9方面分析:研究方法学质量、中医辨证分型、干预措施对比方式及醒脑静用法用量、醒脑静干预时机、治疗时长及随访情况、醒脑静注射液临床评价等。结论纳入文献总体质量较低,未来研究需做好随机序列生成,分配隐藏及盲法以提高研究质量;药物使用存在超说明书用药情况,建议规范使用,用于脑出血伴有昏迷或神志障碍者;结局指标测量上多为短期随访的替代指标,建议将死亡事件发生或mRS作为主要结局指标并注意长期随访,同时需建立中医特色疗效评价标准。

Objective:To systematically retrieve and summarize the randomized controlled trials of Xingnaojing Injection in the treatment of hypertensive intracerebral hemorrhage by using the method of evidence mapping.Methods:8 major Chinese and English databases were searched from inception to September 2020.The included literature was randomized controlled trials of Xingnaojing Injection alone or with conventional Western medicine in the treatment of hypertensive intracerebral hemorrhage.Text description combined with charts and graphs were used to display the present situation of research.Results:A total of 93 literature was included in this study.They were analyzed in following 9 aspects:research methodological quality,syndrome differentiation and type of TCM,usage and dosage of Xingnaojing Injection and comparison of interventions,intervention timing of Xingnaojing Injection,duration of treatment and follow-up,clinical evaluation of Xingnaojing Injection.Conclusion:The overall quality of the included literature is low,so future research needs to do a good job in random sequence generation,allocation hiding and blind methods to improve the research quality.Off-label drug use exists,and it is recommended to standardize the use of drugs for patients with cerebral hemorrhage accompanied by coma or delirium.The outcome indicators are mostly substitute indicators for short-term follow-up.It is suggested to take the occurrence of death or m RS as the main outcome indicators and pay attention to long-term follow-up.At the same time,TCM characteristic efficacy evaluation criteria should be established.