灯盏花素注射剂治疗急性脑梗死有效性和安全性的随机对照试验系统评价和Meta分析
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摘要
目的系统评价灯盏花素注射剂治疗急性脑梗死(ACI)的有效性和安全性。方法检索国内外8个电子数据库及ClinicalTrials临床注册系统,纳入灯盏花素注射剂治疗ACI的随机对照试验。根据Cochrane Handbook 5. 1. 0评价标准进行文献筛选、资料提取和质量评价,对最终纳入研究的[中国脑卒中临床神经功能缺损程度评分量表(CSS)和美国国立卫生研究院脑卒中量表(NIHSS)]总有效率、死亡率、神经功能缺损评分进行Meta分析,并采用GRADE系统对关键结局指标证据质量和等级推荐进行分级。结果共纳入30项研究,其方法学质量普遍偏低。Meta分析显示,在总有效率方面,灯盏花素注射剂联合常规西药治疗优于常规西药治疗[RRCSS=1. 28,95%CI (1. 22,1. 34),P <0. 001;RRNIHSS=1. 16,95%CI(1. 07,1. 25),P <0. 03];灯盏花素注射剂联合常规西药治疗优于维脑路通联合常规西药治疗[RR=1. 36,95%CI (1. 26,1. 45),P <0. 001]。在死亡率方面,灯盏花素注射剂联合常规西药治疗在14天(急性期)的死亡率低于常规西药治疗[RR=0. 31,95%CI (0. 10,0. 93),P=0. 04]。GRADE系统显示总有效率及死亡率的证据级别为低级别,推荐强度为弱推荐。灯盏花素注射剂的不良反应主要表现为面部潮红、轻度头晕,患者均耐受,不影响治疗。结论灯盏花素注射剂联合常规西药治疗ACI有一定的疗效,能降低14天死亡率,且不良反应较小。但纳入研究质量不高,尚需更多设计严谨、高质量、多中心随机双盲对照试验以增加证据强度。
Objective To systematically evaluate the efficacy and safety of Breviscapine Injection in the treatment of acute cerebral infarction(ACI). Methods A total of eight electronic databases and clinical trials were searched to collect randomized controlled trials which were conducted on Breviscapine Injection in the treatment of ACI. According to the Cochrane Handbook 5. 1. 0 literature screening,data extraction and quality evaluation,the Chinese Stroke Clinical Neurological Deficit Rating Scale(CSS) and the National Institutes of Health Stroke Scale(NIHSS) were included in the final study. Meta-analysis of total efficacy,mortality,and neurological deficit scores,and the use of the GRADE system were used to grade the quality and grade recommendations for key outcome indicators. Results A total of 30 studies was included,and the methodological quality was generally low. Meta-analysis results showed the following facts. The combining use of Breviscapine Injection and conventional therapy was superior to conventional therapy in the total effective rate [RRCSS= 1. 28,95% CI =(1. 22,1. 34),P < 0. 001;RRNIHSS=1. 16,95% CI =(1. 07,1. 25),P < 0. 001]. In addition,Breviscapine Injection plus conventional therapy was statistically significant compared with venoruton plus conventional therapy in the total effective rate [RR = 1. 36,95%CI =(1. 26,1. 45),P < 0. 001]. The mortality rate of breviscapine injection plus conventional therapy(14 days in acute phase) was lower than that of conventional therapy [RR = 0. 31,95% CI =(0. 10,0. 93),P = 0. 04]. Based on GRADE,the level of evidence was low and the strength of recommendation was weak in total effective rate and mortality. The main adverse reactions of Breviscapine Injection were flush,slight dizziness that patients could endure and did not affect treatment. Conclusion Breviscapine Injection combined with conventional therapy has certain curative effects on acute cerebral infarction,lower the acute mortality rate and has less adverse reactions. Due to the low quality of the included study,more rigorous,high-quality,multi-centered,randomized double-blind controlled trials are required to increase the strength of the evidence in the future.
Objective To systematically evaluate the efficacy and safety of Breviscapine Injection in the treatment of acute cerebral infarction(ACI). Methods A total of eight electronic databases and clinical trials were searched to collect randomized controlled trials which were conducted on Breviscapine Injection in the treatment of ACI. According to the Cochrane Handbook 5. 1. 0 literature screening,data extraction and quality evaluation,the Chinese Stroke Clinical Neurological Deficit Rating Scale(CSS) and the National Institutes of Health Stroke Scale(NIHSS) were included in the final study. Meta-analysis of total efficacy,mortality,and neurological deficit scores,and the use of the GRADE system were used to grade the quality and grade recommendations for key outcome indicators. Results A total of 30 studies was included,and the methodological quality was generally low. Meta-analysis results showed the following facts. The combining use of Breviscapine Injection and conventional therapy was superior to conventional therapy in the total effective rate [RRCSS= 1. 28,95% CI =(1. 22,1. 34),P < 0. 001;RRNIHSS=1. 16,95% CI =(1. 07,1. 25),P < 0. 001]. In addition,Breviscapine Injection plus conventional therapy was statistically significant compared with venoruton plus conventional therapy in the total effective rate [RR = 1. 36,95%CI =(1. 26,1. 45),P < 0. 001]. The mortality rate of breviscapine injection plus conventional therapy(14 days in acute phase) was lower than that of conventional therapy [RR = 0. 31,95% CI =(0. 10,0. 93),P = 0. 04]. Based on GRADE,the level of evidence was low and the strength of recommendation was weak in total effective rate and mortality. The main adverse reactions of Breviscapine Injection were flush,slight dizziness that patients could endure and did not affect treatment. Conclusion Breviscapine Injection combined with conventional therapy has certain curative effects on acute cerebral infarction,lower the acute mortality rate and has less adverse reactions. Due to the low quality of the included study,more rigorous,high-quality,multi-centered,randomized double-blind controlled trials are required to increase the strength of the evidence in the future.
引文
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