摘要
目的系统评价注射用丹参多酚酸联合化学药治疗急性脑梗死的有效性和安全性。方法计算机检索中国学术期刊全文数据库(CNKI)、万方数据知识服务平台(Wangfang Data)、维普中文期刊全文数据库(VIP)、中国生物医学文献数据库(CBM)、美国生物医学期刊文献数据库(PubMed)、荷兰医学文摘数据库(Embase)、循证医学图书馆(The Cochrane Library)、美国引文数据库(Web of Science)等,检索时间从建库至2021年5月31日,全面收集注射用丹参多酚酸联合化学药治疗急性脑梗死的临床随机对照试验(RCT),采用RevMan 5.3软件进行Meta分析。结果共纳入34项RCTs,总样本量为3401例,试验组1705例、对照组1696例。Meta分析结果显示,在化学药常规治疗基础上加用注射用丹参多酚酸治疗急性脑梗死能提高临床有效率[RR=1.29,95%CI(1.24,1.35)]、降低美国国立卫生研究院卒中量表评分[MD=−2.97,95%CI(−3.74,−2.19)]、提高日常生活能力量表评分[MD=12.60,95%CI(10.10,15.09)],改善蒙特利尔认知评估量表评分[MD=2.41,95%CI(2.03,2.79)],降低C反应蛋白[SMD=−1.71,95%CI(−2.23,−1.19)],与对照组比较差异有统计学意义(P<0.00001);共有24项研究报道了不良反应,其中11项研究报告未出现不良反应,两组不良反应发生率差异无统计学意义。结论注射用丹参多酚酸治疗急性脑梗死具有提高临床有效率,促进神经功能恢复,提高日常生活行为能力,并可改善卒中后认知功能,值得临床推广使用。上述研究仍需多中心、大样本及双盲的RCT试验进一步证实。
Objective To evaluate the efficacy and safety of Salvianolic Acids for Injection(SAFI)combined with western medicine in the treatment of acute cerebral infarction.Methods Databases including CNKI,Wanfang Data,VIP,CBM,PubMed,EMbase,the Cochrane Library,and Web of Science were searched to collect randomized controlled trials(RCT)of SAFI in the treatment of acute cerebral infarction from the date of establishment to May 31,2021.Meta-analysis was performed using RevMan 5.3 software.Results A total of 34 RCTs were included,with a total sample size of 3401 cases,including 1705 cases in the experimental group(SAFI combined with chemical drugs)and 1696 cases in the control group(chemical drugs alone).Meta-analysis showed that compared with control group,SAFI combined with chemical drugs could reduce increase clinical efficiency[RR=1.29,95%CI(1.24,1.35)],reduce NIHSS scores[MD=−2.97,95%CI(−3.74,−2.19)],improve BI scores[MD=12.60,95%CI(10.10,15.09)],improve MOCA scores[MD=2.41,95%CI(2.03,2.79)],and reduce C-reactive protein[SMD=−1.71,95%CI(−2.23,−1.19)],the difference between two groups were statistically significant(P<0.00001).A total of 24 studies reported adverse reactions,of which 11 studies reported no adverse reactions,and there was no significant difference in the incidence of adverse reactions between two groups.Conclusion SAFI in the treatment of acute cerebral infarction can improve the clinical effective rate,promote the recovery of neurological function,improve the ability of daily life and behavior,and improve the cognitive function after stroke.It is worthy of clinical promotion.The above research results still need to be verified by more multicenter,large sample and double-blind randomized controlled trials.
作者
苏小琴
鞠爱春
李德坤
张磊
SU Xiaoqin;JU Aichun;LI Dekun;ZHANG Lei(Tianjin Tasly Pride Pharmaceutical Co.,Ltd.,Tianjin 300410,China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections,Tianjin 300410,China)
出处
《药物评价研究》
CAS
2021年第11期2505-2517,共13页
Drug Evaluation Research
关键词
注射用丹参多酚酸
急性脑梗死
随机对照试验
系统评价
Salvianolic Acids for Injection(SAFI)
acute cerebral infarction
randomized controlled trials(RCT)
system evaluation
