丹参类中药注射剂治疗急性缺血性脑卒中有效性和安全性的网状Meta分析  

Efficacy and safety of salvia miltiorrhiza injection classes in treatment of acute ischemic stroke:a network meta-analysis

作　　者：王哲义 孙怿泽 张媛凤 田金洲[5] 卢涛 WANG Zheyi;SUN Yize;ZHANG Yuanfeng;TIAN Jinzhou;LU Tao(Qilu Hospital,Shandong University,Jinan 250012,P.R.China;Beijing University of Chinese Medicine,Beijing 100029,P.R.China;China Traditional Chinese Medicine Science and Technology Development Center,Beijing 100027,P.R.China;Talent Exchance Center of National Administration of Traditional Chinese Medicine,Beijing 100027,P.R.China;Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing 100010,P.R.China;School of Life Science,Beijing University of Chinese Medicine,Beijing 100029,P.R.China)

机构地区：[1]山东大学齐鲁医院,济南250012 [2]北京中医药大学,北京100029 [3]中国中医药科技发展中心,北京100027 [4]国家中医药管理局人才交流中心,北京100027 [5]北京中医药大学东直门医院,北京100010 [6]北京中医药大学生命科学学院,北京100029

出　　处：《中国循证医学杂志》2022年第2期217-231,共15页Chinese Journal of Evidence-based Medicine

基　　金：北京市双一流高层次人才科研经费(编号:1000041510053)。

摘　　要：目的系统评价丹参类中药注射剂治疗急性缺血性脑卒中的有效性和安全性。方法计算机检索PubMed、EMbase、The Cochrane Library、Web of Science、VIP、WanFang Data和CNKI数据库,搜集有关丹参类中药注射剂治疗急性缺血性脑卒中有效性和安全性的随机对照试验(RCT),检索时限均为建库至2021年2月。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用Stata 16.0软件和RevMan 5.3软件进行网状Meta分析。结果共纳入160个RCT,包括8种治疗措施(7种中药注射剂):丹红注射剂联合常规治疗(DH+CT)、丹参注射剂联合常规治疗(DS+CT)、丹参川芎嗪注射剂联合常规治疗(DSCXQ+CT)、注射用丹参多酚酸联合常规治疗(DSDFS+CT)、复方丹参注射剂联合常规治疗(FFDS+CT)、注射用丹参多酚酸盐联合常规治疗(SI+CT)、丹参酮ⅡA磺酸钠注射剂联合常规治疗(STS+CT)和常规治疗(CT)。网状Meta分析结果显示:(1)在总有效率方面,累积概率排序为:DSDFS+CT(93.0%)>DH+CT(80.5%)>STS+CT(66.7%)>DSCXQ+CT(66.4%)>SI+CT(50.0%)>DS+CT(26.7%)>FFDS+CT(16.7%)>CT(0.1%)。(2)在NIHSS评分方面,累积概率排序为:STS+CT(95.5%)>DH+CT(80.9%)>DSCXQ+CT(70.1%)>SI+CT(64.7%)>DSDFS+CT(42.0%)>FFDS+CT(24.4%)>DS+CT(20.1%)>CT(2.4%)。(3)在Barthel指数方面,累积概率排序为:DH+CT(76.2%)>DSCXQ+CT(74.3%)>STS+CT(64.1%)>DSDFS+CT(62.2%)>FFDS+CT(51.8%)>SI+CT(46.0%)>DS+CT(21.7%)>CT(3.8%)。结论当前证据显示,丹参多酚酸注射液+常规治疗的总有效率最高,丹参酮ⅡA磺酸钠注射液和丹红注射液分别在改善NIHSS评分和Barthel指数方面有优势。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。Objective To systematically review the efficacy and safety of Salvia miltiorrhiza injection in the treatment of acute ischemic stroke(AIS).Methods PubMed,EMbase,The Cochrane Library,Web of Science,VIP,WanFang Data,and CNKI databases were electronically searched to collect randomized controlled trials(RCTs)on the efficacy and safety of Salvia miltiorrhiza injection in treatment of AIS from inception to February 2021.Two reviewers independently screened literature,extracted data,and assessed the risk of bias of the included studies.Network metaanalysis was then performed using Stata 16.0 software and RevMan 5.3 software.Results A total of 160 RCTs were included.The measures included 7 Chinese medicine injections and 8 treatment measures,covering Danhong injection combined with conventional treatment(DH+CT),Danshen injection combined with conventional treatment(DS+CT),Danshen ligustrazine injection combined with conventional treatment(DSCXQ+CT),Danshen polyphenolic acid for injection combined with conventional treatment(DSDFS+CT),compound Danshen injection combined with conventional treatment(FFDS+CT),Danshen polyphenolate for injection combined with conventional treatment(SI+CT),and Sodium TanshinoneⅡA Sulfonate injection combined with conventional treatment(STS+CT)and conventional treatment(CT).Results of network meta-analysis showed that for the total effective rate,the rank of cumulative probability was:DSDFS+CT(93.0%)>DH+CT(80.5%)>STS+CT(66.7%)>DSCXQ+CT(66.4%)>SI+CT(50.0%)>DS+CT(26.7%)>FFDS+CT(16.7%)>CT(0.1%).In terms of NIHSS,the rank of cumulative probability was:STS+CT(95.5%)>DH+CT(80.9%)>DSCXQ+CT(70.1%)>SI+CT(64.7%)>DSDFS+CT(42.0%)>FFDS+CT(24.4%)>DS+CT(20.1%)>CT(2.4%).In the aspect of Barthel index,the rank of cumulative probability was:DH+CT(76.2%)>DSCXQ+CT(74.3%)>STS+CT(64.1%)>DSDFS+CT(62.2%)>FFDS+CT(51.8%)>SI+CT(46.0%)>DS+CT(21.7%)>CT(3.8%).Conclusion Current evidence shows that,for patients with AIS,DSDFS has an improved effect on the total effective rate,while STS and DH show advantages in NIHSS scor

关 键 词：丹参类注射剂 急性缺血性脑卒中 网状Meta分析 随机对照试验 

分 类 号：R277.7[医药卫生—中医学]