| 引用本文:孟甜甜1，2，解小龙1，2，李婷婷1，2，杨芩瑜1，2，许颖智1，2，高颖1，2.银杏内酯注射液辅助治疗急性缺血性脑卒中的系统评价与Meta分析[J].世界中医药,2021,(08):. |
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| 银杏内酯注射液辅助治疗急性缺血性脑卒中的系统评价与Meta分析 |
| Systematic Review and Meta-Analysis of Ginkgolide Injections for the Adjuvant Treatment of Acute Ischemic Stroke |
| 投稿时间：2020-04-24 |
| DOI：10.3969/j.issn.1673-7202.2021.08.011 |
| 中文关键词: 银杏内酯注射液 中医药 缺血性脑卒中 脑梗死 临床疗效 安全性 随机对照试验 系统评价 Meta分析 |
| English Keywords:Ginkgolide injection Traditional Chinese medicine Schemic stroke Cerebral infarctionsystematic review Clinical efficacy Safety Randomised controlled trial Systematic review Meta-analysis |
| 基金项目:国家重点研发计划项目(2018YFC1705000,2018YFC1705001);中医药传承与创新“百千万”人才工程(岐黄工程)——国家中医药领军人才支持计划项目(国中医药人教发［2018］12号) |
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| 中文摘要: |
| 目的:系统评价银杏内酯注射液(GI)治疗急性缺血性脑卒中(AIS)的临床疗效和安全性。方法:检索国内外7大数据库,自建库至2020年4月,应用RevMan5.3软件对GI治疗AIS的临床疗效和安全性进行Meta分析。最后采用GRADE系统评价各结局指标的证据质量。结果:共纳入20项研究,Meta分析显示:在临床有效率方面,GI+西医常规优于单用西医常规(RRNIHSS=1.20,95%CI为1.14~1.27,P<0.000 01;RRNDS=1.28,95%CI为1.02~1.59),P=0.03;RR临床症状=1.26,95%CI为1.03~1.55,P=0.03);GI+阿替普酶+西医常规优于阿替普酶+西医常规(RRNIHSS=1.24,95%CI为1.10~1.41,P=0.000 6;RRmRS=1.27,95%CI为1.10~1.46,P=0.000 6);在改善神经功能方面,GI+西医常规优于单用西医常规(MDNIHSS=-3.12,95%CI为-3.72~-2.52,P<0.000 01;MDNDS=-2.93,95%CI为-3.67~-2.19,P<0.000 01),GI+阿替普酶+西医常规优于阿替普酶+西医常规(MDNIHSS=-3.68,95%CI为-4.89~-2.47,P<0.000 01;MDNDS=-10.58,95%CI为-12.01~-9.15,P<0.000 01);在改善日常生活能力评分方面,GI+西医常规优于单用西医常规(MD=9.61,95%CI为8.44~10.78,P<0.000 01),GI+阿替普酶+西医常规优于阿替普酶+西医常规(MD=8.80,95%CI为5.80~11.80,P<0.000 01);在不良反应发生率方面，GI+西医常规与单用西医常规差异无统计学意义(RR=0.63,95%CI为0.28~1.43,P=0.27)。证据等级评价显示临床有效率和日常生活能力评分的证据级别为中级,神经功能评分的证据级别为低级,推荐强度均为弱推荐。结论:GI+西医常规或GI+阿替普酶+西医常规可提高AIS的临床有效率，改善神经功能、日常生活能力,且不良反应发生率较低,但因纳入文献质量偏低,证据等级较低,有望进一步开展大规模临床试验更深入地研究GI治疗AIS的临床疗效及安全性。 |
| English Summary: |
| To systematically evaluate the clinical efficacy and safety of Ginkgolide injection(GI)in the treatment of acute ischemic stroke(AIS).Methods:A total of 7 databases were systematically retrieved from inception to April 2020.Meta-analysis was performed on the clinical efficacy and safety of GI treatment of AIS by RevMan5.3 software.Finally，the GRADE system was adopted to evaluate the evidence quality of each outcome indicator.Results:A total of 20 studies were included.The results of meta-analysis showed that，in terms of the clinical efficiency，GI+Western medicine treatment(WMT)were superior to WMT(RRNIHSS=1.20,95%CI was 1.14 to 1.27，P<0.000 01; RRNDS=1.28，95%CI was 1.02 to 1.59)，P=0.03; RRclinical symptoms=1.26，95%CI was 1.03 to 1.55，P=0.03); GI+rt-PA+WMT were superior to rt-PA+WMT(RRNIHSS=1.24，95%CI was 1.10 to 1.41，P=0.000 6; RRmRS=1.27，95%CI was 1.10 to 1.46，P=0.000 6).In terms of the neurological function，GI+WMT was superior to WMT(MDNIHSS=-3.12,95%CI was -3.72 to -2.52，P<0.000 01; MDNDS=-2.93,95%CI was -3.67 to -2.19，P<0.000 01); GI+rt-PA+WMT was superior to rt-PA+WMT(MDNIHSS=-3.68,95%CI was -4.89 to -2.47，P<0.000 01; MDNDS=-10.58，95%CI was -12.01 to -9.15，P<0.000 01).In terms of the activity of daily living，GI+WMT were superior to WMT(MD=9.61，95%CI was 8.44 to 10.78，P<0.000 01); GI+rt-PA+WMT were superior to rt-PA+WMT(MD=8.80，95%CI was 5.80 to 11.80，P<0.000 01).In terms of adverse reaction rate，there was no statistical difference between GI+WMT and WMT alone(RR=0.63,95%CI was 0.28 to 1.43，P=0.27).Finally，evidence level evaluation showed that the level of evidence for clinical effectiveness and ability of daily living was intermediate，the level of evidence for neurological function score was low，and the strength of recommendation was weak.Conclusion:GI+Western medicine routine or GI+Alteplase+Western medicine routine can improve the clinical effectiveness，neurological function，and ability of daily living of AIS，and the incidence of adverse reactions is low.However，due to the low quality of the included literature and the low level of evidence，it is expected to carry out further large-scale clinical trials to further study the clinical efficacy and safety of GI treatment of AIS. |
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