中国中药杂志

2021, v.46(06) 1537-1546

[打印本页] [关闭]
本期目录(Current Issue) | 过刊浏览(Past Issue) | 高级检索(Advanced Search)

银杏叶片治疗急性脑梗死临床疗效和安全性的系统评价与Meta分析
Systematic review and Meta-analysis of clinical efficacy and safety of Ginkgo Leaf Tablets in treatment of acute cerebral infarction

孟甜甜;田紫煜;解小龙;李婷婷;刘伟地;高颖;
MENG Tian-tian;TIAN Zi-yu;XIE Xiao-long;LI Ting-ting;LIU Wei-di;GAO Ying;Dongzhimen Hospital,Beijing University of Chinese Medicine;Institute for Brain Disorders,Beijing University of Chinese Medicine;

摘要(Abstract):

系统性评价银杏叶片治疗急性脑梗死(ACI)的临床疗效和安全性。检索国内外7大数据库,经查重、筛选后对纳入的文献进行资料提取,并采用Cochrane协作网研发的偏倚风险评估工具进行研究质量的评价,应用RevMan 5.3软件对银杏叶片治疗ACI的临床总有效率、神经功能评分、血脂、不良反应发生率等进行Meta分析,采用GRADE系统对结局指标进行证据质量的评价并形成推荐意见。共纳入10项研究,886例患者,研究质量均偏低。Meta分析结果显示,(1)在临床总有效率方面,银杏叶片+西医常规治疗优于单用西医常规治疗(RR_(NDS)=1.20,95%CI[1.06,1.36],P=0.005;RR_(NIHSS)=1.35,95%CI[1.09,1.69],P=0.007),银杏叶片+血塞通注射液+西医常规治疗与血塞通注射液+西医常规治疗对比差异无统计学意义(RR=1.16,95%CI[1.00,1.35],P=0.05);(2)在改善神经功能评分方面,银杏叶片+西医常规治疗优于单用西医常规治疗(MD_(NIHSS中(重)度)=-1.55,95%CI[-2.22,-0.88],P<0.000 01;MD_(NIHSS重度)=-7.51,95%CI[-8.00,-7.02],P<0.000 01;MD_(NDS)=-1.36,95%CI[-2.39,-0.33],P=0.01),银杏叶片+丹参注射液+西医常规治疗优于丹参注射液+西医常规治疗(MD_(NDS)=-3.09,95%CI[-3.84,-2.34],P<0.000 01);(3)在调节血脂方面,银杏叶片+西医常规治疗优于单用西医常规治疗(MD_(TC)=-1.40,95%CI[-2.13,-0.66],P=0.000 2;MD_(TG)=-1.29,95%CI[-1.86,-0.73],P<0.000 01;MD_(LDL-C)=-1.48,95%CI[-2.91,-0.04],P=0.04;MD_(HDL-C)=0.07,95%CI[0.02,0.12],P=0.009);(4)在不良反应发生率方面,银杏叶片+西医常规治疗与单用西医常规治疗差异无统计学意义(RR=0.63,95%CI[0.30,1.32],P=0.22)。对结局指标进行证据等级的评价,结果显示各结局指标证据等级均为低级,推荐强度均为弱推荐。结果表明,银杏叶片联合西医常规治疗可改善ACI的临床总有效率、神经功能评分、血脂水平,且不良反应发生率较低,但因纳入研究的数量偏少,质量偏低,证据等级较低,故有望将来开展设计严谨、样本量充足的临床试验以进一步研究银杏叶片治疗ACI的临床疗效及安全性。
To systematically evaluate the clinical efficacy and safety of Ginkgo Leaf Tablets(GLT) in the treatment of acute cerebral infarction(ACI). Seven databases both at home and abroad were systematically retrieved from their establishment to March 2020. The data of the included studies were extracted after review and screening. The quality of the included studies was assessed with the Cochrane risk bias assessment tool, and then the included studies were put into Meta-analysis by RevMan 5.3 to evaluate the total cli-nical efficiency, neurological function score, blood lipids and incidence of adverse reactions in treatment of ACI by GLT. Finally, the GRADE system was adopted to evaluate the evidence quality of each outcome indicator and form recommendations. Ten studies involving 886 participants were included, all of which were of low quality. Meta-analysis results showed that,(1)in terms of the total clinical efficiency, GLT+Western medicine was superior to Western medicine alone(RR_(NDS)=1.20, 95%CI[1.06, 1.36], P=0.005; RR_(NIHSS)=1.35, 95%CI[1.09, 1.69], P=0.007), and there was no statistical difference between GLT+Xuesaitong Injection+Wes-tern medicine and Xuesaitong Injection+Western medicine(RR=1.16, 95%CI[1.00, 1.35], P=0.05).(2)In terms of improving neurological function score, GLT+Western medicine was superior to Western medicine alone(MD_(NIHSS[moderate(severe)])=-1.55, 95%CI[-2.22,-0.88], P<0.000 01; MD_(NIHSS(severe))=-7.51, 95%CI[-8.00,-7.02], P<0.000 01; MD_(NDS)=-1.36, 95%CI[-2.39,-0.33], P=0.01), and GLT+Danshen Injection+Western medicine was superior to Danshen Injection+Western medicine(MD_(NDS)=-3.09, 95%CI[-3.84,-2.34], P<0.000 01).(3)In terms of regulating blood lipids, GLT+Western medicine was superior to Wes-tern medicine alone(MD_(TC)=-1.40, 95%CI[-2.13,-0.66], P=0.000 2; MD_(TG)=-1.29, 95%CI[-1.86,-0.73], P<0.000 01; MD_(LDL-C)=-1.48, 95%CI[-2.91,-0.04], P=0.04; MD_(HDL-C)=0.07, 95%CI[0.02, 0.12], P=0.009).(4)In terms of incidence of adverse reactions, there was no statistical difference between GLT+Western medicine and Western medicine alone(RR=0.63, 95%CI[0.30, 1.32], P=0.22). The results of the evaluation showed that the evidence level of each outcome indicator was low, and the recommendation was at weak level. In conclusion, GLT+Western medicine could improve the total clinical efficiency, neurological function score, and blood lipid status, with a low incidence of adverse reactions. However, due to the small amount of included stu-dies, low study quality and low level of evidence, it is expected to carry out clinical studies with standardized design and large sample size in the future to further investigate the clinical efficacy and safety of GLT in the treatment of ACI.

关键词(KeyWords): 银杏叶片;急性脑梗死;系统评价;Meta分析;疗效;安全性
Ginkgo Leaf Tablets;acute cerebral infarction;systematic review;Meta-analysis;efficacy;safety

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目(2018YFC1705000,2018YFC1705001)

作者(Author): 孟甜甜;田紫煜;解小龙;李婷婷;刘伟地;高颖;
MENG Tian-tian;TIAN Zi-yu;XIE Xiao-long;LI Ting-ting;LIU Wei-di;GAO Ying;Dongzhimen Hospital,Beijing University of Chinese Medicine;Institute for Brain Disorders,Beijing University of Chinese Medicine;

Email:

DOI: 10.19540/j.cnki.cjcmm.20200903.501

参考文献(References):

扩展功能
本文信息
服务与反馈
本文关键词相关文章
本文作者相关文章
中国知网
分享