Meng Tian-Tian, Tian Zi-Yu, Xie Xiao-Long, Li Ting-Ting, Liu Wei-di, Gao Ying
Dongzhimen Hospital,Beijing University of Chinese Medicine Beijing 100700,China Institute for Brain Disorders,Beijing University of Chinese Medicine Beijing 100700,China.
Zhongguo Zhong Yao Za Zhi. 2021 Mar;46(6):1537-1546. doi: 10.19540/j.cnki.cjcmm.20200903.501.
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.
系统评价银杏叶片(GLT)治疗急性脑梗死(ACI)的临床疗效及安全性。系统检索国内外7个数据库自建库至2020年3月的文献。对纳入研究的数据进行审核筛选后提取。采用Cochrane风险偏倚评估工具对纳入研究的质量进行评估,然后用RevMan 5.3软件对纳入研究进行Meta分析,以评价GLT治疗ACI的总临床有效率、神经功能评分、血脂及不良反应发生率。最后采用GRADE系统对各结局指标的证据质量进行评价并形成推荐意见。共纳入10项研究,涉及886例参与者,均为低质量研究。Meta分析结果显示:(1)在总临床有效率方面,GLT联合西药优于单纯西药(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),GLT联合血塞通注射液+西药与血塞通注射液+西药之间无统计学差异(RR=1.16,95%CI[1.00,1.35],P=0.05)。(2)在改善神经功能评分方面,GLT联合西药优于单纯西药(MD_(NIHSS[中度(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),GLT联合丹参注射液+西药优于丹参注射液+西药(MD_(NDS)=-3.09,95%CI[-3.84,-2.34],P<0.000 01)。(3)在调节血脂方面,GLT联合西药优于单纯西药(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,GLT联合西药与单纯西药之间无统计学差异(RR=0.63,95%CI[0.30,1.32],P=0.22)。评价结果显示各结局指标的证据水平较低,推荐等级为弱推荐。综上所述,GLT联合西药可提高总临床有效率、改善神经功能评分及血脂状况,不良反应发生率低。但由于纳入研究数量少、研究质量低、证据水平有限,期望未来开展标准化设计、大样本量的临床研究,进一步探究GLT治疗ACI的临床疗效及安全性。