银杏二萜内酯葡胺注射液治疗脑梗死的疗效及安全性的Meta分析
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摘要
目的银杏二萜内酯葡胺注射液(diterpene ginkgolides meglumine injection,DGMI)在临床广泛用于脑梗死的治疗,然而其疗效和安全性尚无一致结论,笔者通过Meta分析综合评价其在脑梗死治疗中的疗效及安全性。方法通过检索万方、维普、CNKI、PubMed等数据库,筛选合格的随机对照研究(RCT),根据Cochrane系统评价方法对纳入文献进行资料提取和质量评价,然后采用Stata软件进行Meta分析。结果共纳入9个RCT,包括1 129例患者,其中DGMI治疗组706例,对照组423例。Meta分析结果显示:(1)对于脑梗死急性期:在治疗有效率方面,DGMI组优于常规治疗组,差异有统计学意义[RR=1.19,95%CI(1.09,1.31),P<0.000 1];在改善神经功能缺损方面,DGMI组显著优于常规治疗组[SMD=3.23,95%CI(2.87,3.60),P<0.000 1];在日常生活能力改善方面,DGMI组也同样显著优于常规治疗组[SMD=3.23,95%CI(2.87,3.60),P<0.000 1]。(2)对于脑梗死恢复期:在治疗有效率方面,DGMI组优于舒血宁组,差异有统计学意义[RR=1.17,95%CI(1.05,1.30),P<0.05];在改善神经功能缺损方面,DGMI组显著优于舒血宁组[SMD=-0.69,95%CI(-0.88,-0.49),P<0.000 1]。在不良反应发生率方面,DGMI组相较于其他银杏制剂或常规治疗组无显著性差异(P>0.05)。结论银杏二萜内酯葡胺注射液治疗脑梗死急性期和恢复期疗效均优于常规治疗组,且两组之间不良反应发生率无显著性差异。本研究结果还需要更多高质量的RCT加以证实。
Objective Diterpene ginkgolides meglumine injection(DGMI)is widely used in patients with stroke,but its efficacy and safety are not consistent.We performed a Meta-analysis to comprehensively evaluate the efficacy and safety of DGMI in acute ischemic stroke and recovered stroke.Methods The wanfang,VIP,CNKI and PubMed were searched,the randomized controlled trials(RCTs)were enrolled.Data collection and quality evaluation of the included RCTs were performed according to Cochrane systematic evaluation method.Meta-analysis was performed by using Stata software.Results 9RCTs involving 1 129 subjects were included with 706 subjects in DGMI treatment group and 423 subjects in control group.(1) For acute ischemic stroke,DGMI group had superior effective rate compared to conventional therapy group(RR=1.19,95%CI:1.09,1.31,P<0.000 1),improvement of neurologic impairments(SMD=3.23,95%CI:2.87,3.60,P<0.000 1)and improvement of living quality(SMD=3.23,95%CI:2.87,3.60,P<0.000 1).(2) For recovered stroke,DGMI group had better effective rate than Shuxuening injection group(RR=1.17,95%CI:1.05,1.30,P<0.05)and improvement of neurologic impairments(SMD=-0.69,95%CI:-0.88,-0.49,P<0.000 1).There was no significant difference in adverse events between DGMI and control groups(P>0.05).Conclusion DGMI had superior efficacy over control group for both acute ischemic stroke and recovered stroke.There was no significant difference in adverse events between these two groups.However,we still need better quality RCTs to confirm these results.
Objective Diterpene ginkgolides meglumine injection(DGMI)is widely used in patients with stroke,but its efficacy and safety are not consistent.We performed a Meta-analysis to comprehensively evaluate the efficacy and safety of DGMI in acute ischemic stroke and recovered stroke.Methods The wanfang,VIP,CNKI and PubMed were searched,the randomized controlled trials(RCTs)were enrolled.Data collection and quality evaluation of the included RCTs were performed according to Cochrane systematic evaluation method.Meta-analysis was performed by using Stata software.Results 9RCTs involving 1 129 subjects were included with 706 subjects in DGMI treatment group and 423 subjects in control group.(1) For acute ischemic stroke,DGMI group had superior effective rate compared to conventional therapy group(RR=1.19,95%CI:1.09,1.31,P<0.000 1),improvement of neurologic impairments(SMD=3.23,95%CI:2.87,3.60,P<0.000 1)and improvement of living quality(SMD=3.23,95%CI:2.87,3.60,P<0.000 1).(2) For recovered stroke,DGMI group had better effective rate than Shuxuening injection group(RR=1.17,95%CI:1.05,1.30,P<0.05)and improvement of neurologic impairments(SMD=-0.69,95%CI:-0.88,-0.49,P<0.000 1).There was no significant difference in adverse events between DGMI and control groups(P>0.05).Conclusion DGMI had superior efficacy over control group for both acute ischemic stroke and recovered stroke.There was no significant difference in adverse events between these two groups.However,we still need better quality RCTs to confirm these results.
引文
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[12]张雯,宋俊科,何国荣,等.银杏二萜内酯对缺血/再灌注大鼠脑组织中神经递质的影响[J].中国药理学通报,2016,32(12):1648-1656.
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[15]MA S,YIN H,CHEN L,et al.Neuroprotective effect of ginkgolide K against acute ischemic stroke on middle cerebral ischemia occlusion in rats[J].J Nat Med,2012,66(1):25-31.
[2]WANG W,JIANG B,SUN H,et al.Prevalence,incidence and mortality of stroke in China clinical perspective[J].Circulation,2017,135(8):759-771.
[3]王晓勇,骆守真,崔春丽.银杏二萜内酯葡胺注射液治疗急性脑梗死临床研究[J].河北中医,2017,39(9):1328-1331.
[4]李海龙,尹晓新.银杏二萜内酯葡胺注射液治疗急性缺血性脑卒中的临床观察[J].现代医院,2017,17(2):239-240.
[5]骆继业,谢永鹏,陈晓兵,等.银杏二萜内酯葡胺注射液治疗老年急性脑梗死疗效观察[J].世界最新医学信息文摘,2017,17(58):16-18.
[6]王敏,蔡胜男,李迪,等.银杏二萜内酯葡胺注射液对急性脑梗死患者神经功能的影响[J].中国实用神经疾病杂志,2016,19(7):29-31.
[7]邱斌,肖展翅.银杏二萜内酯葡胺注射液治疗急性脑梗死的临床观察[J].中西医结合心脑血管病杂志,2015,13(8):1033-1035.
[8]高聚,姜华,肖展翅,等.银杏二萜内酯葡胺注射液治疗急性脑梗死的临床疗效观察[J].实用心脑肺血管病杂志,2015,23(4):133-134.
[9]肖展翅,倪小红,李钢,等.银杏二萜内酯葡胺注射液对脑梗死恢复期患者血液流变学的影响[J].中西医结合心脑血管病杂志,2015,13(16):1828-1830.
[10]赵宾江,王振中,凌娅,等.银杏二萜内酯葡胺注射液治疗动脉粥样硬化性血栓性脑梗死恢复期(痰瘀阻络证)Ⅲ期临床试验[D].中草药,2013,44(24):3525-3530.
[11]华玉凡.银杏二萜内酯葡胺注射液治疗缺血性卒中恢复期(痰瘀阻络证)的临床研究[D].武汉:湖北中医药大学,2015.
[12]张雯,宋俊科,何国荣,等.银杏二萜内酯对缺血/再灌注大鼠脑组织中神经递质的影响[J].中国药理学通报,2016,32(12):1648-1656.
[13]WANG X,JIANG C M,WAN H Y,et al.Neuroprotection against permanent focal cerebral ischemia by ginkgolides Aand B is associated with obstruction of the mitochondrial apoptotic pathway viainhibition of c-Jun N-terminal kinase in rats[J].J Neurosci Res,2014,92(2):232-242.
[14]GU J H,GE J B,LI M,et al.Inhibition of NF-kappaB activation is associated with anti-inflammatory and anti-apoptotic effects of Ginkgolide B in a mouse model of cerebral ischemia/reperfusion injury[J].Eur J Pharmac Sci,2012,47(4):652-660.
[15]MA S,YIN H,CHEN L,et al.Neuroprotective effect of ginkgolide K against acute ischemic stroke on middle cerebral ischemia occlusion in rats[J].J Nat Med,2012,66(1):25-31.