丁苯酞治疗高危短暂性脑缺血有效性与安全性的系统评价
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摘要
目的:系统评价丁苯酞在治疗高危短暂性脑缺血方面的疗效与安全性。方法:检索PubMed、EMBase、中国知网、维普中文科技期刊数据库、万方数据库及中国生物医学文献数据库等数据库,全面收集丁苯酞治疗高危短暂性脑缺血的随机对照研究(观察组患者采用丁苯酞治疗,对照组患者采用其他药物治疗),采用RevMan 5.3软件进行文献荟萃分析(Meta分析)。结果:共纳入7项随机对照研究,包含560例患者。Meta分析结果显示,观察组患者的临床总有效率明显高于对照组(OR=3.82,95%CI=2.46～5.91,P<0.05),纤维蛋白原(MD=-0.28,95%CI=-0.33～-0.22,P<0.05)、血清三酰甘油(MD=-0.46,95%CI=-0.52～-0.40,P<0.05)、颈动脉内膜中层厚度(MD=-0.62,95%CI=-1.00～-0.24,P<0.05)和颈动脉斑块面积(MD=-0.49,95%CI=-0.96～-0.03,P<0.05)改善情况均明显优于对照组,上述差异均有统计学意义;两组患者不良反应发生率的差异无统计学意义(OR=0.98,95%CI=0.40～2.40,P=0.97)。结论:丁苯酞治疗高危短暂性脑缺血安全有效,由于研究质量限制,该结论尚需更多大样本、高质量的随机对照试验加以验证。
OBJECTIVE: To systematically review the efficacy and safety of butylphthalide in treatment of high-risk transient cerebral ischemia. METHODS: Randomized controlled trials on butylphthalide in treatment of high-risk transient cerebral ischemia(the observation group was treated with butylphthalide, the control group was given other drugs) were overall retrieved from PubMed, EMBase, CNKI, VIP, Wanfang and CBM. RevMan 5.3 was adopted to conduct Meta-analysis. RESULTS: A total of 7 RCTs were involved, including 560 patients. Results of Meta-analysis indicated that the total effective rate of observation group was significantly higher than that of the control group(OR=3.82,95%CI=2.46-5.91,P<0.05); the improvements of fibrinogen(MD=-0.28,95%CI=-0.33--0.22,P<0.05), serum triacylglycerol(MD=-0.46,95%CI=-0.52--0.40,P<0.05), intima-media thickness of carotid artery(MD=-0.62,95%CI=-1.00--0.24,P<0.05) and area of carotid plaque(MD=-0.49,95%CI=-0.96--0.03,P<0.05) of observation group were significantly better than those of the control group, with statistically significant difference; there was no statistical significance in difference in incidences of adverse drug reactions between two groups(OR=0.98,95%CI=0.40-2.40,P=0.97). CONCLUSIONS: Butylphthalide is safe and effective in treatment of high-risk transient cerebral ischemia, while due to the quality limitations of the involved study, this conclusion requires further verification by more large-sample and high-quality RCTs.
OBJECTIVE: To systematically review the efficacy and safety of butylphthalide in treatment of high-risk transient cerebral ischemia. METHODS: Randomized controlled trials on butylphthalide in treatment of high-risk transient cerebral ischemia(the observation group was treated with butylphthalide, the control group was given other drugs) were overall retrieved from PubMed, EMBase, CNKI, VIP, Wanfang and CBM. RevMan 5.3 was adopted to conduct Meta-analysis. RESULTS: A total of 7 RCTs were involved, including 560 patients. Results of Meta-analysis indicated that the total effective rate of observation group was significantly higher than that of the control group(OR=3.82,95%CI=2.46-5.91,P<0.05); the improvements of fibrinogen(MD=-0.28,95%CI=-0.33--0.22,P<0.05), serum triacylglycerol(MD=-0.46,95%CI=-0.52--0.40,P<0.05), intima-media thickness of carotid artery(MD=-0.62,95%CI=-1.00--0.24,P<0.05) and area of carotid plaque(MD=-0.49,95%CI=-0.96--0.03,P<0.05) of observation group were significantly better than those of the control group, with statistically significant difference; there was no statistical significance in difference in incidences of adverse drug reactions between two groups(OR=0.98,95%CI=0.40-2.40,P=0.97). CONCLUSIONS: Butylphthalide is safe and effective in treatment of high-risk transient cerebral ischemia, while due to the quality limitations of the involved study, this conclusion requires further verification by more large-sample and high-quality RCTs.
引文
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[13] 李雪娇.观察丁苯酞治疗高危性短暂性脑缺血发作的临床疗效及安全性[J].中国冶金工业医学杂志,2018,35(2):157-158.
[14] 杨照玲.丁苯酞对高危性短暂性脑缺血发作患者血脂和血液流变学的影响[J].中国药业,2016,25(14):68-71.
[15] 瞿砚舟,吕锦,蓝丽康,等.丁苯酞治疗高危性短暂性脑缺血发作的临床疗效与安全性[J].中国临床药理学杂志,2016,32(5):406-408.
[16] 韩亚杰.丁苯酞治疗高危性短暂性脑缺血发作的近期疗效[J].临床医学研究与实践,2017,2(29):25-26.
[17] Hill MD,Yiannakoulias N,Jeerakathil T,et al.The high risk of str-oke immediately after transient ischemic attacks:A population-based study[J].Neurology,2004,62(11):2015-2020.
[18] Tobin WO,Kinsella JA,Kavanagh GF,et al.Longitudinal assessment of thrombin generation potential in response to alteration of antiplatelet therapy after TIA or ischaemic stroke[J].J Neurol,2013,260(2):590-596.
[19] Geeganage CM,Diener HC,Algra A,et al.Dual or mono antiplatelet therapy for patients with acute ischemic stroke or transient ischemic attack:systematic review and meta-analysis of randomized controlled trials[J].Stroke,2012,43(4):1058-1066.
[20] Hankey GJ,Eikelboom JW.Antithrombotic drugs for patients with ischaemic attack to prevent recurrent major vascular events[J].Lan-cet Neurol,2010,9(3):273-284.
[21] Antithrombotic Trialists’ Collaboration.Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death,myocardial infarction,and stroke in high risk patients[J].BMJ,2002,324(7329):71-86.
[22] Liu CL,Liao SJ,Zeng JS,et al.dl-3n-butylphthalide prevents stroke via improvement of cerebral microvessels in RHRSP[J].J Neurol Sci,2007,260(1-2):106-113.
[23] Liao SJ,Lin JW,Pei Z,et al.Enhanced angiogenesis with dl-3n-butylphthalide treatment after focal cerebral ischemia in RHRSP[J].Brain RES,2009,1289:69-78.
[2] Wang Y,Liu M,Pu C.2014 Chinese guidelines for secondary prevention of ischemic stroke and transient ischemic attack[J].Int J Stroke.2017,12(3):302-320.
[3] Davey AR,Lasserson DS,Levi CR,et al.Management of transient ischemic attacks diagnosed by early-career general practitioners:A cross-sectional study[J].Int J Stroke,2018,13(3):313-320.
[4] Wang X,Sun Y,Dong S,et al.Butyphthalide in the treatment of massive Cerebral Infarction[J].Pak J Med Sci,2019,35(1):220-225.
[5] 崔丽英,李舜伟,张微微,等.dl-3-正丁基苯酞软胶囊与阿司匹林治疗急性缺血性脑卒中的多中心、随机、双盲双模拟对照研究[J].中华神经科杂志,2008,41(11):727-730.
[6] Xu J,Huai Y,Meng N,et al.l-3-n-Butylphthalide Activates Akt/mTOR Signaling,Inhibits Neuronal Apoptosis and Autophagy and Improves Cognitive Impairment in Mice with Repeated Cerebral Ischemia-Reperfusion Injury[J].Neurochem Res,2017,42(10):2968-2981.
[7] Liu RZ,Fan CX,Zhang ZL,et al.Effects of Dl-3-n-butylphthalide on Cerebral Ischemia Infarction in Rat Model by Mass Spectrometry Imaging[J].Int J Mol Sci,2017,18(11):E2451.
[8] Zhu S,Perloff MD.TIA for the internist[J].Am J Med,2014,127(10):901-902.
[9] Higgins JPT,Green S.Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0[EB/OL].[2011-03].http://www.Cochrane-handbook.org.
[10] 井延涛,程乾,鲁秀荣.丁苯酞治疗高危性短暂性脑缺血发作的临床效果及安全性分析[J].北方药学,2018,15(1):151-152.
[11] 徐晶雪.丁苯酞治疗高危性短暂性脑缺血发作的临床疗效评价[J].中国实用医药,2018,13(28):100-101.
[12] 李春生.丁苯酞治疗高危性短暂性脑缺血发作的疗效及安全性分析[J].中国实用神经疾病杂志,2017,20(7):122-123.
[13] 李雪娇.观察丁苯酞治疗高危性短暂性脑缺血发作的临床疗效及安全性[J].中国冶金工业医学杂志,2018,35(2):157-158.
[14] 杨照玲.丁苯酞对高危性短暂性脑缺血发作患者血脂和血液流变学的影响[J].中国药业,2016,25(14):68-71.
[15] 瞿砚舟,吕锦,蓝丽康,等.丁苯酞治疗高危性短暂性脑缺血发作的临床疗效与安全性[J].中国临床药理学杂志,2016,32(5):406-408.
[16] 韩亚杰.丁苯酞治疗高危性短暂性脑缺血发作的近期疗效[J].临床医学研究与实践,2017,2(29):25-26.
[17] Hill MD,Yiannakoulias N,Jeerakathil T,et al.The high risk of str-oke immediately after transient ischemic attacks:A population-based study[J].Neurology,2004,62(11):2015-2020.
[18] Tobin WO,Kinsella JA,Kavanagh GF,et al.Longitudinal assessment of thrombin generation potential in response to alteration of antiplatelet therapy after TIA or ischaemic stroke[J].J Neurol,2013,260(2):590-596.
[19] Geeganage CM,Diener HC,Algra A,et al.Dual or mono antiplatelet therapy for patients with acute ischemic stroke or transient ischemic attack:systematic review and meta-analysis of randomized controlled trials[J].Stroke,2012,43(4):1058-1066.
[20] Hankey GJ,Eikelboom JW.Antithrombotic drugs for patients with ischaemic attack to prevent recurrent major vascular events[J].Lan-cet Neurol,2010,9(3):273-284.
[21] Antithrombotic Trialists’ Collaboration.Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death,myocardial infarction,and stroke in high risk patients[J].BMJ,2002,324(7329):71-86.
[22] Liu CL,Liao SJ,Zeng JS,et al.dl-3n-butylphthalide prevents stroke via improvement of cerebral microvessels in RHRSP[J].J Neurol Sci,2007,260(1-2):106-113.
[23] Liao SJ,Lin JW,Pei Z,et al.Enhanced angiogenesis with dl-3n-butylphthalide treatment after focal cerebral ischemia in RHRSP[J].Brain RES,2009,1289:69-78.