苦碟子注射液治疗急性脑梗死的有效性和安全性研究:随机对照试验的系统评价和Meta分析
|
摘要
为系统评价苦碟子注射液治疗急性脑梗死的疗效和安全性。该研究系统全面地检索四大中文数据库(CNKI,VIP,Wan Fang,Sino Med),3大英文数据库(Cochrane Library,EMbase,Medline)和Clinical Trail.gov,检索时间为各数据库建库至2017年11月,按照预先设定的纳入标准和排除标准筛选出苦碟子注射液治疗急性脑梗死的随机对照试验(randomized controlled trial,RCT)。采用"Cochrane偏倚风险评估"工具对所纳入的研究进行质量评价,并对纳入的研究进行描述分析或应用Rev Man5. 3软件进行Meta定量分析。结果共检索出932篇文献,最终纳入14个研究,除2个多臂试验外,总样本量为1 244例,试验组638例,对照组606例,所纳入研究总体质量不高。Meta分析结果显示:苦碟子+常规治疗急性脑梗死在总有效率上优于常规治疗(RR=0. 86,95%CI[0. 77,0. 96],P=0. 006);苦碟子+常规治疗急性脑梗死在血清炎性因子方面优于常规治疗(MDhs-CRP=-3. 77,95%CI[-4. 17,-3. 37],P<0. 000 01; MDIL-18=-16. 18,95%CI[-19. 26,-13. 11],P<0. 000 01);苦碟子+常规治疗在Barthel指数方面优于常规治疗(MD=12. 52,95%CI[8. 93,16. 10],P<0. 000 01)。纳入研究报告的不良反应均为轻度不良反应。基于此研究结果,表明苦碟子注射液联合常规治疗或其他西药治疗急性脑梗死具有一定的疗效,未见严重的不良反应。但鉴于纳入研究方法学质量普遍不高,影响结论的可靠性,故建议使用该研究的结论时需谨慎。此外,为产生高质量证据来为指导苦碟子注射液运用临床实践提供有力的证据支撑,需要更多大样本、经科学设计、严格实施的随机对照试验来研究苦碟子注射液治疗脑梗死的疗效和安全性。
To systematically review the effectiveness and safety of Kudiezi Injection in treating patients with acute cerebral infarction( ACI). Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med),three English databases( Cochrane Library,EMbase,Medline)and Clinical Trail.gov were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to November 2017. Randomized controlled trials( RCTs) for the treatment of acute cerebral infarction with Kudiezi Injection were screened out according to pre-established inclusion criteria and exclusion criteria. The quality of the included studies was assessed using the Cochrane Risk Assessment Tool,and the included studies were put into descriptive analysis or Meta-analysis using the Rev Man 5. 3 software. A total of 932 articles were retrieved,and finally 14 studies were included. Except for 2 multi-arm trials,the total sample size was 1 244 in the experimental group and 638 in the control group. The overall quality of the included studies was not high. The results of Meta-analysis showed that Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in total effective rate( RR = 0. 86,95% CI[0. 77,0. 96],P = 0. 006); Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in serum inflammatory factors( MDhs-CRP=-3. 77,95% CI[-4. 17,-3. 37],P < 0. 000 01; MDIL-18=-16. 18,95% CI[-19. 26,-13. 11],P<0. 000 01); Kudiezi + conventional therapy was superior to conventional therapy in Barthel index( MD = 12. 52,95%CI[8. 93,16. 10],P<0. 000 01). Adverse reactions included in the study reports showed mild adverse reactions. Based on the results of this study,Kudiezi Injection combined with conventional therapy or other Western medicine had a certain curative effect on acute cerebral infarction,with no serious adverse reactions. However,due to the low quality of the included research methodology,the conclusions of this study were not recommended. In addition,in order to produce high-quality evidence for the clinical application of Kudiezi Injections,more randomized controlled trials with a large sample size,scientific design and strict implementation were required to study the effectiveness and safety of Kudiezi Injection in the treatment of cerebral infarction.
To systematically review the effectiveness and safety of Kudiezi Injection in treating patients with acute cerebral infarction( ACI). Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med),three English databases( Cochrane Library,EMbase,Medline)and Clinical Trail.gov were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to November 2017. Randomized controlled trials( RCTs) for the treatment of acute cerebral infarction with Kudiezi Injection were screened out according to pre-established inclusion criteria and exclusion criteria. The quality of the included studies was assessed using the Cochrane Risk Assessment Tool,and the included studies were put into descriptive analysis or Meta-analysis using the Rev Man 5. 3 software. A total of 932 articles were retrieved,and finally 14 studies were included. Except for 2 multi-arm trials,the total sample size was 1 244 in the experimental group and 638 in the control group. The overall quality of the included studies was not high. The results of Meta-analysis showed that Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in total effective rate( RR = 0. 86,95% CI[0. 77,0. 96],P = 0. 006); Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in serum inflammatory factors( MDhs-CRP=-3. 77,95% CI[-4. 17,-3. 37],P < 0. 000 01; MDIL-18=-16. 18,95% CI[-19. 26,-13. 11],P<0. 000 01); Kudiezi + conventional therapy was superior to conventional therapy in Barthel index( MD = 12. 52,95%CI[8. 93,16. 10],P<0. 000 01). Adverse reactions included in the study reports showed mild adverse reactions. Based on the results of this study,Kudiezi Injection combined with conventional therapy or other Western medicine had a certain curative effect on acute cerebral infarction,with no serious adverse reactions. However,due to the low quality of the included research methodology,the conclusions of this study were not recommended. In addition,in order to produce high-quality evidence for the clinical application of Kudiezi Injections,more randomized controlled trials with a large sample size,scientific design and strict implementation were required to study the effectiveness and safety of Kudiezi Injection in the treatment of cerebral infarction.
引文
[1]徐永健,葛均波.内科学[M].北京:人民卫生出版社,2013.
[2]陈聪,徐运.急性脑梗死溶栓治疗新进展[J].内科急危重症杂志,2013,19(2):65.
[3]庄礼源.脑梗死临床治疗研究进展[J].临床合理用药杂志,2017,10(9):173.
[4]练春玲.脑梗死的中医药治疗研究进展[J].中国民族民间医药,2013,22(13):50.
[5]巩颖,张彦丽,华国栋.苦碟子注射液的临床应用概述[J].医学综述,2014,20(1):100.
[6]谭迪,吴嘉瑞,刘施,等.基于Meta分析的苦碟子注射液治疗脑梗死临床评价研究[J].药物流行病学杂志,2017,26(7):460.
[7]王巍巍,胡晶,王晶,等.苦碟子注射液配合常规西药治疗急性脑梗死的系统评价[J].中华中医药杂志,2014,29(4):1105.
[8]薛斐然,华国栋,张彦丽,等.苦碟子注射液联合奥扎格雷钠注射液治疗脑梗死有效性的系统评价[J].中华中医药杂志,2014,29(6):1797.
[9]刘姣,夏芸,路遥,等.苦碟子注射液治疗急性脑梗死的系统评价[J].北京中医药,2013(7):497.
[10]刘颖.苦碟子注射液治疗急性脑梗死的Meta分析[C].沈阳:中华中医药学会中药分析分会学术交流会,2012.
[11]蒋亚斌,陈克家.碟脉灵注射液治疗急性脑梗死的系统评价[J].中国临床康复,2006(27):100.
[12]王新德.各类脑血管疾病诊断要点[J].中国乡村医药,1996(2):10.
[13] Higgins J,Green S E. Cochrane handbook for systematic reviews of interventions version 5. 1. 0. the cochrane collaboration(Eds):[J]. N-S Arch Pharmacol,2011,5(2):S38.
[14]林盛,何小燕,陈俊斌.苦蝶子注射液治疗急性脑梗死[J].医药论坛杂志,2009(9):6.
[15]冯立群,张茁,马毳,等.碟脉灵注射液治疗急性脑梗死疗效观察[J].中国动脉硬化杂志,2004(3):347.
[16]周芸,刘德军.苦碟子注射液对急性脑梗死患者血清炎症因子、疗效及生活质量的影响[J].中华中医药学刊,2016(4):900.
[17]陈莹.苦碟子注射液对急性脑梗死患者血清hs-CRP,IL-18影响的临床研究[D].长沙:湖南中医药大学,2012.
[18]李洪云.苦碟子注射液治疗急性脑梗死疗效观察[J].黑龙江中医药,2009(4):12.
[19]张荣厚,李新立,张建伟,等.苦碟子对急性脑梗死患者神经功能的影响[J].实用医药杂志,2006(8):939.
[20]涂鄂文,陈莹,刘秋庭,等.苦碟子注射液治疗急性脑梗死及血清hsCRP的影响[J].医药与保健,2014,22(7):74.
[21]汪潇,俞仰光,史玉凤.苦碟子注射液联合尤瑞克林治疗急性脑梗死临床研究[J].浙江中西医结合杂志,2011(8):550.
[22]翟青玲.苦碟子注射液治疗中青年急性脑梗死的临床疗效及对白细胞介素-6、C反应蛋白的影响[J].河北中医,2011(6):900.
[23]张綦慧.苦碟子注射液对急性脑梗死患者血清IL-6的影响[C].南阳:世界中联中医、中西医结合老年医学学术大会,2010.
[24]温静,张连城,张玉莲,等.苦碟子注射液治疗痰热腑实型急性期脑梗死临床研究[J].天津中医药大学学报,2010(1):13.
[25]王延茗.苦碟子注射液辅助治疗急性脑梗死疗效观察[J].现代中西医结合杂志,2008(21):3327.
[26]莫化时.碟脉灵注射液治疗急性脑梗死43例临床观察[J].中国现代医药杂志,2006,8(12):56.
[27]施来运.悦安欣治疗急性脑梗死疗效评价[J].吉林中医药,2006,26(9):13.
[28]张建斌,张丽玲,魏明阳.苦碟子注射液联合蕲蛇酶治疗老年进展性脑梗死的疗效[J].中国老年学杂志,2013(15):3730.
[29]韩伟燕,屈德会.苦碟子治疗脑梗死临床研究[J].现代中西医结合杂志,2012,21(9):1022.
[30]戴锦娜,尹然,陈晓辉,等.苦碟子化学成分和药理作用研究进展[J].西北药学杂志,2006(2):94.
[31] Kanazawa Y,Morioka T,Arakawa S,et al. Nonconvulsive partial status epilepticus mimicking recurrent infarction revealed by diffusion-weighted and arterial spin labeling perfusion magnetic resonance images[J]. J Stroke Cerebrovasc,2015,24(4):731.
[32]徐倩.我院17种中药注射剂浅析[J].海峡药学,2013(8):154.
[33]廖星,曾宪斌,谢雁鸣,等.基于苦碟子注射液HIS数据临床实效研究[J].中国中药杂志,2012,37(18):2723.
[34]崔瑞昭,谢雁鸣,廖星,等.苦碟子注射液用药安全性的系统评价[J].中国中药杂志,2017,42(12):2380.
[35]詹思延.临床流行病学[M]. 2版.北京:人民卫生出版社,2015.
[36]张宏伟,刘建平.临床试验中的盲法[J].中医杂志,2007(5):408.
[2]陈聪,徐运.急性脑梗死溶栓治疗新进展[J].内科急危重症杂志,2013,19(2):65.
[3]庄礼源.脑梗死临床治疗研究进展[J].临床合理用药杂志,2017,10(9):173.
[4]练春玲.脑梗死的中医药治疗研究进展[J].中国民族民间医药,2013,22(13):50.
[5]巩颖,张彦丽,华国栋.苦碟子注射液的临床应用概述[J].医学综述,2014,20(1):100.
[6]谭迪,吴嘉瑞,刘施,等.基于Meta分析的苦碟子注射液治疗脑梗死临床评价研究[J].药物流行病学杂志,2017,26(7):460.
[7]王巍巍,胡晶,王晶,等.苦碟子注射液配合常规西药治疗急性脑梗死的系统评价[J].中华中医药杂志,2014,29(4):1105.
[8]薛斐然,华国栋,张彦丽,等.苦碟子注射液联合奥扎格雷钠注射液治疗脑梗死有效性的系统评价[J].中华中医药杂志,2014,29(6):1797.
[9]刘姣,夏芸,路遥,等.苦碟子注射液治疗急性脑梗死的系统评价[J].北京中医药,2013(7):497.
[10]刘颖.苦碟子注射液治疗急性脑梗死的Meta分析[C].沈阳:中华中医药学会中药分析分会学术交流会,2012.
[11]蒋亚斌,陈克家.碟脉灵注射液治疗急性脑梗死的系统评价[J].中国临床康复,2006(27):100.
[12]王新德.各类脑血管疾病诊断要点[J].中国乡村医药,1996(2):10.
[13] Higgins J,Green S E. Cochrane handbook for systematic reviews of interventions version 5. 1. 0. the cochrane collaboration(Eds):[J]. N-S Arch Pharmacol,2011,5(2):S38.
[14]林盛,何小燕,陈俊斌.苦蝶子注射液治疗急性脑梗死[J].医药论坛杂志,2009(9):6.
[15]冯立群,张茁,马毳,等.碟脉灵注射液治疗急性脑梗死疗效观察[J].中国动脉硬化杂志,2004(3):347.
[16]周芸,刘德军.苦碟子注射液对急性脑梗死患者血清炎症因子、疗效及生活质量的影响[J].中华中医药学刊,2016(4):900.
[17]陈莹.苦碟子注射液对急性脑梗死患者血清hs-CRP,IL-18影响的临床研究[D].长沙:湖南中医药大学,2012.
[18]李洪云.苦碟子注射液治疗急性脑梗死疗效观察[J].黑龙江中医药,2009(4):12.
[19]张荣厚,李新立,张建伟,等.苦碟子对急性脑梗死患者神经功能的影响[J].实用医药杂志,2006(8):939.
[20]涂鄂文,陈莹,刘秋庭,等.苦碟子注射液治疗急性脑梗死及血清hsCRP的影响[J].医药与保健,2014,22(7):74.
[21]汪潇,俞仰光,史玉凤.苦碟子注射液联合尤瑞克林治疗急性脑梗死临床研究[J].浙江中西医结合杂志,2011(8):550.
[22]翟青玲.苦碟子注射液治疗中青年急性脑梗死的临床疗效及对白细胞介素-6、C反应蛋白的影响[J].河北中医,2011(6):900.
[23]张綦慧.苦碟子注射液对急性脑梗死患者血清IL-6的影响[C].南阳:世界中联中医、中西医结合老年医学学术大会,2010.
[24]温静,张连城,张玉莲,等.苦碟子注射液治疗痰热腑实型急性期脑梗死临床研究[J].天津中医药大学学报,2010(1):13.
[25]王延茗.苦碟子注射液辅助治疗急性脑梗死疗效观察[J].现代中西医结合杂志,2008(21):3327.
[26]莫化时.碟脉灵注射液治疗急性脑梗死43例临床观察[J].中国现代医药杂志,2006,8(12):56.
[27]施来运.悦安欣治疗急性脑梗死疗效评价[J].吉林中医药,2006,26(9):13.
[28]张建斌,张丽玲,魏明阳.苦碟子注射液联合蕲蛇酶治疗老年进展性脑梗死的疗效[J].中国老年学杂志,2013(15):3730.
[29]韩伟燕,屈德会.苦碟子治疗脑梗死临床研究[J].现代中西医结合杂志,2012,21(9):1022.
[30]戴锦娜,尹然,陈晓辉,等.苦碟子化学成分和药理作用研究进展[J].西北药学杂志,2006(2):94.
[31] Kanazawa Y,Morioka T,Arakawa S,et al. Nonconvulsive partial status epilepticus mimicking recurrent infarction revealed by diffusion-weighted and arterial spin labeling perfusion magnetic resonance images[J]. J Stroke Cerebrovasc,2015,24(4):731.
[32]徐倩.我院17种中药注射剂浅析[J].海峡药学,2013(8):154.
[33]廖星,曾宪斌,谢雁鸣,等.基于苦碟子注射液HIS数据临床实效研究[J].中国中药杂志,2012,37(18):2723.
[34]崔瑞昭,谢雁鸣,廖星,等.苦碟子注射液用药安全性的系统评价[J].中国中药杂志,2017,42(12):2380.
[35]詹思延.临床流行病学[M]. 2版.北京:人民卫生出版社,2015.
[36]张宏伟,刘建平.临床试验中的盲法[J].中医杂志,2007(5):408.