银杏叶提取物制剂临床不良反应的Meta分析
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摘要
目的:系统评价银杏叶提取物制剂的临床安全性。方法:计算机检索Pubmed、Embase、the Cochrane Library、CNKI、VIP和WanFang Data 2006-01-2018-04公开发表的有关银杏叶提取物的随机对照研究。筛选文献、提取数据并评价方法学质量后,采用Revman 5.3软件进行Meta分析。同时将纳入的研究按不同适应证、给药途径和疗程分为3个亚组分析。结果:最终纳入32篇文献,共纳入研究患者2 876例,其中银杏叶提取物制剂使用者(治疗组)共1 431例,对照组1 445例。Meta分析结果显示,相对危险度(RR)为0.69,95%CI[0.56,0.85],治疗组不良反应发生率(9.36%)低于对照组(13.43%),差异明显(P<0.01)。亚组分析显示:在脑血管系统疾病组、神经精神系统疾病组、口服组、静脉滴注组、使用疗程≤2周组和>4周组这几个亚组中,治疗组患者不良反应发生率均低于对照组(P<0.05)。结论:银杏叶提取物制剂是一种较为安全的药物。在治疗脑血管系统及神经精神系统疾病时,银杏叶提取物制剂的安全性较高。对于特殊人群,给药途径的选择需尤为谨慎。用药过程中应关注患者适应证、合并用药、体质状况、年龄等因素,保障合理用药。
Objective:To systematically evaluate the clinical safety of Ginkgo biloba extract preparations.Method:A randomized controlled study of Ginkgo biloba extract published from January 2006 to April 2018 by Pubmed,Embase,the Cochrane Library,CNKI,VIP and WanFang Data was searched.Meta-analysis was performed using Revman 5.3software after screening the literature,extracting data,and evaluating methodological quality.At the same time,the included studies were divided into three subgroups according to different indications,different usages and different treatment courses.Result:Thirty-two clinical studies were analyzed with a total of 2 876 cases,including 1 431 cases in treatment group and 1 445 cases in the control group.Meta-analysis showed that the relative risk(RR)was 0.69,95%%CI[0.56,0.85],and the incidence of adverse reactions in the treatment group(9.36%)was lower than that in the control group(13.43%),and the difference was significant(P<0.01).The results of subgroup analysis showed that the adverse reactions rate of treatment group was lower than the control group's in cerebrovascular disease group,neuropsychiatric disease group,oral group,intravenous drip group,course of treatment≤2weeks group,and>4weeks group(P<0.05).Conclusion:Ginkgo biloba extract is a safe drug.In the treatment of cerebrovascular and neuropsychiatric diseases,Ginkgo biloba extract preparations are safer.For special population,the choice of route of administration is particularly careful.In the course of medication,attention should be paid to factors such as patient indications,combined medication,physical condition,age,etc.,to ensure rational use of drugs.
Objective:To systematically evaluate the clinical safety of Ginkgo biloba extract preparations.Method:A randomized controlled study of Ginkgo biloba extract published from January 2006 to April 2018 by Pubmed,Embase,the Cochrane Library,CNKI,VIP and WanFang Data was searched.Meta-analysis was performed using Revman 5.3software after screening the literature,extracting data,and evaluating methodological quality.At the same time,the included studies were divided into three subgroups according to different indications,different usages and different treatment courses.Result:Thirty-two clinical studies were analyzed with a total of 2 876 cases,including 1 431 cases in treatment group and 1 445 cases in the control group.Meta-analysis showed that the relative risk(RR)was 0.69,95%%CI[0.56,0.85],and the incidence of adverse reactions in the treatment group(9.36%)was lower than that in the control group(13.43%),and the difference was significant(P<0.01).The results of subgroup analysis showed that the adverse reactions rate of treatment group was lower than the control group's in cerebrovascular disease group,neuropsychiatric disease group,oral group,intravenous drip group,course of treatment≤2weeks group,and>4weeks group(P<0.05).Conclusion:Ginkgo biloba extract is a safe drug.In the treatment of cerebrovascular and neuropsychiatric diseases,Ginkgo biloba extract preparations are safer.For special population,the choice of route of administration is particularly careful.In the course of medication,attention should be paid to factors such as patient indications,combined medication,physical condition,age,etc.,to ensure rational use of drugs.
引文
[1]金晶,董宇翔,李戈.银杏叶提取物在老年性疾病治疗中的应用进展[J].中国老年学杂志,2007,27(6):596-598.
[2]高波,郭张强,刘涛,等.银杏叶提取物对不稳定型心绞痛低、中危患者疗效及血清单核细胞趋化蛋白-1、高敏C反应蛋白的影响[J].临床心血管病杂志,2014,30(9):770-772.
[3]杨乐,杜晓曦,郭晓昕,等.银杏叶提取物注射液不良反应的文献分析[J].中国药物警戒,2014,11(3):163-169.
[4]崔志平.银杏叶制剂与出血[J].中国药师,2002,5(10):621-622.
[5]张玉萌,栗晓东,牛晓芳.银杏达莫注射剂致过敏性休克文献分析[J].中国药物应用与监测,2012,9(5):291-293.
[6]梁师钢.吗替麦考酚酯联合银杏达莫注射液治疗难治性肾病综合征疗效观察[J].蚌埠医学院学报,2017,42(12):1601-1603.
[7]罗向东,吴景芬,周波,等.帕罗西汀联合银杏叶片治疗血管性抑郁的疗效研究[J].西部医学,2011,23(9):1644-1646.
[8]王学燕,王兆军,梁家騋,等.银杏叶滴丸联合米氮平治疗卒中后抑郁临床研究[J].精神医学杂志,2015,28(1):59-60.
[9]罗纯,张建军,胡玲,等.银杏叶注射液治疗晚期肺癌患者血液高凝状态的疗效观察[J].医学研究与教育,2014,31(6):110-115.
[10]陈志东,张勤.银杏叶制剂与化学药品的不良相互作用[J].上海医药,2012,20(9):16-18.
[11]诸敏,姚彤炜,曾苏.银杏黄酮的体外葡醛酸反应及其药物相互作用[J].浙江大学学报:医学版,2004,33(1):15-20.
[12]刘冉.银杏叶提取物对辛伐他汀药物代谢影响的研究[D].中国中医科学院中西医结合临床,2009:1-4.
[2]高波,郭张强,刘涛,等.银杏叶提取物对不稳定型心绞痛低、中危患者疗效及血清单核细胞趋化蛋白-1、高敏C反应蛋白的影响[J].临床心血管病杂志,2014,30(9):770-772.
[3]杨乐,杜晓曦,郭晓昕,等.银杏叶提取物注射液不良反应的文献分析[J].中国药物警戒,2014,11(3):163-169.
[4]崔志平.银杏叶制剂与出血[J].中国药师,2002,5(10):621-622.
[5]张玉萌,栗晓东,牛晓芳.银杏达莫注射剂致过敏性休克文献分析[J].中国药物应用与监测,2012,9(5):291-293.
[6]梁师钢.吗替麦考酚酯联合银杏达莫注射液治疗难治性肾病综合征疗效观察[J].蚌埠医学院学报,2017,42(12):1601-1603.
[7]罗向东,吴景芬,周波,等.帕罗西汀联合银杏叶片治疗血管性抑郁的疗效研究[J].西部医学,2011,23(9):1644-1646.
[8]王学燕,王兆军,梁家騋,等.银杏叶滴丸联合米氮平治疗卒中后抑郁临床研究[J].精神医学杂志,2015,28(1):59-60.
[9]罗纯,张建军,胡玲,等.银杏叶注射液治疗晚期肺癌患者血液高凝状态的疗效观察[J].医学研究与教育,2014,31(6):110-115.
[10]陈志东,张勤.银杏叶制剂与化学药品的不良相互作用[J].上海医药,2012,20(9):16-18.
[11]诸敏,姚彤炜,曾苏.银杏黄酮的体外葡醛酸反应及其药物相互作用[J].浙江大学学报:医学版,2004,33(1):15-20.
[12]刘冉.银杏叶提取物对辛伐他汀药物代谢影响的研究[D].中国中医科学院中西医结合临床,2009:1-4.
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