医院集中监测7189例脑梗死患者使用碟脉灵苦碟子注射液的真实世界用药分析
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摘要
基于大样本真实世界数据分析脑梗死患者使用碟脉灵苦碟子注射液的真实世界用药情况。采用主动监测方式,碟脉灵苦碟子注射液上市后临床安全性医院集中监测获得7 189例脑梗死患者使用碟脉灵的用药信息。从用药人群基本人口学特征、碟脉灵注射液用药及其联合用药分析等三大方面对该药的使用情况进行了具体的统计描述分析和关联规则分析,分析发现该研究所选取的脑梗死人群分布以中医医院为主,医院级别以三级居多,医院所在地域分布以华北地区为多;对于用药相关指标如单次滴速、配液放置时间、注射持续时间、注射室温均无说明书指导;另外发现有非静脉滴注、>14 d疗程用药、使用非指定溶媒以及>40 m L和<10 m L单次剂量等不符合说明书用药情况。而关联规则分析发现,排在靠前的几种药物除了依拉达奉注射液属于指南推荐用药外,其他几种药物的使用均缺乏现有证据支持。另外,同时使用碟脉灵+阿司匹林+前列地尔的情况最为多见,而非目前临床研究所推崇的"双抗"治疗。该研究通过大样本的数据分析,获得有关碟脉灵真实世界的用药情况,能够为临床医生和研究者提供基本的参考信息。但该研究并没有关注疗效评价,因此不能说明用药疗效相关内容。
This is a study based on hospital intensive monitoring to explore medication use of Diemailing Kudiezi injection( one Chinese herbal medicine injection) in real word in the patients with cerebral infarction. The active monitoring model was adopted and hospital intensive monitoring on safety of 7 189 cases of patients with cerebral infarction was conducted to obtain the drug use information of Diemailing injection. The results were analyzed by using statistical description and association rule method. The statistical description and association rule analysis were conducted based on patients' basic demographic characteristics,use of Diemailing injection and combined use of drugs. Sixty-two percent( 4 437/7 189) of the patients were from traditional Chinese medicine hospitals as compared with 39%( 2 752/7 189) from western medicine hospitals; 84%( 6 003/7 189) of the patients were from tertiary hospitals as compared with 16%( 1 186/7 189) from second-class hospitals. The hospitals were mostly located in north China. Drug related indicators such as a single dripping speed,stash time after allocating transfusion,duration of injection,and injecting room temperature were not noted in instruction manual. It was also found that there were off label use in the practice,for instance,non-intravenous infusion, > 14 d treatment course,use of non-designated solvent,and a single dose > 40 m L or < 10 m L. Analysis of association rules showed that only Edaravone among the most frequent combined drugs was listed in the current guideline in China,and the other three most frequent combined drugs deproteinized calf blood extractive injection,Cinepazide Maleate injection and Alprostadil injection were used with little evidence. Diemailing + Aspirin + Alprostadil was the most common combined use in our study,but the recommended clopidogrel + Aspirin was not found in this study. The drug use situation of Diemailing injection in the real world was obtained by data analysis on large size samples,providing basic reference information for clinicians and researchers. However,efficacy was not concerned in this study,so efficacy-related information could not be explained.
This is a study based on hospital intensive monitoring to explore medication use of Diemailing Kudiezi injection( one Chinese herbal medicine injection) in real word in the patients with cerebral infarction. The active monitoring model was adopted and hospital intensive monitoring on safety of 7 189 cases of patients with cerebral infarction was conducted to obtain the drug use information of Diemailing injection. The results were analyzed by using statistical description and association rule method. The statistical description and association rule analysis were conducted based on patients' basic demographic characteristics,use of Diemailing injection and combined use of drugs. Sixty-two percent( 4 437/7 189) of the patients were from traditional Chinese medicine hospitals as compared with 39%( 2 752/7 189) from western medicine hospitals; 84%( 6 003/7 189) of the patients were from tertiary hospitals as compared with 16%( 1 186/7 189) from second-class hospitals. The hospitals were mostly located in north China. Drug related indicators such as a single dripping speed,stash time after allocating transfusion,duration of injection,and injecting room temperature were not noted in instruction manual. It was also found that there were off label use in the practice,for instance,non-intravenous infusion, > 14 d treatment course,use of non-designated solvent,and a single dose > 40 m L or < 10 m L. Analysis of association rules showed that only Edaravone among the most frequent combined drugs was listed in the current guideline in China,and the other three most frequent combined drugs deproteinized calf blood extractive injection,Cinepazide Maleate injection and Alprostadil injection were used with little evidence. Diemailing + Aspirin + Alprostadil was the most common combined use in our study,but the recommended clopidogrel + Aspirin was not found in this study. The drug use situation of Diemailing injection in the real world was obtained by data analysis on large size samples,providing basic reference information for clinicians and researchers. However,efficacy was not concerned in this study,so efficacy-related information could not be explained.
引文
[1]邱兵,罗赛华.缺血性脑卒中危险因素分析[J].临床医学研究与实践,2016(9):127.
[2]胡亚,杨志宏,孙晓波.JAK/STAT信号转导通路及中药干预在缺血性脑卒中的研究进展[J].中国药理学通报,2016(7):889.
[3]杨成,张钰琪,唐迅,等.阿司匹林单独或与氯吡格雷联合治疗对缺血性脑卒中患者再入院影响的回顾性队列研究[J].北京大学学报:医学版,2016(3):442.
[4]中华医学会神经病学分会,中华医学会神经病学分会脑血管病学组.中国急性缺血性脑卒中诊治指南2014[J].中华神经科杂志,2015,48(4):246.
[5]刘强,王肖南,王少卿,等.缺血性中风证候要素诊断量表不完善金标准验证结果的校正[J].中医杂志,2016(11):949.
[6]李静文,李宁.蒋宝素治疗中风经验[J].河南中医,2016(6):983.
[7]李洪亮,薛智慧,陈果,等.针刺配合康复疗法治疗中风后痉挛的系统评价[J].上海针灸杂志,2016(5):612.
[8]闫芳,刘书贵.中药注射剂治疗脑梗死研究进展(二)[J].山东医学高等专科学校学报,2007(1):73.
[9]闫芳,李传云.中药注射剂治疗脑梗死研究进展(一)[J].山东医学高等专科学校学报,2006(6):456.
[10]苏浩,陈懿,葛金文.中西医结合治疗急性脑梗死临床疗效的Meta分析[J].中华中医药学刊,2015(4):806.
[11]郝光磊,朱文涛,庄乾竹,等.中药注射剂治疗急性脑梗死效果与经济性评价的Meta分析[J].世界中西医结合杂志,2013(12):1193.
[12]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.
[13]肖展翅,李钢,刘秋梅,等.依达拉奉联合苦碟子治疗进展性脑梗死的疗效观察[J].中西医结合心脑血管病杂志,2014(3):309.
[14]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(4):1105.
[15]廖星,曾宪斌,谢雁鸣,等.回顾分析真实世界中苦碟子注射液治疗冠心病和脑梗死的联合用药[J].中国中药杂志,2013(18):3110.
[16]常艳鹏,李霖,谢雁鸣,等.苦碟子注射液治疗脑梗死疗效的实效研究[J].中国中药杂志,2013(18):3155.
[17]Wu B,Liu M,Liu H,等.Meta-analysis of traditional Chinese patent medicine for ischemic stroke[J].Stroke,2007,38(6):1973.
[18]Peng W,Yang J,Wang Y,et al.Systematic review and Metaanalysis of randomized controlled trials of xingnaojing treatment for stroke[J].Evid Based Complement Alternat Med,2014,2014(8):210851.
[19]Liu X T,Ren P W,Peng L,et al.Effectiveness and safety of Shen Xiong glucose injection for acute ischemic stroke:a systematic review and GRADE approach[J].BMC Complement Alternat Med,2016,16:68.
[20]Chang C C,Chen T L,Chiu H E,et al.Outcomes after stroke in patients receiving adjuvant therapy with traditional Chinese medicine:a nationwide matched interventional cohort study[J].J Ethnopharmacol,2016,177:46.
[21]徐添.脑卒中发病与预后的前瞻性队列研究[D].苏州:苏州大学,2014.
[22]王成伟,刘梦阅,文谦,等.成都地区缺血性脑卒中急性期患者中医证候规律分析——1 341例横断面调查[J].中医杂志,2015,56(12):1038.
[23]崔晓琳,蔡业峰,卢明,等.739例首发中风急性期辨证分型与危险因素关系的回顾性分析[J].中国中医急症,2005(10):974.
[24]侯兆辉,郭伟君,籍明智,等.缺血性脑卒中患者中医证候分布特点[J].实用中医内科杂志,2013(21):1.
[25]王建华,张哲,肖蕾,等.982例心脑合病患者发病特点分析[J].中医杂志,2014(1):38.
[26]王桂倩,张寅,谢雁鸣,等.基于真实世界的急性脑梗死死亡患者死亡节气时辰与用药分析[J].中华中医药杂志,2016(5):1844.
[27]罗浩铭.苦碟子注射液中有效物质基础的研究[D].长春:吉林大学,2010.
[28]翟玉荣,于小风,曲绍春,等.苦碟子总黄酮对大鼠心肌缺血/再灌注损伤的保护作用[J].中国药理学通报,2010(2):276.
[29]陈春光,贾洪丽,吕首旭,等.苦碟子注射液对大鼠急性脑缺血-再灌注损伤的保护作用[J].中国临床药理学杂志,2012(3):196.
[30]高岩,杨珺.小牛血去蛋白提取物联合前列地尔治疗急性脑梗死的疗效观察[J].中国处方药,2016(5):10.
[31]乐春,徐海松.小牛血去蛋白提取物治疗缺血性脑梗死疗效分析[J].中国临床药理学与治疗学,2009(8):937.
[32]Wang Y,Pan Y,Zhao X,et al.Clopidogrel with Aspirin in acute minor stroke or transient ischemic attack(CHANCE)trial:oneyear outcomes[J].Circulation,2015,132(1):40.
[33]刘思鸿.中西医结合治疗脑梗死的用药规律研究[D].北京:中国中医科学院,2015.
[2]胡亚,杨志宏,孙晓波.JAK/STAT信号转导通路及中药干预在缺血性脑卒中的研究进展[J].中国药理学通报,2016(7):889.
[3]杨成,张钰琪,唐迅,等.阿司匹林单独或与氯吡格雷联合治疗对缺血性脑卒中患者再入院影响的回顾性队列研究[J].北京大学学报:医学版,2016(3):442.
[4]中华医学会神经病学分会,中华医学会神经病学分会脑血管病学组.中国急性缺血性脑卒中诊治指南2014[J].中华神经科杂志,2015,48(4):246.
[5]刘强,王肖南,王少卿,等.缺血性中风证候要素诊断量表不完善金标准验证结果的校正[J].中医杂志,2016(11):949.
[6]李静文,李宁.蒋宝素治疗中风经验[J].河南中医,2016(6):983.
[7]李洪亮,薛智慧,陈果,等.针刺配合康复疗法治疗中风后痉挛的系统评价[J].上海针灸杂志,2016(5):612.
[8]闫芳,刘书贵.中药注射剂治疗脑梗死研究进展(二)[J].山东医学高等专科学校学报,2007(1):73.
[9]闫芳,李传云.中药注射剂治疗脑梗死研究进展(一)[J].山东医学高等专科学校学报,2006(6):456.
[10]苏浩,陈懿,葛金文.中西医结合治疗急性脑梗死临床疗效的Meta分析[J].中华中医药学刊,2015(4):806.
[11]郝光磊,朱文涛,庄乾竹,等.中药注射剂治疗急性脑梗死效果与经济性评价的Meta分析[J].世界中西医结合杂志,2013(12):1193.
[12]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.
[13]肖展翅,李钢,刘秋梅,等.依达拉奉联合苦碟子治疗进展性脑梗死的疗效观察[J].中西医结合心脑血管病杂志,2014(3):309.
[14]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(4):1105.
[15]廖星,曾宪斌,谢雁鸣,等.回顾分析真实世界中苦碟子注射液治疗冠心病和脑梗死的联合用药[J].中国中药杂志,2013(18):3110.
[16]常艳鹏,李霖,谢雁鸣,等.苦碟子注射液治疗脑梗死疗效的实效研究[J].中国中药杂志,2013(18):3155.
[17]Wu B,Liu M,Liu H,等.Meta-analysis of traditional Chinese patent medicine for ischemic stroke[J].Stroke,2007,38(6):1973.
[18]Peng W,Yang J,Wang Y,et al.Systematic review and Metaanalysis of randomized controlled trials of xingnaojing treatment for stroke[J].Evid Based Complement Alternat Med,2014,2014(8):210851.
[19]Liu X T,Ren P W,Peng L,et al.Effectiveness and safety of Shen Xiong glucose injection for acute ischemic stroke:a systematic review and GRADE approach[J].BMC Complement Alternat Med,2016,16:68.
[20]Chang C C,Chen T L,Chiu H E,et al.Outcomes after stroke in patients receiving adjuvant therapy with traditional Chinese medicine:a nationwide matched interventional cohort study[J].J Ethnopharmacol,2016,177:46.
[21]徐添.脑卒中发病与预后的前瞻性队列研究[D].苏州:苏州大学,2014.
[22]王成伟,刘梦阅,文谦,等.成都地区缺血性脑卒中急性期患者中医证候规律分析——1 341例横断面调查[J].中医杂志,2015,56(12):1038.
[23]崔晓琳,蔡业峰,卢明,等.739例首发中风急性期辨证分型与危险因素关系的回顾性分析[J].中国中医急症,2005(10):974.
[24]侯兆辉,郭伟君,籍明智,等.缺血性脑卒中患者中医证候分布特点[J].实用中医内科杂志,2013(21):1.
[25]王建华,张哲,肖蕾,等.982例心脑合病患者发病特点分析[J].中医杂志,2014(1):38.
[26]王桂倩,张寅,谢雁鸣,等.基于真实世界的急性脑梗死死亡患者死亡节气时辰与用药分析[J].中华中医药杂志,2016(5):1844.
[27]罗浩铭.苦碟子注射液中有效物质基础的研究[D].长春:吉林大学,2010.
[28]翟玉荣,于小风,曲绍春,等.苦碟子总黄酮对大鼠心肌缺血/再灌注损伤的保护作用[J].中国药理学通报,2010(2):276.
[29]陈春光,贾洪丽,吕首旭,等.苦碟子注射液对大鼠急性脑缺血-再灌注损伤的保护作用[J].中国临床药理学杂志,2012(3):196.
[30]高岩,杨珺.小牛血去蛋白提取物联合前列地尔治疗急性脑梗死的疗效观察[J].中国处方药,2016(5):10.
[31]乐春,徐海松.小牛血去蛋白提取物治疗缺血性脑梗死疗效分析[J].中国临床药理学与治疗学,2009(8):937.
[32]Wang Y,Pan Y,Zhao X,et al.Clopidogrel with Aspirin in acute minor stroke or transient ischemic attack(CHANCE)trial:oneyear outcomes[J].Circulation,2015,132(1):40.
[33]刘思鸿.中西医结合治疗脑梗死的用药规律研究[D].北京:中国中医科学院,2015.