碟脉灵~?苦碟子注射液临床应用专家共识
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摘要
碟脉灵~?苦碟子注射液目前被广泛用于治疗脑梗死、冠心病心绞痛等疾病。长期的临床应用和相关研究证据均表明,该药在改善心脑血管疾病临床症状方面有较好疗效。但该药目前尚未被收录入任何临床实践指南之中,且近年来发现该药在临床应用中存在使用不规范的问题。为进一步提高临床医生对该药的认识,更好地指导其临床合理用药,邀请来自全国心脑血管疾病领域的临床一线专家编写该专家共识。该共识采用GRADE系统,根据不同结局按照降级因素对证据进行质量分级,然后对证据总体进行评级。然后通过名义组法形成本共识的推荐意见或共识建议。专家共识意见的形成主要考虑6个方面的因素:证据质量、经济性、疗效、不良反应、病人可接受性以及其他。基于这6个方面,如果证据充分,则形成有证据支持的"推荐意见",采用GRADE网格计票规则。如果证据不充分,则形成"共识建议",采用多数计票规则。该共识采用简洁明了的体例格式,对该药的临床适应证、有效性、安全性证据以及相关前期资料进行了系统全面的梳理和总结,可为该药的临床使用提供有价值的参照。该共识已通过中华中医药学会的审核,并进行了发布,编号GS/CACM 202-2019。
Diemailing~? Kudiezi Injection( DKI) is widely used in the treatment of cerebral infarction,coronary heart disease and angina pectoris. Long-term clinical application and related research evidence showed that DKI has a good effect in improving the clinical symptoms of cardiovascular and cerebrovascular diseases. However,this injection has not been included in any clinical practice guideline. It has been found that the use of DKI is in wrong way in clinical practice in recent years. Therefore,clinical experts from the field of cardiovascular and cerebrovascular diseases nationwide are invited to compile this expert consensus in order to guide clinicians.GRADE system is used to grade the quality of evidence according to different outcomes according to degrading factors. Then it forms the recommendation or consensus suggestion through the nominal group method. The formation of expert consensus mainly considers six factors: quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others. Based on these six aspects,if the evidence is sufficient,a " recommendation" supported by evidence is formed,and GRADE grid voting rule is adopted. If the evidence is insufficient,a " consensus suggestions" will be formed,using the majority voting rule. In this consensus,the clinical indications,efficacy,safety evidences and related preliminary data of DKI were systematically and comprehensively summarized in a concise and clear format,which could provide valuable reference for the clinical use of DKI. This consensus has been approved by China association of Chinese medicine which is numbered GS/CACM 202-2019.
Diemailing~? Kudiezi Injection( DKI) is widely used in the treatment of cerebral infarction,coronary heart disease and angina pectoris. Long-term clinical application and related research evidence showed that DKI has a good effect in improving the clinical symptoms of cardiovascular and cerebrovascular diseases. However,this injection has not been included in any clinical practice guideline. It has been found that the use of DKI is in wrong way in clinical practice in recent years. Therefore,clinical experts from the field of cardiovascular and cerebrovascular diseases nationwide are invited to compile this expert consensus in order to guide clinicians.GRADE system is used to grade the quality of evidence according to different outcomes according to degrading factors. Then it forms the recommendation or consensus suggestion through the nominal group method. The formation of expert consensus mainly considers six factors: quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others. Based on these six aspects,if the evidence is sufficient,a " recommendation" supported by evidence is formed,and GRADE grid voting rule is adopted. If the evidence is insufficient,a " consensus suggestions" will be formed,using the majority voting rule. In this consensus,the clinical indications,efficacy,safety evidences and related preliminary data of DKI were systematically and comprehensively summarized in a concise and clear format,which could provide valuable reference for the clinical use of DKI. This consensus has been approved by China association of Chinese medicine which is numbered GS/CACM 202-2019.
引文
[1]方赛男,郭宇博,刘建平,等.中成药临床应用专家共识的制订流程[J].中国中药杂志,2018,43(24):4786.
[2]莫美,廖星,张霄潇,等.中华中医药学会中成药临床应用专家共识报告规范[J].中国中药杂志,2019,44(12):2644.
[3] Yang L,Xie X,Zhang J,et al. Microemulsion electrokinetic chromatography in combination with chemometric methods to evaluate the holistic quality consistency and predict the antioxidant activity of Ixeris sonchifolia(Bunge)Hance Injection[J]. PLoS ONE,2016,11(6):e157601.
[4]彭振宇,宋玉国,申玉华.苦碟子注射液指纹图谱的研究[J].中国药物经济学,2013(7):29.
[5]刘颖,王青,王放,等.苦碟子注射液HPLC指纹图谱与化学模式识别分析[J].中国药学杂志,2013,48(24):2097.
[6]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,2013,33(15):3730.
[7]林海峰,陈逢俭,陈文荣.碟脉灵治疗进展性脑梗死的临床研究[J].中国老年学杂志,2005,25(6):647.
[8]孙常青.缺血性中风早期康复和避免复发中医方案临床疗效和卫生经济学评价[D].济南:山东中医药大学,2012.
[9]中国中西医结合学会神经科专业委员会.中国脑梗死中西医结合诊治指南(2017)[J].中国中西医结合杂志,2018,38(2):136.
[10]方丽萍,肖展翅,柯红艳.苦碟子注射液对脑梗死恢复期患者血液流变学的影响研究[J].实用心脑肺血管病杂志,2016,24(3):93.
[11]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,2010,29(1):13.
[12]中风病证候学与临床诊断的研究课题组,国家中医药管理局脑病急症科研协作组.中风病辨证诊断标准(试行)[J].北京中医药大学学报,1994,17(3):64.
[13]国家卫生计生委合理用药专家委员会,中国药师协会.冠心病合理用药指南[J]. 2版.中国医学前沿杂志,2018,10(6):1.
[14]阎博华,彭成,刘中兴,等.苦碟子注射液(碟脉灵)过敏反应发生机制探讨[J].中国实验方剂学杂志,2016,22(9):101.
[15]王玉娟,艾买提·毛尼牙孜.苦碟子注射液对行经皮冠状动脉介入治疗的急性心肌梗死患者的影响[J].实用心脑肺血管病杂志,2017,25(4):81.
[16]韩燕鸿,张荷.苦碟子注射液治疗不稳定型心绞痛的系统评价[J].中国实验方剂学杂志,2016,22(11):189.
[17]中国中西医结合学会活血化瘀专业委员会,陈可冀,史大卓,等.冠心病血瘀证诊断标准[J].中国中西医结合杂志,2016,36(10):1162.
[18]康玉斌.常用中药注射液配伍后不溶性微粒影响因素的探讨[D].温州:温州医学院,2011.
[19]何慧领.注射用甲磺酸左氧氟沙星与苦碟子存在配伍禁忌[J].中国实用护理杂志,2013,29(26):10.
[20]刘佳.注射用长春西汀与苦碟子注射液存在配伍禁忌[J].中华现代护理杂志,2013,19(21):2582.
[21]凌晓红,戴显风,胡苗叶.苦碟子注射液与硫酸依替米星不宜配伍[J].海峡药学,2009,21(10):176.
[22]谢军,刘圣,朱文君,等.苦碟子注射液与5种常用输液及注射用盐酸川芎嗪配伍后的稳定性考察[J].中成药,2013,35(8):1788.
[23]孙英芬,严洁琼,唐幸丰.注射用兰索拉唑和苦碟子注射液存在配伍禁忌[J].中华现代护理杂志,2016,22(8):1070.
[24]王金环.与苦碟子注射液配伍分析[J].按摩与康复医学,2012,3(6):70.
[25]王会芳.盐酸普罗帕酮与苦碟子注射液存在配伍禁忌[J].医药世界,2009(7):370.
[26]徐玉珍,熊伟,崔玉萍,等.苦碟子与阿莫西林钠克拉维酸钾配伍禁忌[J].实用医技杂志,2008,15(15):1957.
[27]魏宇宁,李久旭,王洪刚,等.苦碟子注射液与5种大输液配伍的稳定性考察[J].中国药房,2008,19(36):2834.
[28]王庆庆,陈迹.常用中药注射剂输液的配伍的稳定性研究[J].中国医院药学杂志,2016(36):434.
[29]阎博华,彭成,谢雁鸣,等.基于SRS的苦碟子注射液(碟脉灵)ADR信号分析-决策树和神经网络模型比较研究[J].时珍国医国药,2016,27(2):455.
[30]廖星,于丹丹,谢雁鸣,等.碟脉灵苦碟子注射液上市后安全性监测:一项30 233例真实世界注册登记研究[J].中国中药杂志,2017,42(15):2857.
[31]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.
[2]莫美,廖星,张霄潇,等.中华中医药学会中成药临床应用专家共识报告规范[J].中国中药杂志,2019,44(12):2644.
[3] Yang L,Xie X,Zhang J,et al. Microemulsion electrokinetic chromatography in combination with chemometric methods to evaluate the holistic quality consistency and predict the antioxidant activity of Ixeris sonchifolia(Bunge)Hance Injection[J]. PLoS ONE,2016,11(6):e157601.
[4]彭振宇,宋玉国,申玉华.苦碟子注射液指纹图谱的研究[J].中国药物经济学,2013(7):29.
[5]刘颖,王青,王放,等.苦碟子注射液HPLC指纹图谱与化学模式识别分析[J].中国药学杂志,2013,48(24):2097.
[6]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,2013,33(15):3730.
[7]林海峰,陈逢俭,陈文荣.碟脉灵治疗进展性脑梗死的临床研究[J].中国老年学杂志,2005,25(6):647.
[8]孙常青.缺血性中风早期康复和避免复发中医方案临床疗效和卫生经济学评价[D].济南:山东中医药大学,2012.
[9]中国中西医结合学会神经科专业委员会.中国脑梗死中西医结合诊治指南(2017)[J].中国中西医结合杂志,2018,38(2):136.
[10]方丽萍,肖展翅,柯红艳.苦碟子注射液对脑梗死恢复期患者血液流变学的影响研究[J].实用心脑肺血管病杂志,2016,24(3):93.
[11]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,2010,29(1):13.
[12]中风病证候学与临床诊断的研究课题组,国家中医药管理局脑病急症科研协作组.中风病辨证诊断标准(试行)[J].北京中医药大学学报,1994,17(3):64.
[13]国家卫生计生委合理用药专家委员会,中国药师协会.冠心病合理用药指南[J]. 2版.中国医学前沿杂志,2018,10(6):1.
[14]阎博华,彭成,刘中兴,等.苦碟子注射液(碟脉灵)过敏反应发生机制探讨[J].中国实验方剂学杂志,2016,22(9):101.
[15]王玉娟,艾买提·毛尼牙孜.苦碟子注射液对行经皮冠状动脉介入治疗的急性心肌梗死患者的影响[J].实用心脑肺血管病杂志,2017,25(4):81.
[16]韩燕鸿,张荷.苦碟子注射液治疗不稳定型心绞痛的系统评价[J].中国实验方剂学杂志,2016,22(11):189.
[17]中国中西医结合学会活血化瘀专业委员会,陈可冀,史大卓,等.冠心病血瘀证诊断标准[J].中国中西医结合杂志,2016,36(10):1162.
[18]康玉斌.常用中药注射液配伍后不溶性微粒影响因素的探讨[D].温州:温州医学院,2011.
[19]何慧领.注射用甲磺酸左氧氟沙星与苦碟子存在配伍禁忌[J].中国实用护理杂志,2013,29(26):10.
[20]刘佳.注射用长春西汀与苦碟子注射液存在配伍禁忌[J].中华现代护理杂志,2013,19(21):2582.
[21]凌晓红,戴显风,胡苗叶.苦碟子注射液与硫酸依替米星不宜配伍[J].海峡药学,2009,21(10):176.
[22]谢军,刘圣,朱文君,等.苦碟子注射液与5种常用输液及注射用盐酸川芎嗪配伍后的稳定性考察[J].中成药,2013,35(8):1788.
[23]孙英芬,严洁琼,唐幸丰.注射用兰索拉唑和苦碟子注射液存在配伍禁忌[J].中华现代护理杂志,2016,22(8):1070.
[24]王金环.与苦碟子注射液配伍分析[J].按摩与康复医学,2012,3(6):70.
[25]王会芳.盐酸普罗帕酮与苦碟子注射液存在配伍禁忌[J].医药世界,2009(7):370.
[26]徐玉珍,熊伟,崔玉萍,等.苦碟子与阿莫西林钠克拉维酸钾配伍禁忌[J].实用医技杂志,2008,15(15):1957.
[27]魏宇宁,李久旭,王洪刚,等.苦碟子注射液与5种大输液配伍的稳定性考察[J].中国药房,2008,19(36):2834.
[28]王庆庆,陈迹.常用中药注射剂输液的配伍的稳定性研究[J].中国医院药学杂志,2016(36):434.
[29]阎博华,彭成,谢雁鸣,等.基于SRS的苦碟子注射液(碟脉灵)ADR信号分析-决策树和神经网络模型比较研究[J].时珍国医国药,2016,27(2):455.
[30]廖星,于丹丹,谢雁鸣,等.碟脉灵苦碟子注射液上市后安全性监测:一项30 233例真实世界注册登记研究[J].中国中药杂志,2017,42(15):2857.
[31]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.