护肝片临床应用专家共识
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摘要
在临床医生问卷调查和护肝片研究文献系统回顾的基础上,采用国际临床医学专家共识研制方法,基于现有最佳证据,充分结合专家经验,遵循"循证为举,共识为主,经验为鉴"的原则,全国22家单位三十余位中医、西医临床和方法学专家研制了中华中医药学会专家共识《护肝片临床应用专家共识》,旨在指导和规范临床医生合理使用护肝片,提高临床疗效和安全性。该共识采用国际公认的证据分级推荐标准:GRADE系统。专家共识意见的形成采用名义组法,主要考虑6个方面的因素:证据质量、疗效、安全性、经济性、患者可接受性及其他。如果证据充分则形成"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。该共识针对护肝片临床应用中的适应症、用法用量、特殊人群用药、安全性等主要问题,提出了2项推荐意见和8项共识建议。该共识通过专家会议以及函审的方式,在全国范围内进行了征求意见和同行评议。该共识适用于在医院及基层卫生服务机构的临床医生,为其合理使用护肝片提供指导和参考。
Hugan Tablets is a Chinese patent medicine,it has the function of anti-inflammation and reducing transaminase. Based on questionnaire investigation of doctors and a systematic review of research literature on Hugan Tablets,using international clinical practice guidelines' developing methods,with the best available evidence and fully combining expert experience,and following the principle of " evidence-based,consensus-based and experience-based",Expert consensus statement on Hugan Tablets in clinical practice was developed by more than 30 multidisciplinary experts from the nationwide,aimed at guiding and standardizing the rational use of Hugan Tablets by clinicians and to improve clinical efficacy and safety. The expert consensus adopts internationally recognized recommendation criteria for classification of evidence: GRADE. The formation of expert consensus adopts the nominal group technique. Six main considerations are quality of evidence,curative effect,safety,economical efficiency,patient acceptability and other factors. If there is sufficient evidence,a " recommendation" is formed,using GRADE grid voting rule. If there isn' t sufficient evidence,a " consensus opinion" is formed,using majority counting rule. Focus on the indication,usage and dosage,drug use in special population and safety of Hugan Tablets,two recommendations and eight consensus opinions were put forward. Through expert meetings and correspondence,a nationwide consultation and peer review was conducted. This consensus applies to clinicians in hospitals and grass-roots health services,to provide guidance and reference for the rational use of Hugan Tablets.
Hugan Tablets is a Chinese patent medicine,it has the function of anti-inflammation and reducing transaminase. Based on questionnaire investigation of doctors and a systematic review of research literature on Hugan Tablets,using international clinical practice guidelines' developing methods,with the best available evidence and fully combining expert experience,and following the principle of " evidence-based,consensus-based and experience-based",Expert consensus statement on Hugan Tablets in clinical practice was developed by more than 30 multidisciplinary experts from the nationwide,aimed at guiding and standardizing the rational use of Hugan Tablets by clinicians and to improve clinical efficacy and safety. The expert consensus adopts internationally recognized recommendation criteria for classification of evidence: GRADE. The formation of expert consensus adopts the nominal group technique. Six main considerations are quality of evidence,curative effect,safety,economical efficiency,patient acceptability and other factors. If there is sufficient evidence,a " recommendation" is formed,using GRADE grid voting rule. If there isn' t sufficient evidence,a " consensus opinion" is formed,using majority counting rule. Focus on the indication,usage and dosage,drug use in special population and safety of Hugan Tablets,two recommendations and eight consensus opinions were put forward. Through expert meetings and correspondence,a nationwide consultation and peer review was conducted. This consensus applies to clinicians in hospitals and grass-roots health services,to provide guidance and reference for the rational use of Hugan Tablets.
引文
[1]龚梦鹃,巫圣乾,岳贺,等.基于血清和肝代谢组学研究护肝片的保肝作用[J].中国药房,2017,28(34):4776.
[2]沈红波,周一农,郑杰,等.基于网络药理学葵花护肝片“多成分-多靶点-多通路”的作用机制研究[J].中国中药杂志2019,44(7):1464.
[3]王永.葵花护肝片治疗药物性肝损伤的疗效观察[J].中国药物经济学,2018,13(11):79.
[4]熊俊,陈日新.系统评价/Meta分析方法学质量的评价工具AMSTAR[J].中国循证医学杂志,2011,11(9):1084.
[5] Cochrane handbook for systematic reviews of interventions[EB/OL].[2019-04-25]. http://handbook.cochrane.org/chapter_8.
[6]陈耀龙,姚亮,Susan Norris,等.GRADE在系统评价中应用的必要性及注意事项[J].中国循证医学杂志,2013,13(12):1401.
[7] GRADE工作组.GRADE:从证据到推荐[J].中国循证医学杂志,2009,9(3):257.
[8]孟庆刚.基于综合集成的中医药共识方法学研究[J].中华中医药学刊,2018,36(3):519.
[9]沈勇.护肝片在急慢性乙型病毒性肝炎中的应用和研究[J].光明中医,2017,32(4):525.
[10]徐德先.护肝片治疗慢性乙型肝炎60例疗效分析[J].实用肝脏病杂志,2005(1):38.
[11]王跃.护肝片联合拉米夫定治疗慢性乙型肝炎的临床疗效观察[J].中国微生态学杂志,2005(6):474.
[12]张东萍,肖招英,巫爱峰,等.多烯磷脂酰胆碱联合护肝片治疗药物性肝损伤疗效观察[J].中国药师,2014,17(9):1524.
[13]官欣,陈希,罗丹.护肝片治疗药物性肝脏损害的临床研究[J].北方药学,2016(9):137.
[14]朱小玉,于东,孟志刚,等.护肝片治疗非酒精性脂肪肝42例临床观察[J].北京医学,2006(8):489.
[15]傅金满.护肝片治疗脂肪肝伴肝功能异常临床疗效观察[J].中华中医药杂志,2005,20(10):590.
[16]王秀芳.拉米夫定联合护肝片对老年肝硬化患者肝功能、免疫功能及血清细胞TIMP-1、ICAM-1、TGF-β1、MMP-1的影响[J].中国老年学杂志,2018,38(3):602.
[17]中华中医药学会.中药上市后安全性医院集中监测技术规范[S].2017.
[2]沈红波,周一农,郑杰,等.基于网络药理学葵花护肝片“多成分-多靶点-多通路”的作用机制研究[J].中国中药杂志2019,44(7):1464.
[3]王永.葵花护肝片治疗药物性肝损伤的疗效观察[J].中国药物经济学,2018,13(11):79.
[4]熊俊,陈日新.系统评价/Meta分析方法学质量的评价工具AMSTAR[J].中国循证医学杂志,2011,11(9):1084.
[5] Cochrane handbook for systematic reviews of interventions[EB/OL].[2019-04-25]. http://handbook.cochrane.org/chapter_8.
[6]陈耀龙,姚亮,Susan Norris,等.GRADE在系统评价中应用的必要性及注意事项[J].中国循证医学杂志,2013,13(12):1401.
[7] GRADE工作组.GRADE:从证据到推荐[J].中国循证医学杂志,2009,9(3):257.
[8]孟庆刚.基于综合集成的中医药共识方法学研究[J].中华中医药学刊,2018,36(3):519.
[9]沈勇.护肝片在急慢性乙型病毒性肝炎中的应用和研究[J].光明中医,2017,32(4):525.
[10]徐德先.护肝片治疗慢性乙型肝炎60例疗效分析[J].实用肝脏病杂志,2005(1):38.
[11]王跃.护肝片联合拉米夫定治疗慢性乙型肝炎的临床疗效观察[J].中国微生态学杂志,2005(6):474.
[12]张东萍,肖招英,巫爱峰,等.多烯磷脂酰胆碱联合护肝片治疗药物性肝损伤疗效观察[J].中国药师,2014,17(9):1524.
[13]官欣,陈希,罗丹.护肝片治疗药物性肝脏损害的临床研究[J].北方药学,2016(9):137.
[14]朱小玉,于东,孟志刚,等.护肝片治疗非酒精性脂肪肝42例临床观察[J].北京医学,2006(8):489.
[15]傅金满.护肝片治疗脂肪肝伴肝功能异常临床疗效观察[J].中华中医药杂志,2005,20(10):590.
[16]王秀芳.拉米夫定联合护肝片对老年肝硬化患者肝功能、免疫功能及血清细胞TIMP-1、ICAM-1、TGF-β1、MMP-1的影响[J].中国老年学杂志,2018,38(3):602.
[17]中华中医药学会.中药上市后安全性医院集中监测技术规范[S].2017.