喜炎平注射液临床应用专家共识(儿童版)
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摘要
喜炎平注射液被多个儿科疾病的指南/共识所推荐,临床应用广泛,但说明书相对简单,对临床应用的指导不够,影响其临床疗效的发挥并带来安全性风险,亟需更加详尽的临床应用指导意见。该共识由国内儿科领域的中西医临床专家共同制定,遵循中华中医药学会发布的《中成药临床应用专家共识的制订流程》,在充分调研临床需求的基础上确定临床问题,依据PICO化的临床问题检索文献,采用GRADE系统开展证据评价、分级和推荐,并采用名义组法形成专家共识。该共识结合了循证证据和专家经验;对于有充分证据支持的临床问题形成"推荐意见",证据不充分则依据专家经验形成"共识建议"。该共识推荐了喜炎平注射液用于儿童疾病的适用疾病、介入时机、给药途径、剂量换算、单用/联合用药指征等,并说明了该药的安全性和注意事项,可为其临床的合理用药提供参考。
Xiyanping Injection is a commonly used medicine in clinical treatment,which is recommended by many pediatric disease guidelines/consensus. However,the instraction is relatively simple and lack of guidance for clinical application,which affects the efficacy and brings safety risks. Therefore,more detailed clinical guidance is urgently needed. This consensus is formulated by clinical experts of traditional Chinese medicine and Western medicine in pediatrics. This consensus follows Manual for the clinical experts consensus of Chinese patent medicine which published by China Association of Chinese Medicine. The study identified clinical problems using clinical investigation,searched the literature based on PICO clinical problems,using GRADE system to carry out evidences evaluation,classification and recommendation,and adopted the nominal grouping method to reach expert consensus. The consensus combines evidence-based evidence with expert experience,sufficient evidence of clinical problems would lead to " recommendations",and clinical problems with insufficient evidence will lead to " consensus suggestions". This expert consensus recommends the indications,intervention time for treatment,route of drug administration,dose conversion,the indications of being used alone,suitability and taboos of medicine combination,and introduces the safety and clinical application,to provide reference for clinical using.
Xiyanping Injection is a commonly used medicine in clinical treatment,which is recommended by many pediatric disease guidelines/consensus. However,the instraction is relatively simple and lack of guidance for clinical application,which affects the efficacy and brings safety risks. Therefore,more detailed clinical guidance is urgently needed. This consensus is formulated by clinical experts of traditional Chinese medicine and Western medicine in pediatrics. This consensus follows Manual for the clinical experts consensus of Chinese patent medicine which published by China Association of Chinese Medicine. The study identified clinical problems using clinical investigation,searched the literature based on PICO clinical problems,using GRADE system to carry out evidences evaluation,classification and recommendation,and adopted the nominal grouping method to reach expert consensus. The consensus combines evidence-based evidence with expert experience,sufficient evidence of clinical problems would lead to " recommendations",and clinical problems with insufficient evidence will lead to " consensus suggestions". This expert consensus recommends the indications,intervention time for treatment,route of drug administration,dose conversion,the indications of being used alone,suitability and taboos of medicine combination,and introduces the safety and clinical application,to provide reference for clinical using.
引文
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[16]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.
[17] Shea B J,Hamel C,Wells G A,et al. AMSTAR is a reliable and valid measurement tool to assess the metho-dological quality of systematic reviews[J]. J Clin Epidemiol,2009,62(10):1013.
[18] Atkins D,Best D,Briss P A,et al. Grading quality of evidence and strength of recommendations[J]. BMJ,2004,328(7454):1490.
[19] Jaeschke R,Guyatt G H,Dellinger P,et al. Use of GRADE grid to research decisions on clinical practice guidelines when consensus is elusive[J]. BMJ,2008,337:a744.
[20]崇岚,罗跃华,杨小玲,等. 17-氢-9-去氢穿心莲内酯-19-硫酸酯钠在大鼠体内的组织分布研究[J].中成药,2013,35(11):2378.
[21]崇岚.喜炎平注射液中有效成分在大鼠体内的药代动力学及组织分布研究[D].南昌:南昌大学,2013.
[22]王思源,平静,谢宁,等.穿心莲内酯磺化物体外抗流感病毒药效学研究[J].中南药学,2013,11(5):331.
[23]平静,王思源,谢宁,等.穿心莲内酯磺化物体外抗腺病毒药效学研究[J].中国实验方剂学杂志,2012,18(21):175.
[24]管晨,李敏,任庆杰,等.穿心莲内酯通过抗炎和调节免疫提高EV71感染小鼠的生存率[J].免疫学杂志,2013,29(9):737.
[25]李立,王燕平,赵静,等.喜炎平注射液防治甲型H1N1流感分子机制的生物信息学分析[J].中医杂志,2014,55(4):337.
[26] Lu C,Liu X,Ding X,et al. A metabolomics profiling study in hand-foot-and-mouth disease and modulated pathways of clinical intervention using liquid chromatography/quadrupole time-offlight mass spectrometry[J]. Evid-Based Compl Alt Med,2013,2013:647452.
[27] Wen T,Xu W,Liang L,et al. Clinical efficacy of andrographolide sulfonate in the treatment of severe hand,foot,and mouth disease(HFMD)is dependent upon inhibition of neutrophil activation[J].Phytother Res,2015,29(8):1161.
[28]余洋,丛艳,权晓丹,等.注射用喜炎平药效学研究[J].辽宁中医药大学学报,2009,11(7):198.
[29]马长沙,段成军,马静洁.穿心莲内酯及其衍生物药理活性研究[J].吉林中医药,2014,34(1):77.
[30]李曙光,叶再元.穿心莲内酯的药理活性作用[J].中华中医药学刊,2008(5):984.
[31]李巧如,张鹏,吴媛媛,等.喜炎平注射液与7种抗菌药物联用的体外抗菌活性研究[J].中国药师,2017,20(6):1136.
[32]吴振起,马融,平静,等.喜炎平对肺炎支原体感染A549细胞分泌炎症因子的影响[J].中成药,2016,38(11):2484.
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