基于不良反应/事件文献分析的骨科中成药安全用药通则规律的初步研究(1)
[摘要]骨科中成药组分复杂，多含药性峻烈及毒性饮片，药物安全窗口较窄，临床禁忌较多，不良反应/事件发生频率较高。为探索骨科中成药安全用药的通则规律，提炼用药教育关键点，以保障临床合理用药，以近80种本院常用骨科中成药为研究对象，通过系统的检索策略，收集汇总来自164篇不良反应文献的237例案例，采用多维度的文献分析和个案荟萃防范，尝试确定骨科中成药安全合理用药的风险共性因素，建立不良反应/事件防范通则。包括①不良反应临床表现方面，无论内服或外用，皮肤过敏反应为最常见的不良反应表现;循环、消化等其他系统不良反应与药品所含毒性成分密切相关;部分药品存在隐匿而累积的肝肾损伤。②不良反应发生时间方面，存在3个重要时间节点，用药30min与患者特异体质相关、用药数月至半年与药源性肝肾损伤相关，最常见的不良反应发生节点为7d，且呈现与药理作用相关的可预测型不良反应特征。③毒性因素对于骨科中成药不良反应的发生(频度、广度、难易度)具有极端重要性。④特殊用药因素如联合西药、中药汤剂，超剂量超疗程用药、自我药疗等也需重点关注。综上，总结骨科中成药不良反应/事件防范的通则规律，为临床医师安全合理用药提供支持，为临床药师用药教育提供指导。
, http://www.100md.com
[关键词]骨科;中成药;不良反应;安全用药;通则规律;文献分析
PreliminarystudyongeneralsafemedicationregularityofChinesepatent
orthopedicmedicinesbasedonadversereaction/eventliteratureanalysis
WANGYu-guang/1，SHIXin-yuan/1，JINRui/1，LIHong-yan/1，KONGXiang-wen1*，QIAOYan-jiang2*
(1.DepartmentofPharmacy，theThirdAffiliatedHospitalofBeijingUniversityofChineseMedicine，Beijing100029，China;
, http://www.100md.com
2.ResearchCenterofTraditonalChineseMedicineInformationEngineering，BeijingUniversityofChineseMedicine，Beijing100102，China;
3.DepartmentofPharmacy，BeijingShijitanHospitalAffiliatedtoCapitalMedicalUniversity，Beijing100038，China)
[Abstracts]Chinesepatentorthopedicmedicinesfeaturecomplexcomponents，mainlyincludingdesperateandtoxicherbalpieces，narrowsafetywindow，moreclinicalcontraindicationsandfrequentadversedrugreaction/events(ADR/ADE).TostudythegeneralsafemedicationregularityofChinesepatentorthopedicmedicines，definekeypointsinthemedicationeducationandensurerationalclinicalmedication，theauthorstook80typesofcommonlyusedChinesepatentorthopedicmedicinesasthestudyobjects，collect237casesfrom164ADR/ADEdocumentsthroughasystemretrievalstrategy，makeamultidimensionalliteratureanalysistodeterminethecommonriskfactorsforsafeandrationalmedicationofChinesepatentorthopedicmedicinesandestablishanADR/ADEpreventionregularity.First，intheaspectofclinicalsymptoms，skinallergyisthemostcommonADR/ADEandcloselyrelatedtothetoxicingredients，particularlyaccumulatedliverorkidneydamagecausedbysomedrugs.Second，therearethreetimenodesintheADR/ADEoccurrence;TheADR/ADEoccurredin30minutesiscloselyrelatedtotheidiosyncrasy;TheADR/ADEoccurredbetweenseveralmonthsandhalfayearisrelatedtothedrug-inducedliverandkidneydamages;ThemostcommonADR/ADEwasobservedwithin7daysandpredictableaccordingtothepharmacologicalactions;Third，toxicityisanimportantfactorintheoccurrenceofADR/ADEofChinesepatentorthopedicmedicines.Fourth，emphasisshallbegiventothespecialmedicationfactors，suchasthecombinationwithwesternmedicinesandChineseherbaldecoctions，overdoseandlong-coursemedicationandself-medicaltherapy.Inconclusion，thegeneralADR/ADEpreventionregularityforChinesepatentorthopedicmedicineswassummarizedtoprovidesupportsforcliniciansinsafeandrationalmedicationandgivetheguidanceforpharmacistinmedicationeducation., http://www.100md.com(王宇光 史新元 金锐 李红燕 孔祥文 乔延江)
, http://www.100md.com
[关键词]骨科;中成药;不良反应;安全用药;通则规律;文献分析
PreliminarystudyongeneralsafemedicationregularityofChinesepatent
orthopedicmedicinesbasedonadversereaction/eventliteratureanalysis
WANGYu-guang/1，SHIXin-yuan/1，JINRui/1，LIHong-yan/1，KONGXiang-wen1*，QIAOYan-jiang2*
(1.DepartmentofPharmacy，theThirdAffiliatedHospitalofBeijingUniversityofChineseMedicine，Beijing100029，China;
, http://www.100md.com
2.ResearchCenterofTraditonalChineseMedicineInformationEngineering，BeijingUniversityofChineseMedicine，Beijing100102，China;
3.DepartmentofPharmacy，BeijingShijitanHospitalAffiliatedtoCapitalMedicalUniversity，Beijing100038，China)
[Abstracts]Chinesepatentorthopedicmedicinesfeaturecomplexcomponents，mainlyincludingdesperateandtoxicherbalpieces，narrowsafetywindow，moreclinicalcontraindicationsandfrequentadversedrugreaction/events(ADR/ADE).TostudythegeneralsafemedicationregularityofChinesepatentorthopedicmedicines，definekeypointsinthemedicationeducationandensurerationalclinicalmedication，theauthorstook80typesofcommonlyusedChinesepatentorthopedicmedicinesasthestudyobjects，collect237casesfrom164ADR/ADEdocumentsthroughasystemretrievalstrategy，makeamultidimensionalliteratureanalysistodeterminethecommonriskfactorsforsafeandrationalmedicationofChinesepatentorthopedicmedicinesandestablishanADR/ADEpreventionregularity.First，intheaspectofclinicalsymptoms，skinallergyisthemostcommonADR/ADEandcloselyrelatedtothetoxicingredients，particularlyaccumulatedliverorkidneydamagecausedbysomedrugs.Second，therearethreetimenodesintheADR/ADEoccurrence;TheADR/ADEoccurredin30minutesiscloselyrelatedtotheidiosyncrasy;TheADR/ADEoccurredbetweenseveralmonthsandhalfayearisrelatedtothedrug-inducedliverandkidneydamages;ThemostcommonADR/ADEwasobservedwithin7daysandpredictableaccordingtothepharmacologicalactions;Third，toxicityisanimportantfactorintheoccurrenceofADR/ADEofChinesepatentorthopedicmedicines.Fourth，emphasisshallbegiventothespecialmedicationfactors，suchasthecombinationwithwesternmedicinesandChineseherbaldecoctions，overdoseandlong-coursemedicationandself-medicaltherapy.Inconclusion，thegeneralADR/ADEpreventionregularityforChinesepatentorthopedicmedicineswassummarizedtoprovidesupportsforcliniciansinsafeandrationalmedicationandgivetheguidanceforpharmacistinmedicationeducation., http://www.100md.com(王宇光 史新元 金锐 李红燕 孔祥文 乔延江)