CAJ | 학술논문

目的：探讨中药注射剂不良反应（ ADR）发生的规律及特点，为安全合理使用中药注射剂提供参考。方法对安徽省淮南新华医疗集团新华医院2010年1月至2013年12月663例ADR报告进行归纳整理，其中103例中药注射剂ADR报告，按患者年龄、性别、给药途径、报告来源、评价、临床表现、ADR涉及系统/器官等方面进行统计、分析。结果103例ADR报告中，共涉及26种药品，均为静脉给药方式，有90例（87.37％）发生在用药30 min 以内，男女性别比例为60：43，60岁以上老年患者 ADR 发生率最高（54.37％），以皮肤及附件损害为主（35例，33．98％），灯盏花素ADR例数最多（15例，14．56％）。结论应坚持开展中药注射剂ADR监测与上市后再评价，规范、合理使用中药注射剂，保障用药安全。
목적：탐토중약주사제불량반응（ ADR）발생적규률급특점，위안전합리사용중약주사제제공삼고。방법대안휘성회남신화의료집단신화의원2010년1월지2013년12월663례ADR보고진행귀납정리，기중103례중약주사제ADR보고，안환자년령、성별、급약도경、보고래원、평개、림상표현、ADR섭급계통/기관등방면진행통계、분석。결과103례ADR보고중，공섭급26충약품，균위정맥급약방식，유90례（87.37％）발생재용약30 min 이내，남녀성별비례위60：43，60세이상노년환자 ADR 발생솔최고（54.37％），이피부급부건손해위주（35례，33．98％），등잔화소ADR례수최다（15례，14．56％）。결론응견지개전중약주사제ADR감측여상시후재평개，규범、합리사용중약주사제，보장용약안전。
Objective To understand the rules and characteristics of adverse drug reaction ( ADR) in Xinhua Hospital of Xinhua Medical Group ( Huainan City Anhui Province )′s traditional Chinese medicine ( TCM) injection ca-ses,and to provide reference for rational and safety usage of TCM injection .Methods Reorganization was preformed on 663 cases of ADR report from January 2010 to November 2013 in this hospital .We selected 103 cases of TCM in-jection′s ADR reports,and made statistics and analysis according to patients′age,sex,drug source,report source,eval-uation,clinical features,system and organ ADR involved,etc.Results 103 cases of ADR reports involved in 26 kinds of drugs.All of them were vein medication .87.37%of the above cases were happened in 30 minutes with gender ratio of 60:43.54.36%were old patients over 60 with the highest incidence rate .33.98%were skin and appendages dis-orders.14.56%were Breviscapine ADR reports which was the most one .Conclusion It must insist on monitoring ADR of TCM injection and re-evaluation of market products ,to use TCM injection normative and rational ,and guaran-tee the medication security .