CAJ | 학술논문

目的：了解患者发生药品不良反应（ADR）时性别差异所呈现的某些基本特点，为实施药品安全性监测，指导临床合理用药提供参考依据。方法收集某三甲医院2005年1月至2010年12月7690例ADR报告。采用回顾性分析方法，将7690例ADR报告中性别因素分别与报告年份、患者年龄、药品类别、前位药品、药物剂型、给药途径、累及系统／器官等指标相关联进行分析评价。结果 7690例报告中，男性4052例，占52．69％，女性3638例，占47．31％，男女之比为1．11∶1；2007至2010年男性比例均高于女性，而2005至2006年男性低于女性；0～21岁及51岁以上男性多于女性，而21～51岁女性多于男性；影响血液及造血系统药、中成药、维生素类药等引起ADR男性多于女性，而影响变态反应和免疫功能药、心血管系统药、呼吸系统药等女性多于男性；注射用奥沙利铂、氟尿嘧啶注射液、地塞米松磷酸钠注射液等7种药品引起ADR男性多于女性，而盐酸左氧氟沙星注射液、乳酸左氧氟沙星氯化钠注射液、注射用头孢曲松钠引起ADR女性多于男性；应用混悬剂、口服溶液剂、粉针剂等6种剂型出现ADR男性多于女性，而应用丸剂、分散片、胶囊剂等4种剂型则女性多于男性；腹腔用药、鞘内用药、静脉注射等给药途径出现ADR男性多于女性，而局部外用、眼内用药、肌内注射等女性多于男性；ADR所致代谢营养障碍、视觉损害、血液系统等例数男性多于女性，而听觉和前庭功能损害、呼吸系统、循环系统等女性多于男性；在一般的、新的一般的、严重的、新的严重的4种ADR严重程度中，男性ADR例数均多于女性。结论在加强ADR监测时，应了解ADR性别差异，其对实施药品安全性监测，指导临床合理用药，具有十分重要的意义；且通过对ADR性别差异的深入分析，可以采取相应对策以减少ADR的发生。目的：瞭解患者髮生藥品不良反應（ADR）時性彆差異所呈現的某些基本特點，為實施藥品安全性鑑測，指導臨床閤理用藥提供參攷依據。方法收集某三甲醫院2005年1月至2010年12月7690例ADR報告。採用迴顧性分析方法，將7690例ADR報告中性彆因素分彆與報告年份、患者年齡、藥品類彆、前位藥品、藥物劑型、給藥途徑、纍及繫統／器官等指標相關聯進行分析評價。結果 7690例報告中，男性4052例，佔52．69％，女性3638例，佔47．31％，男女之比為1．11∶1；2007至2010年男性比例均高于女性，而2005至2006年男性低于女性；0～21歲及51歲以上男性多于女性，而21～51歲女性多于男性；影響血液及造血繫統藥、中成藥、維生素類藥等引起ADR男性多于女性，而影響變態反應和免疫功能藥、心血管繫統藥、呼吸繫統藥等女性多于男性；註射用奧沙利鉑、氟尿嘧啶註射液、地塞米鬆燐痠鈉註射液等7種藥品引起ADR男性多于女性，而鹽痠左氧氟沙星註射液、乳痠左氧氟沙星氯化鈉註射液、註射用頭孢麯鬆鈉引起ADR女性多于男性；應用混懸劑、口服溶液劑、粉針劑等6種劑型齣現ADR男性多于女性，而應用汍劑、分散片、膠囊劑等4種劑型則女性多于男性；腹腔用藥、鞘內用藥、靜脈註射等給藥途徑齣現ADR男性多于女性，而跼部外用、眼內用藥、肌內註射等女性多于男性；ADR所緻代謝營養障礙、視覺損害、血液繫統等例數男性多于女性，而聽覺和前庭功能損害、呼吸繫統、循環繫統等女性多于男性；在一般的、新的一般的、嚴重的、新的嚴重的4種ADR嚴重程度中，男性ADR例數均多于女性。結論在加彊ADR鑑測時，應瞭解ADR性彆差異，其對實施藥品安全性鑑測，指導臨床閤理用藥，具有十分重要的意義；且通過對ADR性彆差異的深入分析，可以採取相應對策以減少ADR的髮生。
목적：료해환자발생약품불량반응（ADR）시성별차이소정현적모사기본특점，위실시약품안전성감측，지도림상합리용약제공삼고의거。방법수집모삼갑의원2005년1월지2010년12월7690례ADR보고。채용회고성분석방법，장7690례ADR보고중성별인소분별여보고년빈、환자년령、약품유별、전위약품、약물제형、급약도경、루급계통／기관등지표상관련진행분석평개。결과 7690례보고중，남성4052례，점52．69％，녀성3638례，점47．31％，남녀지비위1．11∶1；2007지2010년남성비례균고우녀성，이2005지2006년남성저우녀성；0～21세급51세이상남성다우녀성，이21～51세녀성다우남성；영향혈액급조혈계통약、중성약、유생소류약등인기ADR남성다우녀성，이영향변태반응화면역공능약、심혈관계통약、호흡계통약등녀성다우남성；주사용오사리박、불뇨밀정주사액、지새미송린산납주사액등7충약품인기ADR남성다우녀성，이염산좌양불사성주사액、유산좌양불사성록화납주사액、주사용두포곡송납인기ADR녀성다우남성；응용혼현제、구복용액제、분침제등6충제형출현ADR남성다우녀성，이응용환제、분산편、효낭제등4충제형칙녀성다우남성；복강용약、초내용약、정맥주사등급약도경출현ADR남성다우녀성，이국부외용、안내용약、기내주사등녀성다우남성；ADR소치대사영양장애、시각손해、혈액계통등례수남성다우녀성，이은각화전정공능손해、호흡계통、순배계통등녀성다우남성；재일반적、신적일반적、엄중적、신적엄중적4충ADR엄중정도중，남성ADR례수균다우녀성。결론재가강ADR감측시，응료해ADR성별차이，기대실시약품안전성감측，지도림상합리용약，구유십분중요적의의；차통과대ADR성별차이적심입분석，가이채취상응대책이감소ADR적발생。
Objective To understand certain basic characteristics of the presented gender factors during the occurrence of adverse drug reactions (ADR)in patients for the implementation of drug safety monitoring,and to provide a reference for clinical therapy. Methods National Adverse Drug Reaction Monitoring Center database of a hospital from January 2005 to December 2010 which reported 7 690 cases of ADR was collected. A retrospective analysis was performed on the 7 690 cases of ADR reports,and gender factors were analyzed and eval-uated in correlation with other indicators such as patient age,drug class,anterior drugs,drug dosage form,route of administration,involving system/ organ. Results In 7 690 cases of ADR reports,4,052 cases were male,accounting for 52. 69%,3,638 cases were female,ac-counting for 47. 31%,and the male to female ratio was 1. 11 ∶ 1. 4 years from 2007 to 2010 the proportion of males was higher than that of fe-males,and 2 years from 2005 to 2006,male lower than female. In people aged 0 to 20,over the age of 50 years,the number of ADR cases was more in male than in female,and in people aged 21 to 50,the number of ADR cases was more in female than in male. The number of ADR cases caused by drugs affecting the blood and blood-forming system,traditional Chinese medicine,vitamins,etc. ,was more in male than in female,and the number of ADR cases caused by drugs affecting allergy and immune function,cardiovascular system drugs,respirato-ry system drugs,etc. was more in female than in male. ADR cases caused by seven kinds of drugs such as oxaliplatin for injection,fluoroura-cil injection,dexamethasone sodium phosphate injection were more male than female. ADR cases caused by levofloxacin hydrochloride injec-tion,levofloxacin lactate and sodium chloride injection,injection of ceftriaxone sodium were more female than male. ADR cases caused by six kinds of formulations like application suspensions,oral solutions,powder,etc. appeared more in male than in female,and ADR cases caused by four kinds of formulations like the application pills,dispersible tablets,capsules,etc. appeared more in female than in male. ADR number of cases in intraperitoneal administration,intrathecal medication,intravenous route of administration was more in male than in female,and that in topical,intraocular administration,intramuscular injection,etc. was more in female than in male. The number of ADR ca-ses induced metabolic nutritional disorders,visual impairment,blood system was more in male than in female,and in auditory and vestibulardysfunction,respiratory system,circulatory system,the cases were more female than male. Male ADR cases were more than female cases in general,the new general,serious,the new serious ADR severity. Conclusion In strengthening ADR monitoring,ADR gender differences should be understood,and the implementation of drug safety monitoring in clinical therapy has great significance. We can take the appropriate measures to reduce the incidence of ADR through the analysis of gender differences in ADR.