７ ６９０ 例药品不良反应报告中ＡＤＲ 性别差异的回顾性分析

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。

Retrospective analysis of gender differences in ADR of 7 690 cases of reported adverse drug reactions

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.