12249例药品不良反应报告中年龄分布的分析评价

Analysis of the Age Distribution in 12,249 Adverse Drug Reaction Reports

目的：了解发生药品不良反应（ADR）时不同年龄段患者在性别、药品种类、药品剂型等方面所呈现的某些基本特点，为进行药品安全性监测，指导临床对不同年龄患者实施合理用药提供参考。方法：收集国家药品不良反应监测中心数据库中某三甲医院2005～2012年所上报的12249例ADR报告。将发生ADR的患者分为9个年龄段，对各年龄段中患者性别、药品种类、药品剂型、给药途径、ADR累及器官／系统及ADR严重程度等指标进行分析。结果：12249例ADR报告中，男性6496例（53．03％）、女性5753例（46．97％），男女之比为1．13：1：41～50岁、51—60岁、61—70岁3个年龄段ADR构成比居于前三位；21—50岁年龄段女性ADR例数多于男性，其余年龄段男性多于女性。抗感染药物（31．59％）、抗肿瘤药物（28．86％）、中成药（7．15％）引起ADR位于前三位，其中〈10岁患者抗感染药物ADR达972例次（7．79％）；41～70岁患者抗肿瘤药物ADR达2362例次（18．94％），中成药ADR为475例次（3．81％）。注射液（79．41％）、片剂（8．40％）、粉针刑（5．61％）引起ADR列入前三位；而注射液、片剂、粉针剂引起ADR均以41—70岁患者为主；胶囊剂以31—70岁患者为主；颗粒剂、混悬剂、溶液剂均以〈10岁患者为主。静脉滴注（73．04％）、口服（13．51％）、静脉注射（6．06％）引起ADR居于前三位；而静脉滴注、口服、静脉注射引起ADR均以41—70岁患者为主；肌内注射则以31—60岁患者为主。ADR导致消化系统（33．15％）、皮肤及其附件（19．25％）、神经系统（11．58％）损害列为前三位；而消化系统、神经系统、全身性损害均以41～70岁患者为主；皮肤及其附件损害则以〈10岁患者为主。一般的ADR达7757例（63．33％）；新的、严重的ADR为4492例（36．67％）；而一般的、新的一般的ADR均以41—70岁患者为主；严重的、新的严重的ADR则以31—70岁患者为主。结论：不同年龄患者ADR的发生在性别、药品种类、药品剂型等方面存在某些差别，应加强对不同年龄人群药品安全性监测工作，关注影响因素，尽可能减少ADR的发生。

Objective： To understand some basic characteristics in gender, types of drugs, drug dosage form, and other aspects to provide reference for drug safety monitoring, and guiding rational drug use when adverse drug reaction （ADR） occurred to patients of different ages. Methods： 12 249 ADR cases came from the collection of National Adverse Drug Reaction Monitoring Center database reported by a 3A hospital from 2005 to 2012. The patients were divided into nine age groups to conduct the analysis of gender, types of drugs, drug dosage form, route of administration, ADR involving organ / systemand ADR severity indexes analysis. Results：There were 6 496 male cases （53.03%） and 5 753 female cases （46.97%） of 12 249 ADR cases. Male to female ratio was 1.13：1.41 to 50, 51 to 60 and 61 to 70 age groups lay in the top three in ADR constituent ratios. In the 21 to 50 age group, the females were more than the males in the number of ADR cases, and the males were more than the females in the the number of ADR cases of the remaining age group. Anti-infective drugs （31.59% ）, anticaneer drugs （28.86%）, traditional Chinese medicine （7.15 % ） causing ADR remained in the top three, while 〈 10 age group ADRs caused by anti-infective drugs were 972 cases （7.79%）, 41 to 70 age group ADR cases caused by anticancer drugs were 2 362 cases（ 18.94% ）, and 475 cases （3.81% ） were caused by traditional Chinese medicine. Injection （79.41% ）, tablets （ 8.40% ） and powder for injection （ 5.61% ） causing ADRs were included in the top three, while injection, tablets and powder for injection causing ADRs were mainly taken by the 41 to 70 years-old age group. Capsules causing for injection ADR were mainly taken by the 31 to 70 years-old age group, and granules, suspensions, solutions causing ADR were mainly taken by the 〈 10 year old patients. Intravenous infusion （73.04%）, oral administration （13.51%）, intravenous injection （6.06%） appeared in the top three, while intravenous, oral administration and intravenous injections causing ADR cases were mainly related to the 41 to 70 years-old age group. The number of cases caused by ADR intramuscular injection was related to the 31 to 60 years-old age group. The damages caused by ADRs to the digestive system （35.15%）, skin and its appendages（ 19.25% ） and nervous system （11.58% ） ranked at the top three, while digestive system, nervous system and systemic damage caused by ADR cases were related the 41 to 70 yearsold age group. General ADRs reached 7 757 cases （63.33%）, and new ADRs and serious ADRs reached 4 492 cases （36.67%）. The general ADRs and new ADR were mainly related to the 41 to 70 years-old age group. Serious ADR and new serious ADR were mainly related to the 31 to 70 years-old age group. Conclusion：Because the occurrence to different ages of ADR patients had their differences in gender, types of drugs, drug dosage and so on, the drug safety monitoring work of different age groups should be strengthened and attention should be paid to the impact factors to reduce the incidence of ADR as far as possible.