CAJ | 학술논문

目的：了解抗感染药物严重药品不良反应/事件（ADR/ADE）的发生规律及特点，为临床用药提供参考。方法：回顾性收集2009–2013年军队ADR监测管理系统中抗感染药物严重ADR/ADE 1175例，对患者性别、年龄、药品种类、给药途径、剂型、累及系统/器官及临床表现、关联性评价及转归等进行描述性分析。结果：1175例患者中，男女比例为1.58：1，平均年龄（49.62±24.57）岁，给药途径以静脉滴注为主，药物类别中喹诺酮类195例（16.60%）、头孢菌素类184例（15.66%）、β-内酰胺酶抑制剂及其复方制剂159例（13.53%）位居前3位。涉及124个单品种，位居前3位的分别为左氧氟沙星73例（6.21%），莫西沙星64例（5.45%），利奈唑胺59例（5.02%）。1175例ADR/ADE中最多见为全身性损害286例次（19.13%），其次为肝胆系统损害203例次（13.58%），皮肤及其附件损害186例次（12.44%）位居第3位；严重ADR表现中位居前3位的分别是肝功能异常162例次（10.84%）、过敏性休克137例次（9.16%）和血小板减少97例次（6.49%）。结论：抗感染药物所致的严重ADR/ADE涉及多个药物类别、品种，累及多个系统/器官，应用时除关注抗感染疗效外，还应监测患者肝肾、血液系统相关指标，以及时处置用药安全问题。
목적：료해항감염약물엄중약품불량반응/사건（ADR/ADE）적발생규률급특점，위림상용약제공삼고。방법：회고성수집2009–2013년군대ADR감측관리계통중항감염약물엄중ADR/ADE 1175례，대환자성별、년령、약품충류、급약도경、제형、루급계통/기관급림상표현、관련성평개급전귀등진행묘술성분석。결과：1175례환자중，남녀비례위1.58：1，평균년령（49.62±24.57）세，급약도경이정맥적주위주，약물유별중규낙동류195례（16.60%）、두포균소류184례（15.66%）、β-내선알매억제제급기복방제제159례（13.53%）위거전3위。섭급124개단품충，위거전3위적분별위좌양불사성73례（6.21%），막서사성64례（5.45%），리내서알59례（5.02%）。1175례ADR/ADE중최다견위전신성손해286례차（19.13%），기차위간담계통손해203례차（13.58%），피부급기부건손해186례차（12.44%）위거제3위；엄중ADR표현중위거전3위적분별시간공능이상162례차（10.84%）、과민성휴극137례차（9.16%）화혈소판감소97례차（6.49%）。결론：항감염약물소치적엄중ADR/ADE섭급다개약물유별、품충，루급다개계통/기관，응용시제관주항감염료효외，환응감측환자간신、혈액계통상관지표，이급시처치용약안전문제。
Objective:To investigate the characteristics of serious adverse drug reaction and events (ADR/ADE) related to anti-infective agents, and provide references for the clinical rational drug use.Methods:A total of 1175 serious ADR/ADE of anti-infective agents were collected from the database of PLA ADR monitoring center from 2009 to 2013. The data in respect of age and gender of patients, categories of suspected anti-infective drugs, route of administration, dosage form, systems and organs involved and clinical manifestations, relevance evaluation and prognosis were analyzed retrospectively.Results:The male to female ratio was 1.58 : 1, the average age of the patients was (49.62 ± 24.57) years, and the main route of administration was intravenous drip. Among suspected drugs, quinolones (195 cases, 16.60%), cephalosporins (184 cases, 15.66%),β-lactamase inhibitor and its compound preparations (159 cases, 13.53%) ranked the top three positions in terms of ADR/ADE frequency. The ADR/ADE were related to 124 kinds of anti-infective agents, levolfoxacin related reports were 73 cases (6.21%), followed by moxilfoxacin (64 cases, 5.45%) and linezolid (59 cases, 5.02%). The 1175 cases of serious ADR/ADE mainly involved systemic damage (286 cases, 19.13%), followed by hepatobiliary system damage (203 cases, 13.58%) and the skin and its appendages damage (186 cases, 12.44%). Abnormal liver function (162 cases, 10.84%) ranked the first place in appearance of serious ADR/ADE, followed by allergic shock (137 cases, 9.16%) and thrombocytopenia (97 cases, 6.49%). Conclusion:Anti-infective drugs associated serious ADR/ADE involved various categories and multiple systems and organs. Besides the efifcacy of anti-infection, we should focus on the function of liver, kidney and hematological system so as to handle safety issues in time.