目的 了解我院药品不良反应(ADR)发生的规律和特点,为临床合理用药提供参考。方法 收集广州市第一人民医院南沙医院2015年1月1日—2019年12月31日上报国家药品不良反应监测中心的224例ADR,统计分析发生ADR的患者性别、年龄、药品种类、剂型、给药途径、累及系统等情况。结果 224例ADR报告中,女性报告数(51.79%)高于男性(48.21%),50岁以上的病人报告数占48.6%,其中60岁以上属于高发年龄段(30.8%);抗感染药ADR报告数最多(43.3%),其次是心血管系统用药(12.95%),第三是中枢神经系统用药(12.50%);静脉给药ADR报告数最多(57.14%),其次是口服给药(40.18%),剂型因素中,最高为注射液(32.59%),其次为普通片剂(28.57%),第三位粉针剂(24.55%);ADR累及系统中,皮肤及附件损害最多(26.43%),其次是胃肠系统损害(20.70%)和中枢及外周神经系统损害(18.06%);上报来源以药师上报为主(72.77%),护士上报率为0。结论 临床应加强合理用药,尤其抗菌药物使用,减少静脉给药途径,重点关注50岁以上ADR高发人群,加强ADR监测医护宣教,提高ADR上报率和报告质量。

Objective To investigate the occurrence and distribution of adverse drug reaction ADR from 2015 to 2019 in our hospital and provide relevant information for clinical rational usage of medication. Methods 224 ADR reported to National Center were collected from Nansha hospital of Guangzhou First People's Hospital monitoring during 2015~2019.Those ADR were analyzed in terms of gender and age of patients,type of drugs, route of administration,dosage form,etc. Results Among 224 ADR reports,the occurrence rate of ADR in female(51.79%)was higher than male,patients over the age of 50 accounted for 48.6% and age over 60 were at high risk of ADR.The top three of medicine were anti-infectious agent(43.3%),cardiovascular medicine(12.95%)and central nervous system medication(12.50%). Intravenous administration and oral medication accounted for 57.14%,40.18% respectively.For the dosage form factor,the top three were injection (32.59%), ordinary tablet (28.57%) and powder-injection (24.55%).Major systems involved in ADR were lesion of skin and its appendages(26.43%),gastrointestinal system(20.70%),central and peripheral nervous systems(18.06%).Sources of ADR were mainly composed of pharmacist(72.77%)and the nurse reported 0. Conclusion Clinical rational drug use should be strengthen especially antibacterial agents. The intravenous route should be decreased.Patients over the age of 50 deserved special attention. It is necessary to enhance awareness and education of medical workers to improve the reported rate and quality of ADR.

目的 分析药源性双硫仑样反应医疗损害责任纠纷的规律及特点,为规避用药风险、促进合理用药提供参考。方法 以“双硫仑”为关键词,检索中国裁判文书网,时间截至2025年3月25日,将通过筛选的裁判文书基本情况、双硫仑样反应药物关联情况、症状表现、转归、赔偿情况等信息提取录入Excel表,建立评价数据库。结果 共检索得裁判文书81份,纳入裁判文书18例,涉及医疗机构为三级医院3例、二级医院5例、卫生院/卫生室7例、民营医院2例、诊所1例;性别构成中,男15例,女3例;怀疑引起双硫仑样反应的药物有头孢哌酮、头孢呋辛、替硝唑、头孢噻肟、甲硝唑、左氧氟沙星、头孢曲松钠、头孢替安和头孢米诺;患者饮酒和用药间隔多为1~3 d;症状表现有呼吸困难/呼吸骤停、昏迷/意识丧失/休克、面色紫绀/局部发紫/指甲发紫、抽搐/发抖、出汗、不能说话/说话不清楚等;转归结果中,15例结局为死亡,1例为神经症,1例为一级伤残（植物人）,1例为二级伤残（缺氧缺血性脑病后遗四肢功能障碍）;7例患者死亡案例因未尸检影响了结果鉴定;判决情况中,1例和解,1例未公布三审判决结果,余16例医疗机构承担了10%~70%的医疗赔偿责任,赔偿金额43 092.4~1 616 354元;医方存在的过失主要有未认真采集饮酒史、违反诊疗常规用药、违反合理注意义务、未履行知情告知义务等。结论 药源性双硫仑样反应危害大,误诊率高,发病急骤凶险,基层医疗机构对其鉴别和处置能力亟需提高;应重视饮酒史的采集和记录;合理合规处方抗生素;加强对患者的高度注意义务、知情告知义务等履行;医院药学人员应积极参与安全用药工作,做好用药教育。

      Objective  To analyze the regularity and characteristics of the medical damage liability dispute with drug-induced disulfiram-like reaction, to avoid the risk of medication and provide reference for clinical rational drug use. Methods  China Judgements Online had been searched using the keywords of “disulfiram” from inception to March 25,2025. The evaluation table database was established with the excel table to conduct statistical analysis on the basic information of judgements, drug association, clinical performance,outcome of disease and the compensation. Results A total of 81 cases of judgements documents were retrieved,and 18 cases were enrolled. There were 3 tertiary hospitals, 5 second-class hospitals, 7 health-centers, 2 private hospitals,1 clinic among the medical establishments. Fifteen cases were male and 3 cases were female. The drugs suspected causing disulfiram-like reaction were cefoperazone, cefuroxime, tinidazole, cefotaxime, metronidazole, levofloxacin, ceftriaxone, cefotiam, cefminox. The interval between drinking and medication was usually 1-3 days. The symptoms were as follows：dyspnea/respiratory arrest, coma/loss of consciousness/shock, cyanosis /purple nails, convulsion/trembling, sweatiness, inability to speak/lack of clarity, etc. Fifteen cases ended in death, 1 was neurosis, 1 was first-degree disability (vegetative state), 1 was secondary disability (limb dysfunction after hypoxic encephalopathy). The identification of 7 cases of death was affected by the lack of autopsy. One case was settled and the outcome of the third trial was not announced in another case. The remaining 16 medical institutions took 10%-70% of the medical compensation liability, with the compensation amount ranging from 43 092. 4 yuan to 1 615 354 yuan. The main faults of the medical institutions were undetailed drinking history, irregular medication, breaches of duty of reasonable care, failure to fulfill the obligation of informed notification,etc. Conclusions Drug-induced disulfiram-like reaction has the characteristics of graveness of harm and rapid progress. Primary medical institutions need to improve their identification and disposal capacity urgently. Attention should be paid to collecting and recording of drinking history. Antibiotics should be used in a reasonable and compliant manner. Obligation of high attention to patients, information and other obligations should be fulfilled. Hospital pharmacy staff should ensure drug use safety through participating in drug education actively.