144例严重药品不良反应报告分析  

Analysis of 144 Cases of Severe Adverse Drug Reactions

作　　者：史文慧 郭蓉 李俊 马骁龙 蒋黎 赵辉 SHI Wenhui;GUO Rong;LI Jun;MA Xiaolong;JIANG Li;ZHAO Hui(Dept.of Pharmacy,Beidaihe Rehabilitation and Recuperation Center of PLA,Hebi Qinhuangdao 066100,China)

机构地区：[1]中国人民解放军联勤保障部队北戴河康复疗养中心药剂科,河北秦皇岛066100

出　　处：《中国医院用药评价与分析》2023年第7期885-888,共4页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:探讨严重药品不良反应(SADR)的发生规律和特点,为临床安全用药及有效防治SADR提供参考。方法:采用回顾性分析方法,收集2011—2022年该中心上报的144例SADR,对患者的性别、年龄、给药途径、临床表现、药品种类、发生SADR时间、转归及关联性评价等情况进行统计分析。结果:144例发生SADR的患者中,男性多于女性,男女之比为1.15∶1;>55岁的中老年人所占比例最高(67例,占46.53%);口服给药病例数最多(87例,占60.42%),其次为静脉滴注给药(54例,占37.50%);涉及药物中,病例数排序居前3位的依次为抗感染药(38例,占26.39%)、中药制剂(27例,占18.75%)、解热镇痛抗炎药(25例,占17.36%);SADR主要表现为泌尿系统损伤(78例,占54.17%);发生于用药后30 min内的SADR以过敏性样反应为主,发生于用药后1~15 d的SADR以急性肾损伤、骨髓抑制、横纹肌溶解为主,发生于用药后>3个月的SADR多为慢性间质性肾炎;治愈80例(占55.56%),好转21例(占14.58%),有后遗症43例(占29.86%)。结论:导致SADR的因素较为复杂,医疗机构应加强药物警戒工作,临床医、护、药团队尤其要协同加强对重点人群、重点药物的用药监护,准确判断各类可能的SADR并妥善应对,确保患者用药安全。OBJECTIVE:To probe into regularity and characteristics of severe adverse drug reactions(SADR),so as to provide reference for safe drug use and effective prevention and treatment of SADR.METHODS:Retrospective analysis method was used to collect 144 cases of SADR reported in the center from 2011 to 2022.The gender,age,route of administration,clinical manifestations,drug categories,time of occurrence of SADR,outcome and correlation evaluation of patients were statistically analyzed.RESULTS:Of the 144 patients with SADR,there were more males than females,with a male to female ratio of 1.15∶1.Middle-aged and elderly people>55 years old took the lead(67 cases,46.53%).The number of oral administration cases was the largest(87 cases,60.42%),followed by intravenous administration(54 cases,37.50%).Among the drugs involved,the top 3 ranked by number of cases were anti-infective drugs(38 cases,26.39%),traditional Chinese medicine preparations(27 cases,18.75%),and antipyretic and anti-inflammatory drugs(25 cases,17.36%).The main manifestation of SADR was urinary system injury(78 cases,54.17%).The SADR that occurred within 30 min after administration was mainly anaphylactic reaction,the SADR that occurred from 1 to 15 d after administration was mainly acute kidney injury,bone marrow suppression and rhabdomyolysis,and the SADR that occurred>3 months after administration was mostly chronic interstitial nephritis.Totally 80 cases were cured(55.56%),21 cases were improved(14.58%),and 43 cases had sequelae(29.86%).CONCLUSIONS:Factors leading to SADR are complex,medical institutions should strengthen pharmacovigilance work,clinical medical staff,nursing and pharmacy teams should especially work together to strengthen the drug monitoring of key populations and drugs,accurately determine the various types of possible SADR and respond appropriately to ensure the safety of medication.

关 键 词：严重药品不良反应 药物警戒 抗感染药 中药制剂 泌尿系统损伤 过敏性休克 

分 类 号：R969.3[医药卫生—药理学] R97[医药卫生—药学]