山东省头孢噻肟钠致ADR报告分析及其皮试对严重的ADR的影响
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篇名: 山东省头孢噻肟钠致ADR报告分析及其皮试对严重的ADR的影响
TITLE: Analysis of ADR reports caused by cefotaxime sodium in Shandong province and effects of skin test on serious ADR
摘要: 目的 分析山东省头孢噻肟钠致药品不良反应(ADR)的临床表现及特点,探讨头孢噻肟钠用药前皮试对严重的ADR的影响,为临床安全用药提供参考。方法收集2019年12月-2021年12月山东省ADR监测中心上报国家ADR监测系统的头孢噻肟钠致ADR报告的相关数据,对报告涉及的ADR分类、患者年龄、性别、ADR发生时间、给药途径、患者过敏史、原患疾病、ADR累及系统/器官及临床表现、转归情况、用药前是否皮试等进行统计、分析。结果共纳入头孢噻肟钠致ADR报告1057例。1057例ADR中,一般的ADR有867例(82.02%),严重的ADR有190例(17.98%);年龄以<11岁为主(40.30%);给药途径主要为静脉滴注(96.69%);有1033例患者(97.73%)为用药后>30min~24h发生ADR;814例患者(77.01%)无过敏史;原患疾病以呼吸系统感染为主(56.58%);ADR主要累及系统/器官为皮肤及附件、消化系统、呼吸系统,临床主要表现为皮疹、瘙痒、恶心、呕吐、胸闷等;经停药或对症治疗后,有1050例患者(99.34%)痊愈或好转。850例患者在使用头孢噻肟钠前进行皮试(151例患者发生严重的ADR),与207例非皮试患者(39例患者发生严重的ADR)的严重的ADR发生率比较,差异无统计学意义(P=0.718)。结论头孢噻肟钠致ADR主要以<11岁患者为主,多发生在静脉滴注给药后>30min~24h;头孢噻肟钠用药前皮试不能降低严重的ADR的发生风险。临床在使用头孢噻肟钠前应详细询问患者的过敏史、用药史,使用时应重点关注用药后24h内患者的病情状态,防止严重的ADR发生,以保障患者的安全用药。
ABSTRACT: OBJECTIVE To analyze the clinical manifestations and characteristics of adverse drug reactions (ADR) caused by cefotaxime sodium in Shandong province, and to explore the effects of skin test before medication of cefotaxime sodium on serious ADR, so as to provide reference for safe drug use in clinic. METHODS The relevant data of cefotaxime sodium-induced ADR reported by Shandong Province ADR Monitoring Center during December 2019 to December 2021 were collected from National ADR Monitoring System. The ADR classification, age, gender, ADR occurrence time, route of administration, history of allergy, primary diseases, ADR systems/organs involved, clinical manifestations, outcome, skin test or not before medication were statistically analyzed. RESULTS A total of 1 057 ADR reports caused by cefotaxime sodium were included. Among them, there were 867 patients (82.02%) with general ADR and 190 patients (17.98%) with serious ADR. The majority were <11 years old (40.30%). The main route of administration was intravenous drip (96.69%). A total of 1 033 patients (97.73%) developed ADR 30 min to 24 h after medication. A total of 814 patients (77.01%) had no history of allergy. The primary diseases were respiratory system infection (56.58%). Main systems/organs involved in ADR were skin and its appendants, digestive system and respiratory system, and its clinical manifestations were rash, pruritus, nausea, vomiting, chest tightness, etc. After withdrawal or symptomatic treatment, 1 050 patients (99.34%) were cured or improved. Before the use of cefotaxime sodium, 850 patients underwent skin test (151 patients occurred serious ADR); there was no statistical significance in the incidence of serious renzhen202102@163.com ADR, compared with the incidence of serious ADR in 207 patients without skin test (39 patients occurred serious ADR)(P=0.718). CONCLUSIONS ADR caused by cefotaxime sodium is mainly seen in patients <11 years old, mostly occurring 30 min to 24 h after intravenous drip; skin test before medication of cefotaxime sodium cannot reduce the risk of serious ADR. Before using cefotaxime sodium in clinical practice, patients should be asked about their allergy and medication history in detail. During use, it is important to focus on the patient’s condition within 24 h after medication to prevent serious ADR and ensure the safety of clinical medication.
期刊: 2023年第34卷第10期
作者: 任美娟;张红梅;刘畅;李蕊;闫美兴
AUTHORS: REN Meijuan,ZHANG Hongmei,LIU Chang,LI Rui,YAN Meixing
关键字: 头孢噻肟钠;不良反应;用药安全;山东省;皮试
KEYWORDS: cefotaxime sodium; adverse drug reactions; safety of drug use; Shandong province; skin test
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