俄罗斯自发报告数据库中与头孢曲松治疗相关的致命结局分析

Q4 Medicine
Daria L. Klabukova, A.R. Titova, I.S. Krysanov, V.A. Polivanov, V.S. Krysanova, V.Yu. Ermakova
{"title":"俄罗斯自发报告数据库中与头孢曲松治疗相关的致命结局分析","authors":"Daria L. Klabukova, A.R. Titova, I.S. Krysanov, V.A. Polivanov, V.S. Krysanova, V.Yu. Ermakova","doi":"10.36488/cmac.2023.2.159-164","DOIUrl":null,"url":null,"abstract":"Objective. To analyze spontaneous reports (SRs) from the Russian database of adverse reactions (Automated information system «Pharmacovigilance» of Roszdravnadzor), containing information on fatal outcomes during ceftriaxone treatment, and to identify factors associated with an increased risk of death with ceftriaxone use. Materials and Methods. The study included 122 SRs concerning fatal cases during ceftriaxone therapy. All SRs were submitted to the Russian pharmacovigilance database from 06 May 2019 to 23 November 2022. A retrospective analysis of fatal adverse reactions cases in ceftriaxone treatment was carried out according to the following parameters: gender, age, drug intake and route of administration, clinical symptoms of anaphylaxis. Additionally, indications for the simultaneous use of drugs for local anesthesia as a solvent were evaluated. Results. A total of 86 SRs (70.5%) were primary and relevant for further analysis. 16 SRs (18.6%) were registered in the database for 8 months of 2019, 25 (29.1%) – for 2020, 15 (17.4%) – for 2021, for less than 11 months 2022 received 30 reports (34.9%). The number of adverse reactions reports in male and female patients was similar. Among the age groups, the largest number of SRs was observed in middleaged and elderly patients – 27 (31.4%) and 23 (26.7%) reports, respectively, 8 cases (9.3%) were registered in pediatric population. The development of fatal adverse reactions in the hospital was reported in 50 (58.1%) SRs, in outpatient setting – in 31 (36.1%) SRs. 18 SRs were identified with an indication of the patient’s self-treatment, which is 20.9% of all primary reports. Clinical symptoms of anaphylactic shock were noted in 63 reports (73.3%). Additional analysis of the combined use of ceftriaxone and local anesthetics cases revealed a range of medical errors. Conclusions. Ceftriaxone treatment was associated with a high risk of anaphylactic shock. The use of this antibiotic in outpatient setting, especially as self-treatment is an additional risk factor for death. Inappropriate use of local anesthetics in combination with ceftriaxone is an additional serious risk factor for fatal outcome.","PeriodicalId":53392,"journal":{"name":"Klinicheskaia mikrobiologiia i antimikrobnaia khimioterapiia","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Analysis of fatal outcomes associated with ceftriaxone treatment from the Russian database of spontaneous reports\",\"authors\":\"Daria L. Klabukova, A.R. Titova, I.S. Krysanov, V.A. Polivanov, V.S. Krysanova, V.Yu. Ermakova\",\"doi\":\"10.36488/cmac.2023.2.159-164\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Objective. To analyze spontaneous reports (SRs) from the Russian database of adverse reactions (Automated information system «Pharmacovigilance» of Roszdravnadzor), containing information on fatal outcomes during ceftriaxone treatment, and to identify factors associated with an increased risk of death with ceftriaxone use. Materials and Methods. The study included 122 SRs concerning fatal cases during ceftriaxone therapy. All SRs were submitted to the Russian pharmacovigilance database from 06 May 2019 to 23 November 2022. A retrospective analysis of fatal adverse reactions cases in ceftriaxone treatment was carried out according to the following parameters: gender, age, drug intake and route of administration, clinical symptoms of anaphylaxis. Additionally, indications for the simultaneous use of drugs for local anesthesia as a solvent were evaluated. Results. A total of 86 SRs (70.5%) were primary and relevant for further analysis. 16 SRs (18.6%) were registered in the database for 8 months of 2019, 25 (29.1%) – for 2020, 15 (17.4%) – for 2021, for less than 11 months 2022 received 30 reports (34.9%). The number of adverse reactions reports in male and female patients was similar. Among the age groups, the largest number of SRs was observed in middleaged and elderly patients – 27 (31.4%) and 23 (26.7%) reports, respectively, 8 cases (9.3%) were registered in pediatric population. The development of fatal adverse reactions in the hospital was reported in 50 (58.1%) SRs, in outpatient setting – in 31 (36.1%) SRs. 18 SRs were identified with an indication of the patient’s self-treatment, which is 20.9% of all primary reports. Clinical symptoms of anaphylactic shock were noted in 63 reports (73.3%). Additional analysis of the combined use of ceftriaxone and local anesthetics cases revealed a range of medical errors. Conclusions. Ceftriaxone treatment was associated with a high risk of anaphylactic shock. The use of this antibiotic in outpatient setting, especially as self-treatment is an additional risk factor for death. Inappropriate use of local anesthetics in combination with ceftriaxone is an additional serious risk factor for fatal outcome.\",\"PeriodicalId\":53392,\"journal\":{\"name\":\"Klinicheskaia mikrobiologiia i antimikrobnaia khimioterapiia\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Klinicheskaia mikrobiologiia i antimikrobnaia khimioterapiia\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.36488/cmac.2023.2.159-164\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Klinicheskaia mikrobiologiia i antimikrobnaia khimioterapiia","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.36488/cmac.2023.2.159-164","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0

摘要

目标。分析来自俄罗斯不良反应数据库(Roszdravnadzor的“药物警戒”自动信息系统)的自发报告(SRs),其中包含头孢曲松治疗期间致命结局的信息,并确定与使用头孢曲松死亡风险增加相关的因素。材料与方法。该研究包括122例在头孢曲松治疗期间死亡的SRs。所有SRs均于2019年5月6日至2022年11月23日提交至俄罗斯药物警戒数据库。根据性别、年龄、药物摄入及给药途径、过敏反应临床症状对头孢曲松治疗致死性不良反应病例进行回顾性分析。此外,还评估了同时使用局部麻醉药物作为溶剂的适应症。结果。共有86例SRs(70.5%)是主要的,与进一步分析相关。在2019年的8个月里,数据库中登记了16份sr(18.6%), 2020年25份(29.1%),2021年15份(17.4%),不到11个月的2022年收到了30份报告(34.9%)。男性和女性患者报告的不良反应数量相似。在各年龄组中,中老年患者发生SRs最多,分别为27例(31.4%)和23例(26.7%),儿科8例(9.3%)。据报道,在医院有50例(58.1%)SRs发生致命不良反应,在门诊有31例(36.1%)SRs。18例SRs被确定为患者自我治疗的指征,占所有主要报告的20.9%。63例(73.3%)报告出现过敏性休克的临床症状。对联合使用头孢曲松和局部麻醉剂的病例的进一步分析揭示了一系列医疗差错。结论。头孢曲松治疗与过敏性休克的高风险相关。在门诊环境中使用这种抗生素,特别是自我治疗是死亡的另一个危险因素。局麻药与头孢曲松的不适当联合使用是致命结果的另一个严重危险因素。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analysis of fatal outcomes associated with ceftriaxone treatment from the Russian database of spontaneous reports
Objective. To analyze spontaneous reports (SRs) from the Russian database of adverse reactions (Automated information system «Pharmacovigilance» of Roszdravnadzor), containing information on fatal outcomes during ceftriaxone treatment, and to identify factors associated with an increased risk of death with ceftriaxone use. Materials and Methods. The study included 122 SRs concerning fatal cases during ceftriaxone therapy. All SRs were submitted to the Russian pharmacovigilance database from 06 May 2019 to 23 November 2022. A retrospective analysis of fatal adverse reactions cases in ceftriaxone treatment was carried out according to the following parameters: gender, age, drug intake and route of administration, clinical symptoms of anaphylaxis. Additionally, indications for the simultaneous use of drugs for local anesthesia as a solvent were evaluated. Results. A total of 86 SRs (70.5%) were primary and relevant for further analysis. 16 SRs (18.6%) were registered in the database for 8 months of 2019, 25 (29.1%) – for 2020, 15 (17.4%) – for 2021, for less than 11 months 2022 received 30 reports (34.9%). The number of adverse reactions reports in male and female patients was similar. Among the age groups, the largest number of SRs was observed in middleaged and elderly patients – 27 (31.4%) and 23 (26.7%) reports, respectively, 8 cases (9.3%) were registered in pediatric population. The development of fatal adverse reactions in the hospital was reported in 50 (58.1%) SRs, in outpatient setting – in 31 (36.1%) SRs. 18 SRs were identified with an indication of the patient’s self-treatment, which is 20.9% of all primary reports. Clinical symptoms of anaphylactic shock were noted in 63 reports (73.3%). Additional analysis of the combined use of ceftriaxone and local anesthetics cases revealed a range of medical errors. Conclusions. Ceftriaxone treatment was associated with a high risk of anaphylactic shock. The use of this antibiotic in outpatient setting, especially as self-treatment is an additional risk factor for death. Inappropriate use of local anesthetics in combination with ceftriaxone is an additional serious risk factor for fatal outcome.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
0.90
自引率
0.00%
发文量
0
审稿时长
8 weeks
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信