头孢噻利致药品不良反应文献分析

Literature Analysis on Adverse Drug Reactions Induced by Cefoselis

目的:探讨头孢噻利发生药品不良反应(adverse drug reaction,ADR)的一般规律及特点,为临床用药提供参考。方法:检索中国知网数据库、维普中文科技期刊数据库、万方数据库和Pub Med数据库中从建库至2020年1月国内外医药期刊公开发表的头孢噻利致ADR的相关报告,对数据进行统计分析。结果:共检索出同期对照临床研究和非比较性病案报告20篇,使用头孢噻利合计1 218例,报告ADR 121例,ADR发生率为9.93%,其中肝胆系统反应发生率最高(3.69%,45例),其次为胃肠系统反应(2.38%,29例)。共收集头孢噻利致ADR个案报道8篇,有效病例11例,其中男性9例(占81.82%),女性2例(占18.18%),男性明显多于女性;年龄35~87岁,主要集中于> 60岁人群,尤其> 80岁的高龄患者;ADR以意识障碍等中枢神经系统症状为主;给药2~3 d出现的ADR病例数最多,共8例(占72.73%)。结论:临床使用头孢噻利时,应严格把握其适应证,加强用药监测,保证安全、有效、经济用药。

OBJECTIVE: To probe into the general rule and characteristics of adverse drug reaction( ADR)induced by cefoselis,so as to provide references for clinical medication. METHODS: Reports related to ADR induced by cefoselis published in domestic and foreign medical journals from CNKI,VIP,Wanfang and PubMed from basebuilding to Jan. 2020 were retrieved and conducted statistical analysis on the data. RESULTS: Totally 20 controlled clinical studies and non-comparative case reports were retrieved in the same period,a total of 1 218 cases of cefoselis used,121 cases of ADR were reported, with the incidence of ADR was 9. 93%, of which the incidence of hepatobiliary system reactions was the highest( 3. 69%,45 cases),followed by gastrointestinal system reactions( 2. 38%,29 cases). A total of 8 case reports of ADR caused by cefoselis were collected,with 11 valid cases,of which 9 cases( 81. 82%) were male and 2 cases( 18. 18%) were female,with obviously more males than females;the age ranged from 35 to 87 years,mainly concentrated in people aged > 60 years,especially the elderly patients aged > 80 years;the ADR were mainly manifested as central nervous system symptoms such as disturbance of consciousness;the number of ADR cases appeared in 2-3 d of drug administration was the highest,with 8 cases( 72. 73%). CONCLUSIONS: The clinical application of cefoselis should strictly grasp its indications and strengthen medication monitoring to ensure safe,effective and economic medication.