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227例三唑类抗真菌药物不良反应报告分析
Report Analysis of 227 Cases of Adverse Drug Reactions of Triazole Superficial Antifungal Agents
  
DOI:
中文关键词:  三唑类抗真菌药物  药品不良反应  报告  安全用药
英文关键词:Triazole antifungal agents  Adverse drug reactions  Report  Safe medication
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作者单位
王璐 谢裕 ①华中科技大学同济医学院附属同济医院药学部(武汉430030) 
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中文摘要:
      摘 要 目的:分析三唑类抗真菌药物不良反应(ADR)的发生的特点,为临床合理用药提供参考。方法:采用回顾性研究方法,对2012~2014 年湖北省药品不良反应监测中心数据库227例三唑类抗真菌药物ADR报告的患者年龄、性别,药物剂型、给药途径,ADR发生时间、累及器官系统分布及临床表现,ADR分级、关联性评价及其转归情况等进行统计分析。结果:三唑类抗真菌药物所致ADR患者男女比例为1∶1.32;各个年龄段均有分布,其中31~40岁年龄段构成比最高,占38.33%。ADR报告涉及9种药品剂型,以膏剂为主,占总剂型59.03%。ADR报告涉及给药途径主要包括外用(70.04%)和阴道给药(24.23%)等。所致ADR主要累及皮肤及其附件损害(69.87%)和女性生殖系统损害(24.02%)等,ADR临床表现为皮疹、瘙痒、恶心、呕吐、腹泻、腹痛等;其中咪康唑(42.73%)引起的ADR例数最多,酮康唑(36.56%)次之。227例ADR报告中一般的ADR 200例,新的ADR 27例。关联性评价结果:肯定17例,很可能68例,可能142例。ADR病例的转归以治愈和好转为主。结论:应严格控制药物的不合理使用,加强ADR监测,完善药物使用说明书,规范临床用药,以降低ADR/ADE风险。
英文摘要:
      ABSTRACT Objective:Through the analysis characteristics of the adverse reactions of triazole drug,in order to provide some references for rational drug use in the clinic. Methods:Using the method of retrospective study, 227cases of adverse drug reactions of triazole drug reported in the database of the drug adverse reaction monitoring center of Hubei Province during the period from January 2012 to December 2014 were collected and analyzed statistically in respects of age, gender, dosage form, route of administration, occurrence time of ADR, involved organ system distribution and clinical manifestations, ADR classification, relevance evaluation and its results. Results:Adverse reactions caused by the triazole of antifungal drugs, male and female ratio was 1∶1.32, and there were distribution in each age group, among which the incidence of 31 40 years old was the highest, accounting for 38.33%. ADR reports involved 9 kinds of dosage form,which mainly were paste,accounting for 59.03%. The ADR reports involving method mainly includes the topical administration (70.04%) and vaginal administration (24.23%),etc. There were major ADR reports involving the skin and its accessories damage (69.87%) and female reproductive system damage (24.02%), etc. ADR clinical manifestation included skin rashes, itching, nausea, romiting, diarrhoea abdomind pain, etc. The miconazole (42.73%) caused by ADR in the first place, followed by ketoconazole (36.56%). There were general 200 cases, the new 27 cases. Relevance evaluation results: affirmed 17 cases, probably 68 cases, may be 142 cases. The outcome of ADR cases was dominated cure and improvement. Conclusion:It was important to strictly control of the irrational use of drugs, strengthen the monitoring of adverse drug reactions, improve the drug use manual, standardize clinical medication, in order to reduce the incidence of adverse drug reactions.
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