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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。
Objective: To analyze the characteristics of triazole antifungal drug adverse reactions (ADR) and provide references for clinical rational drug use. Methods: A retrospective study was conducted on the age, sex, drug dosage form, route of administration, ADR onset time, organ involvement in 227 patients with ADR reported by Hubei ADRM database from 2012 to 2014. System distribution and clinical manifestations, ADR grading, correlation evaluation and the outcome of such cases for statistical analysis. Results: The ratio of male to female in ADR patients caused by triazole antifungal drugs was 1: 1.32. There was distribution in all age groups, of which the constituent ratio was the highest in age group of 31-40 years (38.33%). ADR report involves nine kinds of pharmaceutical dosage forms, mainly ointment, accounting for 59.03% of the total dosage form. ADR reports involving administration mainly include topical (70.04%) and vaginal (24.23%) and so on. (42.73%) caused by ADR mainly caused skin damage and its accessory damage (69.87%) and female reproductive system damage (24.02%), etc. The clinical manifestations of ADR were rash, itching, nausea, vomiting, diarrhea and abdominal pain. Caused the largest number of ADR cases, ketoconazole (36.56%) followed. In the 227 cases of ADR, there were 200 cases of general ADR and 27 cases of new ADR. Correlation evaluation results: affirmed 17 cases, it is likely 68 cases, 142 cases may be. The outcome of ADR cases is mainly cured and improved. Conclusion: The unreasonable use of drugs should be strictly controlled, the monitoring of ADR should be strengthened, the manual for drug use should be improved, and the clinical medication should be standardized to reduce the risk of ADR / ADE.