目的 总结、分析西安市各级医院第一批国家重点监控药品（以下简称重点监控药品）不良反应/事件（ADR/ADE）发生的情况，以促进重点监控药品合理化使用。方法 对西安市各级医院2013-2018年上报的重点监控药品ADR/ADE报告进行统计分析，包括患者性别、年龄、ADR/ADE发生的时间、产生ADR/ADE的重点监控药品、ADR/ADE所涉及器官/系统和临床症状、ADR/ADE的严重程度分级、后续转归及关联性评价。结果 西安市各级纳入研究的医院同期共上报ADR/ADE 6 683例，其中由重点监控药品引起的463例（6.93%）；在463例ADR/ADE报告中，男性（247例，53.35%）例数略多于女性（216例，46.65%），患者年龄以>40岁为主（361例，77.97%），其中>60岁的有212例（45.79%）；ADR/ADE发生在给药后1 min内（立即）至8 d，其中发生在给药后6~30 min最多（122例，26.35%）；ADR/ADE涉及16个品种，丹参川芎嗪例数占比最高（151例，32.61%）；463例报告共发生598例次ADR/ADE，皮肤及附件损害最多（152例次，25.42%），其次是用药部位损害（110例次、18.39%）和全身性损害（96例次，16.05%），临床表现以注射部位发红最多（93例次），其次为瘙痒（83例次）和皮疹（74例次）；其中主要为轻度ADR/ADR 281例（60.69%），重度ADR/ADE 55例（11.88%），新的ADR/ADE 46例（9.94%），绝大部分患者痊愈或好转，共460例（99.35%），2例（0.43%）不详，1例（0.22%）死亡；416例（89.85%）关联性评价为很可能。结论 重点监控药品临床中应用较广泛，不合理用药现象较多，无指征、超说明书使用等情况突出，导致ADR/ADE发生率较高，30 min内的速发型为主要ADR/ADE类型、这类ADR/ADE主要表现为皮肤及附件的轻度损害，加强和规范重点监控药品的合理应用，可以降低其ADR/ADE发生率。

Objective Summarize and analyze the occurrence of adverse drug reactions/adverse drug events (ADR/ADE) of the first batch of national key monitoring drugs (key monitoring drugs) at all levels of hospitals in Xi'an City to promote rational use of key monitoring drugs. Methods Statistic analysis of ADR/ADE reports of key monitoring drugs reported by hospitals at all levels in Xi'an City from 2013 to 2018 was performed, including patient gender, age, time of occurrence of ADR/ADE, generating ADR/ADE key monitoring drugs, ADR/ADE involved organs/systems and clinical symptoms, ADR/ADE severity classification, subsequent outcomes, and relevance evaluation. Results In Xi'an City, totally 6 683 cases of ADR/ADE were reported in same period, 463 cases were caused by key monitoring drugs (6.93%). Among 463 cases of ADR/ADE, the number of men (247 cases, 53.35%) was slightly higher than that of women (216 cases, 46.65%). The age of patients was mainly over 40 years old (361 cases, 77.97%). Among them, 212 cases (45.79%) were over 60 years old. ADR/ADE occurred within 1 min to 8 days after administration, especially 6-30 min after administration (122 cases, 25.35%). All ADR/ADE involved 16 varieties, the proportion of Danshen Chuanxiongqin Injection was the highest (151 cases, 32.61%). A total of 598 cases of ADR/ADE were reported in 463 cases, with the most damage to skin and appendages (152 cases, 25.42%), followed by site damage (110 cases, 18.39%) and systemic damage (96 cases, 16.05%). The main clinical manifestations were mainly redness at injection site (93 case times), followed by pruritus (83 case times) and rash (74 case times). Among 463 ADR/ADE reports, 55 cases (11.88%) were severe, 46 cases (9.94%) were new ADR/ADE, 460 cases (99.35%) were cured or improved, 2 cases (0.43%) were unknown, 1 cases (0.22%) was died. 416 cases (89.85%) were evaluated as likely to be related. Conclusions Key monitoring drugs are widely used in clinical practice, and there are many unreasonable drug use phenomena, such as no indication and off-label use, leading to a high incidence of ADR/ADE. The main type of ADR/ADE is the rapid hairstyle within 30 minutes. This type of ADR/ADE is mainly manifested as mild damage to the skin and accessories. Therefore, strengthening and regulating the rational application of key monitoring drugs can reduce the incidence of ADR/ADE.

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国家社会科学基金资助项目（18XGL019）；西安市第四医院科研孵化基金项目（FZ-39）