目的 總結(jié)、分析西安市各級醫(yī)院第一批國家重點監(jiān)控藥品（以下簡稱重點監(jiān)控藥品）不良反應(yīng)/事件（ADR/ADE）發(fā)生的情況，以促進重點監(jiān)控藥品合理化使用。方法 對西安市各級醫(yī)院2013-2018年上報的重點監(jiān)控藥品ADR/ADE報告進行統(tǒng)計分析，包括患者性別、年齡、ADR/ADE發(fā)生的時間、產(chǎn)生ADR/ADE的重點監(jiān)控藥品、ADR/ADE所涉及器官/系統(tǒng)和臨床癥狀、ADR/ADE的嚴重程度分級、后續(xù)轉(zhuǎn)歸及關(guān)聯(lián)性評價。結(jié)果 西安市各級納入研究的醫(yī)院同期共上報ADR/ADE 6 683例，其中由重點監(jiān)控藥品引起的463例（6.93%）；在463例ADR/ADE報告中，男性（247例，53.35%）例數(shù)略多于女性（216例，46.65%），患者年齡以>40歲為主（361例，77.97%），其中>60歲的有212例（45.79%）；ADR/ADE發(fā)生在給藥后1 min內(nèi)（立即）至8 d，其中發(fā)生在給藥后6~30 min最多（122例，26.35%）；ADR/ADE涉及16個品種，丹參川芎嗪例數(shù)占比最高（151例，32.61%）；463例報告共發(fā)生598例次ADR/ADE，皮膚及附件損害最多（152例次，25.42%），其次是用藥部位損害（110例次、18.39%）和全身性損害（96例次，16.05%），臨床表現(xiàn)以注射部位發(fā)紅最多（93例次），其次為瘙癢（83例次）和皮疹（74例次）；其中主要為輕度ADR/ADR 281例（60.69%），重度ADR/ADE 55例（11.88%），新的ADR/ADE 46例（9.94%），絕大部分患者痊愈或好轉(zhuǎn)，共460例（99.35%），2例（0.43%）不詳，1例（0.22%）死亡；416例（89.85%）關(guān)聯(lián)性評價為很可能。結(jié)論 重點監(jiān)控藥品臨床中應(yīng)用較廣泛，不合理用藥現(xiàn)象較多，無指征、超說明書使用等情況突出，導(dǎo)致ADR/ADE發(fā)生率較高，30 min內(nèi)的速發(fā)型為主要ADR/ADE類型、這類ADR/ADE主要表現(xiàn)為皮膚及附件的輕度損害，加強和規(guī)范重點監(jiān)控藥品的合理應(yīng)用，可以降低其ADR/ADE發(fā)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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國家社會科學(xué)基金資助項目（18XGL019）；西安市第四醫(yī)院科研孵化基金項目（FZ-39）