《中国医疗机构药品评价与遴选快速指南》评分细则指导我院可致严重不良反应药品在特殊人群中的使用

李宵 邱博 任炳楠 董占军

中圖分类号 R969.3;R197.324 文献标志码 A 文章编号 1001-0408（2021）17-2139-11

DOI 10.6039/j.issn.1001-0408.2021.17.16

摘 要 目的：促进我院可致严重不良反应药品在特殊人群中的安全使用。方法：按照《中国医疗机构药品评价与遴选快速指南》中的量化评分细则，建立我院药品综合评价数据库，提取该数据库中“安全性”维度下不良反应分级或不良事件通用术语标准分级分值为1、2、3、4的药品，按不良反应发生率的不同分别得出十分常见（发生率≥10%）、常见（发生率为1%～<10%）、偶见（发生率为0.1%～<1%）、罕见（发生率<0.1%）等4类可致严重不良反应的药品，依据该4类药品在儿童、孕妇、哺乳期妇女、老年人、肝功能异常者、肾功能异常者等6类特殊人群中的量化评分，分析特殊人群使用可致严重不良反应药品的可行性。结果：我院药品综合评价数据库中的1 172种化学药品中，十分常见、常见、偶见、罕见的可致严重不良反应药品分别有18、73、61、357种。其中，肿瘤用药的严重不良反应发生率较高，故临床需密切关注特殊人群使用肿瘤药物的情况。儿童禁用药品合计173种，因其说明书明确药品具有器官毒性、细胞毒性且无指南推荐可用于儿童，临床使用需格外谨慎。孕妇和哺乳期妇女禁用药品分别为278、228种，因其具有胚胎毒性、生殖毒性等而被禁用于孕期或哺乳期。老年人禁用药品13种，大部分为专科用药。肝功能异常者禁用药品有5种，肾功能异常者禁用药品有7种，多为对肝/肾毒性较强的肿瘤用药。结论：所建量化评分系统可为儿童、孕妇、哺乳期妇女、老年人、肝功能异常者和肾功能异常者等6类特殊人群安全地使用可致严重不良反应药品提供有效指导。

关键词 中国医疗机构药品评价与遴选快速指南;量化评分;安全用药;严重不良反应;特殊人群

Use of Severe ADR-inducing Drugs in Special Population in Our Hospital Guided by the Detailed Quantitative Scoring Rules of Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions

LI Xiao，QIU Bo，REN Bingnan，DONG Zhanjun（Dept. of Pharmacy， Hebei Provincial Peoples Hospital， Shijiazhuang 050051， China）

ABSTRACT   OBJECTIVE： To promote the safe use of severe ADR-inducing drugs in special population in our hospital. METHODS： According to detailed quantitative scoring rules of Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions， comprehensive evaluation database of drugs in our hospital was established. Drugs with ADR rating or ADE general terminology standard rating of 1， 2， 3 and 4 under the "safety" dimension were obtained from the database. According to the difference of the incidence of ADR， 4 kinds of severe ADR-inducing drugs， such as very common （incidence≥10%） ， common （incidence 1%-<10%） ， occasional （incidence 0.1%-<1%） and rare （incidence <0.1%）， were obtained. According to the quantitative scores of these 4 kinds of drugs in six special groups， such as children， pregnant women， lactating women， the elderly， patients with abnormal liver function， and patients with abnormal kidney function， the feasibility for special population to use drugs that cause severe ADR was analyzed. RESULTS： Among 1 172 chemical drugs in drug comprehensive evaluation database of our hospital， 18， 73， 61， and 357 kinds can cause very common， common， occasional and rare severe ADR， respectively. Among them， the incidence of severe ADR caused by tumor drugs was high， so it was necessary to pay close attention to the use of tumor drugs in special populations. Totally 173 kinds of drugs were prohibited for children because the instructions clearly showed organ toxicity， cytotoxicity and there were no guidelines recommending their use in children， so the clinical medication should be used with extraordinary caution. There were 278 and 228 drugs prohibited for pregnant women and lactating women， which were prohibited for pregnant or lactating period due to embryonic toxicity and reproductive toxicity. There were 13 prohibited drugs for the elderly， most of which were specialized drugs. Five kinds of drugs were prohibited in patients with abnormal liver function and seven were prohibited in patients with abnormal kidney function， most of which were tumor drugs with strong hepatorenal toxicity. CONCLUSIONS： Established quantitative score system can provide effective guidance for the safe use of severe ADR-inducing drugs among 6 special populations as children， pregant women， lactating women， the elderly， the patients with abnormal liver function and the patients with renal function.

KEYWORDS   Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions; Quantitative score; Safe drug use; Severe ADR; Special population

保障患者用药安全是医药人员和患者共同追求的永恒主题。据世界卫生組织（WHO）统计结果显示，全球有1/7的患者因不合理用药而死亡，安全用药已成为备受关注的世界卫生问题[1]。儿童、孕妇、哺乳期妇女、老年人、肝肾功能异常者的用药安全问题为临床面临的难题。其中，儿童因器官功能发育不完善，一些经肝肾代谢的药物的药动学参数与成年人相比差异明显[2];孕妇和哺乳期妇女需平衡药物治疗与胎儿或婴儿安全的关系[3];老年人和肝肾功能异常者因其自身生理、病理特点以及免疫等功能的衰退，使机体对药物的代谢能力减弱，易造成药物蓄积中毒，增加药品不良反应的发生风险[4]。因此，如何保障以上特殊人群用药安全、合理是目前亟待解决的问题。

2020年7月30日，由健康中国研究中心药品与健康产品专家委员会等8个组织联合发布的《中国医疗机构药品评价与遴选快速指南》（以下简称“《指南》”）为我国医疗机构建立了一套统一的药品评价与遴选的量化评分系统。……