Page 101 - 2021年17期

《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 Δ

＊
李 宵 ，邱 博，任炳楠，董占军（河北省人民医院药学部，石家庄 050051）
#
中图分类号 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 People’s 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
Δ 基金项目：白求恩·医学科学研究基金资助项目（No.N089NH）
function.
＊主管药师，硕士。研究方向：药品临床综合评价。电话：0311-
KEYWORDS Quick Guide for Drug Evaluation and
85988640。E-mail：379346168@qq.com
# 通信作者：主任药师，硕士生导师，硕士。研究方向：医院药学、 Selection in Chinese Medical Institutions；Quantitative score；
药事管理。电话：0311-85988640。E-mail：13313213656@126.com Safe drug use；Severe ADR；Special population

中国药房 2021年第32卷第17期 China Pharmacy 2021 Vol. 32 No. 17 ·2139 ·