Page 112 - 《中国药房》2026年9期

·药学服务·

根因分析结合知信行理论的药学服务降低儿童临床试验用药品
方案违背发生率的效果评价
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郭春彦 ，张 怡，杨禹欣，梁宇光，丁 倩，王 谦，张成玥，孙 雨，郭 鹏（国家儿童医学中心/首都医科大学
附属北京儿童医院临床研究中心，北京 100045）

中图分类号 R95 文献标志码 A 文章编号 1001-0408（2026）09-1206-05
DOI 10.6039/j.issn.1001-0408.2026.09.17

摘 要 目的 探讨基于根因分析（RCA）问题导向与知信行（KAP）理论的药学服务在降低儿童临床试验用药品方案违背发生率
方面的应用效果。方法 选取我院 2016 年 1 月－2020 年 12 月开展的 69 个药物临床试验项目的 617 名研究参与者作为对照组，
2022年1月－2025年12月开展的72个药物临床试验项目的868名研究参与者作为观察组。通过对对照组发生的试验用药品方
案违背进行RCA，确定方案违背类型及其发生原因。对照组开展药物临床试验常规药学服务；观察组在常规药学服务基础上，基
于RCA发现的造成问题的根本原因，从知识、态度、行为3个层面实施精准药学服务。比较两组试验用药品方案违背的发生情况。
结果 观察组试验用药品方案违背总体发生率、轻微方案违背发生率、重大方案违背发生率均较对照组显著降低（P＜0.001）。两
组发生的方案违背类型主要为漏用/少用/多用药品、给药时间不符合要求、未按要求调整药品剂量和违背方案合并用药/疫苗等。
在试验用药品方案违背的责任主体方面，观察组中由研究参与者及其监护人以及研究人员、偶发性因素为责任主体导致的方案违
背发生率均显著低于对照组（P＜0.001、P＜0.001、P＝0.025）；而由申办者导致的方案违背发生率与对照组比较差异无统计学
意义（P＞0.05）。结论 由药师主导的基于RCA问题导向结合KAP理论的药学服务，可有效降低儿童临床试验用药品方案违背
发生率，从而有效保障研究参与者的安全与权益。
关键词 方案违背；试验用药品；儿童药物临床试验；根因分析；知信行理论模式；药学服务

Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on
decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials
GUO Chunyan，ZHANG Yi，YANG Yuxin，LIANG Yuguang，DING Qian，WANG Qian，ZHANG Chengyue，SUN
Yu，GUO Peng（Clinical Research Center， Beijing Children’s Hospital Affiliated to Capital Medical University/
National Children’s Medical Center， Beijing 100045， China）

ABSTRACT OBJECTIVE To investigate the effect of pharmaceutical services guided by root cause analysis （RCA） in a
problem-oriented manner combined with knowledge-attitude-practice （KAP） theory on reducing the incidence of protocol violations
of investigational medicinal products in pediatric clinical trials. METHODS A total of 617 participants from 69 drug clinical trial
projects conducted in our hospital from January 2016 to December 2020 were selected as the control group， and 868 participants
from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the
protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control
group received routine pharmaceutical services for drug clinical trials， while the observation group was provided with precision
pharmaceutical services from the three dimensions of knowledge， attitude and practice on the basis of routine pharmaceutical
services， according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations
was compared between the two groups. RESULTS The total incidence of protocol violations of investigational medicinal products，
as well as the incidences of minor and major protocol violations， were all significantly lower in the observation group than in the
control group （P＜0.001）. The main types of protocol violations in both groups included missed/under-/over-dosing of medications，
non-adherence to administration time， failure to adjust dosage
Δ 基金项目 北京市卫生健康科技成果和适宜技术推广项目（No. as required， and combined medication/vaccination in violation
BHTPP2024068） of the protocol. Regarding the responsible subjects of protocol
＊第一作者 副主任药师，硕士。研究方向：儿童临床试验及伦理 violations， the incidences of protocol violations attributed to
管理、临床中药学。电话：010-58531216。E-mail：guochunyan205@
participants and their guardians as well as investigators and
163.com
# 通信作者 研究员，博士。研究方向：儿童临床试验、临床药理 accidental factors were significantly lower in the observation
学。电话：010-58531212。E-mail：guopeng@bch.com.cn group than in the control group （P＜0.001， P＜0.001， P＝

· 1206 · China Pharmacy 2026 Vol. 37 No. 9 中国药房 2026年第37卷第9期