Page 108 - 《中国药房》2026年5期

·药学服务·

参芪扶正注射液超适应证用药分级管理标准的建立
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吴 敏 ，郁 梅 ，殷生楠，柳冬梅（泰州市中医院药学部，江苏 泰州 225300）
中图分类号 R969.3 文献标志码 A 文章编号 1001-0408（2026）05-0650-05
DOI 10.6039/j.issn.1001-0408.2026.05.17

摘 要 目的 建立参芪扶正注射液超适应证用药分级管理标准。方法 系统检索中国知网、PubMed、the Cochrane Library等中英
文数据库收录的参芪扶正注射液相关指南/共识、系统评价/Meta分析和随机对照试验（RCT），分别采用AGREE Ⅱ、AMSTAR Ⅱ
和Cochrane协作网推荐的偏倚风险评估工具RoB 1.0评价其证据质量，采用Thomson分级系统构建参芪扶正注射液超适应证用
药分级管理标准。结果 共纳入534篇文献，其中指南11篇、系统评价/Meta分析22篇、RCT 501篇。参芪扶正注射液超适应证用
药疾病谱涉及79种疾病：癌症相关性疲乏、结直肠癌、乳腺癌3种疾病具有高质量证据，分级管理等级为A级（Ⅰ级推荐），允许全
院医师开具；卵巢癌、肝癌、白血病、心力衰竭、脑梗死5种疾病的分级管理等级为B级（Ⅱa级推荐），仅限中级及以上职称医师在
相关科室使用；脓毒症、宫颈癌、食管癌等11种疾病分级管理等级为C级（Ⅱb级推荐），需经高级职称医师严格评估后使用；其他
疾病因缺乏有效证据而被明确禁止。结论 参芪扶正注射液超适应证用药现象普遍。本研究通过循证医学方法建立的分级管理
标准，为中药注射剂的规范化应用提供了科学依据，并为医疗机构实施差异化用药监管提供了可操作范式。
关键词 参芪扶正注射液；超适应证用药；Thomson分级系统；循证医学；分级管理

Establishment of graded management standards for off-label use of Shenqi fuzheng injection
WU Min，YU Mei，YIN Shengnan，LIU Dongmei（Dept. of Pharmacy， Taizhou Hospital of Traditional Chinese
Medicine， Jiangsu Taizhou 225300， China）

ABSTRACT OBJECTIVE To establish the graded management standards for off-label use of Shenqi fuzheng injection.
METHODS Systematic searches were conducted in databases including CNKI， PubMed and the Cochrane Library to retrieve
guidelines/consensuses， systematic reviews/meta-analyses， and randomized controlled trials （RCTs） of Shenqi fuzheng injection.
The quality of evidence was evaluated using AGREE Ⅱ， AMSTAR Ⅱ， and the Risk of Bias 1.0 tool recommended by Cochrane
Collaboration， and the graded management standard for off-label use of Shenqi fuzheng injection was developed by using the
Thomson grading system. RESULTS A total of 534 articles were involved， including 11 guidelines， 22 systematic reviews/meta-
analysis， and 501 RCTs. They covered 79 off-label indications for Shenqi fuzheng injection： cancer-related fatigue， colorectal
cancer and breast cancer， all with high-quality evidence were classified under grade A management （grade Ⅰ commendation），
allowing all physicians across the hospital to prescribe relevant treatments； five diseases， such as ovarian cancer， liver cancer，
leukemia， heart failure and cerebral infarction， were classified under grade B management （grade Ⅱ a commendation）， with
prescription restricted to physicians with intermediate or higher professional titles in specific departments； eleven diseases，
including sepsis， cervical cancer， esophageal cancer， etc.， were classified under grade C management （grade Ⅱb commendation），
requiring strict evaluation by senior physicians before prescription； the use of Shenqi fuzheng injection for other conditions was
explicitly prohibited due to a lack of sufficient evidence. CONCLUSIONS Off-label use of Shenqi fuzheng injection is prevalent.
The graded management standard established by evidence-based medical approach provides a scientific basis for standardizing the
clinical application of traditional Chinese medicine injections
Δ 基金项目 江苏省中医药科技发展计划项目（No.MS2022128）；
and offers an operable paradigm for implementing
2023年泰州市科技（社会发展）项目（No.TS202312）；2024年中华国际
医学交流基金会医药临床与成果转化基金-临床药学发展专项基金项 differentiated drug use supervision in medical institutions.
目（No.Z-2014-08-2309-5） KEYWORDS Shenqi fuzheng injection； off-label use；
＊ 第一作者 药 师 ，硕 士 。 研 究 方 向 ：药 事 管 理 。 E-mail： Thomson grading system； evidence-based medicine； graded
wumin9904@163.com
management
# 通信作者 副主任中药师，博士。研究方向：药事管理。E-mail：
jinzeyourself@163.com

· 650 · China Pharmacy 2026 Vol. 37 No. 5 中国药房 2026年第37卷第5期