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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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| 篇名： | 参芪扶正注射液超适应证用药分级管理标准的建立 |
| TITLE： | Establishment of graded management standards for off-label use of Shenqi fuzheng injection |
| 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、theCochraneLibrary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AGREEⅡ、AMSTARⅡ和Cochrane协作网推荐的偏倚风险评估工具RoB1.0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、RCT501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。 |
| 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 Ⅱa 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 and offers an operable paradigm for implementing differentiated drug use supervision in medical institutions. |
| 期刊： | 2026年第37卷第05期 |
| 作者： | 吴敏；郁梅；殷生楠；柳冬梅 |
| AUTHORS： | WU Min，YU Mei，YIN Shengnan，LIU Dongmei |
| 关键字： | 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 |
| KEYWORDS： | Shenqi fuzheng injection； off-label use； |
| 阅读数： | 3 次 |
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