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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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

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，JiangsuTaizhou2253oO，China）

ABSTRACTOBJECTIVEToestablishthegradedmanagementstandardsforof-labeluseof Shenqifuzheng injection. METHODS Systematic searches were conducted in databases including CNKI，PubMedand the Cochrane Library toretrieve guidelines/consensuses，systematicreviews/meta-analyses，andrandomizedcontroledtrials（RCTs）of Shenqi fuzheng injection. Thequalityof evidence was evaluatedusing AGREEII，AMSTARII，and theRisk of Bias1.OtoolrecommendedbyCochrane Colabration，andthegradedmanagementstandardforof-labeluseof Shenqifuzhenginjectionwasdevelopedbyusing the Thomsongradingsystem.RESULTSAtotalof534articleswereinvolved，inluding11guidelines，22systematicreviews/metaanalysis，and5OlRCTs.Theycovered79of-labelindicationsforShenqifuzhenginjection：cancer-relatedfatigue，colorectal cancerandbreastcancer，allwithhigh-qualityevidencewereclasifiedunder gradeAmanagement（gradeIcommendation）， allowingallphysiciansacross thehospitaltoprescriberelevanttreatments；fivediseases，suchasovariancancer，livercancer， leukemia，heartfailureandcerebral infarction，wereclasifiedundergradeBmanagement（gradeIacommendation），with prescriptionrestrictedtophysicianswithintermediateorhigherprofesionaltitlesinspecificdepartments；elevendiseases， including sepsis，cervicalcancer，esophagealcancer，tc.，were clasifiedundergradeCmanagement（gradeIbcommendation）， requiringstrictevaluationbyseniorphysicians beforeprescription；theuseofShenqi fuzheng injectionforotherconditios was explitly prohibitedduetoalackofsuffcientevidence.CONCLUsIONsOf-labeluseofShenqifuzhenginjectionisprevalent. Thegradedmanagementstandardestablishedbyevidence-based medicalaproach providesascientificbasisforstandardizing theclinical application of traditional Chinese medicine injections and offersanoperableparadigmforimplementing differentiated drug use supervision in medical institutions.

KEYWORDS Shenqifuzheng injection; off-labeluse; Thomson grading system；evidence-based medicine；graded management

参芪扶正注射液（Shenqi fuzhenginjection）是以党参和黄芪为主要药味的中药注射剂，具有益气扶正的功效，用于肺脾气虚引起的神疲乏力、少气懒言、自汗眩晕，以及肺癌、胃癌见上述证候者的辅助治疗。（剩余6878字）