某医院血液科24种抗肿瘤药超说明书用药评价

Evaluation of off-label use of 24 kinds of anti-tumor drugs in the department of hematology in a hospital

目的 回顾性调查某院血液科抗肿瘤药物超说明书用药现状并进行循证医学评价,为制定超说明书用药政策提供基线数据,为临床超说明书用药提供合理用药依据。方法 收集昆明医科大学第二附属医院血液科2019年7—12月出院病人的病历资料,依据药品说明书,判断其抗肿瘤药用药医嘱是否超说明书,通过Micromedex的Thomson分级系统对超说明书用药进行评价,Micromedex数据库检索不到的,临床药师进一步查询证据后进行Thomson分级评价。结果 2019年7—12月该院血液科共有24种药品存在超说明书用药,375条超说明书用药医嘱,共有36项不同类型超说书用药,其中有效性等级Class Ⅰ(治疗有效)有2项、Class Ⅱa(证据支持有效)24项、Class Ⅱb(有效性具有争议)9项、Class Ⅲ(治疗无效)1项;推荐等级Class Ⅰ(治疗有效)有2项、Class Ⅱa(证据支持有效)2项、Class Ⅱb(有效性具有争议)30项、Class Ⅲ(治疗无效)2项、Indeterminate(不明确)0项;证据等级Catagory A 0项、Catagory B 35项、Catagory C 1项、No Evidence 0项。结论 该院血液科抗肿瘤药物超说明书用药情况较为常见,超说明书用药均有循证医学证据,但个别证据等级低、有效性有限。医疗机构应加强超说明书用药管理,构建超说明书用药循证评价系统,规范超说明书用药行为,促进临床合理用药。

Objective To retrospectively investigate the current status of off-label use of anti-tumor drugs in the department of hematology in a hospital and conduct evidence-based medical evaluation, to provide baseline data for formulating off-label drug policies,and to promote rational use of basis for clinical off-label drugs.Methods The medical records of hospitalized patients in the Department of Hematology of the Second Affiliated Hospital of Kunming Medical University from July 2019 to December 2019 were conducted. According to the drug instructions, whether their anti-tumor drug orders were out of the instructions were evaluated. The off-label medications were estimated by Micromedex’s Thomson grading system. For off-label medications these cannot be retrieved from the Micromedex database, clinical pharmacists conducted Thomson grading evaluation after further inquiry of evidence.Results 24 off-label uses of anti-tumor drugs were collected from July 2019 to December 2019 in the department of hematology of this hospital, involving 375 off-label medication orders, and 36 different types of off-label use medications. Among them, the effectiveness level of Class Ⅰ(treatment effective) has 2 items, Class Ⅱa(valid supported by evidence) 24 items, Class Ⅱb(effectiveness is controversial) 9 items,Class Ⅲ(treatment ineffective) 1 item;recommendation level Class Ⅰ(treatment effective) has 2 items, Class Ⅱa(evidence supports effective) 2 items, Class Ⅱb(Effectiveness is controversial) 30 items, Class Ⅲ(treatment ineffective) 2 items, Indeterminate(unclear) 0items. Evidence level Catagory A 0 items, Catagory B 35 items, Catagory C 1 item, No Evidence 0 items.Conclusions The off-label use of anti-tumor drugs in hematology outpatients of this hospital is common, and all of them are supported by evidence-based medicine. However, the evidences of individual drug use are low grade and poor effectiveness. Medical institutions should strengthen the management of off-label drug use, build an evidence-based evaluation system for off-label drug use, standardize off-label drug use behavior, and promote clinical rational drug use.