紫杉醇(白蛋白结合型)超说明书治疗妇科肿瘤的循证评价  

Evidence-Based Evaluation on Off-label Use of Paclitaxel(Albumin Bound)Against Gynecologic Cancer

作　　者：李元文 张双 赵丹 刘俊 孙楠[1] 任艳丽[1] 郭华[1] LI Yuanwen;ZHANG Shuang;ZHAO Dan;LIU Jun;SUN Nan;REN Yanli;GUO Hua(Department of Pharmacy,the Third Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)

机构地区：[1]郑州大学第三附属医院药学部,河南郑州450052

出　　处：《河南医学研究》2025年第8期1371-1375,共5页Henan Medical Research

基　　金：河南省医学科技攻关计划联合共建项目(LHGJ20200463)。

摘　　要：目的 评价注射用紫杉醇(白蛋白结合型)超说明书治疗宫颈癌、子宫内膜癌、卵巢癌的合理性。方法 查阅国内外最新版药品说明书、Micromedex数据库、权威指南;系统检索PubMed、Embase、Cochrane Library、CNKI、VIP和万方数据库,质量评价后,进行循证医学等级评价。结果 注射用紫杉醇(白蛋白结合型)治疗复发转移性宫颈癌、复发性卵巢癌,有效性等级Ⅱa,推荐等级Ⅱb,证据等级B;治疗复发性子宫内膜癌,有效性等级Ⅱa,推荐等级Ⅱb,证据等级C。结论 目前紫杉醇(白蛋白结合型)治疗妇科肿瘤的证据级别较低,需要高质量临床研究验证其有效性和安全性。Objective To evaluate the rationality of off-label use of paclitaxel(albumin bound)in the treatment of cervical cancer,endometrial carcinoma and ovarian cancer.Methods The latest edition of domestic and foreign drug labels,Micromedex datebase and authoritative guidelines were retrieved;PubMed,Embase,Cochrane Library,CNKI,VIP,and Wanfang databases were systematically searched.Evidence-based medicine grade evaluation was conducted after quality evaluation.Results Paclitaxel(albumin bound)for treatment of recurrent or metastatic cervical cancer and recurrent ovarian cancer,its effectiveness level was classⅡa,recommendation level was classⅡb,and evidence level was class B.For treatment of recurrent ovarian cancer,its effectiveness level was classⅡa,recommendation level was classⅡb,and evidence level was class C.Conclusion At present,there is only low level evidence for paclitaxel(albumin bound)against gynecologic cancer.Therefore,high-quality clinical studies are needed to demonstrate its safety and efficacy.

关 键 词：宫颈癌 子宫内膜癌 卵巢癌 紫杉醇(白蛋白结合型) 超说明书用药 循证评价 

分 类 号：R-05[医药卫生]