陈富钦;刘海;梁蔚婷;刘庆;龚泳琪;黄红兵;刘韬;陈卓佳;
CHEN Fuqin;LIU Hai;LIANG Weiting;LIU Qing;GONG Yongqi;HUANG Hongbing;LIU Tao;CHEN Zhuojia;Pharmaceutical Department of Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine;

• 1:中山大学肿瘤防治中心药学部/华南肿瘤学国家重点实验室/肿瘤医学协同创新中心

摘要(Abstract)：

目的调查分析某肿瘤专科医院白蛋白结合型紫杉醇超说明书使用情况,为规范临床用药提供循证依据。方法抽取2018年1月～2019年12月使用白蛋白结合型紫杉醇的1 631份用药医嘱进行分析,依据国家药品监督管理局(NMPA)颁布的说明书、美国食品和药物管理局(FDA)批准的药品说明书以及美国国立综合癌症网络(NCCN)临床实践指南的推荐,对说明书外用药情况进行分析及评价。结果 1 631份病例中,用于说明书内适应证转移性乳腺癌有120例,占7.36%;用于说明书外适应证如黑色素瘤、胃癌、胰腺癌、非小细胞肺癌、肝癌、淋巴瘤、头颈部癌、卵巢癌、宫颈癌、鼻咽癌、食管癌、输尿管癌等共1 511例,占92.64%;其中,白蛋白结合型紫杉醇用于非小细胞肺癌和胰腺癌符合美国FDA批准,分别为259例和353例;用于转移性黑色素瘤、局部晚期或转移性膀胱癌、宫颈癌、子宫内膜癌和复发性卵巢癌符合NCCN指南推荐,而食管癌、鼻咽癌等瘤种目前仍处于Ⅱ期或Ⅲ期临床试验中,尚无权威的指南推荐使用。结论某院白蛋白结合型紫杉醇的临床使用存在超说明书用药现象。国家相关部门及专业医药学术组织应制定权威的药物治疗指南,为临床合理超说明书用药提供依据。
OBJECTIVE To investigate and analyze the off-label uses on indications of albumin-bound paclitaxel in a cancer hospital,and to provide evidence for standardizing clinical medication. METHODS 1 631 medical advices including the uses of albumin-bound paclitaxel from January 2018 to December 2019 were selected,analyzed and evaluated according to the specification issued by the National Medical Products Administration( NMPA),the Food and Drug Administration( FDA) and the recommendations of the clinical practice guidelines of the National Comprehensive Cancer Network( NCCN). RESULTS In a total of 1 631 medical advices,there were 120 cases conformed to the indications of specification,which accounting for 7.36%. 1 511 cases were off-label uses on indications of albumin-bound paclitaxel,including pancreatic cancer,non-small cell lung cancer,liver cancer,lymphoma,head and neck cancer,ovarian cancer,cervical cancer,nasopharyngeal carcinoma,melanoma,gastric cancer,esophageal cancer and ureteral cancer,which were accounted for 92.64%. Among them,albumin-bound paclitaxel was approved by the FDA for using in non-small cell lung cancer and pancreatic cancer,and was recommended to use for metastatic melanoma,locally advanced or metastatic bladder cancer,cervical cancer,endometrial carcinoma,and recurrent ovarian cancer by NCCN guidelines. There is no relevant guidelines or clinical evidence for other diseases such as esophageal cancer and nasopharyngeal carcinoma. CONCLUSION Off-label uses on indications exist in the clinical use of albumin-bound paclitaxel. Relevant departments and professional medical academic organizations should formulate authoritative drug treatment guidelines,and provide evidence for standardizing clinical medication.

关键词(KeyWords)： 白蛋白结合型紫杉醇;肿瘤专科;超说明书
albumin-bound paclitaxel;cancer hospital;off-label usage

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 陈富钦;刘海;梁蔚婷;刘庆;龚泳琪;黄红兵;刘韬;陈卓佳;
CHEN Fuqin;LIU Hai;LIANG Weiting;LIU Qing;GONG Yongqi;HUANG Hongbing;LIU Tao;CHEN Zhuojia;Pharmaceutical Department of Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine;

Email:

DOI:

参考文献(References)：

• [1]FDA.ABRAXANE[EB/OL].Washington FDA.https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021660s047lbl.pdf．
• [2]国家药品监督管理局．注射用紫杉醇(白蛋白结合型)(克艾力R)[Z].2020.http://zy.yaozh.com/instruct/smshb20190715/669.pdf
• [3]Rizvi N A,Riely G J,Azzoli C G,et al.Phase I/II trial of weekly intravenous 130-nm albumin-bound paclitaxel as initial chemotherapy in patients with stage IV non-small-cell lung cancer[J].J Clin Oncol,2008,26(4):639-643．
• [4]孙宜康，张易青．胰腺癌相关基因及分子靶向治疗的研究进展[J]．中国临床保健杂志，2018,21(5):705-708．
• [5]Hersh E M,Del Vecchio M,Brown M P,et al.A randomized,controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-na?ve patients with metastatic melanoma[J].Ann Oncol,2015,26(11):2267-2274．
• [6]National Comprehensive Cancer Network.NCCN Clinical Practice Guidelines in Oncology:Bladder Cancer (Version 5.2018)[EB/OL].http://www.nccn.org/professionals/physician_gls/default.aspx#bladder．
• [7]National Comprehensive Cancer Network.NCCN Clinical Practice Guidelines in Oncology:Ovarian Cancer (Version 2.2018)[EB/OL].http://www.nccn.org/professionals/physician_gls/default.aspx#ovarian．
• [8]郭凤，黄伟，赵莉，等．白蛋白结合型紫杉醇联合卡铂在晚期、复发性上皮卵巢癌治疗中的应用价值[J]．实用癌症杂志，2018,33(1):156-158．
• [9]National Comprehensive Cancer Network.NCCN Clinical Practice Guidelines in Oncology:Cervical Cancer (Version 1.2019)[EB/OL].http://www.nccn.org/professionals/physician_gls/default.aspx#cervical．
• [10]尹晓东，姚嫱，李维廉．白蛋白结合型紫杉醇的研究进展[J]．现代肿瘤医学，2011,19(7):1449-1452．
• [11]杨智勇．内分泌治疗联合白蛋白结合型紫杉醇在中晚期前列腺癌患者中的应用[J]．肿瘤，2017,37(7):782-787．
• [12]龚继芳，李洁，李燕，等．纳米白蛋白结合型紫杉醇联合替吉奥胶囊二线治疗进展期胃癌的效果[J]．肿瘤综合治疗电子杂志，2018,4(1):48-53．
• [13]He M M,Wang F,Jin Y,et al.Phase II clinical trial of S-1 plus nanoparticle albumin-bound paclitaxel in untreated patients with metastatic gastric cancer[J].Cancer Sci,2018,109 (11):3575-3582．
• [14]Wang H Y,Yao Z H,Tang H,et al.Weekly nanoparticle albuminbound paclitaxel in combination with cisplatin versus weekly solvent-based paclitaxel plus cisplatin as first-line therapy in Chinese patients with advanced esophageal squamous cell carcinoma[J].Onco Targets Ther,2016,9:5663-5669．
• [15]Wang D Q,Zhang W C,Qian D,et al.Efficacy and safety of weekly nab-paclitaxel plus cisplatin with concurrent intensity-modulated radiotherapy in patients with inoperable,locally advanced esophageal cancer:A pilot trial[J].Oncotargets Ther,2018,11:6333-6338．
• [16]Ke L R,Xia W X,Qiu W Z,et al.A phase II trial of induction NAB-paclitaxel and cisplatin followed by concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma[J].Oral Oncol,2017,70:7-13．
• [17]吴永勇，王素玲，张雪琳，等．白蛋白结合型紫杉醇联合奥沙利铂治疗晚期胆系肿瘤的疗效观察[J]．现代肿瘤医学，2016,24(17):2737-2740．
• [18]Sahai V,Catalano P J,Zalupski M M,et al.Nab-paclitaxel and gemcitabine as first-line treatment of advanced or metastatic cholangiocarcinoma:A phase 2 clinical trial[J].JAMA Oncol,2018,4(12):1707-1712．
• [19]姬时宇，胡毅．白蛋白结合型紫杉醇治疗晚期原发性肝癌的效果观察[J]．临床肝胆病杂志，2016,32(10):1911-1915．
• [20]牛晓辉，杨勇昆，黄真，等．白蛋白结合型紫杉醇二线治疗骨肉瘤肺转移的临床观察[J]．临床肿瘤学杂志，2013,18(2):114-116．
• [21]Metts J L,Alazraki A L,Clark D,et al.Gemcitabine/nab-paclitaxel for pediatric relapsed/refractory sarcomas[J].Pediatr Blood Cancer,2018,65(9):e27246．
• [22]广东省药学会．超药品说明书用药中患者知情同意权的保护专家共识[J]．今日药学，2019,29(6):361-367.