今日药学

2013, v.23(10) 667-671+674

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贝伐珠单抗超说明书适应症用药情况调研
Investigation of Off-Label Application on Indication of Bevacizumab

刘韬;陈富钦;黄雪玲;林子超;黄红兵;
LIU Tao;CHEN Fu-qin;HUANG Xue-ling;LIN Zi-chao;HUANG Hong-bing;State Key Laboratory of Oncology in South China,Department of Pharmacy,Sun Yat-sen University Cancer Center;

摘要(Abstract):

目的对本院贝伐珠单抗超说明书适应症用药情况进行调研。方法调查2010-10~2012-10使用了贝伐珠单抗的375份病例,依据食品药品监督管理局(SFDA)颁布的药品说明书、美国FDA批准的适应症以及NCCN临床实践指南推荐的适应症对贝伐珠单抗超说明书适应症用药情况进行分析。结果贝伐珠单抗超说明书适应症用药现象普遍存在,375例病例中,用于说明书内适应症转移性结直肠癌的有130例,占34.67%;用于肺癌、肝癌、淋巴瘤、软组织肉瘤、乳腺癌、卵巢癌、鼻咽癌、黑色素瘤、胃癌、胰腺癌及其他原发灶不明的恶性肿瘤等说明书外适应症的有245例,占65.33%;其中,非小细胞肺癌、卵巢癌、软组织肉瘤、乳腺癌是FDA和NCCN批准和推荐的适应症,而其他病种目前仍处于Ⅱ期或Ⅲ期临床试验中,尚未有权威的指南推荐使用。结论国家相关管理部门应加快针对超说明书用药的法规建设,各级学会和医疗机构应建立可具操作性的专家共识和管理规范,以便从法律法规、技术指导、管理流程等各个环节确保超说明书适应症用药安全可控。
Objective To investigate the off-label application on indication of bevacizumab in the hospital and evaluate its rationality,so as to provide reference for clinical rational drug application. Methods A total of 375 cancer patients using bevacizumab in the hospital from Oct. 2010 to Oct. 2012 were analyzed retrospectively according to drug directions from SFDA,FDA and the NCCN guideline. Results The off-label application on indication of bevacizumab existed widely. Of the total 375 cases,130( 34. 67%) cases were used for metastatic colorectal cancer( mCRC) according to the drug directions approved by SFDA,and 245( 65. 33%) cases were used for lung cancer,hepatocellular carcinoma,lymphoma,soft-tissue sarcoma,breast cancer,ovarian cancer,nasopharyngeal carcinoma,melanoma,gastric carcinoma,pancreatic cancer and other unknown primary malignant tumor. Among these indications which were off-label uses,nonsmall-cell lung cancer( NSCLC),breast cancer,ovarian cancer and soft-tissue sarcoma were recommended by FDA and NCCN,and others are tested by phase Ⅰ,Ⅱ or Ⅲ clinical trial now. Conclusion It is necessary to establish the laws,common view and regulations about off-label uses so as to achieve safe and effective drug use.

关键词(KeyWords): 贝伐珠单抗;超说明书用药
bevacizumab;off-label uses

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基金项目(Foundation): 广东省药学会科学研究项目基金(编号:2012ZX003)

作者(Author): 刘韬;陈富钦;黄雪玲;林子超;黄红兵;
LIU Tao;CHEN Fu-qin;HUANG Xue-ling;LIN Zi-chao;HUANG Hong-bing;State Key Laboratory of Oncology in South China,Department of Pharmacy,Sun Yat-sen University Cancer Center;

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