今日药学

2021, v.31(11) 815-820

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我院贝伐珠单抗超说明书用药循证评价
Evidence-based Evaluation of Off-label Use of Bevacizumab in A Cancer Center

韩笑;梁蔚婷;陈卓佳;黄红兵;刘韬;
HAN Xiao;LIANG Weiting;CHEN Zhuojia;HUANG Hongbing;LIU Tao;School of Pharmaceutical Sciences,Sun Yat-sen University;Department of Pharmacy,Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine;

摘要(Abstract):

目的对我院贝伐珠单抗超说明书用药进行循证评价,为临床应用提供依据和参考。方法统计2020年1月1日~12月31日我院贝伐珠单抗医嘱,引用Thomson系统对超说明书用药的收录结果,无结果可引用的情况则检索相关临床研究后,使用GRADE方法评价超说明书用药循证证据的质量等级。结果我院贝伐珠单抗超说明书用药主要有卵巢癌、乳腺癌、宫颈癌、肝癌、肾癌、恶性胸膜间皮瘤、腹膜癌、输卵管癌、恶性黑色素瘤、淋巴瘤和软组织肉瘤。Thomson系统已收录的瘤种为卵巢癌、乳腺癌、宫颈癌、肝癌、肾癌、恶性胸膜间皮瘤、腹膜癌和输卵管癌;未收录的瘤种为恶性黑色素瘤、淋巴瘤和软组织肉瘤,使用GRADE方法评价证据质量,评价结果均为低等级。结论贝伐珠单抗用于特定情况下的卵巢癌、乳腺癌、宫颈癌、肝癌、肾癌、恶性胸膜间皮瘤、腹膜癌和输卵管癌具有一定的合理性;用于晚期恶性黑色素瘤、淋巴瘤和软组织肉瘤仍缺乏高质量循证证据,需谨慎用药。
OBJECTIVE To investigate and evaluate clinical drug off-label application of bevacizumab in a cancer center, for providing basis and reference for clinical application. METHODS The tumors patients used bevacizumab in the cancer center from January 1,2020 to December 31,2020 were counted.List of off-label drug were analyzed and evaluated the situation and reasonability of off-label applications according to the Thomson system and no in list but having relevant clinical studies were analyzed and evaluated according to the GRADE method. RESULTS The off-label application of bevacizumab in the cancer center mainly included ovarian cancer, breast cancer, cervical cancer, liver cancer, kidney cancer, malignant pleural mesothelioma, primary peritoneal cancer, fallopian tube cancer, malignant melanoma, lymphoma and soft tissue sarcoma.Thomson system recommended for ovarian cancer, breast cancer, cervical cancer, liver cancer, kidney cancer, malignant pleural mesothelioma, primary peritoneal cancer and fallopian tube cancer.Advanced melanoma, lymphoma, and soft tissue sarcoma were not recommended by Thomson system.The result of GRADE method showed their evidence quality and the reasonability were low. CONCLUSION Bevacizumab is reasonable for ovarian cancer, breast cancer, cervical cancer, liver cancer, kidney cancer, malignant pleural mesothelioma, primary peritoneal cancer and fallopian tube cancer, but for dvanced melanoma, lymphoma, and soft tissue sarcoma still lacking high-quality evidence.It should be used with caution.

关键词(KeyWords): 贝伐珠单抗;超适应证;循证医学;用药评价
bevacizumab;off-label use;evidence-based medicine;drug evaluation

Abstract:

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基金项目(Foundation): 吴阶平医学基金会临床科研专项资助基金(320.6750.2020-10-91)

作者(Author): 韩笑;梁蔚婷;陈卓佳;黄红兵;刘韬;
HAN Xiao;LIANG Weiting;CHEN Zhuojia;HUANG Hongbing;LIU Tao;School of Pharmaceutical Sciences,Sun Yat-sen University;Department of Pharmacy,Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine;

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