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目的:了解贝伐珠单抗在肿瘤治疗中的临床应用现状。方法:对其院2015年1月-2016年1月期间使用过贝伐珠单抗的209例患者,897次用药情况进行回顾性分析,按原发疾病分类,参考说明书及药品信息对患者治疗情况进行统计、评价及安全性评估。结果:209例患者数据分析中显示,适应证应用基本符合中国CFDA、美国FDA审批批准的范围,说明书内适应证治疗用药比例为53.73%,超说明书用药比例为46.27%,其中包含FDA批准适应证、NCCN指南推荐及其他超说明书用药。贝伐珠单抗应用期间所出现的不良反应(ADR)基本与说明书相符。结论:贝伐珠单抗超说明书应用普遍存在,部分超说明书应用有一定的循证学依据。应加强对超说明书用药的监管规范,确保药物安全合理使用。
Objective: To understand the clinical application of bevacizumab in the treatment of cancer. Methods: 209 patients with bevacizumab in their hospital from January 2015 to January 2016 were retrospectively analyzed on 897 doses. The patients were treated according to the primary disease classification, reference manual and drug information Situation statistics, evaluation and safety assessment. Results: The data analysis of 209 patients showed that the application of indications basically met the approval of China FDA and FDA. The proportion of indications and therapeutic drugs used in the manual was 53.73% and 46.27% respectively. The FDA included indications NCCN guidelines recommend and other super instructions medication. The adverse reactions (ADRs) that occurred during the application of bevacizumab were basically consistent with the instructions. Conclusion: The application of Bevacizumab super instruction manual is ubiquitous, and some application of super instruction manual has some evidence basis. Should supervise the regulation of super manual medication, to ensure the safe and rational use of drugs.