贝伐珠单抗应用分析与合理性评价

发布时间：2019-04-03 05:43

【摘要】：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。
[Abstract]:Objective: to investigate the clinical application of bevacizumab in the treatment of tumor. Methods: from January 2015 to January 2016, 209 patients who had used bevacizumab during the period from January 2015 to January 2016 were analyzed retrospectively. According to the classification of primary diseases, reference instructions and drug information, the treatment situation of the patients was statistically analyzed. Evaluation and safety assessment. Results: according to the data analysis of 209 patients, the application of adaptation card was basically in accordance with the scope of approval and approval of Chinese CFDA, American FDA. The proportion of indications used in the manual was 53.73%, and the proportion of super manual drug use was 46.27%. These include FDA approval indications, NCCN guidelines and other ultra-prescriptive medications. The adverse reaction (ADR) occurred during the application of bevacizumab was basically in accordance with the specification. Conclusion: the application of bevacizumab in the application of ultra-specification is universal, and some of the application of ultra-specification has some evidence of syndrome. Supervision and regulation should be strengthened to ensure safe and reasonable use of drugs.
【作者单位】：中国医科大学肿瘤医院辽宁省肿瘤医院药学部;中国医科大学药学院药剂教研室;
【分类号】：R979.1

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