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| 基于真实世界的安罗替尼临床应用及安全性分析 |
| Investigation on the Use and Safety of Anlotinib Based on Real World Study |
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| DOI： |
| 中文关键词: 安罗替尼 真实世界研究 安全性评价 药品不良反应 |
| 英文关键词:Anlotinib Real world study Safety evaluation Adverse drug reaction |
| 基金项目: |
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| 摘要点击次数: 823 |
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| 中文摘要: |
| 摘 要 目的：观察安罗替尼在真实世界中的临床应用情况及安全性。方法：采用集中监测方法，从某市级肿瘤专科医院收集2018年7～12月使用安罗替尼的患者30例，对其基本情况、诊断、用药信息等临床应用情况和安全性等进行统计分析。结果：安罗替尼在实际临床使用中存在超适应证、联用其他抗肿瘤药物等超说明书使用的情况。本研究的总不良反应（ADR）发生率为73.3%，发生率前3位的ADR分别为高血压、血小板计数降低和呕吐，严重程度≥3级的ADR共3例，分别为中性粒细胞绝对值下降、口腔黏膜炎和咯血。结论：初步观察安罗替尼上市后发生的ADR与Ⅲ期临床试验结果相似，应进一步把握使用指征，同时注意与现有治疗方案的平衡。 |
| 英文摘要: |
| ABSTRACT Objective:To observe the use and safety of anlotinib in real world. Methods:30 inpatients using anlotinib capsules from July to December 2018 in a cancer hospital were observed. The data of patients’ characteristics, main diagnosis, medication and safety were collected and analyzed. Results: Off label use of anlotinib including unapproved indications and combinations with other antineoplastic agents was common. The overall incidence of adverse drug reaction(ADR) in this study was 73.3%, mainly hypertension, thrombocytopenia and vomiting. Severe ADR included neutropenia, mucotitis and hemoptysis. Conclusion: ADR of anlotinib observed in our study is similar to the result of phase Ⅲ clinical trials, and more consideration and caution should be required in the indications and usage of it. |
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