摘要
目的:了解我院尼妥珠单抗的临床应用现状、疗效及不良反应。方法:收集我院2009年2月-2010年2月107例应用尼妥珠单抗患者的临床资料,分析其诊断与药品说明书适应证的相符性,评价其疗效和用药安全性。结果:与药品说明书适应证范围的相符率为69.2%,符合国内、外文献资料提供的参考适应证为12.2%,有18.7%用于"说明书适应证、国内外指南及文献推荐"之外的用法。结论:尼妥珠单抗总体不良反应较轻,与放疗合用可使临床获益。该药超说明书适应证范围应用现象较普遍,符合循证药学、伦理学精神,但违背法学规范,应加强药学监护。
OBJECTIVE： To investigate the application, therapeutic efficacy and adverse drug reaction of nimotuzumab in our hospital. METHODS： Clinical information of patients who were treated with nimotuzumab was collected from our hospital during Feb. 2009-Feb. 2010. The clinical diagnosis and the conformance of drug use to package inserts were analyzed. The therapeutic efficacy and safety of drug use were evaluated. RESULTS： The conformance rate of drug use to the indications of package inserts was 69.2%, and the conformance rate of drug use to indications stated in foreign literatures was 12.2%. 18.7% of nimotuzumab use was beyond indications of package insert and domestic and foreign literatures. CONCLUSION： Nimotuzumab combined with radiotherapy is helpful for clinical treatment with mild adverse drug reactions. The application of nimotuzumab beyond the indications of package inserts is widespread, which is up to evidence-base medicine and the spirit of ethics, but not fit to legal norms. Thus, pharmaceutical care needs to be strengthened.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第22期2039-2041,共3页
China Pharmacy
关键词
尼妥珠单抗
临床应用
分析
Nimotuzumab
Clinical application
Analysis
