国产AccStar医用直线加速器的临床验证  

The clinical test of domestic linear accelerator AccStar

作　　者：孙建国[1] 陈正堂[1] 周一兵[1] 李德志[1] 李光辉[1] 李启明[1] 蒲萍[1] 张豫萍[1] 万久庆[1] 

机构地区：[1]第三军医大学新桥医院全军肿瘤研究所,重庆400037

出　　处：《中华放射医学与防护杂志》2013年第4期409-412,共4页Chinese Journal of Radiological Medicine and Protection

基　　金：国家自然科学基金（81272496）

摘　　要：目的 临床验证国产医用直线加速器（AccStar）的各项技术指标,与国家相关标准对照确定其临床应用的精确性、有效性和安全性.方法 选取鼻咽癌和肺癌自愿受试患者,使用AccStar医用直线加速器对患者进行适形放射治疗,按国家临床试验标准实施多项目检查,依据RECIST标准和RTOG标准分别进行放射治疗临床疗效和急性放射反应的评价,按照IEC/TR60977国际标准以及GB/T 19046和GBZ126-2002等国家标准规定,对该加速器的机械、电气、辐射和几何性能参数进行质量检测与校正.结果 共入组43例,其中鼻咽癌患者21例,非小细胞肺癌患者22例,全部完成临床治疗和辅助检查,总体疾病控制率达到100％,放射反应均能耐受,多为皮肤反应和口腔黏膜反应,经对症处理后改善；临床试验前、中、后期各阶段,检测AccStar医用直线加速器的物理技术参数及设备性能等各项技术指标,均符合上述标准.结论 AccStar医用直线加速器放射治疗的精确性、有效性和安全性均符合国家相关标准和临床要求,可应用于临床.Objective To clinically validate the technical parameters of domestic linear accelerator AccStar,and to assess its accuracy,efficiency and safety in clinical application based on the relevant national standards.Methods Volunteers who suffered nasopharyngeal carcinoma and lung cancer were selected to accept conformal radiation therapy using AccStar medical linear accelerator.A variety of tests were conducted based on the national standards for clinical trials.The clinical efficacy of the radiation therapy was assessed based on the RECIST standard.Acute radiation response was evaluated based on the RTOG standards,and the mechanical and the geometric properties of the accelerator were tested and corrected based on the international standards of IEC and the national standards.Results Forty-three cases were included,of which there were 21 patients with nasopharyngeal carcinoma,and 22 with non small cell lung cancer.All of them received the clinical treatment and auxiliary examination.The overall disease control rate reached 100% and the patients could tolerate the radiation reactions,most of which were skin and oral mucosa reactions.During the clinical trials,all the technical parameters were tested,including the physical parameters and performance parameters,could meet the standards mentioned above.Conclusions The accuracy,efficiency and safety of AccStar meet the relevant national standards and the clinical requirements,so that it can be applied to clinical setting.

关 键 词：国产医用直线加速器 放射治疗 鼻咽癌 肺癌 

分 类 号：R730[医药卫生—肿瘤]