国产全自动多叶光栅临床验证研究  

The clinical validation study of domestic automatic multi-leaf grating

作　　者：李德志[1] 陈正堂[1] 周一兵[1] 万久庆[1] 蒲萍[1] 郝萍[1] 王卫东[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：《重庆医学》2007年第19期1960-1962,共3页Chongqing medicine

摘　　要：目的临床验证成都海泰医疗设备有限公司研制的全自动多叶光栅(AC-MLC 2000B)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。方法把AC-MLC 2000B全自动多叶光栅外挂于医用直线加速器机头,与本研究所的治疗计划系统连接,用于肿瘤患者的适形放射治疗。选取鼻咽癌和肺癌自愿受试患者共30例进行放射治疗,与同期30例未使用多叶光栅的患者对照,按国家临床试验标准实施多项目检查,根据WHO评价方法评价治疗效果和急性放射性反应。结果全自动多叶光栅(AC-MLC 2000B)的各项技术指标检测结果符合国家食品药品管理局批准的相关标准(国51-32- 2004),30例患者治疗后发生急性放射反应情况和常规放疗中放射反应结果基本一致,差异无统计学意义。与常规放疗比较,近期疗效稍好,差异无统计学意义。结论该设备用于肿瘤患者适形放射治疗的精确性、有效性和安全性,均符合国家相关标准和临床要求。全自动多叶光栅(AC-MLC 2000B)可用于临床。Objective To study the Automatic multi-leaf grating （AC-MLC 2000B） various technical indicators produced by Chengdu Limited Haitai medical equipment,and the relevant state control standards to determine its clinical accuracy, effectiveness and safety. Methods AC-MLC 2000B automatic multi-leaf grating pylon in the LINAC nose, was linked with treatment planning system for cancer patients conformal radiation therapy. 30 cases lung cancer and nasopharyngeal cancer patients voluntarily tested by radiation treatment,with the same period in 30 cases did not use the multi-leaf grating control patients,according to national standards for clinical trial implementation of the multi item inspection, According to the WHO evaluation method, by the therapeutic effect and the acute radiation reaction was evaluated. Results Automatic multi-leaf grating （AC-2000B MLC） of the technical indicators results in line with the national standards 30 patients after treatment of acute radiation response and conventional radiotherapy radiation reaction basically the same results. No significant differences were found. Compared with conventional radiotherapy, the effect was somewhat better recently,no significant differences were found. Conclusion The equipment used for cancer patients conformal radiation therapy accuracy,effectiveness and safety are in line with national standards and clinical requirements. Automatic multi-leaf grating （AC-2000B MLC） can be used for clinical.

关 键 词：国产全自动多叶光栅 放射治疗 鼻咽癌 肺癌 

分 类 号：R730.5[医药卫生—肿瘤]