摘要
目的:分析中国首台碳离子治疗系统用于肿瘤患者放疗的临床不良事件。方法:回顾性分析甘肃省药物警戒中心获取的相关单位临床试验监测数据,对2018年11月—2019年2月于甘肃省武威肿瘤医院参与临床试验、接受碳离子治疗的46例肿瘤患者的人口学特征、放疗技术、照射部位和剂量参数、放疗术后随访及不良事件发生信息进行描述性研究。采用频数和百分比描述分析不同分组下的肿瘤患者碳离子治疗后不良事件发生情况。根据治疗剂量和分割方式对接受放疗的受试者进行分组分析。结果:46例放疗患者中位年龄为47岁,男女比例为30∶16,头颈部、胸部、腹部、盆腔及四肢脊柱肿瘤患者分别为15、5、8、9、9例。放疗总时长为2~4周,总次数10~16次。不良事件共发生45例(98%)246例次,未发生重度不良事件。与碳离子器械肯定相关的不良事件占19.1%,未发生与器械相关的严重不良事件。按照常见不良反应事件评价标准(CTCAE),主要为CTCAE 2级及以下不良反应,其中仅1例(2%)头颈部肿瘤患者(鼻咽恶性肿瘤)发生CTCAE 3级不良反应。43例(93%)患者发生急性不良反应,主要涉及皮肤、黏膜、眼、耳、咽和食管、上消化道、下消化道(包括盆腔)、肺、生殖泌尿道、心脏、中枢神经系统、血液学(白细胞、血小板及中性粒细胞)等部位。结论:使用中国首台碳离子治疗系统治疗后,患者的不良反应主要为CTCAE 2级及以下,其临床不良事件轻微可控。
Objective To analyze the clinical adverse events of the first carbon ion therapy system in radiotherapy for cancer patients in China.Methods A retrospective analysis was conducted on the clinical trial monitoring data of the carbon ion therapy system obtained by the Pharmacovigilance Center of Gansu Province.A descriptive study was conducted on the demographic characteristics,radiotherapy techniques,irradiation site and dose parameters,postoperative follow-up,and adverse event information of 46 tumor patients who received carbon ion therapy and participated in the clinical trial in Wuwei Cancer Hospital,Gansu Province from November 2018 to February 2019.Frequency and percentage were used to describe and analyze the occurrence of adverse events after carbon ion therapy for cancer patients in different groups.All subjects who received radiotherapy were grouped according to the treatment dose and fractionation method.Results The median age of the 46 patients was 47 years old,and the male to female ratio was 30:16.There were 15,5,8,9,and 9 patients with head and neck,chest,abdomen,pelvic cavity,and limb spinal tumors,respectively.The total duration of radiotherapy was 2-4 weeks for 10-16 times.There were 246 adverse events in 45 cases,with an incidence of 98%.No severe adverse events occurred.The adverse events definitely related to carbon ion devices accounted for 19.1%,and no severe adverse events related to carbon ion devices occurred.According to the evaluation criteria of common terminology criteria for adverse events(CTCAE),the main adverse events were CTCAE grade 2 and below,with only 1(2%)head and neck tumor patient(nasopharyngeal malignant tumor)experienced CTCAE grade 3 adverse events after treatment.In addition,43 patients developed acute adverse reactions,with an incidence of 93%,mainly involving the skin,mucosa,eyes,ears,pharynx and esophagus,upper gastrointestinal tract,lower gastrointestinal tract(including pelvic cavity),lung,genitourinary tract,heart,central nervous system and hematology(white blood
作者
强晓婷
张丽
王雪
祁英
杜晓月
刘蓉
马宵云
刘宇琴
杨亚娟
刘双慧
郑山
Qiang Xiaoting;Zhang Li;Wang Xue;Qi Ying;Du Xiaoyue;Liu Rong;Ma Xiaoyun;Liu Yuqin;Yang Yajuan;Liu Shuanghui;Zheng Shan(Pharmacovigilance Center of Gansu Province,Lanzhou 730070,China;School of Public Health,Lanzhou University,Lanzhou 730000,China;Heavy ion Therapy Center,Wuwei Cancer Hospital,Gansu Province,Wuwei730000,China)
出处
《中华放射肿瘤学杂志》
CSCD
北大核心
2023年第10期907-913,共7页
Chinese Journal of Radiation Oncology
关键词
放射疗法
碳离子
肿瘤
不良事件
Radiotherapy
Carbon ion
Neoplasms
Adverseevents
