内镜定位标记液用于内镜下病变标记的有效性和安全性临床研究  

Efficacy and safety of endoscopic marking with SPOT for gastrointestinal lesions

作　　者：王佳旭 武珊珊 王文海 李荣雪 赵宇 周卫真[2] 王艳[2] 孙秀静 李鹏 郝建宇[2] 张澍田 Wang Jiaxu;Wu Shanshan;Wang Wenhai;Li Rongxue;Zhao Yu;Zhou Weizhen;Wang Yan;Sun Xiujing;Li Peng;Hao Jianyu;Zhang Shutian(Department of Gastroenterology,Beijing Friendship Hospital,Capital Medical University,National Clinical Research Center for Digestive Diseases,Beijing Digestive Disease Center,Faculty of Gastroenterology of Capital Medical University,Beijing Key Laboratory for Precancerous Lesions of Digestive Diseases,Beijing 100050,China;Department of Gastroenterology,Beijing Chao-Yang Hospital,Capital Medical University,Beijing 100020,China)

机构地区：[1]首都医科大学附属北京友谊医院消化内科,国家消化系统疾病临床医学研究中心,北京市消化疾病中心,首都医科大学消化病学系,消化疾病癌前病变北京市重点实验室,北京100050 [2]首都医科大学附属北京朝阳医院消化内科,北京100020

出　　处：《中华消化内镜杂志》2022年第9期701-706,共6页Chinese Journal of Digestive Endoscopy

基　　金：北京市科技计划(Z191100006619082)。

摘　　要：目的验证一种含炭定位标记液(SPOT)临床应用于内镜下病变标记的有效性和安全性。方法前瞻性纳入2019年4月—2019年11月期间在首都医科大学附属北京友谊医院和首都医科大学附属北京朝阳医院确诊胃肠道病变需行内镜治疗或外科手术的115例患者,内镜检查时应用SPOT标记病灶,内镜治疗或外科手术时寻找标记点。采用单组目标值法计算产品标记有效率。观察标记后有无不良事件发生,比较标记前后患者血常规和肝肾功能等变化情况。结果受试者SPOT标记的有效率为99.13%(114/115),标记维持时间可达57 d,标记过程中无穿刺肠壁或注射到腹腔情况。标记后,仅1例患者出现轻度发热,不良事件发生率为23.48%(27/115),均与试验器械无关。标记前后患者血常规和肝肾功能检查差异均无统计学意义(P>0.05)。结论SPOT内镜定位标记液对胃肠道病灶能有效、安全地进行染色标记,无严重不良事件发生,可满足临床使用要求。Objective To evaluate the efficacy and safety of SPOT(GI Supply,USA),a new carbon-based permanent marker approved by the Food and Drug Administration(FDA),in the endoscopic marking for gastrointestinal lesions.Methods A total of 115 patients with gastrointestinal lesions who underwent endoscopic treatment or surgery in Beijing Friendship Hospital or Beijing Chao-Yang Hospital from April 2019 to November 2019 were enrolled in the study.SPOT was used to mark the lesions,and marking points were found during endoscopic treatment or surgery to calculate the effective marking rate by single-group target value method.Adverse events after marking were recorded,and the changes of blood routine test,liver and kidney functions before and after marking were compared.Results The effective rate of endoscopic marking with SPOT was 99.13%(114/115).The longest marking time was 57 days.There was no puncture of intestinal wall or injection into abdominal cavity during the marking process.One patient developed mild fever after marking.The incidence of adverse events was 23.48%(27/115),which were all unrelated to the test equipment.There was no significant difference in blood routine tests or liver and kidney functions before and after marking(P>0.05).Conclusion SPOT produced by GI Supply can effectively mark gastrointestinal lesions without serious adverse events,which meets the requirements of clinical use.

关 键 词：染色与标记 定位 内窥镜检查 胃肠道 有效性 安全性 

分 类 号：R57[医药卫生—消化系统]