国产^99Tc^m-双半胱氨酸注射液多中心临床试验  

Multi-centric clinical study of ^99Tc^m-ethylenedicysteine

作　　者：陈绍亮[1] 陈雪芬[1] 李蓓蕾[1] 虞燕华[2] 罗世能[2] 陈志明[2] 刘兴党[3] 朱汇庆[3] 李方[4] 龙旺清[4] 马庆杰[5] 朱兆荣[6,7] 张云[6,7] 唐安戊[8] 李东江[8] 韩燕[9] 吉志明[9] 陈雪红[10] 王正江[10] 陈建辉[11] 常金利[11] 刘增礼[12] 杨仪[12] 万卫星[13,14] 尤徐阳[13,14] 梁昌华[15] 李新辉[15] 胡平[16] 吴翼伟[17] 桑士标[17] 

机构地区：[1]复旦大学核医学研究所、复旦大学附属中山医院核医学科,上海200032 [2]江苏省原子医学研究所 [3]复旦大学附属华山医院核医学科 [4]中国医学科学院、中国协和医科大学北京协和医院核医学科 [5]吉林大学第三医院核医学科 [6]苏州大学附属第三医院 [7]常州市第一人民医院核医学科 [8]广东省人民医院核医学科 [9]海南农垦总局医院核医学科 [10]兰州医学院附属第二医院核医学科 [11]南华大学附属第一医院核医学科 [12]苏州大学附属第二医院核医学科 [13]苏州大学附属第四医院 [14]无锡市第四人民医院核医学科 [15]中南大学湘雅医院核医学科 [16]中山大学附属第一医院核医学科 [17]苏州大学附属第一医院核医学科

出　　处：《中华核医学杂志》2008年第5期323-324,共2页Chinese Journal of Nuclear Medicine

摘　　要：目的在扩大临床应用基础上，考察国产^99Tc^m-双半胱氨酸（Ec）注射液的有效性、安全性和不良反应。方法全国8个省、市的14家医院参加了该次临床多中心试验。分析11批次药盒的328例^99Tc^m-EC肾动态显像结果，并进行药物质量控制指标、图像质量和药物安全性评价。结果11批药盒标记后放化纯均〉90％。各项药物质量控制指标均符合要求。显像质量达到临床要求，肾影显示较好，图像清晰，显像成功率达100％。试验过程中各研究中心患者均无不良事件发生。结论国产^99Tc^m-药盒用作肾动态功能显像剂质量优良、使用安全。Objective ^99Tc^m-ethylenedieysteine （EC） is a new radiopharmaceutical for renal dynamic imaging produced by Jiangsu Institute of Nuclear Medicine,China. The aim of this phase Ⅳ clinical trial was to evaluate the efficacy and safety of ^99Tc^m-EC in a large number of patients with various renal disorders. Methods Fourteen Chinese hospitals had participated in this multi-center clinical trial. The ^99Tc^m- EC kits from eleven production batches were used. Three hundred and twenty-eight patients were entered into the study. Patients were intravenously injected with ^99Tc^m-EC and a series of dynamic renal imaging was acquired in each patient. The quality of kits and images was analyzed. Possible adverse events were observed and recorded. Results All quality control parameters of the radiopharmaceutical kits were up to the standard requirement. The radiochemical purity of ^99Tc^m-EC in all production batches exceeded 90%. All functioning kidneys were clearly visualized and high-quality renograms were obtained in all 328 patients. No adverse events were recorded during or after the examination process. Conclusion ^99Tc^m-EC is a potentially useful radiopharmaceutical in dynamic renal functional studies.

关 键 词：半胱氨酸 锝 临床试验 多中心研究 

分 类 号：R686[医药卫生—骨科学]