国产99Tcm-双半胱氨酸注射液多中心临床试验
국산99Tcm-쌍반광안산주사액다중심림상시험
Multi-centric clinical study of 99Tcm-ethylenedicysteine
  • 万方数据
    中华核医学杂志 중화핵의학잡지
    CHINESE JOURNAL OF NUCLEAR MEDICINE
    2008年 5期 323-324 ,共2页

    陈绍亮%陈雪芬%李蓓蕾%虞燕华%罗世能%陈志明%刘兴党%朱汇庆%李方%龙旺清%马庆杰%朱兆荣%张云%唐安戊%李东江%韩燕%吉志明%陈雪红%王正江%陈建辉%常金利%刘增礼%杨仪%万卫星%尤徐阳%梁昌华%李新辉%胡平%吴翼伟%桑士标

    진소량%진설분%리배뢰%우연화%라세능%진지명%류흥당%주회경%리방%룡왕청%마경걸%주조영%장운%당안무%리동강%한연%길지명%진설홍%왕정강%진건휘%상금리%류증례%양의%만위성%우서양%량창화%리신휘%호평%오익위%상사표

    半胱氨酸%锝%临床试验%多中心研究 半胱氨痠%锝%臨床試驗%多中心研究
    반광안산%득%림상시험%다중심연구
    Cysteine desulfthydrase%Technetium%Clinical trials%Multicenter studies
    目的 在扩大临床应用基础上,考察国产99Tcm-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99Tcm-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99Tcm-EC药盒用作肾动态功能显像剂质量优良、使用安全.
    목적 재확대림상응용기출상,고찰국산99Tcm-쌍반광안산(EC)주사액적유효성、안전성화불량반응.방법 전국8개성、시적14가의원삼가료해차림상다중심시험.분석11비차약합적328례99Tcm-EC신동태현상결과,병진행약물질량공제지표、도상질량화약물안전성평개.결과 11비약합표기후방화순균>90%.각항약물질량공제지표균부합요구.현상질량체도림상요구,신영현시교호,도상청석,현상성공솔체100%.시험과정중각연구중심환자균무불량사건발생.결론 국산99Tcm-EC약합용작신동태공능현상제질량우량、사용안전.
    Objective 99Tcm-ethylenedicysteine (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 99Tcm-EC in a large number of patients with various renal disorders. Methods Fourteen Chinese hospitals had participated in this multi-center clinical triM. The 99TcmEC kits from eleven production batches were used. Three hundred and twenty-eight patients were entered into the study. Patients were intravenously injected with 99Tcm-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 99Tcm-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 99Tcm-EC is a potentially useful radiopharmaceutical in dynamic renal functional studies.
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