CAJ | 학술논문

目的研究锝[99Tcm]替曲膦注射液一步法新药盒用于心肌灌注显像的效果及安全性.方法采用随机、双盲、平行、对照设计.以习用的心肌灌注显像剂99Tcm-甲氧基异丁基异腈(MIBI)为锝[99Tcm]替曲膦的对照药物.确定入选者符合标准并签署知情同意书后,进行双嘧达莫(潘生丁)负荷和静息心肌显像.观察心肌显像前后的生命体征和有无不良反应.由2位核医学科医师双盲判读心肌显像图并对图像质量作出评价.结果 100例病例人组锝[99Tcm]替曲膦心肌显像(试验)组,108例入组99Tcm-MIBI对照组.所有病例均未观察到使用心肌显像药物引起的不良反应.试验组100例均获得合格的心肌影像并足以提供诊断依据,心肌影像质量良好.与对照组相比,心肌影像质量没有明显差异.结论锝[99Tcm]替曲膦注射液标记简便,制剂稳定,心肌影像图像质量优良,且使用安全.
목적 연구득[99Tcm]체곡련주사액일보법신약합용우심기관주현상적효과급안전성.방법 채용수궤、쌍맹、평행、대조설계.이습용적심기관주현상제99Tcm-갑양기이정기이정(MIBI)위득[99Tcm]체곡련적대조약물.학정입선자부합표준병첨서지정동의서후,진행쌍밀체막(반생정)부하화정식심기현상.관찰심기현상전후적생명체정화유무불량반응.유2위핵의학과의사쌍맹판독심기현상도병대도상질량작출평개.결과 100례병례인조득[99Tcm]체곡련심기현상(시험)조,108례입조99Tcm-MIBI대조조.소유병례균미관찰도사용심기현상약물인기적불량반응.시험조100례균획득합격적심기영상병족이제공진단의거,심기영상질량량호.여대조조상비,심기영상질량몰유명현차이.결론 득[99Tcm]체곡련주사액표기간편,제제은정,심기영상도상질량우량,차사용안전.
Objective A new myocardial perfusion imaging kit, 99Tcm-bis [bis (2-ethoxyethyl) phosphinol] ethane (tetrofosmin) was produced by Jiangsu Institute of Nuclear Medicine. The purpose of this study was to evaluate the safety and efficiency of this drug. Methods It was a random, double-blind, parallelism, and control experiment. After registration consent forms finished by the patients, stress (dipyridamole) and rest myocardial perfusion imaging were performed. The physical signs, including blood pressure, heart rate, rhythm of the heart, and breath before and after intravenous injection were be monitored within 4h. If any patient experienced to have any discomfort or any unfavourable sign, he (or she) would be sent to emergency room for further evaluation and (or) treatment. Results Totally 208 patients with coronary artery disease entered. Of the 208 volunteers, 100 belonged to study group (with the 99Tcm-tetrofosmin that was produced by Jiangsu Institute of Nuclear Medicine) and 108 belonged to control group [with the 99Tcm-methoxyisobutylisonitrile (MIBI) that was not produced by Jiangsu Institute of Nuclear Medicine]. No adverse event was noted among these 208 patients. Moreover, no statistical difference between diagnostic accuracy was noted in these two groups, or in imaging quality. Conclusion The phase IV clinical trial demonstrated that this new myocardial perfusion imaging kit was safe and had a comparable quality as compared with other commercial products.