国产锝[^99Tc^m]替曲膦注射液临床验证研究

Phase Ⅳ clinical trial of ^99Tc^m-tetrofosmin injection ： safety and efficiency for myocardial perfusion imaging

目的研究锝[^99Tc^m]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^99Tc^m-甲氧基异丁基异腈（MIBI）为锝[^99Tc^m]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[^99Tc^m]替曲膦心肌显像（试验）组，108例人组^99Tc^m-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[^99Tc^m]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。

Objective A new myocardial perfusion imaging kit, ^99Tc^m-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 4 h. 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 ^99Tc^m-tetrofosmin that was produced by Jiangsu Institute of Nuclear Medicine） and 108 belonged to control group [ with the ^99Tc^m-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.