[Translation] Using adenosine injection (90mg/30mL) as a control to evaluate the randomized, crossover, multicenter phase IIIb clinical application of higenamine hydrochloride injection (2ml: 2.5mg) in the diagnosis of coronary heart disease by radionuclide myocardial perfusion imaging test
将盐酸去甲乌药碱注射液及腺苷注射液作为心脏负荷药物用于核素心肌灌注显像诊断冠心病的结果,分别与冠状动脉造影(金标准)的结果相比较,计算盐酸去甲乌药碱注射液与腺苷注射液诊断冠心病的敏感性,并基于敏感性评估盐酸去甲乌药碱注射液与腺苷注射液的非劣效关系,最终为药物注册申请提供充分的依据。
[Translation] The results of using higenamine hydrochloride injection and adenosine injection as cardiac stress drugs in the diagnosis of coronary heart disease by radionuclide myocardial perfusion imaging were compared with the results of coronary angiography (gold standard), respectively, and the results of norhydrochloride hydrochloride were calculated. The sensitivity of higenamine injection and adenosine injection in the diagnosis of coronary heart disease, and the non-inferiority relationship between higenamine hydrochloride injection and adenosine injection was evaluated based on the sensitivity, and finally provided sufficient basis for drug registration application .