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中药复方新制剂——活心丹治疗缺血性心脏病疗效评价,按全国临床药理会议新药临床评价意见,在第一期临床试验中,选择30例缺血性心脏病者以硝酸甘油作对照,观察活心丹的临床药理作用、毒副反应、药物开始作用及持续时间,从而获得安全有效剂量、合理给药方案及适应症,在第二、三期扩大临床试验中,有北京、南京、抚顺、广东等17个医疗单位参加,三期试验共观察了309例,总结如下: 一、一般资料
In the first phase of clinical trial, 30 patients with ischemic heart disease were selected as controls according to the clinical evaluation opinion of new drug of National Clinical Pharmacology meeting. , To observe the clinical pharmacological effects of live heart Dan, side effects, drug onset and duration, to obtain safe and effective dose, reasonable dosing regimens and indications, in the second and third phase of expanded clinical trials, Beijing, Nanjing , Fushun, Guangdong and other 17 medical units to participate in the three phase of the trial were observed in 309 cases, summarized as follows: First, the general information