国产乌拉地尔注射液临床生物等效性研究

Clinical assessment of bioequivalent efficacy and safety of domestic urapidil injection

目的 :比较国产和进口乌拉地尔 (Urapidil)注射液治疗围手术期高血压病的临床疗效及安全性。 方法 :选择围手术期中、重度高血压病患者 46例 ,采用双盲法随机分为两组 ,每组均为 2 3例。两组患者分别注射 0 .5mg kg的国产 (试验组 )和进口 (对照组 )乌拉地尔 ,1min内静脉推注完毕。分别记录用药前、用药后 1、3、5、10、2 0和 30min血压、心率和不良反应。同时记录治疗前后血、尿常规和肝、肾功能等指标。 结果 :与给药前比 ,用药后 1、3、5、10、2 0和 30min两组患者收缩压和舒张压均显著降低 (P <0 .0 1) ,试验组给药后 1min收缩压明显降低 (P <0 .0 5 ) ,但组间差异不显著。患者用药前后血、尿常规和肝、肾功能未见明显差异。两种药物不良反应发生情况和发生率亦基本相同 ,组间比较差异亦不显著。 结论 :两种药物临床疗效和安全性差异不显著 ,表明国产乌拉地尔注射液是一种安全。

Objectives:To evaluate the clinical efficacy and safety of domestic Urapidil injection for peri-operative patients with middle-severe or severe hypertension. Methods:Fourty-eight peri-operative patients with hypertension were double-blindly and randomly allocated into two groups. The patients were respectively administrated with 0.5 mg/kg of domestic (group T , n=23) and imported ( group C, n=23 ) Urapidil injection. Before and after 1, 3, 5, 10, 20, 30 min of Urapidil infusion, the values of SBP and DBP and HR were recorded. Blood and urine routine examinations, hepatic and renal functions were measured. Side effects were also observed. Results: After 1, 3, 5, 10, 20, 30 min of Urapidil infusion, SBP and DBP dropped significantly (P<0.01), but there was no difference between both groups. Blood and urine routine examinations, hepatic and renal functions, were not significantly different before and after the treatment with Urapidil. Conclusions:There was no difference between domestic and imported Urapidil in efficacy and side effects. Domestic Urapidil injection is a safe, effective and tolerable antihypertension agent.