国产甲磺酸多沙唑嗪Ⅰ期临床耐受性试验

Tolerance Observation of Domestic Doxazosin in Chinese

目的:评价国产多沙唑嗪片剂口服的耐受性,为临床应用的剂量范围提供依据。方法:24例健康成年人,随机分为五组,分别单次口服1mg、2mg、4mg、6mg或8mg多沙唑嗪片,观察服药前、服药后2、4、6、8、10和24小时的坐、卧、立位血压、心率变化及不良反应,服药前及服药后24小时化验血、尿常规及肝肾功能、心电图。结果:多沙唑嗪2～8mg口服均有明显降压作用。体位性低血压是其主要不良反应,总发生率达70.83％,伴随头晕、恶心、心悸、耳鸣等不适,发生率与用药剂量明显正相关。6mg组发生晕厥1例,平卧后意识立即恢复,无后遗症状。其他不良反应有头痛和鼻塞,均轻微。在试验剂量范围内对肝肾功能无明显影响,血WBC有轻度降低。结论:多沙唑嗪口服推荐2～4mg,每日1次。首次服药注意体位性低血压发生。

Objective: To investigate the tolerance ol doxazosin in Chinese and find the proper dosage in clinics. Methods: Twen-ty- four healthy adults were enrolled in and divided into 5 groups randomly,They were given 1mg, 2mg, 4mg, 6mg or 8mg doxa-zosia once respectively. Before and after dose, the BP, HR, respiratory rate, side effects were observed and laboratory -tests were performed. Result: Significant BP lowering effect was observed in 2 to 8 mg groups, espicically diastolic BP. The reduction of BP was proportionated to dosage and time positively. Postual hypotension and its complicated symptoms, such as dazziness, palpitation, tinnitus and naasea were the most common side effects, A person in 6mg group suffered syncope when standing at the time 4 hours, postdose and revived immediately when lying down. There was no difference in electrolytes, liver and renal junction, glucose aad lipids before and after treatment.(P > 0.05) . The mean value of WBC decreased from (6.14±1.21) (109/L) to(5.21±1.08) (109/L), P < 0.01. Conclusion: Doxazosin can be tolerated by a majority of Chinese people in 2 to 4mg once daily, Pay attention to positive hypotension when doxazosin was used at first.