国产硫酸特布他林注射液治疗喘息的临床研究

A Multi centered Clinical Study an Domestic Intravenous Turbutalin S ulfate in the Treatment of Asthma and Chronic Asthmatic Bronchitis

目的 对国产硫酸特布他林注射液治疗支气管哮喘和慢性喘息型支气管炎的有效性与安全性进行评价。方法 分别采用国产硫酸特布他林注射液 (试验组 )和进口博利康尼注射液 (对照组 )治疗支气管哮喘和慢性喘息型支气管炎患者各 6 0例。试验药与对照药均为 0 .2 5 m g/次 ,每日 3次 ,静脉滴注给药 ,疗程 3～ 5天。结果 试验组和对照组的临床显效率分别为 6 6 .7%和 73.3% ( P>0 .0 5 ) ;总有效率分别为 98.3%和 10 0 .0 % ( P>0 .0 5 )。肺功能改善显效率分别为 78.4%和 76 .6 % ;总有效率分别为 88.3%和 90 .0 % ( P>0 .0 5 )。临床综合疗效分析显示 ,试验组与对照组的显效率均为 6 1.6 % ,( P>0 .0 5 ) ;总有效率分别为 88.3%和 90 .0 % ( P>0 .0 5 )。两组的不良反应发生率分别为 13.3%和 15 .0 % ,多为轻度 ,勿需处理及中断治疗。

Objective This multi centered clinical trial was designed to assess the effica cy and safety of domestic intravenous Turbutalin Sulfate in the treatment of ast hma and chronic asthmatic bronchitis. Methods Bricanyl was used as control. A total of 120 patients were included in this randomized controlled study. The two medicati ons, both at a dose of 0.25 mg intravenous drip, were given three times a day fo r 3 5 days.Results The two drugs' clinical excellent rates wer e 6 6.7% and 73.3%; overall efficacy rates were 98.3% and 100.0%, respectively. Thei r pulmonary functional excellent rates were 78.4% and 76.6%; overall effect rate s were 88.3% and 90.0%, respectively. Composite curative evaluation showed that t he two drug's composite excellent rates were 61.6% both; their overall efficacy rates were 88.3% and 90.0%, respectively. All of these showed no significant dif ference ( P >0.05). The incidence rates of adverse side effects of the two gro ups were 13.5% and 15.0%, respectively; most of them were mild and tolerable. Conclusion Domestic intravenous Terbutalin Sulfate is effective and safe in treating asthma and chronic asthmatic bronchitis.