Jain N K, Sharma S D, Garg V K, Sharma T N, Devpura K
Department of Tuberculosis and Chest Diseases, Sawai Man Singh Medical College, Jaipur, Rajasthan, India.
J Asthma. 1993;30(1):29-35. doi: 10.3109/02770909309066377.
Bronchodilator effect and toxicity of theophylline 300 mg twice a day (R1), salbutamol 4 mg tid (R2), their combination in higher (200/4mg, R3), and lower doses (100/2mg R4), and placebo (calcium lactate 300 mg) tid (R5) were compared in 25 patients with bronchial asthma in a randomized crossover trial. Statistically significant improvement in forced expiratory volume in one second (FEV1) was observed in all the active treatment groups (R1 to R4) compared with placebo (R5). The mean improvement in FEV1 was 29.0%, 22.0%, 28.0%, 30.0%, and 0.73% in regimen R1, R2, R3, R4, and R5, respectively day 1, and corresponding improvement was 30.0%, 24.0%, 29.0%, 34.0%, and 4.4% on completion of one week therapy. On intergroup statistical comparison, mean improvement in pulmonary function test values were statistically significant or highly significant in regimens R1 to R4, as compared with placebo. However, improvement between any two regimens was not statistically significant in any of the regimens (R1-R4). Almost all the regimens were tolerated well and no patient showed major adverse reactions or cardiotoxicity necessitating withdrawal of the drug. On the other hand, minor adverse reactions were common and the high dose combination (R3) was found to have more adverse reactions than the low dose combination and either drug used alone.
在一项随机交叉试验中，对25例支气管哮喘患者比较了每日两次300毫克氨茶碱（R1）、每日三次4毫克沙丁胺醇（R2）、高剂量（200/4毫克，R3）和低剂量（100/2毫克，R4）的二者联合用药以及每日三次安慰剂（300毫克乳酸钙）（R5）的支气管扩张作用和毒性。与安慰剂组（R5）相比，所有活性治疗组（R1至R4）的一秒用力呼气量（FEV1）均有统计学意义的显著改善。第1天，R1、R2、R3、R4和R5方案中FEV1的平均改善率分别为29.0%、22.0%、28.0%、30.0%和0.73%，一周治疗结束时相应的改善率分别为30.0%、24.0%、29.0%、34.0%和4.4%。组间统计学比较显示，与安慰剂相比，R1至R4方案中肺功能测试值的平均改善具有统计学意义或高度统计学意义。然而，在任何方案（R1 - R4）中，任意两种方案之间的改善均无统计学意义。几乎所有方案耐受性良好，没有患者出现需要停药的严重不良反应或心脏毒性。另一方面，轻微不良反应很常见，且发现高剂量联合用药方案（R3）比低剂量联合用药方案以及单独使用任何一种药物都有更多的不良反应。
