弗多司坦对呼吸道感染病人祛痰作用的随机对照临床研究

A randomized controlled trial of fudosteine versus ambroxol in patients with respiratory tract infection as an expectorant

目的：评价弗多司坦片对呼吸道感染病人祛痰作用的临床疗效和安全性。方法：确诊的呼吸道感染病人60例,按随机双盲对照试验设计分为2组,弗多司坦组30例,口服弗多司坦片,400 mg,tid；氨溴索组30例,口服氨溴索片,30 mg,tid,疗程均为7～10 d。结果：综合疗效分析,弗多司坦组临床控制率和有效率分别为33%和83%,氨溴索组临床控制率和有效率分别为33%和80%；祛痰疗效分析,弗多司坦组显效率和有效率分别为80%和97%,氨溴索组显效率和有效率分别为77%和94%,2组差异无显著意义。弗多司坦组未发现不良反应,2组不良反应率差异无显著意义。结论：弗多司坦片辅助治疗呼吸道感染有效且安全。

AIM： To evaluate the efficacy and safety of fudosteine tablets in the treatment of respiratory tract infection（RTI） as an expectorant. METHODS： In a hospital-based randomized controlled study, 60 patients with RTI were randomized into two groups. Thirty patients of fudosteine group were treated with fudosteine tablets, 400 mg,tid for 7-10 d; 30 patients of ambroxol group were treated with ambroxol tablets, 30 mg, tid for 7 - 10 d. RESULTS： The control rate and effective rate were 33 % and 83 % in fudosteine group and 33 % and 80 % in ambroxol group respectively by comprehensive analysis. The marked improvement rate and effective rate were 80 % and 97 % in fudosteine group and 77 % and 94 % in control group respectively. There was no significant difference （P 〉 0.05） between two groups. The incidence rate of adverse reactions was 0 in fudosteine group and 3 % in ambroxol group （P 〉 0.05）. CONCLUSION： Fudosteine is an effective and safe medicine in patients with RTI.