复方磷酸可待因片治疗中重度咳嗽的Ⅱ期临床研究

A phaseⅡclinical trial for compound codeine phosphate tablets in treatment of moderate or severe cough

目的:考察复方磷酸可待因片(奥舒灵)对中度以上咳嗽的镇咳祛痰效果和安全性。方法:采用多中心随机双盲双模拟对照,对209例中度或重度咳嗽症状患者的镇咳祛痰进行临床评价。试验组(n=105)口服奥舒灵(2片)及可待因桔梗片(可桔片)模拟药(1片),对照组(n=104)口服可桔片(1片)及奥舒灵模拟药(2片),tid,连用3～7d。对咳嗽程度、痰量、痰黏稠度和痰性质与外观进行逐日评分,并观察首次用药后的镇咳效果。结果:试验组和对照组的镇咳有效率分别为61．0%和58．7%,总有效率分别为60．0%和50．0%,两组比较差异均无统计学意义(P＞0．05)。结论:奥舒灵是安全有效的镇咳祛痰药。

Objective： To assess efficacy and safety of compound codeine phosphate tablets （fustalm） in the relief of moderate or severe cough and sputum. Methods： A multi-center, randomized, double-blinded and double-dummy, parallel controlled clinical trial recruited 209 patients with moderate or severe cough, who were randomly taken with an oral dose of either 2 fustalm tablets （n = 105, test group） plus 1 stimulant tablet or 1 codeine platycodon compound tablet plus 2 stimulant tablets （n = 104, control group） three times a day for 3 ～7 days. Cough degree and quantity, viscidity and character of sputum were monitored daily, and antitussive efficacy after the first dose was evaluated. Results： The total antitussive rate of test and control group was 61.0% and 58.7% , respectively, and the overall efficacy was 60. 0% and 50. 0% , respectively ; the P value showed no statistical difference （ P 〉 0. 05 ）. Conclusion： Fustalm tablets provided alternative antitussives and expectorants.