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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 investigate the antitussive and expectorant effect and safety of compound codeine phosphate (Orsolphide) on patients with moderate to severe cough. Methods: A multicenter randomized, double-blind, double-dummy, controlled clinical trial of antitussive and expectorant in 209 patients with moderate or severe cough symptoms was performed. The test group (n = 105) was given oral Orsolurin (2 tablets) and codeine Campanulaceae tablets (can be orange tablets) simulation drug (1 tablet), the control group (n = 104) Shuling simulation drug (2), tid, once every 3 ~ 7d. The degree of cough, sputum volume, sputum viscosity and the nature and appearance of sputum were scored daily, and the antitussive effect after the first administration was observed. Results: The effective rates of antitussive in experimental group and control group were 61.0% and 58.7%, respectively, and the total effective rates were 60.0% and 50.0% respectively. There was no significant difference between the two groups (P > 0.05). Conclusion: Orsolphine is a safe and effective antitussive expectorant.