氯酚伪麻缓释片治疗普通感冒和流行性感冒的疗效和安全性

Efficacy and safety of loratadine paracetamol and pseudoephedrine sustained release tablets in the treatment of common cold and influenza

目的评价氯酚伪麻缓释片(抗感冒药)治疗普通感冒和流行性感冒的安全性和有效性。方法用多中心、随机、双盲、平行对照临床试验,试验组(n=118)给予氯酚伪麻缓释片,对照组(n=119)给予双扑伪麻片。结果试验组的临床症状改善率不低于对照组(P<0.05),试验前后2组临床症状总积分均无明显差别(P>0.05);试验组和对照组的总有效率分别为96.33%和96.36%(P>0.05)。试验组和对照组的药物不良反应发生率分别为7.02%和11.82%(P>0.05)。结论氯酚伪麻缓释片治疗普通感冒和流行性感冒具有明显疗效和安全性。

Objective To evaluate the efficacy and safety of the loratadine paracetamol and pseudoephedrine （LPP） sustained-release tablets in the treatment of common cold and influenza compared with compound pseudoephedrine hydrochloride tablets. Methods Multi-center, randomized, double-blinded controlled clinical trial. One hundred eighteen patients were given LPP sustained-release tablets as trial group, 119 were given pseudoephedrine hydrochloride as control group. Results Non-inferiority statistics showed that the improvement rate of clinical symptoms in trial group were not lower than that in control group （P 〈 0.05）. The total symptom score did not differ in trial group and control group （ P 〉 0. 05 ）. The effective rate in trial group and control group were 96.33% and 96. 36% （P 〉 0. 05 ）. The incidence of adverse drug reactions in trial group and control group was 7.02% and 11.82% , respectively （P 〉 0.05 ）. Conclusion LPP sustained-release tablets is effective and safe in the treatment of common cold and influenza.