仙璐贝滴剂治疗急性鼻窦炎的疗效与安全性

目的:评价仙璐贝滴剂治疗急性鼻窦炎(包括慢性鼻窦炎急性发作)的疗效和安全性.方法:采用随机、多中心、平行对照的研究方法,共入组191例患者,试验组94例,对照组97例.试验组口服仙璐贝滴剂,d1～5:每次100滴,tid;d6～10:每次50滴,tid.对照组口服吉诺通胶囊,每次1粒,tid,连服10d.结果:对于急性鼻窦炎,仙璐贝组临床总有效率为91.5%,吉诺通组为82.5%.2组疗效无统计学差别(P>0.05).2组局部压痛消失率差别在治疗d11有统计学意义,试验组优于对照组(P<0.05).共有2例不良事件报告,试验组1例,表现为失眠易醒;对照组1例,表现为胃肠道反应.两例均与试验药物无关.心、肝、肾功能、血液系统未见异常变化.结论:仙璐贝滴剂对急性鼻窦炎(包括慢性鼻窦炎急性发作)是安全、有效的,其疗效与吉诺通相当.

The efficacy and safety of Sinupret drops in treatment of acute sinusitis

Objective:To evaluate the efficacy and the safety of Sinupret drops in treatment of acute sinusitis and acute episode of chronic sinusitis. Methods: Randomized, multicenter, parallel-controlled clinical trial was conducted. 191 patients were enrolled. 94 of them were allocated to receive Sinupret 6.2mL on first 5days,3. 1mL on 6 -10days 3 times daily and 97 were received Gelomyrtol 1 capsule 3 times daily with a total duration of 10 days. Results: The total effective rate was 91.5% for Sinupret and 52.5% for Gelomyrtol. No statistically significant difference was found between the two groups(P>0. 05) . On the 11th day,the difference of extinction rate of local tenderness reached statistical level,and Sinupret is better than Gelomyrtol(P< 0. 05). The total adverse events were 2 cases, one is insomnia and easy to wake up in Sinupret, the other is gastrointestinal tract disorders in Gelomyrtol. Both of the two cases had nothing to do with the two drugs. There were no abnormalities observed in heart function, liver function, kidney function and blood system. Conclusion: Sinupret drops is safe and effective in treatment of acute sinusitis and acute episode of chronic sinusitis. Its efficacy is similar to Gelomyrtol.