仙璐贝~滴剂治疗急性鼻窦炎(含慢性鼻窦炎急性发作)的临床研究  

A clinical trial of Sinupret~ drops in patients with acute sinusitis(including the acute episode of chronic sinusitis)

作　　者：能玲玲[1] 刘杨[1] 董明敏[1] 

机构地区：[1]郑州大学第一附属医院耳鼻咽喉头颈外科,河南郑州450052

出　　处：《中国民康医学》2007年第7期244-246,共3页Medical Journal of Chinese People’s Health

摘　　要：目的:观察仙璐贝滴剂治疗急性鼻窦炎(含慢性鼻窦炎急性发作)的临床疗效和安全性。方法:采用开放、多中心、单剂量自身对照研究设计。患者口服仙璐贝滴剂,前3天每次100滴,每天3次;后4天每次50滴,每天3次,疗程共7天,然后观察患者症状体征的改善情况。结果:本研究共有250例患者可供疗效和安全性分析。与服药前相比,患者服药第3、第7天各临床症状(包括鼻塞、流涕、头痛)、体征(鼻黏膜充血肿胀)评分及总分的改善均有统计学意义(P<0.001)。仙璐贝滴剂治疗急性鼻窦炎(含慢性鼻窦炎急性发作)的显效率为80.4%,总有效率达98.4%。在用药过程中共有2例患者报告了不良反应,为轻度胃肠道不适。未出现严重不良反应。结论:仙璐贝滴剂可有效控制急性鼻窦炎(含慢性鼻窦炎急性发作)患者的症状和体征,疗效较高,耐受性较好。Objective： To evaluate the efficacy and safety of Sinupret drops in the relief of symptoms （ such as nasal congestion, runny nose, headache） and signs（ congested nasal mucosa） in patients with acute sinusitis（ including the acute episode of chronic sinusitis）. Methods ：An open, muhic- entre, single- dose, self- controlled clinical trial was conducted. Sinupret drops （100 drops on first 3 days, 50 drops on 4 - 7 days 3 times daily with a total duration of 7 days） was given to patients with acute sinusitis（ including the acute episode of chronic sinusitis）. Results： A total of 250 patients were eligible for efficacy and safety analysis. The symptoms and signs improved significantly after medication, improvements of Day 3 and Day 7 in individual symptom and sign scores and the total scores were highly statistically significant （P 〈0. 001 ）. The total score of symptoms and sign were ＂much improved＂ in 80.4% of patients and the total effective rate reached 98.4%. 2 patients reported adverse events and both were mild gastrointestinal tract disorders. There were no serious adverse events during the study. Conclusions： Sinupret drops was effective in controlling acute sinusitis （including the acute episode of chronic sinusitis） symptoms and signs and well tolerated.

关 键 词：仙璐贝滴剂 急性鼻窦炎 慢性鼻窦炎急性发作 疗效 安全性 

分 类 号：R765.21[医药卫生—耳鼻咽喉科]