摘要
目的通过临床试验客观评价其临床疗效及安全性,进一步考察辛夷鼻炎丸对急慢性鼻炎及变应性鼻炎的疗效,申报国家中药保护品种。方法将452例临床确诊的急慢性鼻炎及变应性鼻炎患者按单纯随机方法分为两组(试验组304例和对照组138例)。急性鼻炎:试验组,口服辛夷鼻炎丸一次3g,3次/d,共5d;对照组,口服芎菊上清丸一次6g,2次/d,共5d;慢性鼻炎及变应性鼻炎:试验组,口服辛夷鼻炎丸一次3g,3次/d,共28d;对照组,开水冲服通窍鼻炎颗粒,一次2g,3次/d,共28d,比较两组疗效并观察药物不良反应。结果急性鼻炎、慢性鼻炎、变应性鼻炎总有效率,试验组分别为98.31%、98.40%、93.44%,对照组分别为98.31%、97.96%、90.00%,说明两组药物治疗慢性鼻炎总疗效相似,未发现明显不良反应及毒副作用。结论辛夷鼻炎丸治疗急性鼻炎(外感风热证)、慢性鼻炎及变应性鼻炎是安全和有效的。
Objective To evaluation of clinical trials through the clinical efficacy and safety, further examination Xinyi Biyan pill on acute rhinitis, chronic rhinitis and allergic rhinitis, to declare the State Chinese Medicine of the protected variety. Methods The 452 cases of clinically confirmed acute and chronic rhinitis and allergic rhinitis patients were divided into two groups by simple random method （test group of 304 cases and the control group of 138 cases）. Acute rhinitis： the test group, oral Xinyi Biyan pill once 3g/d/3 times, a total of 5d; the control group, oral Gung Ju supematant pills once 6g/dg2 times, a total of 5d; chronic rhinitis and allergic rhinitis： the test group oral Xinyi Biyan pill once 3g/d/3 times, a total of 28d; control group, boiled water Tongqiao rhinitis particles, one 2g/d/3 times, a total of 28d, compare the two groups and to observe the effect of adverse drug reactions. Results Acute rhinitis, chronic rhinitis, allergic rhinitis, the total effective rate, the test group were as follows： 98.31%, 98.40%, 93.44%; the control group were as follows： 98.31%, 97.96%, 90.00%, indicating that the two groups of drug treatment of chronic rhinitis total similar effect was not found significant adverse reactions and side effects. Conclusion Xinyi Biyan pill treatment of acute rhinitis, rhinitis （Exogenous Wind-heat Syndrome）, chronic rhinitis, and allergic rhinitis is safe and effective.
出处
《中国医药指南》
2010年第8期24-27,共4页
Guide of China Medicine
关键词
辛夷鼻炎丸
急性鼻炎
慢性鼻炎
变应性鼻炎
Xinyi Biyan pill
Acute rhinitis
Chronic rhinitis
Allergic rhinitis
