A Multicenter,Randomized,Open-Label,Parallel Active-Controlled Clinical Trial of Kouyanqing Granule(口炎清颗粒)(Sugar-Free)on Chronic Pharyngitis
Objective To evaluate the efficacy and safety of Kouyanqing Granule(口炎清颗粒)(sugar-free)on chronic pharyngitis.Methods A total of 186 patients were randomly divided into experimental group[Kouyanqing Granule(sugar-free),2 bags for each time,twice a day]and control group[Manyanshuning Qingyanlihou Granule(慢严舒柠®清喉利咽颗粒),1 bag for each time,3 times a day]with 1∶1 ratio by multicenter,randomized,open-label and parallel active-controlled method.The treatment of both groups lasted 4 weeks.The clinical symptoms of chronic pharyngitis in patients,such as pharyngeal pain,pha-ryngeal itch and pharyngeal dryness were observed.Results There were 92 patients in the experimental group and 88 patients in the control group.The clinical symptoms and total effective rate at day 28 which was the main effectiveness indicator was 76.7％in the experimental group and 71.8％in the control group,and there was no statistical significance between the two groups(P＞0.05).The total effective rate of the experimental group was not inferior to that of the control group.The clinical symptoms and total effective rate at day 7 which was the secondary effectiveness indicators was 32.6％in the experimental group and 16.3％in the control group,and there were statistical differences between the two groups(P＜0.05).The single clinical symptoms and the disappearance rate of pharyngeal pain at day 28 was 58.0％in the experimental group and 34.0％in the control group,and the difference between the two groups was statistically significant(P＜0.05).For other secondary effectiveness indicators,there was no statistical significance between the two groups,but the points estimated of the experimental group were higher than that of the control group.The incidence of adverse events was 30.4％in the experimental group and 27.3％in the control group.There was 1 case with serious adverse events in the experimental group and 2 cases in the control group.There were 2 cases of adverse e-vents related to the experimental drug in both the experimental group and the control group.There was no significant difference in the incidence of adverse events between the two groups(P＞0.05).Conclusion Kouyanqing Granule(sugar-free)can effective-ly improve the clinical symptoms in the treatment of chronic pharyngitis,and the clinical application is safe.
万方数据
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