摘要
目的 评价口炎清颗粒(无糖)治疗慢性咽炎的有效性和安全性.方法 采用多中心、随机、开放、阳性平行对照方法,将纳入的186例慢性咽炎患者按1∶1比例随机分为试验组与对照组,分别给予口炎清颗粒(无糖)、慢严舒柠®清喉利咽颗粒,服用方法为口炎清颗粒(无糖)一次2袋,2次/d,慢严舒柠®清喉利咽颗粒一次1袋,3次/d,两组疗程均为4周.观察慢性咽炎患者的咽痛、咽痒、咽干等临床症状.结果 调整意向治疗患者,试验组92例,对照组88例.主要有效性指标第28天的临床症状与总有效率,试验组为76.7％,对照组为71.8％,两组差异无统计学意义(P＞0.05),总有效率试验组非劣效于对照组.次要有效性指标第7天的临床症状与体征总有效率,试验组为32.6％,对照组为19.3％,两组比较差异有统计学意义(P＜0.05).治疗第28天单项临床症状与体征咽痛消失率,试验组为58.0％,对照组为34.0％,两组比较差异有统计学意义(P＜0.05).其他次要有效性评价指标,两组差异均无统计学意义,但试验组的点估计值高于对照组.试验中,不良事件发生率试验组为30.4％,对照组为27.3％.严重不良事件,试验组1例,对照组2例.与试验药物相关的治疗期不良事件试验组和对照组均有2例.两组不良事件发生率比较,差异无统计学意义(P＞0.05).结论 口炎清颗粒(无糖)治疗慢性咽炎,可有效改善临床症状,且临床应用安全性较好.
Abstract
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.
维普
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