蒲地蓝消炎口服液治疗成人急性咽炎/扁桃体炎(非细菌感染)多中心临床研究  

Multi-Centre Clinical Study of Pudilan Anti-Inflammatory Oral Solution(蒲地蓝消炎口服液)for the Treatment of Acute Pharyngitis/Tonsillitis(Non-Bacterial Infection)in Adults

作　　者：王祺[1] 翟娜 孟硕 于雪峰[1] 庞敏[1] 张炜[2] 马战平 张念志[4] 曲仪庆[5] WANG Qi;ZHAI Na;MENG Shuo;YU Xuefeng;PANG Min;ZHANG Wei;MA Zhanping;ZHANG Nianzhi;QU Yiqing(Liaoning Academy of Traditional Chinese Medicine,The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110034,Liaoning,China;Shuguang Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shaanxi Provincial Hospital of Chinese Medicine,Xi’an 710003,Shaanxi,China;The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230601,Anhui,China;Qilu Hospital of Shandong University,Jinan 250063,Shandong,China)

机构地区：[1]辽宁省中医药研究院,辽宁中医药大学附属第二医院,辽宁沈阳110034 [2]上海中医药大学附属曙光医院,上海201203 [3]陕西省中医医院,陕西西安710003 [4]安徽中医药大学第一附属医院,安徽合肥230601 [5]山东大学齐鲁医院,山东济南250063

出　　处：《辽宁中医药大学学报》2025年第5期1-8,共8页Journal of Liaoning University of Traditional Chinese Medicine

基　　金：国家重点研发计划项目(2018YFC1707410);国家中医药管理局第五批全国中医临床优秀人才研修项目(国中医药人教函[2022]1号)。

摘　　要：目的通过随机、阳性对照、多中心方案,观察不同剂量蒲地蓝消炎口服液治疗成人急性咽炎/扁桃体炎(非细菌感染)的有效性和安全性。方法依据研究方案4家中心共纳入受试者402例,采用以中心为分层的区组随机方法,将受试者分为10 mL剂量组(蒲地蓝消炎口服液)、20 mL剂量组(蒲地蓝消炎口服液)和对照组(双黄连口服液),治疗7 d,观察治疗前后3组受试者的咽痛总有效率、咽痛起效时间及消失时间、咽痛视觉模拟评分(visual analogue scale,VAS)、疾病痊愈率等疗效指标,同时进行安全性分析及卫生经济学分析,采用SPSS 25.0软件对研究结果数据进行统计学分析。结果临床疗效评价中,蒲地蓝消炎口服液20 mL剂量组和10 mL剂量组均优于对照组,20 mL剂量组优于10 mL剂量组;蒲地蓝消炎口服液具有较好的安全性;蒲地蓝消炎口服液卫生经济学评价结果提示对照组相对于10 mL剂量组为“劣势方案”,20 mL剂量组与10 mL剂量组比较,其增加的成本完全值得。结论蒲地蓝消炎口服液治疗急性咽炎/扁桃体炎(非细菌感染)临床疗效确切且安全性较好,其中20 mL剂量组优势明显。Objective To observe the efficacy and safety of different doses of Pudilan Anti-Inflammatory Oral Liquid(蒲地蓝消炎口服液)in the treatment of acute pharyngitis/tonsillitis(non-bacterial infections)in adults by means of a randomised,positive-controlled,multicentre protocol.Methods A total of 402 subjects were enrolled in four centres according to the study protocol.Using a stratified block group randomiation method with the centre as the stratification,the subjects were divided into the 10 mL dosage group(Pudilan Anti-Inflammatory Oral Liquid),the 20 mL dosage group(Pudilan Anti-Inflammatory Oral Liquid)and the control group[Shuanghuanglian Oral Liquid(双黄连口服液)],and the treatment was carried out for 7 days.The total effective rate of sore throat,the onset time of the sore throat,the time of disappearance of sore throat in the three groups before and after the treatment,sore throat VAS score,disease recovery rate and other efficacy indicators were observed.Safety analysis and health economics analysis were carried out using SPSS 25.0 software.Results In the clinical efficacy evaluation,the 20 mL dose group and 10 mL dose group of Pudilan Anti-Inflammatory Oral Liquid were superior to the control group,and the 20 mL dose group had an advantage over the 10 mL dose group.Pudilan Anti-Inflammatory Oral Liquid had a better safety profile.The results of the hygiene economics evaluation of Pudilan Anti-Inflammatory Oral Liquid suggested that the control group was a“disadvantageous programm”compared with the 10 mL dose group,and the increased cost of the 20 mL dose group compared with the 10 mL dose group was fully worthwhile.Conclusion The clinical efficacy and safety of Pudilan Anti-Inflammatory Oral Liquid in the treatment of acute pharyngitis/tonsillitis(non-bacterial infection)are accurate,and the advantage of the 20 mL dose group is obvious.

关 键 词：蒲地蓝消炎口服液 急性咽炎 急性扁桃体炎 

分 类 号：R276.1[医药卫生—中医五官科学]