摘要
目的评价百蕊颗粒治疗急性咽炎风热证的临床疗效及安全性。方法采用多中心、双盲、双模拟、随机对照试验方法,选取来自7个中心的162例急性咽炎风热证患者,各中心按照试验组与对照组2∶1的比例分组。试验组108例应用百蕊颗粒+热炎宁颗粒模拟剂口服,对照组54例应用热炎宁颗粒+百蕊颗粒模拟剂口服,疗程5天,并于第6天随访。分别采用全分析集(FAS)和符合方案集(PPS)进行分析。主要疗效指标为治疗5天后咽痛消失率;次要疗效指标为治疗3天后咽痛消失率,治疗前、治疗每天及第6天随访时咽痛视觉模拟评分法(VAS)评分,治疗前及第6天随访时进行中医证候评分,并于第6天随访时评价中医证候疗效;记录治疗前后生命体征、血常规、尿常规、肝功能、肾功能等变化,不良事件的发生情况,进行安全分析集(SS)分析。结果本研究162例患者进入FAS和SS分析,158例(试验组105例,对照组53例)进入PPS分析。FAS分析显示,试验组治疗5天后咽痛消失率为80.56%(87/108),对照组为64.81%(35/54),两组差异有统计学意义(χ^(2)=5.10,P=0.0239);PPS分析显示,试验组患者治疗5天后咽痛消失率为80.00%(84/105),对照组为64.15%(34/53),两组差异有统计学意义(χ^(2)=4.85,P=0.0277)。FAS和SS分析均显示,两组治疗3天后咽痛消失率差异无统计学意义(P>0.05);与本组治疗前比较,两组治疗第2、3、4、5天及第6天随访时咽痛VAS评分均降低(P<0.01),但两组间各时间点比较差异无统计学意义(P>0.05);两组第6天随访时中医证候评分均低于本组治疗前,且试验组低于对照组(P<0.01);试验组中医证候疗效痊愈率、愈显率均显著高于对照组(P<0.01)。治疗前后两组患者血常规、尿常规、肝功能、肾功能差异均无统计学意义(P>0.05),均未发生严重不良事件。结论百蕊颗粒治疗急性咽炎风热证临床疗效肯定,可显著改善临床症状,且安全性好。
Objective To evaluate the clinical effectiveness and safety of Bairui Granules(百蕊颗粒)in the treatment of acute pharyngitis with wind-heat syndrome.Methods A multicenter,double-blind,double-simulation,randomised controlled trial was conducted,in which 162 patients with acute pharyngitis and wind-heat syndrome from 7 centers were recruited,and each center was divided into trial group and control group on the ratio of 2∶1.In the trial group,108 cases were orally administered with Bairui Granules plus Reyanning Granules(热炎宁颗粒)simulant,and in the control group,54 cases were orally administered with Reyanning Granules plus Bairui Granules simulant for 5 days,with a follow-up visit on the 6th day.Full analysis set(FAS)analysis and per protocol set(PPS)were used for analysis,respectively.The primary efficacy index was the disappearance rate of sore throat after 5-day treatment;the secondary efficacy indexes were the disappearance rate of sore throat after 3-day treatment,as well as the visual analogue score(VAS)of sore throat before treatment,every day during the treatment,and follow-up on day 6,and the traditional Chinese medicine(TCM)syndrome score was performed before treatment and at the follow-up on day 6.The effectiveness on TCM syndrome was evaluated at the follow-up on day 6,and the changes of vital signs,blood routine,urine routine,liver functions,kidney function,the adverse events before and after the treatment were recorded,and safety analysis set(SS)was analysed.Results 162 patients entered the FAS and SS analyses,and 158 cases(105 cases in the trial group and 53 cases in the control group)entered the PPS analysis.FAS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.56%(87/108)in the trial group and 64.81%(35/54)in the control group,and the difference between groups was statistically significant(χ^(2)=5.10,P=0.0239).PPS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.00%(84/105)in the trial group and 64.15%(34/53)in the control group,and the difference between groups was statistically significant(χ^(2)=4.85,P=0.0277).FAS and SS analyses both showed that the difference in disappearance rate of sore throat between groups on 3-day treatment was not statistically significant(P>0.05).Compared with those before treatment,the VAS scores of sore throat were lower in both groups during treatment on day 2,3,4,5,and follow-up on day 6(P<0.01),but the difference between groups at each time point was not statistically significant(P>0.05).TCM syndrome scores of both groups at the follow-up were lower than that before treatment,and those of the trial group were lower than those of the control group(P<0.01).The cure rate and effective rate of TCM syndrome of the trial group were significantly higher than those of the control group(P<0.01).There was no significant difference in blood routine,urine routine,liver function,kidney function between groups before and after treatment(P>0.05),and no serious adverse events occured in both groups.Conclusion Bairui Granules showed clinical effectiveness in the treatment of acute pharyngitis of wind-heat syndrome,and it could significantly improve the clinical symptoms,accelerate the disappearance time of sore throat with good safety.
作者
刘思溟
周晖
李强
周敏
吴启相
杨善军
王珺
原晶晶
张莹
朱子奇
胡静怡
吴爽
李梦婷
闫占峰
LIU Siming;ZHOU Hui;LI Qiang;ZHOU Min;WU Qixiang;YANG Shanjun;WANG Jun;YUAN Jingjing;ZHANG Ying;ZHU Ziqi;HU Jingyi;WU Shuang;LI Mengting;YAN Zhanfeng(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing,100700;Affiliated Hospital of Chengdu University;Luohe Hospital of Traditional Chinese Medicine,Henan Province;Luoyang Third People's Hospital,Henan Province;Kaifeng Hospital of Traditional Chinese Medicine,Henan Province;The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine;The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine)
出处
《中医杂志》
CSCD
北大核心
2024年第11期1139-1145,共7页
Journal of Traditional Chinese Medicine
基金
北京中医药大学一流学科建设引导项目
北京中医药大学课程思政建设专项(KCSZZD-06)
北京中医药大学2023年度基本科研业务费项目(2023-BUCMXJKY009)。
关键词
急性咽炎
风热证
咽痛
百蕊颗粒
随机对照试验
acute pharyngitis
wind-heat syndrome
sore throat
Bairui Granules(百蕊颗粒)
randomised controlled trial
