中国中西医结合杂志2025，Vol.45Issue(2)：183-189,7.DOI:10.7661/j.cjim.20240925.060
人工熊胆粉治疗急性咽炎(肝胃郁热证)有效性和安全性多中心随机对照研究
Efficacy and Safety of Artificial Bear Bile Powder in the Treatment of Acute Pharyngitis(Syndrome of Gan-Wei Stagnant Heat):A Multicenter Randomized Controlled Trial
摘要
Abstract
Objective To evaluate the efficacy and safety of artificial bear bile powder(BBP)in acute pharyngitis patients with Gan-Wei stagnant heat syndrome(GWSHS).Methods A multi-center,block randomized,double-blind,positive drug parallel-controlled trials was designed.Totally 160 acute pharyngitis patients with GWSHS collected from 10 hospitals from October 2021 to June 2022 were randomly assigned to high-dose experimental group(39 cases,artificial BBP bear bile capsule,0.2 g each capsule,containing 0.2 g of artificial BBP,once 1 capsule),low-dose experimental group(40 cases,artificial BBP bear bile capsule,0.25 g each capsule,containing 0.05 g of artificial BBP,once 2 capsules),high-dose control group(41 cases,bear bile capsule,0.2 g each capsule,containing 0.2 g BBP,once 1 capsule),and low-dose control group(40 cases,bear bile capsule,0.25 g each capsule,containing BBP 0.05 g,once 2 capsules)Each group was treated 3 times a day for 5 days.The improvement of GWSHS,the Visual Analogue Score(VAS)of throat,the disappearance rate and time of the main symptom(sore throat),and the adverse reactions were observed.Results In the experimental group,39 cases were completed in high-dose group and 39 cases in low-dose group.In the control group,40 cases in the high-dose group,and 39 cases in the low-dose group.The main efficacy outcomes of Chinses medicine syndrome(GWSHS)score decreased by 13.7 points in the experimental group and 13.8 points in the control group,and the OR and 90％CI of the two groups were 0.99(0.927,1.061).The VAS of throat decreased by 5.0 points in the experimental group and 5.1 points in the control group,and the OR and 90％CI of the two groups were 0.98(0.912,1.038).The results of the analysis of the subgroups of high and low doses were consistent with the overall trial.No serious adverse reactions were found during the trial,there was no significant difference in the incidence of adverse events between the two groups(P＞0.05).Conclusions Artificial BBP is clinically equivalent to BBP in the treatment of acute pharyngitis(GWSHS)with good safety and low incidence of adverse reactions,which could be used as a substitute for BBP.关键词
人工熊胆粉/熊胆胶囊/急性咽炎/肝胃郁热证/等效性/随机对照试验/中成药Key words
artificial bear bile powder/bear bile capsule/acute pharyngitis/Gan-Wei stagnant heat syndrome/equivalence/randomized controlled trial/Chinese patent medicine引用本文复制引用
王建新,朱镇华,马华安,于博,李庆娜,杨巧宁,高蕊,刘静,张予,刘建华,谯凤英,郑兆晔,王仁忠,陈文勇,周凌..人工熊胆粉治疗急性咽炎(肝胃郁热证)有效性和安全性多中心随机对照研究[J].中国中西医结合杂志,2025,45(2):183-189,7.基金项目
国家中医药管理局中医药科学技术研究专项(No.GZY-KJS-2021-019) （No.GZY-KJS-2021-019）
中国中医科学院科技创新工程重大攻关项目(No.CI2021A04701) （No.CI2021A04701）
中国中医科学院科技创新工程-中药临床药理学培育项目(No.CI2021A04708) （No.CI2021A04708）
