摘要
目的 评价人工熊胆粉治疗急性咽炎(肝胃郁热证)的有效性与安全性。方法 采用多中心、区组随机、双盲、阳性药平行对照临床试验设计,选取2021年10月-2022年6月10家医院急性咽炎(肝胃郁热证)患者160例,随机分为试验高剂量组39例(人工熊胆粉熊胆胶囊,每粒0.2 g,含人工熊胆粉0.2 g,每次1粒),试验低剂量组40例(人工熊胆粉熊胆胶囊,每粒0.25 g,含人工熊胆粉0.05 g,每次2粒),对照高剂量组41例(熊胆胶囊,每粒0.2 g,含熊胆粉0.2 g,每次1粒),对照低剂量组40例(熊胆胶囊,每粒0.25 g,含熊胆粉0.05 g,每次2粒)。每组均为每天3次,持续5天。观察急性咽炎肝胃郁热证候改善、咽痛视觉模拟评分(VAS)改善、主要症状(咽痛)消失率、主要症状(咽痛)消失时间以及药物不良反应。结果 试验高剂量组完成39例,试验低剂量组完成39例,对照高剂量组完成40例,对照低剂量组完成39例。急性咽炎肝胃郁热证候积分试验组较基线下降13.7分,对照组下降13.8分,两组OR值及90%CI为0.99(0.927,1.061)。急性咽炎咽痛症状VAS评分试验组较基线下降5.0分,对照组下降5.1分,两组OR值及90%CI为0.98(0.912,1.038)。高、低剂量两个亚组的分析结果与整体试验一致。试验期间未见严重不良反应,两组不良事件发生率比较,差异无统计学意义(P>0.05)。结论 人工熊胆粉替代熊胆粉治疗急性咽炎肝胃郁热证与熊胆粉临床等效,改善咽喉肿痛的功效与熊胆粉一致,安全性良好,不良反应发生率低,可替代熊胆粉使用。
WANG Jian-xin;LIU Jing;ZHANG Yu;LIU Jian-hua;QIAO Feng-ying;ZHENG Zhao-ye;WANG Ren-zhong;CHEN Wen-yong;ZHOU Ling;ZHU Zhen-hua;MA Hua-an;YU Bo;LI Qing-na;YANG Qiao-ning;GAO Rui;Institute of Clinical Pharmacology,Xiyuan Hospital,China Academy of Chinese Medical Sciences;Postdoctoral Research Station of China Academy of Chinese Medical Sciences;Laboratory for Clinical Research and Evaluation of Chinese Medicine,National Medical Products Administration;Department of Otorhinolaryngology Disease,Guang'anmen Hospital,China Academy of Chinese Medical Sciences;Department of Otorhinolaryngology ,Dongzhimen Hospital,Beijing University of Chinese Medicine;Department of Otorhinolaryngology,First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine;Department of Otorhinolaryngology,Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine;Department of Otorhinolaryngology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine;Department of Otorhinolaryngology,Guangdong Provincial Hospital of Traditional Chinese Medicine;Department of Otorhinolaryngology,First Affiliated Hospital of Heilongjiang University of Chinese Medicine;Deartment of Otorhinolaryngology,First Affiliated Hospital of Hunan University of Chinese Medicine;Department of Otorhinolaryngology,Jiangsu Provincial Hospital of Traditional Chinese Medicine;Department of Otorhinolaryngology,Zhongshan Anshi Bio-pharmaceutical Co.,LTD;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 5.1points 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.
作者
王建新
刘静
张予
刘建华
谯凤英
郑兆晔
王仁忠
陈文勇
周凌
朱镇华
马华安
于博
李庆娜
杨巧宁
高蕊
WANG Jian-xin;LIU Jing;ZHANG Yu;LIU Jian-hua;QIAO Feng-ying;ZHENG Zhao-ye;WANG Ren-zhong;CHEN Wen-yong;ZHOU Ling;ZHU Zhen-hua;MA Hua-an;YU Bo;LI Qing-na;YANG Qiao-ning;GAO Rui(Institute of Clinical Pharmacology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing,100091;Postdoctoral Research Station of China Academy of Chinese Medical Sciences,Beijing,100091;Laboratory for Clinical Research and Evaluation of Chinese Medicine,National Medical Products Administration,Beijing 100091;Department of Otorhinolaryngology Disease,Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053;Department of Otorhinolaryngology,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 101021;Department of Otorhinolaryngology,First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193;Department of Otorhinolaryngology,Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300150;Department of Otorhinolaryngology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 250010;Department of Otorhinolaryngology,Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou 510120;Department of Otorhinolaryngology,First Affiliated Hospital of Heilongjiang University of Chinese Medicine,Harbin 150040;Department of Otorhinolaryngology,First Affiliated Hospital of Hunan University of Chinese Medicine,Changsha 410007;Department of Otorhinolaryngology,Jiangsu Provincial Hospital of Traditional Chinese Medicine,Nanjing 210029;Department of Otorhinolaryngology,Zhongshan Anshi Bio-pharmaceutical Co.,LTD,Guangdong 528400)
出处
《中国中西医结合杂志》
北大核心
2025年第2期183-189,共7页
Chinese Journal of Integrated Traditional and Western Medicine
基金
国家中医药管理局中医药科学技术研究专项(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)
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)。
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
artificial bear bile powder
bear bile capsule
acute pharyngitis
Gan-Wei stagnant heat syndrome
equivalence
randomized controlled trial
Chinese patent medicine
