不同剂量蒲地蓝消炎口服液治疗细菌感染所致成人急性咽炎/扁桃体炎的多中心临床研究  

A Multicenter Clinical Trial of Pudilan Anti-inflammatory Oral Liquid of Different Doses in Treatment of Acute Pharyngitis/Tonsillitis Caused by Bacterial Infection in Adults

作　　者：李丁蕾[1,2] 崔英海[1] 于雪峰[1] 庞敏[1] 张炜[3] 马战平 张念志[5] 黄涛[6] 廖明波[7] 曲仪庆[8] 李竹英[9] 谷秀 倪理琪 LI Dinglei;CUI Yinghai;YU Xuefeng;PANG Min;ZHANG Wei;MA Zhanping;ZHANG Nianzhi;HUANG Tao;LIAO Mingbo;QU Yiqing;LI Zhuying;GU Xiu;NI Liqi(Liaoning Academy of Traditional Chinese Medicine(TCM),The Second Affiliated Hospital of Liaoning University of TCM,Shenyang 110034,China;Liaoning University of TCM,Shenyang 110847,China;Shuguang Hospital,Shanghai University of TCM,Shanghai 201203,China;Shaanxi Provincial Hospital of Chinese Medicine,Xi'an 710003,China;The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230601,China;Changchun University of Chinese Medicine Hospital,Changchun 130021,China;The First Clinical Hospital of Jilin Academy of TCM,Changchun 130021,China;Qilu Hospital of Shandong University,Jinan 250063,China;First Affiliated Hospital,Heilongjiang University of Chinese Medicine,Harbin 150040,China;The Fourth Affiliated Hospital of China Medical University,Shenyang 110165,China;Jichuan Pharmaceutical Group Co.Ltd.,Taizhou 225400,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,沈阳110034 [2]辽宁中医药大学,沈阳110847 [3]上海中医药大学附属曙光医院,上海201203 [4]陕西省中医医院,西安710003 [5]安徽中医药大学第一附属医院,合肥230601 [6]长春中医药大学附属医院,长春130021 [7]吉林省中医药科学院第一临床医院,长春130021 [8]山东大学齐鲁医院,济南250063 [9]黑龙江中医药大学附属第一医院,哈尔滨150040 [10]中国医科大学附属第四医院,沈阳110165 [11]济川药业集团股份有限公司,江苏泰州225400

出　　处：《中国实验方剂学杂志》2023年第19期136-144,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家重点研发计划项目(2018YFC1707410);国家中医药管理局区域中医诊疗中心项目(中医肺病专业);庞敏教授全国名老中医药专家传承工作室项目;乔世举辽宁省名中医传承工作室项目。

摘　　要：目的:通过随机、双盲双模拟、阳性对照、多中心设计方案,分析蒲地蓝消炎口服液在治疗细菌感染所致成人急性咽炎/扁桃体炎时其剂量与疗效及安全性的关系;进一步验证蒲地蓝消炎口服液对淀粉样蛋白A(SAA)、C反应蛋白(CRP)、白细胞(WBC)、中性粒细胞百分比(NE%)、红细胞沉降率(ESR)等炎症标志物的调控作用;探索性研究蒲地蓝消炎口服液替代抗生素治疗感染性疾病的可行性,为临床合理用药提供依据。方法:采用分层区组随机、双盲双模拟、阳性对照、多中心设计方法,9家中心共纳入该病受试者220例,按照1∶1∶1比例,随机分为蒲地蓝消炎口服液20 mL剂量组73例、10 mL剂量组73例和对照组(阿莫西林组)74例,疗程7 d,观察咽痛总有效率、咽痛起效时间和消失时间、健康状态评分、治疗时间和炎症标志物。结果:(1)数据集划分。进入全分析数据集(FAS)211例,符合方案数据集(PPS)208例,安全数据集(SS)218例。(2)有效性评价。咽痛总有效率、咽痛消失时间、健康状态方面的3组间比较,差异均具有统计学意义(P<0.05),20 mL剂量组、10 mL剂量组均非劣于阿莫西林组,20 mL剂量组和10 mL剂量组差异具有统计学意义(P<0.05);咽痛起效时间组间比较,3组差异无统计学意义。与本组治疗前比较,用药第7天3组患者CRP、WBC、NE%均显著降低(P<0.01)。(3)安全性评价。不良事件主要发生在各类检查指标中,组间比较差异无统计学意义,未发生不良反应和严重不良事件。(4)经济学评价。相对于阿莫西林组,10 mL剂量组、20 mL剂量组增加的成本完全值得;10 mL剂量组与20 mL剂量组比较,10 mL剂量组方案为“劣势方案”。结论:蒲地蓝消炎口服液在治疗细菌感染所致的急性咽炎/扁桃体炎时可代替抗生素单独使用;蒲地蓝消炎口服液具有较好的安全性;蒲地蓝消炎口服液可以下调CRP、WBC、NE%等炎症指标,说明其具有一Objective:Through a randomized,double-blind,double-simulation,positive-control,multicenter design,this study aimed to analyze the relationship between the dosage,efficacy,and safety of Pudilan anti-inflammatory oral liquid in treating acute pharyngitis/tonsillitis in adults caused by bacterial infection and validate the regulatory effect of Pudilan anti-inflammatory oral liquid on inflammatory markers such as serum amyloid A(SAA),C-reactive protein(CRP),white blood cells(WBC),neutrophil percentage(NE%),and erythrocyte sedimentation rate(ESR),thereby exploring the feasibility of using Pudilan anti-inflammatory oral liquid as a substitute for antibiotics in the treatment of infectious diseases and providing a basis for rational clinical medication.Method:Using a stratified randomized,double-blind,double-simulation,positive-control,multicenter design,220 participants were enrolled from nine centers.The participants were randomly divided into three groups at 1∶1∶1—a Pudilan anti-inflammatory oral liquid 20 mL group(73 cases),a Pudilan anti-inflammatory oral liquid 10 mL group(73 cases),and a control group(amoxicillin group,74 cases).The treatment course was 7 days.The study observed parameters including the total effective rate of sore throat,onset and disappearance time of sore throat,health status score,treatment time,and inflammation markers.Result:①Dataset division:The 211 cases were included in the full analysis dataset(FAS),208 cases were included in the per-protocol dataset(PPS),and 218 cases were included in the safety dataset(SS).②Efficacy evaluation:There were statistically significant differences(P<0.05)in the comparison of the three groups regarding the total effective rate of sore throat,disappearance time of sore throat,and health status.Both the 20 mL and 10 mL groups were non-inferior to the control group,and there was a statistically significant difference between the 20 mL and 10 mL dosage groups(P<0.05).There was no statistically significant difference in the comparison of onset time of s

关 键 词：蒲地蓝消炎口服液 急性咽炎 急性扁桃体炎 阿莫西林胶囊 多中心临床研究 

分 类 号：R242[医药卫生—中医临床基础] R2-031[医药卫生—中医学] R259R287R766.14R766.18