鼻窦炎口服液治疗儿童急性鼻-鼻窦炎有效性和安全性研究  

Study on the efficacy and safety of Bi Dou Yan oral liquid in the treatment of acute rhinosinusitis in children

作　　者：魏萍[1] 刘大新[2] 许政敏[3] 姚红兵[1] 李海霞[4] 孙岗 邓世明[6] 刘辉[7] 杨丽丽 李湘 李晓艳[10] 赵小兵[11] 蒋路云[12] 李兰[13] 雷刚[14] 陈洁[15] 马立吉 王平康[17] 唐伟[18] 梁小华[1] WEI Ping;LIU Da-xin;XU Zheng-min(Children's Hospital of Chongqing Medical University,Chongqing 400014,China;不详)

机构地区：[1]重庆医科大学附属儿童医院,重庆400014 [2]北京中医药大学东方医院,北京100078 [3]国家儿童医学中心复旦大学附属儿科医院,上海201102 [4]河南大学淮河医院,河南开封475000 [5]乌鲁木齐儿童医院,新疆乌鲁木齐83000 [6]绵阳市中医医院,四川绵阳621000 [7]石家庄市第一医院,河北石家庄050011 [8]长治市人民医院,山西长治046099 [9]广东省中西医结合医院,广东佛山528253 [10]上海市儿童医院,上海200062 [11]枣庄市妇幼保健院,山东枣庄261031 [12]成都中医药大学附属医院,四川成都610075 [13]深圳市儿童医院,广东深圳518038 [14]重庆市中医院,重庆400021 [15]上海交通大学医学院附属上海儿童医学中心,上海200127 [16]淄博市中心医院,山东淄博255036 [17]简阳市人民医院,四川简阳641400 [18]石河子大学医学院第一附属医院,新疆石河子832008

出　　处：《中国实用儿科杂志》2022年第5期385-390,共6页Chinese Journal of Practical Pediatrics

摘　　要：目的探讨鼻窦炎口服液治疗儿童急性鼻-鼻窦炎的有效性及安全性。方法采用多中心、随机、双盲、对照的临床研究方法,于2016年9月至2019年2月纳入国内17个中心480例病例,其中试验组和对照组各240例,试验组给予常规治疗+鼻窦炎口服液,对照组给予常规治疗+安慰剂,对药物疗效和安全性进行评价。结果试验组主要症状消失时间为5d低于对照组7d(P<0.01),鼻内镜检查客观量化评分(P<0.01)与中医证候积分(P<0.01)均显著低于对照组;中医证候总有效率试验组(P<0.01)明显高于对照组;试验组主要症状复发率与VAS评分数值都低于对照组,但两组间均无统计学差异(P>0.05)。试验组不良事件发生率与药物相关不良反应发生率均与对照组无统计学差异(P>0.05)。结论鼻窦炎口服液治疗儿童急性鼻-鼻窦炎效果显著,安全性好,值得儿科临床用药广泛推广。Objective To investigate the efficacy and safety of Bi Dou Yan oral liquid in the treatment of children with acute rhinosinusitis.Methods A multi-center,randomized,double-blind,controlled clinical research method was adopted.From September 2016 to February 2019,480 children with acute rhinosinusitis from 17 centers in China were enrolled,and were randomly divided into two groups with 240 cases in each one.The experimental group was given conventional treatment and Bi Dou Yan oral liquid;the control group was given conventional treatment and placebo;the efficacy and safety were evaluated.Results The disappearance time of main symptoms in the experimental group(5 days)was shorter than that of the control group(7 days)(P<0.01).The objective quantitative score of nasal endoscopy(P<0.01)and traditional Chinese medicine(TCM)syndrome score(P<0.01)were significantly lower in the experimental group than those in control group(P<0.01);the total effective rate of TCM syndromes in the experimental group was significantly higher than that in the control group(P<0.01).The recurrence rate of major symptoms(P>0.05)and the Visual Analogue Scale(VAS)score(P>0.05)were lower inthe experimental group than in control group,but there was no statistical difference between the two groups.There was no significant difference in the incidence of adverse events or drug-related adverse reactions between the two groups(P>0.05).Conclusion Bi Dou Yan oral liquid has significant effect and good safety in the treatment of pediatric acute rhinosinusitis,and is worthy of widespread application in pediatric clinical medication.

关 键 词：鼻窦炎口服液 急性鼻-鼻窦炎 儿童 有效性 安全性 

分 类 号：R72[医药卫生—儿科]