清宣止咳颗粒治疗儿童流感(风热犯肺证)多中心、随机、对照研究  

A multicenter,randomized,controlled study on the treatment of pediatric influenza(wind-heat invading lung)with Qingxuan Zhike granules

作　　者：明溪 申晓东 陈金妮 王进雅 王杰民[6] 陈风展[7] 沈惠平[8] 黄会惠 卢盈竹 郑佳琳 王紫薇 边际 冯子豪 冯乃超 陈思齐 刘训洲 严晓华[6] 王小燕[7] 谢雯[8] 熊磊 Ming Xi;Shen Xiaodong;Chen Jinni;Wang Jinya;Wang Jiemin;Chen Fengzhan;Shen Huiping;Huang Huihui;Lu Yingzhu;Zheng Jialin;Wang Ziwei;Bian Ji;Feng Zihao;Feng Naichao;Chen Siqi;Liu Xunzhou;Yan Xiaohua;Wang Xiaoyan;Xie Wen;Xiong Lei(Department of Pediatrics,the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine,Kunming 650031,China;Yunnan University of Traditional Chinese Medicine,Kunming 650500,China;Department of Pediatrics,Zhaotong Hospital of Traditional Chinese Medicine,Zhaotong 657000,China;Department of Respiratory,Hainan Women and Children′s Medical Center,Haikou 570100,China;Department of Pediatrics,Gulou Hospital,Nanjing University School of Medicine,Nanjing 210000,China;Department of Pediatrics,Shaanxi Provincial People′s Hospital,Xi′an 710000,China;Department of Pediatrics,Taizhou Second People′s Hospital,Taizhou 225300,China;Department of Pediatrics,Yixing People′s Hospital,Yixing 214200,China)

机构地区：[1]云南中医药大学第一附属医院儿科,昆明650031 [2]云南中医药大学,昆明650500 [3]昭通市中医医院儿科,昭通657000 [4]海南省妇女儿童医学中心呼吸科,海口570100 [5]南京大学医学院附属鼓楼医院儿科,南京210000 [6]陕西省人民医院儿科,西安710000 [7]泰州市第二人民医院儿科,泰州225300 [8]宜兴市人民医院儿科,宜兴214200

出　　处：《中华实用儿科临床杂志》2024年第8期597-601,共5页Chinese Journal of Applied Clinical Pediatrics

基　　金：国家中医药管理局高水平中医药重点学科建设项目(ZYYZDXK-2023190);云南省科技厅重点研发计划(202103AC100005);熊磊全国名老中医药专家传承工作室项目;云南省万人计划青年拔尖人才专项(YNWR-QNBJ-2019-196);云南省兴滇英才支持计划(医疗卫生人才专项)(XDYC-YLWS-2023-0092)。

摘　　要：目的评价清宣止咳颗粒改善儿童流感(风热犯肺证)咳嗽症状、缩短病程的有效性及临床应用的安全性。方法多中心、随机、对照临床试验。收集2023年4月至12月云南中医药大学第一附属医院等7家医院门诊流感患儿240例,采用区组随机方法,通过SAS软件将受试者随机分为对照组和试验组,2组间比较采用t检验、校正t检验及χ^(2)检验。对照组予磷酸奥司他韦颗粒,口服,2次/d。体重≤15 kg,30 mg/次;体重>15~23 kg,45 mg/次;体重>23~40 kg,60 mg/次;体重>40 kg,75 mg/次;若年龄≥13岁,75 mg/次。试验组在对照组基础上加用清宣止咳颗粒,口服,3次/d。1~3岁,每次1/2包;>3~6岁,每次3/4包;>6~14岁,每次1包。疗程:治疗5 d,停药观察2 d。观察2组患儿咳嗽疗效、退热疗效、临床痊愈率、临床痊愈时间、加拿大急性呼吸道疾病和流感量表(CARIFS)评分、中医证候疗效、并发症发生率及不良反应发生情况。结果最终纳入统计232例,其中试验组115例,对照组117例。治疗前后,试验组CARIFS咳嗽评分与对照组比较差异均无统计学意义(均P>0.05);治疗后试验组CARIFS咳嗽评分变化值[(-1.00±0.91)分]与对照组[(-0.75±0.98)分]比较,差异有统计学意义(t=-1.995,P=0.047);治疗后试验组中医证候咳嗽评分变化值[(-1.69±1.51)分]与对照组[(-0.97±1.63)分]比较,差异有统计学意义(t′=-0.035,P=0.001)。试验组完全退热时间[(44.82±22.72)h]短于对照组[(51.35±27.07)h],2组比较差异有统计学意义(t=-1.966,P=0.050)。发热维度评分显示,试验组CARIFS症状维度发热评分与时间的曲线下面积为4.40±2.42,对照组为5.12±2.44,2组比较差异有统计学意义(t=-2.252,P=0.025)。试验组临床痊愈率为93.91%(108/115),对照组临床痊愈率为92.31%(108/117),2组比较差异无统计学意义(χ^(2)=0.233,P>0.05)。试验组临床痊愈时间[(2.93±1.21)d]短于对照组[(3.29±1.15)d],2组比较差异有统计学意义(t=-2.279,P=0.024)�Objective To evaluate the efficacy and safety of Qingxuan Zhike granules in improving cough symptoms and shortening the course of influenza(wind-heat invading lung)in children.Methods In this multicenter,randomized,controlled clinical trial,a total of 240 outpatient influenza patients from 7 hospitals,including the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine,from April 2023 to December 2023 were collected.The subjects were randomly divided into the control group and the experimental group via SAS software using the block randomization method.The differences between two groups were compared with t test,corrected t test andχ^(2) test.Subjects in the control group were given Oseltamivir phosphate granules,orally,twice a day(weight≤15 kg,30 mg/time;weight>15-23 kg,45 mg/time;weight>23-40 kg,60 mg/time;weight>40 kg,75 mg/time;age≥13 years,75 mg/time).In addition to Oseltamivir phosphate granules,subjects in the experimental group were also given Qingxuan Zhike granules,orally,3 times a day(1-3 years old,1/2 bag each time;>3-6 years old,3/4 bag each time;>6-14 years old,1 bag each time).After 5 days of treatment,the medication was suspended for 2 days.The effect of cough,antipyretic effect,clinical recovery rate,clinical recovery time,Canadian Acute Respiratory Illness and Flu Scale(CARIFS)score,traditional Chinese medicine(TCM)syndrome effect,complication rate,and adverse reactions were evaluated between the two groups.Results Finally,232 cases were included in the study,including 115 cases in the experimental group and 117 cases in the control group.Before and after treatment,there were no significant difference in CARIFS cough score between the experimental group and the control group(all P>0.05).After treatment,the change in CARIFS cough score in the experimental group[(-1.00±0.91)scores]was significantly higher than that in the control group[(-0.75±0.98)scores](t=-1.995,P=0.047).After treatment,the change in TCM syndrome cough score in the experimental group[(-1.69±1.51)s

关 键 词：儿童 流感 清宣止咳颗粒 奥司他韦 

分 类 号：R272[医药卫生—中医儿科学]