复方芩兰口服液联合奥司他韦治疗流行性感冒的多中心随机双盲双模拟对照研究  

A multicenter randomized double-blind double-simulation study of Compound Qinlan Oral Liquid combined with oseltamivir in treatment of influenza

作　　者：阮桂英 陈卡蒙 章新辉 张海波 RUAN Gui-ying;CHEN Ka-meng;ZHANG Xin-hui;ZHANG Hai-bo(Department of Pediatric Internal Medicine,Taizhou Women’s and children’s Hospital,Taizhou 318000,China;Department of Pediatrics,Yingtan Hospital of Traditional Chinese Medicine,Yingtan 335000,China;Department of Pediatrics,Chengde Maternal and Child Health Hospital,Chengde 067000,China)

机构地区：[1]台州市妇女儿童医院儿童内科,浙江台州318000 [2]鹰潭市中医院儿科,江西鹰潭335000 [3]承德市妇幼保健院儿内科,河北承德067000

出　　处：《现代药物与临床》2023年第11期2756-2762,共7页Drugs & Clinic

摘　　要：目的 分析复方芩兰口服液联合奥司他韦治疗流行性感冒的多中心随机双盲双模拟对照研究。方法 采用多中心随机、双盲、双模拟对照研究,纳入3个医院门诊或住院部在2021年4月—2023年5月收治的240例流行性感冒患儿,按区组随机化方法并根据1∶1∶1比例原则将所有患者分为3组,即对照1组、对照2组、治疗组,每组各80例。对照1组用温开水冲服磷酸奥司他韦颗粒体,体质量≤15 kg,30 mg/次;体质量16~23 kg,45 mg/次;体质量24~40 kg,60 mg/次;体质量>40 kg,75 mg/次;2次/d;同时服用复方芩兰口服液安慰剂,用法用量同对照2组。对照2组口服复方芩兰口服液,患儿≤1岁,2.5 mL/次;1岁<患儿≤3岁,5 mL/次;3岁<患儿≤7岁,5~10 mL/次;患儿>7岁,10~20 mL/次;3次/d;同时服用磷酸奥司他韦颗粒安慰剂,其用法用量同对照1组。治疗组口服复方芩兰口服液和磷酸奥司他韦颗粒,用法用量与对照1组、2组相同。3组连续治疗1周。观察3组的临床疗效、症状缓解时间。比较3组治疗前后中医症候评分、炎症因子、免疫球蛋白、免疫因子水平的变化情况。结果 治疗后,治疗组总有效率是97.50%,显著高于对照1组85.00%、对照2组87.50%(P<0.05)。治疗后,治疗组退热、头身痛、咽痛、咳嗽流涕缓解时间均显著短于对照1组、2组(P<0.05)。治疗后,3组发热评分、口渴喜饮评分、咽痛评分、咳嗽评分均较治疗前显著降低(P<0.05);治疗后,治疗组中医症候评分均低于对照1组、2组(P<0.05)。治疗后,3组患儿C反应蛋白(CRP)、白细胞介素(IL)-6、干扰素(IFN)-γ水平均较治疗前显著降低(P<0.05);且治疗后,治疗组CRP、IL-6、IFN-γ水平低于对照组(P<0.05)。治疗后,3组患儿免疫球蛋白(Ig)A、IgG、IgM水平均较治疗前显著增加(P<0.05),且治疗后,治疗组免疫球蛋白水平显著高于对照1组、2组(P<0.05);治疗后,对照2组免疫球蛋白水平高于对照1组(P<0.05)。治疗后,3组患Objective To analyze a multicenter randomized double-blind double-simulated controlled study of Compound Qinlan Oral Liquid combined with oseltamivir in treatment of influenza.Methods A multicenter randomized double-blind double-simulated control study was conducted to include 240 children with influenza admitted to outpatient or inpatient departments of 3 hospitals from April 2021 to May 2023.All patients were divided into 3 groups according to the block randomization method and the ratio principle of 1:1:1,namely control group 1,control group 2 and treatment group,with 80 cases in each group.Children in control group 1 were po administered with Oseltamivir Phosphate Granules with warm boiling water,body weight≤15 kg,30 mg/time;body weight 16—23 kg,45 mg/time;body weight 24—40 kg,60 mg/time;body weight>40 kg,75 mg/time;twice daily.And they were po administered with Compound Qinlan Oral Liquid placebo,and the administration and dosage were the same as that of control group 2.Children in control group 2 were po administered with Compound Qinlan Oral Liquid,0 to 1 year old,2.5 mL/time;1 to 3 years old,5 mL/time;3 to 7 years old,5—10 mL/time;over 7 years old,10—20 mL/time;3 times daily.And they were po administered with Oseltamivir Phosphate Granules placebo,and the administration and dosage were the same as that of control group 1.Children in treatment group were po administered with Oseltamivir Phosphate Granules and Compound Qinlan Oral Liquid,and the administration method was the same as that of control group 1 and control group 2.3 groups were treated continuously for 1 week.The clinical efficacy and symptom remission time of 3 groups were observed.The changes of TCM symptom score,inflammatory factors,immunoglobulin and immune factors before and after treatment were compared in the 3 groups.Results After treatment,the total effective rate of treatment group was 97.50%,which was significantly higher than that of control group 1(85.00%)and control group 2(87.50%)(P<0.05).After treatment,the relief time

关 键 词：复方芩兰口服液 磷酸奥司他韦颗粒 流行性感冒 症状缓解时间 C反应蛋白 免疫球蛋白 诱导蛋白-10 单核细胞趋化蛋白-1 

分 类 号：R974[医药卫生—药品]