小儿热速清糖浆联合对乙酰氨基酚治疗儿童发热的多中心随机双盲双模拟的比较研究  

A multicenter randomized double-blind double-simulation study of Xiaoer Resuqing Syrup combined with paracetamol in treatment of fever in children

作　　者：董寒梅 陈凤干 王艳玲 赵路平 DONG Han-mei;CHEN Feng-gan;WANG Yan-ling;ZHAOLu-ping(Department of Pediatrics,Mudanjiang First People’sHospital,Mudanjiang 157000,China;Department of Pediatrics,Tengzhou Maternal and Child Health Care Hospital,Tengzhou 277599,China;Department of Pediatrics,Mudanjiang Maternal and Child Health Hospital,Mudanjiang 157000,China)

机构地区：[1]牡丹江市第一人民医院儿科,黑龙江牡丹江157000 [2]滕州市妇幼保健院儿科,山东滕州277599 [3]牡丹江市妇幼保健院儿科,黑龙江牡丹江157000

出　　处：《现代药物与临床》2023年第11期2775-2781,共7页Drugs & Clinic

摘　　要：目的分析小儿热速清糖浆联合对乙酰氨基酚治疗儿童发热的多中心随机双盲双模拟的比较研究。方法采用多中心随机双盲双模拟的对比试验方法,病例来源于2021年4月—2023年4月牡丹江市第一人民医院、滕州市妇幼保健院、牡丹江妇幼保健院门诊或住院部就诊及招募的外感发热患儿240例,利用SAS统计软件按区组随机化法分为对照1组(80例)、对照2组(80例)、治疗组(80例)。对照1组口服对乙酰氨基酚混悬液,1~3岁,体质量12~15 kg,3 mL/次;4~6岁,体质量16~21 kg,5 mL/次;7~9岁,体质量22~27 kg,8 mL/次;10~12岁,体质量28~32 kg,10 mL/次。若持续发热或疼痛,每隔4~6 h重复用药1次,24 h不可超过4次。同时服用小儿热速清糖浆模拟剂,服用方法同对照2组。对照2组口服小儿热速清糖浆,1~3岁,5~10 mL/次;4~6岁:10~15 mL/次;7~12岁,15~20 mL/次;3~4次/d。同时口服对乙酰氨基酚混悬液模拟剂,其方法同对照1组。治疗组口服对乙酰氨基酚混悬液联合小儿热速清糖浆,服用方法与对照1组、对照2组相同。1个疗程72 h,3组均连续用药1个疗程。观察3组的临床疗效、体温和症状缓解时间。比较3组治疗前后中医证候评分、血清炎性因子、免疫指标的变化情况。观察3组患儿退热反复、高热惊厥发生情况,并计算发生率。结果治疗后,治疗组总有效率是98.75%,显著高于对照1组88.75%、对照2组90.00%(P<0.05)。治疗后,治疗组治疗30 min、6 h、24 h、48 h、72 h患儿体温均较治疗前逐渐降低(P<0.05);治疗组治疗30 min、6 h、24 h时体温均显著低于对照1组、2组(P<0.05)。治疗后,治疗组退热起效时间、退热时间、咽痛缓解时间均显著短于对照1组、对照2组(P<0.05)。治疗后,3组C反应蛋白(CRP)、白细胞介素(IL)-1β、IL-6水平均较同组治疗前显著降低(P<0.05);且治疗后,治疗组CRP、IL-6、IL-1β水平均显著低于对照1组、对照2组(P<0.05)。治疗后,3组患儿CD3^(+)、Objective To analyze a multicenter randomized double-blind double-simulation study of Xiaoer Resuqing Syrup combined with paracetamol in treatment of fever in children.Methods A multicenter randomized double-blind double-simulation comparative trial method was used to study 240 children with external fever who were recruited from the outpatient or inpatient department of Mudanjiang First People’s Hospital,Tengzhou Maternal and Child Health Care Hospital and Mudanjiang Maternal and Child Health Care Hospital from April 2021 to April 2023.Using SAS statistical software,they were divided into control group 1(80 cases),control group 2(80 cases)and treatment group(80 cases)by block randomization method.Children in control group 1 were po administered with Paracetamol Oral Suspension,1—3 years old,body weight 12—15 kg,3 mL/time;4—6 years old,body weight 16—21 kg,5 mL/time;7—9 years old,body weight 22—27 kg,8 mL/time;10—12 years old,body weight 28—32 kg,10 mL/time.If the fever or pain persists,repeat the drug once every 4—6 hours,and not more than 4 times in 24 hours.At the same time,they were po administered with Xiaoer Resuqing Syrup simulant,and the method of administration was the same as that of control group 2.Children in control group 2 were po administered with Xiaoer Resuqing Syrup,1—3 years old,5—10 mL/time;4—6 years old,10—15 mL/time;7—12 years old,15—20 mL/time;3—4 times daily.At the same time,they were po administered with Paracetamol Oral Suspension simulant,and the method of administration was the same as that of control group 1.Children in treatment group were po administered with Paracetamol Oral Suspension and Xiaoer Resuqing Syrup,and the administration method was the same as that of control group 1 and control group 2.A course of treatment lasted 72 h,and all the 3 groups were given continuous medication for 1 course.The clinical efficacy,body temperature and symptom remission time of the 3 groups were observed.The changes of TCM syndrome scores,serum inflammatory fa

关 键 词：小儿热速清糖浆 对乙酰氨基酚口服混悬液 儿童发热 退热起效时间 C反应蛋白 

分 类 号：R974[医药卫生—药品]