重组人干扰素α2b喷雾剂(假单胞菌)治疗儿童急性上呼吸道感染有效性和安全性多中心随机对照临床研究  

A multicenter,randomised,controlled clinical study on efficacy and safety of recombinant human interferon α 2b spray (P.putida) in treatment of acute upper respiratory tract infection in children

作　　者：申昆玲[1] 尚云晓[2] 张贺[3] 刘长山[4] 杨巧芝[5] 陈玉君[6] 田利远[7] 沈照波 曾慧慧[9] 林娟 叶冰 杨芳[12] 崔玉霞[13] 曲书强[14] 田维敏[15] SHEN Kun-ling;SHANG Yun-xiao;ZHANG He(Department of Pneumology,Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China;不详)

机构地区：[1]首都医科大学附属北京儿童医院呼吸科,北京100045 [2]中国医科大学附属盛京医院小儿呼吸内科,辽宁沈阳110004 [3]新乡医学院第一附属医院儿科,河南新乡453100 [4]天津医科大学第二医院儿科,天津300211 [5]聊城市人民医院儿科,山东聊城252004 [6]广西医科大学第二附属医院儿科,广西南宁530007 [7]河北省儿童医院呼吸一科,河北石家庄050030 [8]河南省儿童医院呼吸科,河南郑州450053 [9]首都医科大学附属北京妇产医院怀柔区妇幼保健院儿科,北京100191 [10]福建省福州儿童医院呼吸内科,福建福州350005 [11]山东大学齐鲁儿童医院急诊科,山东济南250022 [12]福建省立医院儿科,福建福州350001 [13]贵州省人民医院儿科,贵州贵阳550002 [14]哈尔滨医科大学附属第二医院儿内科,黑龙江哈尔滨150001 [15]厦门大学附属中山医院儿科,福建厦门361004

出　　处：《中国实用儿科杂志》2019年第12期1010-1016,共7页Chinese Journal of Practical Pediatrics

基　　金：中国初级卫生保健基金会儿童相关疾病临床研究项目(编号CB20191001)

摘　　要：目的评价重组人干扰素(rhIFN)α2b喷雾剂(假单胞菌)治疗儿童非流感急性上呼吸道感染的临床疗效、安全性及耐受性。方法 2019年1月至7月,由首都医科大学附属北京儿童医院和中国医科大学附属盛京医院牵头,在全国开展rhIFNα2b喷雾剂治疗儿童急性上呼吸道感染的多中心、随机对照临床研究。共纳入符合入选标准的急性上呼吸道感染患儿575例,分为rhIFNα2b喷雾剂组291例和利巴韦林组284例,分别给予rhIFNα2b喷雾剂和利巴韦林气雾剂治疗,并对药物疗效和安全性进行评定。结果完成本研究的符合方案集(perprotocol set,PPS)病例共448例,其中rhIFNα2b喷雾剂组233例,利巴韦林组215例。主要疗效指标完全退热时间rhIFNα2b喷雾剂组为25.0 h,利巴韦林组为33.6 h,差异有统计学意义(P=0.0001);上呼吸道感染症状缓解时间比较,rhIFNα2b喷雾剂组在鼻塞、流涕、咽喉痛、咳嗽等症状消退时间均早于利巴韦林组,差异有统计学意义(均P<0.05),rhIFNα2b喷雾剂组和利巴韦林组的痊愈时间分为92 h、112 h,rhIFNα2b喷雾剂组优于利巴韦林组,差异有统计学意义(P<0.0001)。两组不良反应发生率差异无统计学意义(P=0.2461)。结论 rhIFNα2b喷雾剂用于儿童病毒性急性上呼吸道感染治疗起效快、疗效显著,尤其有助于快速缓解发热及减轻鼻咽部症状,缩短病程,且安全和耐受性良好,适合在临床中推广使用。Objective To evaluate the efficacy,safety and tolerability of recombinanat human interferon α2 b(rhIFNα2b)spray in treatment of acute upper respiratory tract infection(except the flu)in children. Methods In total,575 children who met the inclusion criteria were enrolled from January,2019 to July,2019. They were divided into rhIFNα2b spray group(291 cases)and ribavirin group(284 cases). The children in rhIFNα2b spray group were given the rhIFNα2b spray(P.putida),and those in ribavirin groups were treated with the ribavirin spray. The curative effect and safety between the two groups were compared. Results The per-protocol set(PPS) comprised 448 patients(233 in the rhIFNα2b spray group,215 in the ribavirin group). The primary efficacy endpoint was antipyretic time which in rhIFNα2b spray group(25.0 h)was significantly shorter than that in the ribavirin group(33.6 h)(P=0.0001). In the comparison of symptomatic relief time,the relief time of nasal congestion,runny nose,sore throat and cough in rhIFNα2b spray group was shorter than that in ribavirin group(P<0.05). The recovery time in the rhIFNα2b spray group was 92 h,which showed significant decrease compared with the ribavirin group(112 h)(P<0.0001). The incidence of adverse events had no statistical differences between the two groups(P=0.2461). Conclusion The rhIFNα2b spray treatment for acute upper respiratory tract infection in children is proved to be significantly effective;particularly,it can evidently relieve fever symptoms and promote the disappearance of nasal and pharyngeal symptoms. It has good safety and tolerability,so the rhIFNα2b spray is worthy to be promoted in clinical application.

关 键 词：儿童急性上呼吸道感染 重组人干扰素α2b喷雾剂(假单胞菌) 局部用药 病毒 感染 

分 类 号：R72[医药卫生—儿科]