重组人干扰素α2b喷雾剂治疗小儿手足口病有效性和安全性的多中心对照临床研究  

A multicenter controlled clinical study on the efficacy and safety of recombinant human interferon α2b spray in the treatment of hand, foot and mouth disease in children

作　　者：徐艳利[1] 李颖[2] 陈益平[3] 辛素霞[4] 谢露[5] 梁跃东 杨松[1] 万钢[1] 李兴旺[1] Xu Yanli;Li Ying;Chen Yiping;Xin Suxia;Xie Lu;Liang Yuedong;Yang Song;Wan Gang;Li Xingwang(Department of Infectious Diseases, Beijing Ditan Hospital Affiliated to Capital Medical University, Beijing 100015, China)

机构地区：[1]首都医科大学附属地坛医院感染科,北京100015 [2]天津市第二人民医院感染科 [3]温州医科大学附属第二医院育英医院感染科 [4]河北省儿童医院感染科 [5]云南省昆明市妇幼保健院儿科 [6]贵州省贵阳市公共卫生救治中心

出　　处：《中华传染病杂志》2018年第2期101-106,共6页Chinese Journal of Infectious Diseases

摘　　要：目的评价重组人干扰素α2b喷雾剂治疗小儿手足口病的临床疗效。方法纳入2015年3月至2017年2月首都医科大学附属北京地坛医院、天津市第二人民医院、河北省儿童医院、温州医科大学附属第二医院、昆明市妇幼保健和贵阳市公共卫生救治中心共6家医院接诊并符合本研究入选标准的轻症手足口病患儿共313例，分为干扰素α2b组148例和利巴韦林组165例，分别予以重组人干扰素α2b喷雾剂和利巴韦林喷雾剂治疗的同时给予统一的标准干预措施。对疗效和安全性进行评定。计量资料组间比较采用t检验，非正态定量资料采用Wilcoxon秩和检验。结果本研究最终有效病例308例，其中干扰素α2b组144例、利巴韦林组164例。两组患儿在7 d随访期内均完全退热，皮疹和疱疹均有结痂或消退，给药72 h时干扰素α2b组患儿总有效率为74.15%，利巴韦林组总有效率为49.09%，两组比较差异有统计学意义（Z＝4.44，P〈0.01）。干扰素α2b组体温恢复正常的时间平均为（27.03±21.99） h，利巴韦林组为（33.21±26.71） h，两组比较差异有统计学差异（ t＝－2.13，P〈0.05）。干扰素α2b组即刻退热时间平均为（23.56±13.96） h，利巴韦林组为（28.51±18.84） h，两组比较差异有统计学意义（t＝－2.07，P〈0.05）。两组口腔溃疡消退时间、手足皮疹结痂时间、新鲜皮疹消失时间及食欲改善时间比较差异均有统计学意义（χ2值分别为＝4.94、3.17、3.55和58.89，均P＝0.000）。两组患儿入组前后及治疗过程中均无不良事件发生。结论重组人干扰素α2b喷雾剂治疗手足口病起效快，疗效显著，尤其对缓解发热症状、促进口腔溃疡愈合、改善食欲有明显作用，临床无明显不良反应。临床试验注册 中国临床试验注册中心，ChiCTR-OIN-17013182。ObjectiveTo evaluate the curative effect of recombinant human Interferon α2b （rhIFN α2b） spray in hand, foot and mouth disease （HMFD）. MethodsIn total, 313 HMFD children were enrolled from Beijing Ditan Hospital affiliated to Capital Medical University, Tianjing Second People′s Hospital, Hebei Children′s Hospital, the Second Hospital affiliated to Wenzhou Medical College, Kunming Maternal and Child Health Hospital and Guiyang Public Health Treatment Center from March, 2015 to February, 2017. They were divided into rhIFN α2b group （148 cases） and ribavirin group （165 cases）. The children in rhIFN α2b group were given with the rhIFN α2b spray, and those in ribavirin group were given with the ribavirin spray. Meanwhile, the children were given unified standard interventions for basic treatment. The curative effect and safety between two groups was compared. The t test was used for intergroup comparison and the Wilcoxon rank test was used for non-normal quantitative data.ResultsAt the end of the follow-up period, all kids reached the recovery level, with 144 cases in the rhIFN α2b group and 164 cases in the ribavirin group. Fever, herpes and rashes all disappeared with 7-day follow-up. The total efficiency of the rhIFN α2b group measured at the 72h after treatment was 74.15%, which showed significant differences compared with the ribavirin group with 49.09% efficiency （Z=4.44, P〈0.01）. As the secondary outcome measures, the complete disappearance time of fever and the immediate disappearance time of fever in the rhIFN α2b group were significantly shorter than those in the ribavirin group （[27.03±21.99] vs [33.21±26.71], t=-2.13; [23.56±13.96] vs [28.51±18.84], t=-2.07, both P〈0.05）. The appetite improvement and the disappearance times of oral herpes and rashes in the rhIFN α2b group were shorter than those in the ribavirin group, with significant differences （χ2=4.94, 3.17 and 3.55, respectively, all P=0.000）. No adverse event in both groups. ConclusionsrhIFN α2b s

关 键 词：手足口病 重组人干扰素α2b喷雾剂 抗病毒药 

分 类 号：R725.1[医药卫生—儿科]