重组人干扰素α2b口咽部喷雾治疗疱疹性咽峡炎的有效性和安全性多中心随机对照研究  

A prospective multicenter randomized controlled study on the efficacy and safety of pharyngeal spraying recombinant human interferon alpha 2b in the treatment of children with herpangina

作　　者：潘家华 杨泽玉 潘家严 温晓红[4] 韩旻[5] 羊礼荣[6] 程贤高[7] 李艳玲[8] 林海庆 李传景[10] 严成明 Pan Jiahua;Yang Zeyu;Pan Jiayan;Wen Xiaohong;Han Min;Yang Lirong;Cheng Xian′gao;Li Yanling;Lin Haiqing;Li Chuanjing;Yan Chengming(Department of Pediatrics,the First Affiliated Hospital of University of Science and Technology of China,Hefei 230031,China;Department of Respiratory Medicine,Anhui Provincial Children′s Hospital,Hefei 230051,China;Department of Pediatrics,the First People′s Hospital of Wuhu City,Wuhu 241000,Anhui Province,China;Department of Pediatrics,the First People′s Hospital of Hefei City,Hefei 230031,China;Department of Pediatrics,the Third People′s Hospital of Bengbu,Bengbu 233000,Anhui Province,China;Department of Pediatrics,the People′s Hospital of Chizhou,Chizhou 247000,Anhui Province,China;Department of Pediatrics,Anqing Municipal Hospital,Anqing 246004,Anhui Province,China;Department of Pediatrics,the First People′s Hospital of Huainan City,Huainan 232038,Anhui Province,China;Department of Pediatrics,the First People′s Hospital of Xuancheng City,Xuancheng 242000,Anhui Province,China;Department of Pediatrics,Suzhou Municipal Hospital,Suzhou 234000,Anhui Province,China;Department of Pe-diatrics,Anhui Women and Child Health Care Hospital,Hefei 230011,China)

机构地区：[1]中国科技大学附属第一医院儿科,合肥230031 [2]安徽省儿童医院呼吸内科,合肥230051 [3]芜湖市第一人民医院儿科,安徽芜湖241000 [4]合肥市第一人民医院儿科,合肥230031 [5]蚌埠市第三人民医院儿科,安徽蚌埠233000 [6]池州市人民医院儿科,安徽池州247000 [7]安庆市立医院儿科,安徽安庆246004 [8]淮南市第一人民医院儿科,安徽淮南232038 [9]宣城市第一人民医院儿科,安徽宣城242000 [10]宿州市立医院儿科,安徽宿州234000 [11]安徽省妇幼保健院儿科,合肥230011

出　　处：《中华实用儿科临床杂志》2020年第4期279-284,共6页Chinese Journal of Applied Clinical Pediatrics

摘　　要：目的评估重组人干扰素α2b(rhIFNα2b)口咽部喷雾治疗小儿疱疹性咽峡炎的有效性和安全性。方法本研究采用前瞻性、随机、开放、对照、多中心研究方法,2018年8月至2019年3月参加本研究的安徽省内11家三甲医院共收集了疱疹性咽峡炎患儿180例,按住院的时间顺序随机分为干扰素治疗组和利巴韦林对照组。在清热解毒和抗感染治疗基础上,治疗组患儿咽部喷洒rhIFNα2b 9 g/L盐水溶液[100万IU/mL,10万IU/(0.1 mL·揿)],对照组患儿咽部喷洒利巴韦林喷剂(0.5 mg/揿,150揿),2组治疗方法相同,均为每次3揿,每日4次,连续给药5 d,提前痊愈者不再给药治疗。所有患儿观察至临床痊愈,比较2组患儿的疗效、症状和体征消失时间,并评估口咽局部喷洒rhIFNα2b的安全性。结果180例患儿均完成研究,其中治疗组90例,对照组90例,2组性别、年龄、体质量和就诊前病程等方面比较差异均无统计学意义(均P>0.05),具有临床可比性。治疗组显效率[63.3%(57/90例)]显著高于对照组[38.9%(35/90例)],差异有统计学意义(χ^2=10.934,P=0.004);治疗组总有效率为96.7%(87/90例),与对照组[92.2%(83/90例)]比较差异无统计学意义(χ^2=2.924,P=0.169)。治疗组发热[(32.59±20.73)h比(45.72±26.96)h]、充血[(76.48±23.12)h比(92.44±24.31)h]、疱疹[(72.99±25.77)h比(85.09±26.62)h]、流涎[(45.44±24.96)h比(54.42±31.20)h]和畏食[(62.70±23.99)h比(78.71±30.54)h]等症状和体征持续时间均短于对照组,差异均有统计学意义(均P<0.05)。用药前2组血清肿瘤坏死因子α(TNF-α)[(13.02±4.41)ng/L比(13.57±9.27)ng/L]、白细胞介素-6(IL-6)[(26.48±11.31)ng/L比(30.15±15.55)ng/L]和C反应蛋白(CRP)[(19.34±14.11)mg/L比(19.83±14.57)mg/L]比较差异均无统计学意义(均P>0.05);治疗后,治疗组血清TNF-α和IL-6水平分别为(7.26±1.99)ng/L和(2.42±0.73)ng/L,均低于对照组[(12.09±6.39)ng/L和(7.32±11.51)ng/L],差异均有统计学意义(均P<0.05),但2组患Objective To evaluate the efficacy and safety of pharyngeal spraying recombinant human interfe-ron alpha 2b(rhIFNα2b)in the treatment of herpangina in children.Method s A prospective,multicenter,rando-mized,opened and controlled study was carried out in 11 hospitals in Anhui province from August 2018 to March 2019.According to the time of admission,180 patients diagnosed as herpangina were prospectively and randomly divided into rhIFNα2b treatment group and Ribavirin control group.On the basis of giving both groups the heat-clearing,detoxifying and anti-infection treatment,the patients in treatment group received pharyngeal spraying rhIFNα2b 9 g/L saline solution[1 million IU/mL,0.1 million IU/(0.1 mL·press)],and the patients in control group were treated by pharyngeal spraying Ribavirin(0.5 mg RBV/press,150 press),3 presses per time,4 times per day,continuous administration for 5 days for both groups.Those who recovered in advance were no longer given medication.All patients were observed to fully recover.The clinical efficacy and the disappearing time of symptoms and signs between two groups were compared,and the safety of pharyngeal spraying rhIFNα2b for patients was evaluated.Result s All of the 180 patients completed the study,including 90 cases in the treatment group and 90 cases in the control group.There was no statistically significant difference in terms of gender,age,weight and course of illness before treatment between the two groups(all P>0.05),which had clinical comparability.The apparent efficiency of the treatment group[63.3%(57/90 cases)]was significantly higher than that in the control group[38.9%(35/90 cases)]and the difference was statistically significant(χ^2=10.934,P=0.004);no significant difference in the total efficiency between the treatment group[96.7%(87/90 cases)]and the control group[92.2%(83/90 cases)]was observed(χ^2=2.924,P=0.169).The duration of fever[(32.59±20.73)h vs.(45.72±26.96)h],hyperemia[(76.48±23.12)h vs.(92.44±24.31)h],herpes[(72.99±25.77)h vs.(85.09±26.62)h]

关 键 词：疱疹性咽峡炎 重组人干扰素Α2B 利巴韦林 咽部喷雾 

分 类 号：R76[医药卫生—耳鼻咽喉科]