重组人干扰素α-2b喷雾剂治疗小儿疱疹性咽峡炎的效果观察

Observation on the clinical efficacy of recombinant human interferon α-2b spray on children with herpangina

目的观察重组人干扰素α-2b喷雾剂(捷扶)对特定年龄段小儿疱疹性咽峡炎的炎症指标及血生化指标的影响及临床疗效、安全性。方法本研究为前瞻性临床试验,预先制定随机化分组方法及各分组的治疗方案。按入院时间自2016年6月开始入组第1例至2018年10月完成试验方案,实际入组患儿120例,按治疗方案分为干预组及对照组,每组各60例。两组患儿均给予相应的基础治疗,包括按需饮食、多饮水、补充营养,加强口腔护理等治疗;对照组患儿除基础治疗外应用利巴韦林按适当频次喷雾双侧扁桃体及咽后壁,干预组患儿除基础治疗外应用捷扶按方案制定的频次喷雾同前咽部病灶处。记录两组疱疹性咽峡炎患儿治疗期间的体温、咽峡部疱疹及其破损后口腔黏膜情况、饮食食欲情况及最终住院时间;并在治疗前后分别检测血常规中WBC、C-反应蛋白及肝肾功、心肌酶等情况。并记录患儿治疗期间的不良反应或并发症等情况。结果所入组120例疱疹性咽峡炎患儿均按方案完成试验,无脱落、退出;干预组患儿体温恢复正常、咽部疱疹消退、口腔黏膜愈合及食欲基本恢复时间分别为(24.53±20.84)小时、(3.87±0.62)天、(3.77±0.79)天、(3.12±0.92)天,均分别小于对照组(33.93±25.15)小时、(4.08±0.53)天、(4.05±0.70)天、(3.67±0.86)天,且各项目具有显著性差异(P<0.05)。治疗前WBC水平在干预组[(11.93±4.84)×109/L]与对照组[(11.65±5.30)×109/L]患儿组间对比无差异(P>0.05),治疗后WBC均降低且具有显著性差异(P<0.05),但WBC在干预组[(6.082.85)×109/L]与对照组[(5.942.26)×109/L]组间对比无差异(P>0.05)。治疗前肌酸肌酶(CK)水平在干预组[(95.0±67.3)U/L]与对照组[(111.9±127.6)U/L]患儿组间对比无差异(P>0.05),治疗后两组患儿CK水平均显著降低(P<0.05),CK水平在干预组[(67.4±32.1)U/L]患儿较对照组[(84.0±107.7)U/L]更低且有显著性差异(P<0.05)。经过相应治疗至出院,干预组住院时间[(4.98±1.05)天]与对照组住院时间[(5.43±1.24)天]相比更短,差异有统计学意义(P<0.05)。所有患儿在参与临床试验前后未发生与治疗相关并发症及不良反应。结论重组人干扰素α-2b喷雾剂可降低小儿疱疹性咽峡炎的炎症指标及心肌酶,缩短退热、症状缓解及住院时间,安全有效。

Objective To observe the impact of recombinant human interferonα-2b(rhIFNα-2b)spray on inflammatory biomarkers and serum biochemical indicator in children with herpangina,and its clinical efficacy and safety.Methods This study was a prospective clinical trial,and the randomization method and treatment plan of each group were formulated in advance.According to the admission time,the first case was enrolled at June 2016 and the trial protocol was completed in October 2018.Totally 120 children with herpangina were enrolled in the study and according to the plan they were divided into 2 groups:the intervention group and the control group,and finally every group got 60 children.Not only the intervention group but also the control group were given basic treatment,including keeping diet as needed,drinking more water,supplementing nutrition,strengthen oral care and so on.In addition to basic treatment above,ribavirin spray was sprayed to the surface of bilateral tonsils,posterior pharyngeal wall at appropriate frequency in the control group.While rhIFNα2b spray was sprayed to the lesions according to the designed frequency in the intervention group.The time of body temperature,herpes in the pharynx isthmus,oral mucosa,appetite and the hospitalization time were recorded.WBC,myocardial enzymes,C reactive protein,liver and kidney function of the two groups were tested before and after the treatment.The adverse reactions associated with the treatment and complications of the two groups were also recorded.Results All the enrolled one hundred and twenty children with herpangina completed the experiment according to the plan without anyone dropping out.In the intervention group,the time of body temperature’s becoming normal,oral mucosa healing,herpes disappearing,appetite recovering were(24.53±20.84)hours,(3.77±0.79)days,(3.87±0.62)days,(3.12±0.92)days,which were all shorter than the corresponding time of the control group[(33.93±25.15)hours,(4.08±0.53)days,(4.05±0.70)days,(3.67±0.86)days]with statistically significance(P<0.05).There were no significant difference in white blood cells count between the intervention group[(11.93±4.84)×109/L]and the control group[(11.65±5.30)×109/L]before the treatment(P>0.05).After treatment count of WBC in both groups were decreased(P<0.05),however,there was no significant difference in WBC between intervention group(6.08±2.85)×109/L and control group(5.94±2.26)×109/L(P>0.05).Before treatment,there was no difference in creatine kinase(CK)level between the intervention group[(95.0±67.3)U/L]and the control group[(111.9±127.6)U/L](P>0.05).After the treatment,Creatine kinase(CK)in the intervention group[(67.4±32.1)U/L]was lower than the control group[(84.0±107.7)U/L],with statistically significance(P<0.05).The hospitalization time of intervention group[(4.98±1.05)days]was shorter than the control group[(5.43±1.24)days],with statistically significance(P<0.05).There were no treatment-related adverse reactions or complications occurred during the clinical trial.Conclusions Treating the herpangina with recombinant human interferonα-2b spray could shorten the fever disappearing time,relive the symptom,reduce inflammatory biomarkers and creatine kinase,shorten the hospitalization time,it is safe and effective.