桉柠蒎肠溶软胶囊辅助药物治疗儿童分泌性中耳炎的临床研究

Clinical Study of Eucalyptol,Limonene and Pinene Enteric Soft Capsules Assisting Drug in the Treatment of Children with Secretory Otitis Media

目的:研究桉柠蒎肠溶软胶囊辅助阿奇霉素在儿童分泌性中耳炎治疗中的临床效果及安全性。方法:选取2015年1月~2020年6月在本院儿科住院及门诊接受治疗的分泌性中耳炎患儿116例为研究对象,采用随机数字表法随机分为试验组和对照组,每组58例。对照组患儿给予羟甲唑啉和阿奇霉素进行常规治疗,试验组在对照组的基础上给予桉柠蒎肠溶软胶囊,观察两组患儿的治疗效果和安全性。结果:试验组患儿的总有效率(93.10%)高于对照组(72.41%,Z=-2.937,P<0.05);治疗前两组患儿分泌性中耳炎临床常见阳性症状(如耳痛、鼓膜异常、气骨导差值等)发生率无统计学差异(P>0.05);但治疗后两组患儿分泌性中耳炎阳性症状的发生率均低于治疗前,且试验组低于对照组(P<0.05);试验组患儿在药物治疗期间不良反应的总发生率为10.34%,对照组为12.07%,无统计学差异(P>0.05)。结论:桉柠蒎肠溶软胶囊辅助阿奇霉素在儿童分泌性中耳炎治疗中具有良好效果,并且安全性较好。

Objective:To study the clinical effect and safety analysis of eucalyptol,limonene and pinene enteric soft capsule assisted azithromycin in the treatment of pediatric secretory otitis media.Methods:A total of116 children with secretory otitis media who were treated in the pediatric department of our hospital from January2015 to June 2020 were selected as research subjects,and randomly divide into the experimental group and the control group by the random number table method,with 58 in each group.The children in the control group were given oxymetazoline and azithromycin as usual treatment,and the experimental group was given eucalyptol,limonene and pinene enteric soft capsules in addition to the basic treatment of the children in the control group.The therapeutic effect and safety of the two groups were observed.Results:The overall effective rate of children in the experimental group(93.10%)was higher than that in the control group(72.41%,Z=-2.937,P<0.05).Before treatment,there was no statistically difference in the two groups of children with secretory otitis media had common clinical positive symptoms(such as ear ache,tympanic membrane abnormality,air-bone conduction difference,etc.)(P>0.05).However,the incidence of positive symptoms of secretory otitis media after treatment in the two groups was lower than that before treatment,and the experimental group was lower than the control group(P<0.05).The total incidence of adverse reactions in the experimental group during treatment was 10.34%,compared with 12.07%in the control group,there was no statistical difference(P>0.05).Conclusion:Eucalyptol,limonene and pinene enteric soft capsules assisted with azithromycin in the treatment of pediatric secretory otitis media have obvious effects and good safety.