糠酸莫米松鼻喷雾剂联合孟鲁斯特钠咀嚼片治疗儿童中重度过敏性鼻炎的疗效及安全性

目的 研究糠酸莫米松鼻喷雾剂联合孟鲁斯特钠咀嚼片治疗儿童中重度过敏性鼻炎的疗效及安全性.方法 研究对象选自2011年9月至2012年3月在同济医学院附属同济医院门诊就诊的6～12岁中重度过敏性鼻炎患儿.将患儿按就诊时间的先后顺序用随机数字法分为2组:联合用药组和单独用药组.联合用药组采用糠酸莫米松鼻喷雾剂100 μg/d联合孟鲁斯特钠咀嚼片5 mg/d,单独用药组单用糠酸莫米松鼻喷雾剂100 μg/d治疗,疗程均为2周.治疗第7、14天采用0～10 cm视觉模拟量表进行过敏性鼻炎总体症状和喷嚏、流涕、鼻痒、鼻塞症状评分,记录不良反应.结果 共入选患儿252例.联合用药组127例,男54例,女73例,平均年龄(8.1±2.6)岁;单独用药组125例,男58例,女67例,平均年龄(8.7±3.0)岁.2组患儿性别、年龄分布、病程、鼻炎总体症状及单个症状评分比较差异均无统计学意义(均P>0.05).联合用药组有2例患儿因用药后出现关节疼痛、腹痛和睡眠障碍而退出研究.与治疗前相比,治疗第7、14天鼻炎总体症状评分联合用药组分别下降(4.7±1.9)和(5.5±2.2)分(2.6±1.7)、(1.8±1.7)分比(7.3±1.3)分],单独用药组下降(3.9±2.2)和4.9±1.7分(3.2±2.0)、(2.3±2.1)分比(7.2±1.5)分],差异均有统计学意义(均P<0.05),联合用药组改善程度优于单独用药组(P<0.05).单项症状评分中,治疗第7、14天联合用药组对流涕和鼻塞症状的疗效均优于单独用药组(均P<0.05).联合用药组有5例发生不良反应(3.9%),其中与糠酸莫米松鼻喷雾剂相关的不良反应为鼻出血(2例)和鼻腔干燥(1例),与孟鲁斯特钠咀嚼片相关的不良反应为关节疼痛、腹痛(1例)和睡眠障碍(1例);单独用药组有4例发生不良反应(3.2%),鼻腔干燥和鼻出血各2例.2组间不良反应发生率差异无统计学意义(P>0.05).2组患儿不良反应均较轻微,停药后很快自行缓解.2组均无严重不良反应发生.结论 糠酸莫米松鼻喷雾剂联合孟鲁斯特钠咀嚼片治疗儿童中重度过敏性鼻炎疗效优于单用糠酸莫米松鼻喷雾剂,且安全性良好.

Efficacy and safety of concomitant use of mometasone furoate nasal spray and montelukast sodium chewable tablets in children with moderate to severe allergic rhinitis

Objective To evaluate the efficacy and safety of concomitant use of mometasone furoate nasal spray and montelukast sodium chewable tablets in children with moderate to severe allergic rhinitis.Methods The subjects were selected from the children who were aged from 6 to 12 with moderate to severe allergic rhinitis and presented to outpatient department of Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology from September 2011 to March 2012.According to the time order of treatment,the children were divided into the following 2 groups using randomized digital table: the combination therapy group and the mono-drug therapy group.The children were treated with mometasone furoate nasal spray 100 μg once daily plus one chewable tablet of montelukast sodium 5 mg once daily in the combination therapy group and mometasone furoate nasal spray alone 100 μg once daily in the mono-drug therapy group.The treatment course was 2 weeks in the 2 groups.On days 7 and 14 of treatment,the symptoms of allergic rhinitis were scored using 0-10 cm visual analogue scale,the adverse reactions were recorded,and the statistical analysis were performed in the 2 groups.Results A total of 252 children were entered in this study.The combination therapy group comprised 127 children,including 54 boys and 73 girls with average age of(8.1±2.6) years.The mono-drug therapy group comprised 125 children,including 58 boys and 67 girls with average age of(8.7±3.0) years.The differences in gender,age distribution,treatment course,general symptoms of allergic rhinitis,and single symptom of allergic rhinitis between the 2 groups were not statistically significant(P>0.05).Two children were withdrawn from the study due to joint pain,abdominal pain,and sleep disorders after the drug use.Compared with the scores before treatment,the scores of general symptoms of allergic rhinitis on days 7 and 14 of treatment decreased by(4.7±1.9) and(5.5±2.2) scores (2.6±1.7) and(1.8±1.7) vs(7.3±1.3) scores] in the combination therapy group,(3.9±2.2) and(4.9±1.7) scores (3.2±2.0) and(2.3±2.1) scores vs(7.2±1.5) scores] in the mono-drug therapy group.The differences before and after treatment in the 2 groups were statistically significant(P<0.05 for all comparison).The efficacy in the combination therapy group was better than that in the mono-drug therapy group(P<0.05).On days 7 and 14 of treatment,the efficacy for single symptom of runny nose or stuffy nose in children in the combination therapy group were better than that in the mono-drug therapy group(P<0.05 for all comparison).The differences in runny nose and stuffy nose scores between the 2 groups were statistically significant(P<0.05).The differences in sneezing and itchy nose scores between the 2 groups were not statistically significant(P>0.05).Five children presented with adverse reactions in the combination therapy group(3.9%);of them,mometasone furoate nasal spray-related adverse reactions were nasal bleeding(2 cases) and dry nose(1 case),and montelukast sodium chewable tablets-related adverse reactions were joint pain,abdominal pain(1 case),and sleep disorders(1 case).Four children(3.2%) in the mono-drug therapy group presented with adverse reactions,including 2 cases of nasal bleeding and 2 cases of dry nose.The difference in adverse reaction incidence between the 2 groups was not statistically significant(P>0.05).All adverse reactions in the 2 groups were mild,and resolved soon after drug withdrawal.No severe adverse reactions occurred in the 2 groups.Conclusion The efficacy of the concomitant use of mometasone furoate nasal spray and montelukast sodium chewable tablets is better than that of mometasone furoate nasal spray alone.The combination therapy has a good safety.