Clinical Study On Combined Treatment Of Different Medicines On Children Ages5and Up With Moderate Persistent Asthma

Purpose: To study the clinical therapeutic effect of two different combinedtreatments：inhaled corticosteroids (ICS)+long acting beta2agonists（LABA）and ICS+leukotriene receptor antagonist（LTRA) on children ages5and up with moderate persistentasthma, so as to provide subjective clinical support for reasonable treatment on childrenages5and up with moderate persistent asthma.Method: Randomly divide the60children ages5and up with moderate persistentasthma from May2013to May2014into two groups: Group A (ICS+LABA treatmentgroup) and Group B (ICS+LTRA treatment group). There are30such children in Group A,given Seretide50μg./100μg (produced by GlaxoSmithKline, each inhale containsSalmeterol50μg and Fluticasone propionate100μg) for treatment, one inhale every time,twice per day. Meanwhile there are also30such children in Group B, given Flixotide(produced by GlaxoSmithKline, each inhale contains Fluticasone propionate125μg) fortreatment, applying storage tank with mouth containing device to inhale, one inhale everytime, twice per day, combined with Singular(produced by Merck, each includingMontelukast sodium5mg),one pill each time, once a day. Observe the indexes such asdaytime symptom, night symptom/suffocated, the appliance of emergency medicine,activity limitation, acute onset frequency, children asthma control test (C-ACT) grade,peripheral blood eosinophilic(EOS) level, lung function before treatment, after four-weektreatment, and after twelve-week treatment respectively. Meanwhile, observe the nasalimprovement of children with allergic rhinitis in both group, and observe all children’scompliance and correctness of drug use as well as adverse reaction of drug.Results:1. Asthma control level comparison of two groups before and after treatment:before treatment, all patients of two groups were not control, comparison between twogroups has no statistical meaning. After four-week treatment, the overall response rate of Group A is86.67%,Group B is73.33%. Group A is higher than Group B,with statisticaldifference (p＜0.05). After twelve-week of treatment, overall response rate Group A is100%，Group B is96.673%. Group A compared to Group B is not obvious, with nostatistical difference (p＞0.05).2. C-CAT grades comparison of two groups before and after treatment: the C-ACTgrades of tow groups before treatment were16.27±1.23and16.23±1.22，comparisonbetween two groups before treatment does not have statistical meaning (p＞0.05). ForInternal comparison after treatment, after four-week and twelve-week treatment, C-ACTgrades comparison inside Group A has statistical meaning (p <0.05), and C-ACT gradescomparison inside Group B also has statistical meaning (p<0.05). Comparison betweengroups, after four-week treatment, C-ACT grades of Group A have more obvious increase,with statistical difference (p＜0.05), while after twelve-week treatment, the C-ACT gradesof the two groups have no statistical difference (p>0.05).3. Peripheral blood EOS level comparison of two groups before and after treatment:peripheral blood EOS level comparison before treatment, the difference has no statisticalmeaning (p＞0.05). After treatment, comparisons inside groups both have statisticalmeaning (p＜0.05); comparison between two groups, peripheral blood EOS level has moreobvious decrease in Group B (p＜0.05), with statistical meaning.4. Lung function comparison of two groups before and after treatment: beforetreatment, there were no significant differences in each index of lung function in the twogroups (p＞0.05). Comparison after four-week, twelve-week treatment; indexes’ sdifferences of lung function between two groups have statistical meaning (p＜0.05).Comparison between groups, after four-week treatment, improvement in FEV1%、PEF%,and FEF25%、FEF50%、FEF75%in Group A is obvious, has statistical meaning,(p valueof all indexes＜0.05). After twelve-week treatment, there is no obvious difference in theabove lung function indexes of two groups, has no statistical meaning (p value of allindexes＞0.05).5. Nasal improvement of children with allergic rhinitis: after the four-week treatment,children with allergic rhinitis in Group B get improvement in their nasal symptom, aftertwelve-week treatment, they have obvious nasal improvement, while children in Group A have no improvement for their allergic rhinitis.6. Observe two groups of compliance and correctness of drug use: for Group A:preschool children are difficult to grasp inhalation technique, so preschool children haverelatively weaker compliance, while children at school age are ideal. For Group B,preschool children can be used correctly, the compliance is good.7. Observation on adverse reaction: there are two patients having adverse reaction inGroup A (6.6%), a child feel palpitation and another child have voice hoarse symptoms.And one patient in Group B (3.3%),feel pharynx part indisposed. The adverse reactionsymptom is slight, which will naturally disappear after one week without treatment. Nostatistical difference between two groups (p＞0.05).Conclusion:1.Applying the two combined treatments ICS+LABA and ICS+LTRA tocure children ages5and up with moderate persistent asthma, two groups has good curativeeffect after twelve-week treatment， and the two treatments have equivalent effect.ICS+LABA combined treatment can faster relieve clinical symptom and improve the lungfunction. For children asthma complicated with allergic rhinitis, combined treatment withLTRA can better improve the nasal symptom, and lower the peripheral blood EOS level.2.For preschool children, we suggest applying ICS+LTRA treatment so as to improvecompliance and correctness of drug use.3. The C-ACT and lung function have goodcorrelation in judging asthma control level, which is easier to be accepted by children andparents. Therefore, C-ACT is easier to be implemented in primary-level hospitals, and isworth promoting in pediatric asthma department.