| BackgroundAsthma is a heterogeneous disease with different clinical courses and treatment responses.Classic asthma(CA)can be quickly diagnosed and treated based on its symptoms and related tests.However,atypical asthma is often misdiagnosed due to the dearth of asthmatic symptoms and wheezing.Cough variant asthma(CVA)is a subtype of bronchial asthma.In China,nearly one-third of patients with chronic cough are diagnosed with CVA.Unlike classic asthma(wheezing,shortness of breath and chest tightness),cough can be the sole presenting symptom of CVA and often accompanied with irritating cough at night,affecting the life quality of patients in various degrees.CVA has the same pathophysiologic features and eosinophilic airway inflammation as CA.However,about 30%to 40%CVA patients will develop into CA due to overlook.Thus,it is necessary to study and better understand the pathogenesis of asthma to improve the life quality of patients with CVA.And more importantly,the study can largely reduce the possibility of being developed into CA in the future and thus delay the damage of lung function.Aim:To investigate the clinical efficacy and prognosis of two different initial doses of budesonide/formoterol combined with montelukast in patients with CVA,explore the risk factors of recurrence and provide theoretical basis for clinical treatmentMethods:A total of one hundred newly diagnosed subjects were randomly assigned to two groups:group A(n=50),budesonide/formoterol 160?g/4.5?g twice daily,and group B(n=50),budesonide/formoterol 320?g/9.0?g twice daily.The treatment will last for six months continuously,and during which,montelukast(10mg/tablet,once daily)was added in the initial three-month.Follow-up was performed at the end of 3-month,6-month,9-month and 12-month after the enrollment.At each visit,subjects underwent cough-related questionnaires,pulmonary function tests,blood drawing tests,induced sputum tests and other related examinations.The primary end point was recurrence rate of cough.Subjects who completed all visits were included in the final statistical analysis.Results:During twelve months of follow-ups,78 eligible subjects were finally included in the analysis:group A(n=38)and group B(n=40).There was no significant difference between the two groups at baseline(P>0.05).After treatment,forced expiratory volume in one second(FEV1)/predicted%in group B increased gradually,and group A was much improved compared with B since the third visit(P<0.05).The maximal mid expiratory flow(MMEF)and peak expiratory flow(PEF)increased in both groups,but the increase of MMEF appeared earlier in group B.Bronchial provocation test showed that more subjects in group B presented a decrement in airway responsiveness(P<0.05).In the study,the percentage of sputum eosinophils(EOS%)was decreasing in both,however,group B improved better(P<0.05).At the same time,the value of exhaled nitric oxide(FeNO)in group B continued to decrease throughout the follow-up and more pronounced than group A since the 6-month visit(P<0.05).After treatment,daily cough scores and Leicester Cough Questionnaire(LCQ)life quality scores were significantly improved,nevertheless,the improvements were superior in group B at most visits.Furthermore,the levels of inflammatory cytokines(TNF-?,IL-4,and IL-5)attenuated to some extent in both groups(P<0.05),and the decrement in group A was after group B.Throughout the study,the recurrence rate in group A was considerably higher than group B(40%versus 10%;P<0.05).Drug-related adverse reactions were less,and there was no statistical difference between two groups(P>0.05).Regression analysis found that the onset of the CVA,cough symptom scores,MMEF,PD20-FEV1 and treatment protocols were all independent prognostic factors for CVA recurrence.Conclusions:Higher doses of anti-inflammatory regimens for initial treatment of CVA had advantages in the control of clinical symptoms and airway inflammation,as well as its prognosis,and it was well tolerated.Adults who had an early onset of the cough,combined with poor small airway function and airway hyperresponsiveness,meanwhile gained low cough symptom scores were more likely to relapse after insufficient treatment.(Chinese Clinical Trial Registry:ChiCTR-OOD-16008838)... |
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