Comparison of the efficacy and safety of ciclesonide 160 μg once daily vs. budesonide 400 μg once daily in children with asthma

Ciclesonide is an onsite-activated inhaled corticosteroid (ICS) for the treatment of asthma. This study compared the efficacy, safety and effect on quality of life (QOL) of ciclesonide 160 microg (ex-actuator; nominal dose 200 microg) vs. budesonide 400 microg (nominal dose) in children with asthma. Six hundred and twenty-one children (aged 6-11 yr) with asthma were randomized to receive ciclesonide 160 microg (ex-actuator) once daily (via hydrofluoroalkane metered-dose inhaler and AeroChamber Plus spacer) or budesonide 400 microg once daily (via Turbohaler) both given in the evening for 12 wk. The primary efficacy end-point was change in forced expiratory volume in 1 s (FEV1). Additional measurements included change in daily peak expiratory flow (PEF), change in asthma symptom score sum, change in use of rescue medication, paediatric and caregiver asthma QOL questionnaire [PAQLQ(S) and PACQLQ, respectively] scores, change in body height assessed by stadiometry, change in 24-h urinary cortisol adjusted for creatinine and adverse events. Both ciclesonide and budesonide increased FEV1, morning PEF and PAQLQ(S) and PACQLQ scores, and improved asthma symptom score sums and the need for rescue medication after 12 wk vs. baseline. The non-inferiority of ciclesonide vs. budesonide was demonstrated for the change in FEV1 (95% confidence interval: -75, 10 ml, p = 0.0009, one-sided non-inferiority, per-protocol). In addition, ciclesonide and budesonide showed similar efficacy in improving asthma symptoms, morning PEF, use of rescue medication and QOL. Ciclesonide was superior to budesonide with regard to increases in body height (p = 0.003, two-sided). The effect on the hypothalamic-pituitary-adrenal axis was significantly different in favor of ciclesonide treatment (p < 0.001, one-sided). Both ciclesonide and budesonide were well tolerated. Ciclesonide 160 microg once daily and budesonide 400 microg once daily were effective in children with asthma. In addition, in children treated with ciclesonide there was significantly less reduction in body height and suppression of 24-h urinary cortisol excretion compared with children treated with budesonide after 12 wk.     

Evaluation of clinical and immunological effects of inactivated influenza vaccine in children with asthma

Although annual influenza vaccinations are recommended by many authorities, some doctors may be reluctant to vaccinate asthmatic children because of the risk of inducing bronchial reactivity and exacerbating the asthma. In this study, the effect of split influenza vaccine on clinical symptoms, airway responsiveness and its influence on T lymphocytes was evaluated. Twenty-one asthmatic children with stable asthma were recruited and divided into two groups. Eleven patients who received the influenza vaccine formed the vaccination group and 10 patients who received a placebo formed the placebo group. Forced expiratory volume in 1 s ( FEV ₁), airway response (PC₂₀ methacholine, PC₂₀ = provocation concentration causing a 20% fall in FEV ₁) and the T lymphocyte subset ratio (Th1/Th2) were recorded on day 1 pre-vaccination and day 14 post-vaccination. Patients were also asked to record their peak expiratory flow (PEF) every morning and evening and to complete daily symptom scores over the period of 2 weeks. There were no significant changes in PC₂₀, FEV ₁, PEF variability, symptom scores and the Th1/Th2 ratio between the vaccination and placebo groups between day 1 pre-vaccination and day 14 post-vaccination. Similar results of PEF variability and asthma symptom score were obtained when the analysis was restricted to the day 1 pre-vaccination and day 3 post-vaccination. Immunization with split influenza vaccine does not exacerbate asthma in children either with a clinical or immunological effect. These results suggest that children with stable asthma can safely be immunized with a split influenza vaccine.     

妥洛特罗贴剂治疗咳嗽变异性哮喘的有效性和安全性研究

目的评价妥洛特罗贴剂治疗咳嗽变异性哮喘的有效性和安全性。方法将100例咳嗽变异性哮喘患儿随机分成试验组和对照组,每组各50例。两组均给予抗组胺药和选择性白三烯受体拮抗剂,试验组加用妥洛特罗贴剂。比较两组症状评分、症状总积分改善的百分率、呼气峰流速(PEF)评分及不良反应的发生情况。结果试验组的症状评分明显下降,与对照组比较差异有统计学意义(P<0.05);试验组总积分改善的百分率在观察后期达到临床控制,与对照组比较差异有统计学意义(P<0.05);两组PEF评分差异无统计学意义(P>0.05)。结论妥洛特罗贴剂治疗咳嗽变异性哮喘疗效显著,安全可靠。     

Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma

OBJECTIVE: To evaluate efficacy, safety, health outcomes, and cost-effectiveness of fluticasone propionate (FP) versus montelukast (MON) in 342 children (6 to 12 years of age) with persistent asthma. STUDY DESIGN: Randomized, double-blind, 12-week study of treatment with FP inhalation powder 50 mug twice daily or MON chewable 5 mg once daily for 12 weeks. RESULTS: Compared with MON, FP significantly increased mean percent change from baseline FEV1 (forced expiratory volume in 1 second) (P=.002), morning PEF (peak expiratory flow) (P=.004), evening PEF (P=.020), and percent rescue-free days (P=.002) at end point, and it significantly reduced nighttime symptom scores (P <.001) and mean total (P=.018), and nighttime (P <.001) albuterol use. Withdrawals from the study were more frequent with MON (21%) than with FP (13%). Adverse events (69% vs 71%) and mean end point to baseline 12-hour urinary cortisol excretion ratios were similar. Parents and physicians were more satisfied with FP treatment than with MON (P=.006 and P=.016, respectively, at Week 12). Mean total daily asthma-related cost per patient in the FP group was approximately one-third of that in the MON group ($1.25 vs $3.49). CONCLUSION: FP was significantly more effective than MON in improving pulmonary function, asthma symptoms, and rescue albuterol use. Both therapies had similar safety profiles. Parent- and physician-reported satisfaction ratings were higher with FP treatment, and asthma-related costs were lower.     

Budesonide/formoterol improves lung function compared with budesonide alone in children with asthma.

We aimed to compare the efficacy and safety of budesonide/formoterol (Symbicort) with budesonide alone (Pulmicort) or budesonide (Pulmicort) and formoterol (Oxis) administered via separate inhalers in children with asthma. In a 12 wk, double-blind study, a total of 630 children with asthma (mean age 8 yr [4-11 yr]; mean forced expiratory volume in 1 s (FEV(1)) 92% predicted; mean inhaled corticosteroid dose 454 microg/day) were randomized to: budesonide/formoterol (80/4.5 microg, two inhalations twice daily); a corresponding dose of budesonide alone (100 microg, two inhalations twice daily); or a corresponding dose of budesonide (100 microg, two inhalations twice daily) and formoterol (4.5 microg, two inhalations twice daily) (budesonide + formoterol in separate inhalers). The primary efficacy variable was the change from baseline to treatment (average of the 12-wk treatment period) in morning peak expiratory flow (PEF). Other changes in lung function and asthma symptoms were assessed, as was safety. Budesonide/formoterol significantly improved morning PEF, evening PEF and FEV(1) compared with budesonide (all p < 0.001); there was no significant difference between budesonide/formoterol and budesonide + formoterol in separate inhalers for these variables. All other diary card variables improved from baseline in all treatment groups; there were no significant between-group differences. Adverse-event profiles were similar in all groups; there were no serious asthma-related adverse events in any treatment group. Conclusion: budesonide/formoterol significantly improved lung function in children (aged 4-11 yr) with asthma compared with budesonide alone. Budesonide/formoterol is a safe and effective treatment option for children with asthma.     

Treatment compliance, passive smoking, and asthma control: a three year cohort study.

AIMS: To study the role of treatment compliance and parents' smoking on asthma control in children with recently diagnosed mild or moderate persistent asthma who were prescribed inhaled anti-inflammatory treatment. METHODS: Prospective cohort study of 167 children aged 6-12 years (64% boys). Patients were examined at inclusion and followed up for three years with a visit every four months. Peak expiratory flow (PEF) was measured twice a day during the week before each visit. Two control criteria were monitored: (1) symptom control = having diurnal or nocturnal exacerbations less than once a week and no symptoms between exacerbations, at all visits; and (2) PEF control = daily PEF variability <20% on each of the seven days before each visit. RESULTS: Symptom control was achieved by 25.1% of children and PEF control by 53.3%. Symptom control was positively related to having understood the way in which the medication worked and taking the prescribed doses (odds ratios (OR) = 3.38 and 4.82 respectively). It was inversely related to smoking within the home (OR = 0.34). PEF control was positively related to taking the prescribed doses (OR = 3.58). It was less frequently achieved if the mother smoked within the home (OR = 0.34). CONCLUSIONS: Results suggest that, to maximise the benefits of available asthma medication and to improve health outcomes, further efforts should be made to convince the parents of asthmatic children not to smoke in the house, and to improve compliance by increasing the patients' understanding of the disease and its treatment.     

Efficacy and safety of montelukast as monotherapy in children with mild persistent asthma

OBJECTIVE: To study the efficacy and tolerability of montelukast as monotherapy in the treatment of mild persistent bronchial asthma. DESIGN: Open, non-comparative, prospective, 12-month study. SETTING: Asthma clinic in urban multi-speciality trust hospital. METHODS: Children (age 3-11 yrs) with mild persistent asthma, not on any prophylactic drugs were enrolled consecutively (from January to December 2003) and started on 4 mg (2-4 yrs) or 5mg (<4 yrs) montelukast for a period of 12 weeks. Efficacy was assessed by improvements in clinical score, peak expiratory flow rates (PEFR), spirometry measurements and reduction in reliever drug requirement after 4 and 12 weeks of therapy. Side effects were also judged after 12 weeks of therapy. RESULTS: 50 children (mean age 5.41 +/-2.11 years) completed the study. There was association with positive family history (92%), allergic rhinitis (64%), exercise induced asthma (40%), cough variant asthma (24%), seasonal asthma (80%) and high IgE (12%) levels. Clinical scores, viz, activity, wheeze and cough, improved effectively from (1.64 +/-0.5253) at baseline to (0.7 +/-0.7071) and (1.72 +/-0.701) to (0.92 +/-0.6952) and (1.5 +/-0.6145) to (0.88 +/-0.8241) respectively after 12 weeks of therapy. Significant clinical improvement (p >0.001) was also noted after 4 weeks of therapy. Peak expiratory flow rates (done in 19 cases) documented improvement from (120.21 +/-12.23) at baseline to (135.41 +/-23.34) after 12 weeks. FEV1 / FVC (done in 11 cases) improved from (71.44 +/-1.35%) to (87.10 +/-8.34%) after 12 weeks. Mean improvement in all the parameters demonstrated P value less than >.001. A total of 19 of 50 cases showed mild side-effects as anorexia (16%), elevated liver function tests (18%) and headache (10%). CONCLUSION: The clinical outcome showed significant improvement (p < 0.01) after 4 and 12 weeks.     

粉尘螨滴剂舌下特异性免疫治疗对儿童咳嗽变异性哮喘的有效性

目的：探讨粉尘螨滴剂舌下特异性免疫（SLIT）治疗对儿童咳嗽变异性哮喘的有效性及安全性。方法：将确诊为咳嗽变异性哮喘并且粉尘螨变应原皮肤点刺试验呈阳性反应的106例4～14岁患儿随机分为SLIT组（n=53）和常规治疗组（n=53）。常规治疗组按照儿童哮喘规范化治疗方案治疗,SLIT组在常规规范化治疗的基础上,加用舌下含服粉尘螨滴剂。观察两组患儿治疗后咳嗽哮喘症状评分改善情况及临床症状开始改善的时间,同时检测血嗜酸性粒细胞（EOS）水平以及最大呼气峰流速(PEF)的变化。记录两组不良反应发生情况。结果：治疗25周后,SLIT组的症状评分降低值、PEF升高幅度及血EOS比例下降程度均显著高于常规治疗组,差异均有统计学意义（P＜0.05）;SLIT组症状改善时间较常规治疗组短,差异亦有统计学意义（P＜0.05）。SLIT组的有效率显著高于常规治疗组,差异有统计学意义（85% vs 68%,P＜0.05）。SLIT组部分患儿出现红、肿、瘙痒等局部反应,均于次日自行消失。结论：粉尘螨滴剂舌下免疫对儿童咳嗽变异性哮喘具有良好的效果,且安全性高。     

Treatment compliance,passive smoking,and asthma control: a three year cohort study

Aims: To study the role of treatment compliance and parents'' smoking on asthma control in children with recently diagnosed mild or moderate persistent asthma who were prescribed inhaled anti-inflammatory treatment. Methods: Prospective cohort study of 167 children aged 6–12 years (64% boys). Patients were examined at inclusion and followed up for three years with a visit every four months. Peak expiratory flow (PEF) was measured twice a day during the week before each visit. Two control criteria were monitored: (1) symptom control = having diurnal or nocturnal exacerbations less than once a week and no symptoms between exacerbations, at all visits; and (2) PEF control = daily PEF variability <20% on each of the seven days before each visit. Results: Symptom control was achieved by 25.1% of children and PEF control by 53.3%. Symptom control was positively related to having understood the way in which the medication worked and taking the prescribed doses (odds ratios (OR) = 3.38 and 4.82 respectively). It was inversely related to smoking within the home (OR = 0.34). PEF control was positively related to taking the prescribed doses (OR = 3.58). It was less frequently achieved if the mother smoked within the home (OR = 0.34). Conclusions: Results suggest that, to maximise the benefits of available asthma medication and to improve health outcomes, further efforts should be made to convince the parents of asthmatic children not to smoke in the house, and to improve compliance by increasing the patients'' understanding of the disease and its treatment.     

Montelukast added to budesonide in children with persistent asthma: a randomized, double-blind, crossover study

OBJECTIVE: We tested the hypothesis that adding montelukast to budesonide would improve asthma control in children with inhaled glucocorticoid-dependent persistent asthma. STUDY DESIGN: In a multicenter, randomized, double-blind, crossover study, we compared the benefit of adding montelukast, 5 mg, or placebo once daily to budesonide, 200 microg, twice daily. RESULTS: After a 1-month run-in with budesonide, 200 microg, twice daily, 279 children were randomized to montelukast or placebo. The mean +/- SD age was 10.4 +/- 2.2 years, the mean forced expiratory volume in 1 second (FEV(1)) was 77.7% +/- 10.6% predicted, and reversibility was 18.1% +/- 12.9%. Compared with adding placebo to budesonide, adding montelukast produced significant improvements in mean percent change from baseline FEV(1) (P =.062 [P =.010 for per-protocol analysis]), mean absolute change from baseline FEV(1) (P =.040), mean increase from baseline in morning (P =.023) and evening (P =.012) peak expiratory flows, decrease in exacerbation days by approximately 23% (P <.001), decreased beta2-agonist use (P =.013), and reduced blood eosinophil counts (P <.001). The treatments did not differ significantly with regard to safety. CONCLUSIONS: Montelukast, 5 mg, added to budesonide improved asthma control significantly, indicated by a small additive effect on lung function and a clinically relevant decrease in asthma exacerbation days.     

Hand-held turbine spirometer: Agreement with the conventional spirometer at baseline and after exercise

Portable hand-held spirometers are widely used in outpatient clinics and in field surveys when examining children for asthma. However, the validity of the results obtained from the hand-held spirometers has not been assessed in population-based studies. We evaluated the agreement between the forced expiratory volume (FEV1) values got by the conventional flow volume spirometer (FVS) and the pocket-sized turbine spirometer (TS) at baseline and after exercise, among the 212 children screened for asthma and asthma-like symptoms from a population of 1633 school-aged children. The comparison was made between and within three diagnostic groups: clinical asthma (n = 34), possible asthma (n = 31), and controls (n = 147). In general, the differences in FEV1 between the FVS and the TS were small. For all children, the mean difference in FEV1 and the limits of agreement (difference +/-2 s.d.) was 0.05 l (0.23 to -0.13) at baseline and 0.06 l (0.24 to -0.12) after exercise. No significant differences were observed in the agreement between the diagnostic groups. In conclusion, although FEV1 results obtained by the hand-held spirometer are not interchangeable with those by the conventional spirometer, they are in reasonable agreement. The agreement is similar both at baseline and after exercise, and is not influenced by the presence of asthma.     

A doctor's ability to assess the severity of childhood asthma by simple clinical features

Aims: To ascertain whether the severity of childhood asthma can be reliably assessed by simple clinical features, 94 newly diagnosed, school-aged asthmatic children were investigated. Methods: The study included parental interviews, physical examination, skin prick tests, lung function studies, including a brief visual interpretation of the flow-volume curve, and a 6-min exercise challenge test on a treadmill, which was used as a reference. Results: Baseline lung function studies showed a concave-shaped flow-volume curve in 40 (43%) patients, reduced maximal mid-expiratory flow (MMEF) in 25 (27%) and a reduced ratio of forced expiratory volume in 1 s to forced vital capacity (FEV₁/FVC) in 14 (15%). The drop in peak expiratory flow (PEF) after exercise ranged from 0 to 79% of the baseline (mean 21.3%) and exceeded 12.5% in 52 (55%) patients. There was a small but significant correlation between the baseline FEV₁/FVC and MMEF values and the response to exercise (r=-0.39 and -0.35; p=0.000, respectively), but when studied by linear regression analysis, the response to exercise was best predicted by the past symptom rate and a concave pattern in the pre-test maximal expiratory flow-volume curve. The values of traditional lung function tests or age, atopy, duration of symptoms or history of exercise-induced wheezing did not remain in the model.

Conclusions: These results show that the severity of asthma in school-aged children can be predicted at the first visit based on the past rate of symptoms and a visual interpretation of the maximal expiratory flow-volume curve.     

Low‐dose budesonide improves exercise‐induced bronchospasm in schoolchildren

The aim of this study was to compare the clinical efficacy of low‐dose inhaled budesonide (once or twice daily) and placebo, administered via Turbuhaler^®, on exercise‐induced bronchoconstriction (EIB) in children with mild asthma. Fifty‐seven steroid‐naive children (7–16 years old; 41 boys, 16 girls) with EIB participated in this sub‐population study according to the following inclusion criterion: a maximum fall in forced expiratory volume in 1 s ( FEV ₁) ≥ 10% after a standardized treadmill test. Mean baseline FEV ₁ was 100.3% of predicted, and mean maximum fall in FEV ₁ after the standardized exercise test was 22%. The study was a double‐blind, randomized, parallel‐group design. After 2 weeks of run‐in, the children received inhaled budesonide 100 µg or 200 µg once daily in the morning, 100 µg twice daily, or placebo, for 12 weeks. After 12 weeks of treatment, the fall in FEV ₁ after the exercise test was significantly less in all three budesonide groups (7.2–7.8%) vs. placebo (16.7%). Daytime symptom scores were significantly lower in all three budesonide groups compared with placebo (p < 0.02). The three budesonide groups did not differ significantly, and no significant change in lung function was found in any group. Therefore children with mild asthma, but with significant EIB, improved their exercise tolerance and symptom control after 3 months of treatment with a low dose of inhaled budesonide given once or twice daily.     

Effect of formoterol on clinical parameters and lung functions in patients with bronchial asthma: a randomised controlled trial.

AIMS: To determine the role of formoterol in the treatment of children with bronchial asthma who are symptomatic despite regular use of inhaled corticosteroids. METHODS: A randomised, double blind, parallel group, placebo controlled study to investigate the effects of inhaled formoterol (12 microg twice a day) in 32 children with moderate to severe bronchial asthma. The study consisted of two week run in periods and six week treatment periods, during both of which the patients continued their regular anti-inflammatory drugs. The efficacy parameters were symptom scores, bronchodilator use, daily peak expiratory flow rates (PEFR), methacholine hyper-reactivity, forced expiratory volume in one second (FEV1), lung volumes, and airway conductance. RESULTS: Formoterol treatment for six weeks decreased symptom scores, PEFR variability, and the number of rescue salbutamol doses, and increased morning and evening PEFR significantly. No adverse reactions were seen. CONCLUSION: These findings suggest that inhaled formoterol is effective in controlling chronic asthma symptoms in children who are symptomatic despite regular use of inhaled corticosteroids.     

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目的观察布地耐德(BUD)联用福莫特罗(FOM)与单用双倍剂量BUD干粉吸入疗法对轻度持续性哮喘患儿的有效性和安全性,探讨儿童轻度持续性哮喘的理想治疗方案。方法选取2005-01—2005-06在广州医学院附属第一医院呼研所专科门诊就诊的轻度持续哮喘患儿50例,采取开放、随机、平行对照方法把50例患儿分为两组,分别吸入BUD联用FOM(B+F组)或双倍剂量BUD(Double B组)8周,药物均用都保干粉吸入装置吸入。8周的观察期内由患儿或家长记录哮喘日记,包括日间和夜间症状评分、无症状天数、其它平喘药物(包括应急用速效β2-受体激动剂、长效缓释茶碱、口服长效β2-受体激动剂、全身用糖皮质激素)使用情况,同时以简易峰流速仪监测其呼气峰流速值(PEF)作为主要肺功能指标。结果B+F组和Double B组在治疗8周后,日间症状及PEF均较治疗前明显改善,无症状天数明显增加,差异具有统计学意义(均P<0.05);与治疗前比较,B+F组在治疗8周后夜间症状评分明显下降(P<0.05),而Double B组治疗前后比较差异无统计学意义(P>0.05);两组间日间症状评分、夜间症状评分、无症状天数及PEF治疗前及治疗后比较差异均无统计学意义(均P>0.05)。两组间病情反复发作次数、需联合应用速效β2-受体激动剂次数及口服强的松、长效缓释茶碱或口服长效β2-受体激动剂的天数均无统计学意义(均P>0.05)。结论低剂量吸入糖皮质激素(ICS)联用长效β2-受体激动剂(LABA)与单用双倍剂量ICS治疗儿童轻度持续性哮喘的疗效相当。但从减少或避免ICS潜在的全身性副反应方面考虑,联用低剂量ICS+LABA可能是更好的选择。     

妥洛特罗贴剂治疗咳嗽变异性哮喘的疗效

目的 观察妥洛特罗贴剂治疗咳嗽变异性哮喘(CVA)患儿的临床疗效和安全性.方法 106例CVA患儿随机分为治疗组和对照组2组.治疗组在吸入性糖皮质激素的基础上给予妥洛特罗贴剂,用法:1～3岁0.5 mg,>3～9岁1.0 mg,>9～12岁 2.0 mg,每日1贴.对照组给予盐酸丙卡特罗片剂,用法:6岁以下1.25 μg·kg-1·次-1,6岁以上25 μg·次-1,2次·d-1.治疗2周后进行咳嗽症状评分,根据咳嗽程度的转变进行疗效判定,观察不良反应,并测定其1秒钟用力呼气容积(FEV1)、最大呼气峰流速(PEF),肺通气功能异常者(FEV1、PEF一项以上<80%)行支气管舒张试验,肺通气功能正常者行运动激发试验.结果 1.治疗组第3天咳嗽症状明显减轻,较对照组止咳见效时间更短(P＜0.05);2.治疗2周后,治疗组与对照组总有效率分别为90.4%、79.6%,2组总有效率比较差异有统计学意义(P＜0.05);3.治疗组较对照组治疗后FEV1、PEF明显改善(Pa＜0.05);4.妥洛特罗贴剂与盐酸丙卡特罗片剂在减轻呼吸道高反应性方面无显著差异(P＞0.05);5.妥洛特罗贴剂不良反应发生率低,依从性好.结论 妥洛特罗贴剂在儿童CVA治疗中疗效显著,安全可靠,依从性好.     

Cough, airway inflammation, and mild asthma exacerbation.

BACKGROUND: Prospective data on the temporal relation between cough, asthma symptoms, and airway inflammation in childhood asthma is unavailable. AIMS AND METHODS: Using several clinical (diary, quality of life), lung function (FEV(1), FEV(1) variability, airway hyperresponsiveness), cough (diary, cough receptor sensitivity (CRS)), and inflammatory markers (sputum interleukin 8, eosinophilic cationic protein (ECP), myeloperoxidase; and serum ECP) of asthma severity, we prospectively described the course of these markers in children with asthma during a non-acute, acute, and resolution phase. A total of 21 children with asthma underwent these baseline tests; 11 were retested during days 1, 3, 7, and 28 of an exacerbation. RESULTS: Asthma exacerbations were characterised by increased asthma and cough symptoms and eosinophilic inflammation. Sputum ECP showed the largest increase and peaked later than clinical scores. Asthma scores consistently related to cough score only early in the exacerbation. Neither CRS nor cough scores related to any inflammatory marker. CONCLUSION: In mild asthma exacerbations, eosinophilic inflammation is dominant. In asthmatic children who cough as a dominant symptom, cough heralds the onset of an exacerbation and increased eosinophilic inflammation, but cough scores and CRS do not reflect eosinophilic airway inflammation.     

哮喘和咳嗽变异性哮喘儿童肺常规通气功能的比较

目的：比较哮喘与咳嗽变异性哮喘（CVA）患儿肺常规通气功能的变化。方法：选择2010年 5月至2011年5月确诊为哮喘或CVA的患儿140例,分为哮喘急性发作组（发作组,50例）、哮喘缓解组（缓解组,50例）和CVA组（40例）;同期正常健康体检儿童30例作为对照组。测定4组儿童用力肺活量(FVC)、一秒钟用力呼气容积(FEV1)、最大呼气峰流速(PEF)、用力呼气25%流速(FEF25)、用力呼气50%流速(FEF50)、用力呼气75%流速(FEF75)、最大呼气中期流速(MMEF75/25)等7项肺功能指标。结果：发作组患儿各项肺功能指标如大气道指标FVC、FEV1、PEF、FEF25及小气道指标FEF50、FEF75、MMEF75/25的实际值/预计值平均水平均<80%,且以FEF50、FEF75、MMEF75/25等小气道指标下降为著。CVA组患儿小气道指标FEF75、MMEF75/25实际值/预计值的平均水平<80%。发作组各项肺常规通气功能指标均低于对照组;缓解组、CVA组FVC、FEV1、FEF25及 MMEF75/25实际值/预计值的平均水平低于对照组;发作组各项肺功能指标均明显低于缓解组和CVA组;CVA组与缓解组各项肺功能指标差异均无统计学意义。结论：哮喘急性发作期患儿存在大小气道功能障碍,以小气道功能障碍为主;CVA患儿以小气道功能轻微障碍为主,与哮喘缓解期相似。     

舌下含服粉尘螨滴剂治疗儿童过敏性哮喘和变应性鼻炎的临床评价

目的评估舌下特异性免疫治疗药物“粉尘螨滴剂”治疗儿童过敏性哮喘及变应性鼻炎的疗效及安全性。方法采用随机双盲、安慰剂平行对照的研究方法,将278例年龄4—18岁粉尘螨过敏的哮喘和（或）鼻炎患儿随机分为治疗组（139例）和安慰剂组（139例）,分别给予舌下含服“粉尘螨滴剂”或安慰剂,在治疗第2,3,4,6,10,14,18,22周进行随访,治疗第25周结束临床观察。对两组治疗前后的哮喘和鼻炎症状与体征评分、用药计分、肺功能及各项实验室指标、不良事件进行分析比较,并在试验结束前让患儿进行疾病转归的自我评价。结果（1）278例研究对象中,共251例完成试验;（2）治疗组过敏性哮喘患者PEF日内变异率改变量-1．38,而安慰剂组仅为-0．90（P〈0．05）;（3）治疗结束后,过敏性哮喘治疗组应急用药改变量较基线有所下降（x=-0．08）,而安慰剂组用药则有所增加（x=0．52）,两组用药剂量较基线改变量的差异有显著性（W=-2．45,P〈0．05）;（4）治疗组鼻炎患者每日症状积分改变量为-1．96,而安慰剂组为-1．03（W=3．90,P〈0．01）;（5）鼻炎患者安慰剂组应急用药量较基线改变量为0．01,治疗组为-0．25,但两组差异无统计学意义（W=1．40,P〉0．05）;（6）用药25周以后,两组血清特异性IgE（sIgE）水平较用药前无显著改变,而治疗组的血清特异性IgG4平均水平显著增高（P〈0．05）;（7）试验期间未发生严重不良事件,与研究药物可能有关的不良反应主要表现为哮喘轻度发作和局部皮疹。结论“粉尘螨滴剂”是一种安全有效治疗儿童过敏性哮喘和变应性鼻炎的舌下特异性免疫治疗药物。     

Central airways stenosis in school-aged children: differential diagnosis from asthma

This study assessed the value of spirometry and chest X-rays in the diagnosis of airways stenosis in the tracheal or laryngeal regions at school age. A series of 14 patients was studied. Six of them had vascular ring anomalies, four subglottic stenosis, two aberrant innominate artery, one tracheal stenosis and one a laryngeal web. Four patients were suffering from chronic cough and ten from dyspnoea, noisy breathing and cough upon physical exercise. Two had had their symptoms since infancy and five since 3-6 y of age, whereas seven had had their first symptoms at school age. Nine patients had previously been suspected of having asthma, and five of them had been using inhaled corticosteroids, one inhaled sodium cromoglycate and one peroral terbutaline without any effect. The ratio of forced expiratory volume in 1 s (FEV 1 ) to peak expiratory flow (PEF) was abnormally high in most of the patients. All six children with vascular ring anomalies also had an abnormal aortic configuration on a chest X-ray, and narrowing of the trachea was seen in two of the four with subglottic stenosis. Two children had both chest X-rays and spirometry values within the normal limits.

Conclusion: The results show that children with stenosis in the laryngeal or tracheal region may not have their first symptoms until school age. Many patients are falsely suspected of having asthma. Simple spirometry and chest X-rays will help the physician to make the correct diagnosis in these patients.