Efficacy and safety of fluticasone propionate hydrofluoroalkane inhalation aerosol in pre-school-age children with asthma: a randomized, double-blind, placebo-controlled study

OBJECTIVE: To evaluate the efficacy and tolerability of fluticasone propionate (FP) hydrofluoroalkane (HFA) in children age 1 to < 4 years with asthma. STUDY DESIGN: Children were assigned (2:1) to receive FP HFA 88 mug (n = 239) or placebo HFA (n = 120) twice daily through a metered-dose inhaler with a valved holding chamber and attached facemask for 12 weeks. The primary efficacy measure was mean percent change from baseline to endpoint in 24-hour daily (composite of daytime and nighttime) asthma symptom scores. RESULTS: The FP-treated children had significantly greater (P < or = .05) reductions in 24-hour daily asthma symptom scores (-53.9% vs -44.1%) and nighttime symptom scores over the entire treatment period compared with the placebo group. Daytime asthma symptom scores and albuterol use were slightly more decreased with FP than with placebo; however, the differences were not statistically significant. Increases in the percentage of symptom-free days were comparable. The percentage of patients who experienced at least 1 adverse event was similar in the 2 groups. Baseline median urinary cortisol excretion values were comparable between the groups, and there was little change from baseline at endpoint. FP plasma concentrations demonstrated that systemic exposure was low. CONCLUSIONS: FP HFA 88 mug twice daily was effective and well tolerated in pre-school-age children with asthma.     

Once-daily ciclesonide in children: efficacy and safety in asthma

OBJECTIVE: To compare the efficacy and safety of once-daily inhaled ciclesonide 40 mug (CIC40), 80 mug (CIC80), and 160 mug (CIC160) with placebo in children with persistent asthma of all severities. STUDY DESIGN: Overall, 1031 children age 4 to 11 years were randomized into 2 identical double-blinded, placebo-controlled, parallel group studies consisting of a run-in phase followed by 12 weeks of treatment. Both studies were designed to allow for a prespecified integrated analysis. The primary outcome variable was change in forced expiratory volume in 1 second (FEV(1)) percent predicted between baseline and study end; treatment comparisons were assessed using analysis of covariance. Additional endpoints included asthma symptom scores, daily albuterol use, and safety, including hypothalamic-pituitary-adrenal (HPA) axis function. RESULTS: Baseline characteristics were comparable; 59.4% of patients had moderate asthma, and 24.1% had severe asthma. All ciclesonide doses were associated with greater improvements in baseline to week 12 FEV(1) percent predicted versus placebo (CIC40, 11.97; CIC80, 13.58, P <.05; CIC160, 14.17, P < .01). Significant improvements in asthma symptoms (P < .01) and reductions in albuterol use were reported. Ciclesonide was well tolerated with no effect on HPA axis function. CONCLUSIONS: In this integrated analysis, ciclesonide was effective and well tolerated in children with persistent asthma.     

Efficacy and safety of high-dose inhaled steroids in children with asthma: a comparison of fluticasone propionate with budesonide

OBJECTIVE: To compare the efficacy and adverse effects of inhaled fluticasone propionate (FP), 400 microgram/d, with those of budesonide (BUD), 800 microgram/d, in children with moderate to severe asthma. METHODS: Three hundred thirty-three children, ages 4 to 12 years, receiving inhaled corticosteroids were enrolled in a double-blind, double-dummy, randomized, parallel-group study. After a 2-week run-in phase, 166 children received FP and 167 received BUD for 20 weeks. The primary outcome variable was mean morning peak expiratory flow; the 2 treatments were to be regarded as equivalent if the 90% CI for the treatment difference was within +/- 15 L/min. Pulmonary function, height, and diary cards were assessed at each visit; and morning serum cortisol levels were determined before and after treatment. RESULTS: Baseline peak expiratory flow was similar, FP 236 +/- 72 (SD) L/min and BUD 229 +/- 74, increasing after treatment to 277 +/- 41 and 257 +/- 28, a difference between treatments of 12 L/min (90% CI 6-19 L/min; P =.002). Symptom control and use of rescue medication were the same. Cortisol levels after treatment were 199 nmol/L (FP) and 183 nmol/L (BUD) (treatment ratio = 1.09; 90% CI 0.98-1.21; P =.172). Linear growth was less in those receiving BUD (mean difference, 6.2 mm; 95% CI 2.9-9.6; P =.0003). CONCLUSION: FP at half the dose was superior to BUD in improving peak expiratory flow and comparable in controlling symptoms. Growth was reduced with BUD compared with FP, but there was no difference in serum cortisol suppression or hepatic or renal function.     

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.     

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.     

Variability in asthma severity in pediatric subjects with asthma previously receiving short-acting beta2-agonists

OBJECTIVE: An analysis of 5 double-blinded, randomized, 12-week asthma trials was undertaken to evaluate pediatric subjects (4 to 11 years; n=276) who were previously receiving short-acting beta2-agonists alone and subsequently received treatment with placebo. At baseline, all subjects met National Asthma Education and Prevention Program criteria for moderate/severe asthma. STUDY DESIGN: Asthma severity was categorized individually for symptoms, albuterol use, and morning peak expiratory flow and then overall taking into account all three parameters. RESULTS: Subjects spent the majority of weeks (55%) in the moderate/severe category. Subjects spent approximately 48%, 31%, and 22% of weeks in intermittent, mild, and moderate/severe categories and 57%, 27%, and 15% of weeks, respectively, based on asthma symptoms and albuterol use. Subjects spent approximately 62%, 31%, and 8% of weeks in intermittent/mild, moderate, and severe categories, based on peak expiratory flow; however, >35% of subjects exhibited >or=15 changes in asthma severity classification, based on peak expiratory flow. CONCLUSIONS: Asthma is a disease with varying symptomatology, and pediatric subjects frequently move between severity categories, especially in children with inadequate asthma control. These data also emphasize that asthma severity cannot be determined in many pediatric subjects by discrete, point-in-time assessments of lung function, albuterol use, or asthma symptoms. Failure to recognize this problem may contribute to underestimation of disease severity in pediatric subjects.     

Clinical comparability of ventolin formulated with hydrofluoroalkane or conventional chlorofluorocarbon propellants in children with asthma

BACKGROUND: Aerosolized asthma medications with chlorofluorocarbon (CFC) propellants are being phased out because of environmental concerns about the ozone layer. Medications are being reformulated with non-ozone-depleting propellants. OBJECTIVE: To evaluate the clinical comparability of albuterol sulfate formulated in a new hydrofluoroalkane-134a (HFA) propellant (Ventolin HFA Inhalation Aerosol), and conventional CFC-containing albuterol (Ventolin Inhalation Aerosol) in children with asthma. DESIGN: Randomized, double-blind, placebo-controlled 2-week clinical trial with a 1- to 2-week run-in period. During the run-in, patients took Ventolin CFC as needed. Patients (n = 135) aged 4 to 11 years with asthma then were assigned randomly to treatment with Ventolin HFA, Ventolin CFC, or placebo administered 4 times daily via metered-dose inhaler for 2 weeks. All patients were allowed rescue albuterol use in matching propellant as needed for relief of breakthrough symptoms. The main outcome measure was the mean percentage of predicted peak expiratory flow (PEF) after the morning dose of study drug on day 1 and after 2 weeks as assessed by results of 6-hour serial tests. RESULTS: At day 1, the mean (+/- SE) percentage of predicted PEF increased postdose by 14% (+/- 1%) in the Ventolin HFA group and 13% (+/- 1%) in the Ventolin CFC group compared with 6% (+/- 2%) in the placebo group (P相似文献   

Comparison of albuterol delivered by a metered dose inhaler with spacer versus a nebulizer in children with mild acute asthma.

OBJECTIVE: In children with mild acute asthma, to compare treatment with a single dose of albuterol delivered by a metered dose inhaler (MDI) with a spacer in either a weight-adjusted high dose or a standard low-dose regimen with delivery by a nebulizer. STUDY DESIGN: In this randomized double-blind trial set in an emergency department, 90 children between 5 and 17 years of age with a baseline forced expiratory volume in 1 second (FEV1 ) between 50% and 79% of predicted value were treated with a single dose of albuterol, either 6 to 10 puffs (n = 30) or 2 puffs (n = 30) with an MDI with spacer or 0.15 mg/kg with a nebulizer (n = 30). RESULTS: No significant differences were seen between treatment groups in the degree of improvement in percent predicted FEV1 (P =.12), clinical score, respiratory rate, or O2 saturation. However, the nebulizer group had a significantly greater change in heart rate (P =.0001). Our study had 93% power to detect a mean difference in percent predicted FEV1 of 8 between the treatment groups. CONCLUSION: In children with mild acute asthma, treatment with 2 puffs of albuterol by an MDI with spacer is just as clinically beneficial as treatment with higher doses delivered by an MDI or by a nebulizer.     

Airway obstruction at time of symptoms prompting use of reliever therapy in children with asthma

Background: In asthma treatment, doses of inhaled corticosteroids are often adapted to symptoms and need for bronchodilators. However, in cross‐sectional studies in emergency room settings, lung function and respiratory symptoms are not always concordant. Available longitudinal data are based on written peak flow diaries, which are unreliable. Using home spirometry, we studied prospectively whether mild respiratory symptoms, prompting reliever therapy are accompanied by a clinically relevant drop in lung function in children with asthma. Methods: For 8 weeks, children with asthma scored symptoms and measured peak expiratory flow (PEF) and forced expiratory volume in 1 sec (FEV₁) on a home spirometer twice daily. Additional measurements were recorded when respiratory symptoms prompted them to use bronchodilators. Results: The mean difference between symptom free days and at times of symptoms was 6.6% of personal best for PEF (95% CI: 3.2–10.0; p = 0.0004) and 6.0% of predicted for FEV₁ (95% CI: 3.0–9.0; p = 0.0004). There was complete overlap in PEF and FEV₁ distributions between symptom free days and at times of symptoms. Conclusions: Although statistically significant, the degree of airway narrowing at times of respiratory symptoms, prompting the use of reliever therapy, is highly variable between patients, limiting the usefulness of home spirometry to monitor childhood asthma.     

Inaccuracy of portable peak flow meters: correction is not needed

Abstract This study examined whether correction of peak expiratory flow (PEF) values for the inaccuracy of the meter would affect asthma management in 102 children (7–14 y old). PEF was recorded with a mini Wright meter twice daily for 2 weeks. As expected, measured PEF overestimated PEF level and asthma control in these children on many diary days. The actual numerical differences between measured and corrected PEF on these days were very small (>5% in only five patients, maximum 10%). It is unlikely that such small changes in PEF justify changes in asthma management, even if these changes cause PEF levels to cross arbitrary borders between various levels of asthma control used in self-management plans. The clinical importance of the inaccuracy of portable PEF meters is negligible.     

Higher-dose intravenous magnesium therapy for children with moderate to severe acute asthma

OBJECTIVE: To evaluate the efficacy of a 40-mg/kg dose of intravenous magnesium sulfate for moderate to severe asthma exacerbations in pediatric patients. STUDY DESIGN: Double-blind placebo-controlled trial. SETTING: Two urban tertiary care pediatric emergency departments. SUBJECTS: Thirty patients, aged 6 to 17.9 years, being treated for an acute asthma exacerbation. INTERVENTION: Eligible patients received either a magnesium sulfate infusion of 40 mg/kg or saline solution. RESULTS: At 20 minutes, the time at which the infusion was completed, the magnesium group had a significantly greater percentage of absolute improvement from baseline in each of the following: predicted peak expiratory flow rate (8.6% vs 0.3%, P<. 001), forced expiratory volume in 1 second (7.0% vs 0.2%,P<.001), and forced vital capacity (7.3% vs -0.7%, P<.001). The improvement was greater at 110 minutes: peak expiratory flow rate (25.8% vs 1.9%, P<.001), forced expiratory volume in 1 second (24.1% vs 2.3%; P<. 001), and forced vital capacity (27.3% vs 2.6%, P<.001). Patients who received intravenous magnesium were more likely to be discharged to their homes than those who received the placebo (8/16 vs 0/14; P=. 002). CONCLUSION: Children treated with 40 mg/kg of intravenous magnesium sulfate for moderate to severe asthma showed remarkable improvement in short-term pulmonary function.     

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??Objective To investigate the efficacy and safety of fluticasone propionate??FP?? inhalation solution compared with oral prednisone??PRE?? in Chinese pediatric and adolescent subjects??aged 4 to 16 years?? with an acute exacerbation of asthma. Methods This was a randomized?? double-blind?? double-dummy?? active-controlled?? parallel-group?? multi-center??non-inferiority study involving subjects??aged 4 to 16 years old??inclusive?? with an acute exacerbation of asthma??to compare the morning Peak expiratory flow??AM PEF??. Oral PRE once daily 2 mg/??kg·d????up to 40 mg/d for 4 d??then 1 mg/??kg·d?? or half of the original dose??up to 20 mg/d for 3 d?? for 7 d. The study comprised a 7-d treatment period and a 14-d follow-up period??. Results In terms of the primary efficacy endpoint mean AM PEF??the low limit of 95% CI was -9.64 L/min??which was above the pre-defined non-inferiority margin -12 L/min. Conclusion??FP inhalation solution was shown to be non-inferior to oral PRE in the treatment of acute exacerbation of asthma in Chinese pediatric and adolescent patients. FP inhalation solution demonstrates good safety.     

Impact of acute chest syndrome on lung function of children with sickle cell disease

OBJECTIVE: To test the hypothesis that children with sickle cell disease (SCD) who experienced an acute chest syndrome (ACS) hospitalization episode would have worse lung function than children with SCD without ACS episodes. STUDY DESIGN: Forced expiratory volume in 1 second (FEV(1)); forced vital capacity (FVC); FEV(1)/FVC ratio; peak expiratory flow (PEF); forced expiratory flow at 25% (FEF(25)), 50% (FEF(50)), and 75% (FEF(75)) of FVC; airway resistance (Raw); and lung volumes were compared in 20 children with ACS and 20 aged-matched children without ACS (median age, 11 years; range, 6 to 16 years). Fourteen age-matched pairs were assessed before and after bronchodilator use. RESULTS: The mean Raw (P = .03), TLC (P = .01), and RV (P = .003) were significantly higher in the group with ACS than in the group without ACS. There were no significant differences in the changes in lung function test results in response to bronchodilator administration between the 2 groups, but the children with ACS had a lower FEF(25) (P = .04) and FEF(75) (P = .03) pre-bronchodilator use and a lower mean FEV(1)/FVC ratio (P = .03) and FEF(75) (P = .03) post-bronchodilator use. CONCLUSIONS: Children with SCD who experienced an ACS hospitalization episode had significant differences in lung function compared with those who did not experience ACS episodes. Our results are compatible with the hypothesis that ACS episodes predispose children to increased airway obstruction.     

Impact of fluconazole prophylaxis on incidence and outcome of invasive candidiasis in a neonatal intensive care unit

OBJECTIVES: We assessed the impact of intravenous fluconazole prophylaxis (FP) in extremely low birth weight (ELBW [<1000 g]) infants on the incidence of and outcome from invasive candidiasis (IC) in all infants admitted to a neonatal intensive care unit (NICU). STUDY DESIGN: Beginning April 1, 2002, FP was given to ELBW infants aged < 5 days admitted to the NICU of Woman's Hospital of Texas. Infants in NICU in whom IC developed during the first 2 years of FP (FP period) were compared with those with IC during 2000-2001. RESULTS: During 2000-2001 and the FP period, the incidence of IC in ELBW infants decreased from 7% (15 of 206) to 2% (5 of 240) (P=.01), and the IC-related mortality rate decreased from 12% (4 of 33) to 0 (0 of 40) (P=.04); the incidence of IC increased from 0.1% (4 of 2806) to 0.2% (8 of 3372) in infants of birth weight > or = 1000 g (P=.06), and no IC-related deaths occurred. During the FP period, IC developed in older infants (24 vs 12 days; P=.12) who had similar risk factors for IC. CONCLUSION: Invasive candidiasis occurred in our NICU in spite of FP and shifted to bigger, more mature infants who had a better outcome.     

呼气峰值流量在儿童哮喘诊断及管理中的应用进展

呼气峰值流量（peak expiratory flow，PEF）是一种简单、可靠、低成本的肺功能检查方法。PEF可反映呼气气流受限情况，其变异率可判断气流受限有无可逆性，为儿童哮喘的诊断提供客观依据。短期监测PEF可协助管理哮喘急性发作、查找诱发因素、评估治疗效果等。长期监测PEF有助于哮喘控制的评估及预警急性发作，适用于重度哮喘患儿。该文就儿童PEF的检查方法、影响因素、结果判读，以及在儿童哮喘诊断和管理中的应用进展进行综述，为儿童PEF的临床应用提供参考。     

Costs and effectiveness of spacer versus nebulizer in young children with moderate and severe acute asthma

OBJECTIVE: To compare the costs and effectiveness of albuterol by metered dose inhaler (MDI) and spacer versus nebulizer in young children with moderate and severe acute asthma. DESIGN: Randomized, double-blind, placebo-controlled trial in an emergency department at a children's hospital. The participants were children 1 to 4 years of age with moderate to severe acute asthma. Patients assigned to the spacer group received albuterol (600 microg) by MDI by spacer (AeroChamber) followed by placebo by nebulizer (n = 30). The nebulizer group received placebo MDI by spacer followed by 2.5 mg albuterol by nebulizer (n = 30). Treatments were repeated at 20-minute intervals until the patient was judged to need no further doses of bronchodilator, or a total of 6 treatments. RESULTS: Clinical score, heart rate, respiratory rate, auscultatory findings, and oxygen saturation were recorded at baseline, after each treatment, and 60 minutes after the last treatment. Baseline characteristics and asthma severity were similar for the treatment groups. The spacer was as effective as the nebulizer for clinical score, respiratory rate, and oxygen saturation but produced a greater reduction in wheezing (P =.03). Heart rate increased to a greater degree in the nebulizer group (11.0/min vs 0.17/min for spacer, P <.01). Fewer children in the spacer group required admission (33% vs 60% in the nebulizer group, P =.04, adjusted for sex). No differences were seen in rates of tremor or hyperactivity. The mean cost of each emergency department presentation was NZ$825 for the spacer group and NZ$1282 for the nebulizer group (P =.03); 86% of children and 85% of parents preferred the spacer. CONCLUSION: The MDI and spacer combination was a cost-effective alternative to a nebulizer in the delivery of albuterol to young children with moderate and severe acute asthma.     

Nebulizers vs metered-dose inhalers with spacers for bronchodilator therapy to treat wheezing in children aged 2 to 24 months in a pediatric emergency department

OBJECTIVE: To determine if administration of albuterol by a metered-dose inhaler with a spacer device is as efficacious as administration of albuterol by nebulizer to treat wheezing in children aged 2 years and younger. DESIGN: Double-blind, randomized, placebo-controlled clinical trial. SETTING: Pediatric emergency department. PATIENTS: From a convenience sample of wheezing children aged 2 to 24 months, 85 patients were enrolled in the nebulizer group and 83 in the spacer group. INTERVENTIONS: The nebulizer group received a placebo metered-dose inhaler with a spacer followed by nebulized albuterol. The spacer group received albuterol by a metered-dose inhaler with a spacer followed by nebulized isotonic sodium chloride solution. Treatments were given every 20 minutes by a single investigator blinded to group assignment. MAIN OUTCOME MEASURES: The primary outcome was admission rate. Pulmonary Index score and oxygen saturation were measured initially and 10 minutes after each treatment. RESULTS: The nebulizer group had a significantly higher mean (SD) initial Pulmonary Index score compared with the spacer group (7.6 [2.5] vs 6.6 [2.0]; P =.002). With the initial Pulmonary Index score controlled, children in the spacer group were admitted less (5% vs 20%; P =.05). Analyses also revealed an interaction between group and initial Pulmonary Index score; lower admission rates in the spacer group were found primarily in children having a more severe asthma exacerbation. CONCLUSION: Our data suggest that metered-dose inhalers with spacers may be as efficacious as nebulizers for the emergency department treatment of wheezing in children aged 2 years or younger.     

Ipratropium bromide plus nebulized albuterol for the treatment of hospitalized children with acute asthma

OBJECTIVE: To determine whether the addition of repeated doses of nebulized ipratropium bromide (IB) to a standardized inpatient asthma care algorithm (ACA) for children with status asthmaticus improves clinical outcome.STUDY DESIGN: Children with acute asthma (N = 210) age 1 to 18 years admitted to the ACA were assigned to the intervention or placebo group in randomized double-blind fashion. Both groups received nebulized albuterol, systemic corticosteroids, and oxygen according to the ACA. The intervention group received 250 microg IB combined with 2.5 mg albuterol by jet nebulization in a dosing schedule determined by the ACA phase. The placebo group received isotonic saline solution substituted for IB. Progression through each ACA phase occurred based on assessments of oxygenation, air exchange, wheezing, accessory muscle use, and respiratory rate performed at prescribed intervals. RESULTS: No significant differences were observed between treatment groups in hospital length of stay (P =.46), asthma carepath progression (P =.37), requirement for additional therapy, or adverse effects. Children >6 years (N = 70) treated with IB had shorter mean hospital length of stay (P =.03) and more rapid mean asthma carepath progression (P =.02) than children in the placebo group. However, after adjustment was done for baseline group differences, the observed benefit of IB therapy in older children no longer reached statistical significance. CONCLUSION: The routine addition of repeated doses of nebulized IB to a standardized regimen of systemic corticosteroids and frequently administered beta-2 agonists confers no significant enhancement of clinical outcome for the treatment of hospitalized children with status asthmaticus.     

轻度持续性支气管哮喘患儿单用孟鲁司特的疗效

目的评估在实际生活条件影响下轻度持续性支气管哮喘(哮喘)患儿单独使用孟鲁司特进行控制治疗的效果。方法选取2～14岁在社区进行治疗的轻度持续哮喘患儿,进行前瞻性、单组、非盲观察性研究。孟鲁司特每天1次,2～5岁年龄组每次4 mg,6～14岁年龄组每次5 mg,持续12周,患儿通过监护人员给药,采取门诊复诊、随访的方式进行治疗及评估。分别在研究的0、4、8、12周,对过去7 d的日间症状、夜间症状进行严重程度评分,对峰值流速(PEF)、短效β2受体激动剂使用量进行检测和记录。采用SPSS 16.0统计软件进行统计分析。结果 2个年龄组日间症状、夜间症状严重程度评分在各随访时间点的评分逐步降低,各相邻时间点均数差异有统计学意义(P<0.05);短期使用短效β2受体激动剂的量明显下降,从第0周到第4周观察到显著的减少量(P<0.05);PEF不断改善,终点观察值(第12周)与起始值(第0周)比较差异有统计学意义(P<0.05)。结论对轻度持续哮喘患儿在社区实际生活条件影响下单用孟鲁司特仍可以有效控制哮喘症状的发作。     

普米克气雾剂治疗儿童哮喘疗效观察

目的　观察普米克气雾剂治疗儿童哮喘前后的最高呼气峰流速值 (PEF)及血清嗜酸细胞阳离子蛋白 (ECP)的变化。方法　对 113例儿童哮喘病人 ,使用普米克气雾剂 [(2 0 0～ 80 0 ) μg/d],3月～ 1年。采用峰流速仪监测PEF ,并用荧光免疫法 ,使用PharmaciaCAP系统 (瑞典 )测定部分病儿治疗前后的血清ECP。结果　使用普米克治疗后 ,PEF明显增高 ,3个月、6个月、1年的PEF占预计值的百分比 (PEF % )分别为 (93.6± 5 .4) ,(93.0± 4.2 ) ,(94.5± 4.5 ) ,与治疗前 (70 .4± 19.1)比较 ,差异有显著性 ,P <0 .0 1。治疗后ECP为 (7.5± 2 .7)μg/L ,比治疗前 (2 4.0± 17.1) μg/L明显下降 ,P <0 .0 1,差异有显著性。结论　普米克气雾剂治疗儿童哮喘副作用小、安全有效、方法简便 ,用于儿童哮喘的中、长期防治 ,值得推广。