The comparison of cetirizine, levocetirizine and placebo for the treatment of childhood perennial allergic rhinitis

Cetirizine (Zyrtec) is a potent and long-acting second-generation histamine H1- receptor antagonist for the treatment of allergic disease, such as allergic rhinitis and chronic idiopathic urticaria, in adult and child. It is a racemic mixture of levocetirizine (Xyzal) and dextrocetirizine. The purpose of this present study was to compare the efficacy of cetirizine, levocetirizine and placebo for the treatment of pediatric perennial allergic rhinitis. 74 perennial allergic rhinitis patients, aged 6 to 12 years old, assigned to 1 of 3 treatment groups for 12 weeks randomly. The effects of the three agents were compared with the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) and Total Symptom Score (TSS) by diary. Nasal peak expiratory flow rate (nPEFR) and laboratory examinations including serum immunoglobulin E level, eosinophil cationic protein (ECP), blood eosinophil counts and eosinophil percentage in a nasal smear were evaluated among the three groups. The results revealed that both cetirizine and levocetirizine improved TSS in comparison with the placebo group, and ceterizine appeared to be more efficacious than levocetirizine at week 8 and week 12. The PRQLQ score showed significant decreased both in cetirizine and levocetirizine group, but there was no statistic significant difference between both groups. The eosinophil proportion in a nasal smear significantly decreased among the cetirizine in comparison with the placebo group but there was no statistic significant in levocetirizine groups. Both cetirizine and levocetirizine showed significant improvement in nPEFR in comparison with the placebo group, and ceterizine appeared to be more efficacious than levocetirizine. The 12-week treatment program showed that cetirizine was more effectious than levocetirizine.     

Prevalence of allergic rhinitis and nasal smear eosinophilia in 11- to 15 yr-old children in Shiraz

Allergic rhinitis (AR) is a common condition among schoolchildren. The prevalence rate of AR differs among countries and even among regions within the same country. The objective of this study was to determine the prevalence of nasal symptoms and signs of AR and nasal smear eosinophilia in 11- to 15-yr-old children in Shiraz. A total of 4584 children aged 11-15 yr of both sexes were surveyed from May 1995 to April 1996, and nasal symptoms and signs of AR (sneezing, rhinorrhea, nasal blockage, itching, color change, mucosal swelling, nasal wetness, and nasal crease), based on questionnaire and ear, nose and throat (ENT) examination were recorded. In addition, smears were taken from nasal secretions and stained. The results compared with nasal smears related to 340 healthy children. 1008 (22%) schoolchildren had nasal symptoms of AR (based on the questionnaire), 445 (9.7%) were identified as having nasal symptoms and signs of AR (based on the questionnaire and ENT specialist examination), and 226 (5.8%) had nasal symptoms and signs of AR associated with nasal eosinophilia (based on the questionnaire, ENT specialist examination and positive nasal smear for eosinophilia). Nasal eosinophilia was present in 274 (62%) children with nasal symptoms and signs of AR. This survey showed that prevalence of nasal symptoms and signs of AR was high in schoolchildren in Shiraz. Nasal smear eosinophilia had a diagnostic specificity of 96% and sensitivity of 62% and seems to be a potentially valuable test for AR.     

Do the leukotriene receptor antagonists work in children with grass pollen‐induced allergic rhinitis?

Although cysteinyl-leukotriene receptor antagonists were recently approved for use in allergic rhinitis (AR), there has been no study to date investigating their application in children. The aim was to evaluate whether montelukast provides any benefit in nasal allergen challenge-induced symptoms in children, and whether it could improve the control provided by an antihistamine during pollen season. Two randomized studies, one a double-blind, placebo-controlled, nasal allergen challenge study and one an open-label, cross-over, parallel-group clinical study, were performed in 18 (11.7+/-0.7 years) and 32 children (10.5+/-0.5 years), respectively, with grass pollen allergy. In the first study, the effect of a single dose of montelukast and its combination with loratadine were compared with placebo on nasal responses induced by allergen challenge. In the second study, the additive effect of montelukast to loratadine was tested in an open-label cross-over clinical study. In the challenge study, early-phase and late-phase nasal reactions peaked at 15 min and 4 h after the challenge respectively. During the early phase, combination improved total nasal symptoms (p=0.004) during the first hour and sneezing (p=0.012) at 15 min compared with placebo group. During the late phase, montelukast (p=0.017) and combination (p=0.011) caused less nasal obstruction at 4 h and combination caused less sneezing at 6 h (p=0.015). In the clinical trial, montelukast provided protection on seasonal increase in pulmonary symptoms [0 (0, 14) vs. 6.5 (0, 27.7); p=0.016] and on the decrease in FEF25-75 [-0.09 (-0.34, 0.17) vs. -0.28 (-0.66, 0.02); p=0.002]. However, there was no improvement in nasal symptoms and flows. Although we showed protection against nasal challenge-induced congestion with montelukast, we were not able to show the same in the clinical study possibly because of low pollen counts and mildness of the symptoms of the patients with AR. However, montelukast provided better control of pulmonary symptoms and protection from seasonal decrease in lung function, indicating its potential therapeutic benefit in children with AR.     

A placebo-controlled trial of cetirizine in seasonal allergic rhino-conjunctivitis in children aged 6 to 12 years

A total of 124 children of both sexes aged between 6 and 12 years with pollen-associated rhino-conjunctivitis were included in a multicentre double-blind study of parallel group design to compare the effects of cetirizine 10 mg daily, given as 5 mg morning and evening for 2 weeks, with those of placebo of identical appearance. Rhinorrhea, sneezing, nasal obstruction and nasal and ocular pruritus were evaluated using symptom scores by patients on daily self-evaluation cards and by investigators who, in addition, made a global evaluation at the end of treatment. Appropriate wash-out periods for previous medicines were observed. Unchanged treatment of asthma was allowed and inhaled corticosteroids were continued in 3 placebo patients. Compliance was checked and found to be less than 80% of the prescribed dosage in 2 cetirizine patients. The mean percentage of study days when symptoms were absent or at the most mild (i.e. present but not disturbing), as reported daily by the patients, was significantly greater with cetirizine (56.2%) than placebo (29.7%). This 26.5% difference was considered clinically significant. The value of this method of expressing treatment effects in allergic rhinitis is discussed. Improvement in maximum symptom scores (severest symptoms) assessed by investigators was better for cetirizine than placebo after treatment for 1 week and 2 weeks. Improvement in individual daily symptoms was greater for cetirizine than placebo after a few days. Global evaluations of response by investigators at the end of the study showed improvement in both groups that was significantly greater with cetirizine, providing a response that was considered excellent or good in 79% of patients on cetirizine compared with 50% of patients on placebo. Tolerance was good. Somnolence that was generally mild and transient was reported in 6 patients of the cetirizine group and in 2 patients of the placebo group.     

Montelukast decreased exhaled nitric oxide in children with perennial allergic rhinitis

BACKGROUND: Measurement of exhaled nitric oxide (eNO) is a simple and noninvasive method for assessment of inflammatory airway diseases. eNO is elevated in adolescent patients with perennial allergic rhinitis and related to bronchial hyperresponsiveness. The aim of this study was to investigate whether oral loratadine, montelukast, nasal budesonide or nasal sodium cromoglycate could reduce airway inflammation as indicated by decrease of eNO in children with perennial allergic rhinitis as demonstrated by eNO levels. METHODS: A randomized and investigator-blinded study was conducted in a hospital-based outpatient clinic. Children with perennial allergic rhinitis were divided into four groups and treated by loratadine, loratadine with nasal sodium cromoglycate, loratadine with oral montelukast, and loratadine with nasal budesonide, respectively. Allergic rhinitis scores, eNO and peak expiratory flow were measured before and 2, 4, 6 and 8 weeks after treatment. RESULTS: Results showed that eNO in children with perennial allergic rhinitis was reduced by nasal budesonide and oral montelukast within 2 weeks (24.56 +/- 14.42 vs 18.42 +/- 12.48, P < 0.001, in budesonide group; 27.81 +/- 13.4 vs 19.09 +/- 10.45, P < 0.001, in montelukast group), but not in the loratadine and cromoglycate groups. In contrast, loratadine or sodium cromoglycate also did not decrease eNO levels although they could decrease the symptom scores. CONCLUSIONS: It was concluded that four common treatment modalities could effectively release symptom scores, but decrease of airway inflammation as determined by decrease of eNO might be only achieved by nasal budesonide and montelukast, but not nasal sodium cromoglycate and loratadine. Children with perennial allergic rhinitis with high eNO levels may require oral montelukast or nasal budesonide treatment to prevent airway hyperresponsiveness.     

Efficacy and safety of once-daily fluticasone furoate nasal spray in children with seasonal allergic rhinitis treated for 2 wk

The objective of this study was to evaluate the efficacy and safety of fluticasone furoate (FF) nasal spray 55 and 110 μg once daily in children with seasonal allergic rhinitis (SAR). Patients (n = 554) received placebo nasal spray or FF, administered using a unique side-actuated device, in a 2-wk, randomized, double-blind study. Symptoms were evaluated by patients using a 4-point categorical scale. Efficacy assessments included reflective and instantaneous total nasal symptom scores (r/iTNSS). Primary analyses were conducted in patients aged 6–11 yr in the intent-to-treat population (ITT); the 2–11 yr group provided supportive analyses. In patients aged 6–11 yr, FF 110 μg once daily significantly improved the daily rTNSS compared with placebo. FF 55 μg once daily was only numerically better for rTNSS and iTNSS. Secondary pre-dose iTNSS and overall response to therapy were significant with FF 110 μg. The significant findings for FF 110 μg were supported by analyses in the entire ITT population of 2–11 yr olds. Both doses of FF were well tolerated. These study results suggest that FF nasal spray administered once daily for 2 wk is well tolerated and effective for the treatment of SAR symptoms in children aged 2–11 yr.     

Steroid-sensitive indices of airway inflammation in children with seasonal allergic rhinitis

Previous studies involving adults have demonstrated that airway glucocorticosteroids inhibit plasma exudation and eosinophil activity in allergic rhinitis. This study explores the possibility that plasma exudation, exudative responsiveness, and the occurrence of eosinophil activity-related proteins are glucocorticosteroid-sensitive nasal mucosal indices in allergic children. Using a placebo-controlled, parallel-group design effects of nasal budesonide (64 µg per nasal cavity b.i.d) were determined in children with seasonal allergic rhinitis. Nasal lavage fluid levels of eotaxin, eosinophil cationic protein (ECP), and α₂-macroglobulin, indicating plasma exudation, were determined, the latter with and without challenge with topical histamine. Nasal lavage fluid levels of α₂-macroglobulin and ECP increased significantly during the pollen season, and the acute plasma exudation response to histamine was significantly greater during than outside the season. There was a trend towards a seasonal increase in nasal lavage fluid levels of eotaxin. Budesonide significantly inhibited the seasonal increase in α₂-macroglobulin as well as the exudative hyperresponsiveness to histamine. Any tendency of increases in mucosal output of eotaxin and ECP was abolished by the glucocorticosteroid treatment. We conclude that mucosal exudation of plasma, as a global sign of active inflammatory processes, is a glucocorticosteroid-sensitive facet of allergic rhinitis in children. Exudative hyperresponsiveness, potentially caused by several weeks of mucosal inflammation, emerges as a significant feature of allergic rhinitis in children, and its development is prevented by local treatment with a glucocorticosteroid drug. The seasonal increase in ECP and the trend for an increase in eotaxin were absent in the glucocorticosteroid-treated subjects.     

Efficacy of pollen immunotherapy in seasonal allergic rhinitis

BACKGROUND: The efficacy of subcutaneous pollen immunotherapy has been documented in published double-blind, placebo-controlled studies related to treatment of seasonal allergic rhinitis. In the present study, subjective (symptom scores) and objective (nasal peak inspiratory flow, nasal smear, nasal biopsy) parameters were used to study the efficacy of pollen immunotherapy. METHODS: Forty-eight patients (32 male), mean +/- SE age 13.6 +/- 2.8 years allergic to grass-pollen participated in the present study. Patients were divided into three groups: group I, 24 patients who did not receive pollen immunotherapy; group II, 12 patients who received the build-up phase of pollen immunotherapy; and group III, 12 patients who had just finished pollen immunotherapy. With regard to objective and subjective parameters these three groups were compared. RESULTS: When group I was compared to groups II and III, the patients who had not received any immunotherapy were found to have a high daytime nasal symptoms score (P < 0.01), high daytime eye symptoms score(P < 0.01) and high night-time symptoms score (P < 0.01). In objective parameters, it was found that group I had low nasal peak inspiratory flow (P < 0.05), and a high eosinophil count in nasal smears (P < 0.05) and peripheral blood (P < 0.05). It was also demonstrated that there was an increased eosinophil infiltration (P < 0.01) and mast cell infiltration (P < 0.05) in nasal biopsy in group I. There was no significant difference between group II and group III according to these results (P > 0.05). CONCLUSIONS: Immunotherapy leads to a better clinical and histopathological prognosis in children with seasonal allergic rhinitis.     

Cetirizine for seasonal allergic rhinitis in children aged 2-6 years

A total of 107 children of both sexes between 2 and 6 years of age with pollen-indueed seasonal allergic rhinitis (SAR) were entered in a multicentre study of double-blind parallel group design in which the effects of 5 mg cetirizine, given as drops from a solution containing 10 mg/ml once daily each evening for two weeks, were compared with those of identical placebo. Sneezing, rhinorrhea, nasal obstruction and nasal and ocular pruritus were the symptoms evaluated by means of symptom scores by investigators and on daily record cards, by parents. Investigators also made a global evaluation at the end of treatment. Cetirizine was more active than placebo for eaeh symptom evaluated both by parents and investigators. There were significant by more (p = 0.002) days during which symptoms were absent or mild, in the cetirizine than in the placebo group. When the maximum symptom scores rated by investigators at each visit were compared, the difference in favour of cetirizine at the end of treatment was statistically signifieant (p = 0.04). Global evaluation by investigators of changes in symptoms at the end of the study showed an improvement in both groups which was significantly greater with cetirizine. providing excellent or good improvement in 34/54 patients compared with 25/53 patients on placebo (p = 0.039). Toleranee was good. Three patients on cetirizine and none on placebo experienced mild somnolence.     

Comparative effect of triamcinolone, nedocromil and montelukast on asthma control in children: A randomized pragmatic study

Asthma severity can be judged by measurements of symptoms, lung function, and medication requirements. The objective was to compare the effect of a 4-wk monotherapy with low-dose triamcinolone, montelukast and nedocromil on asthma control, lung function, eosinophil blood count, and bronchial hyper-reactivity in children with mild to moderate asthma allergic to dust mite. Two hundred fifty-six children, aged 6-18 yr, with mild to moderate asthma, participated in an 8-wk study. This was a three-arm, randomized no blinding or placebo pragmatic trial comparing the effect of triamcinolone acetonide (400 microg/day), inhaled nedocromil and montelukast sodium on clinical parameters of asthma [score, forced expiratory volume in 1 s (FEV(1))], PC20H, and eosinophil blood count. Two hundred forty-six children completed the study. After 4 wk of treatment with triamcinolone and montelukast, FEV(1) and PC20H significantly increased, and mean total symptoms score and mean number of eosinophil count in serum significantly decreased. Triamcinolone had a stronger effect on PC20H than montelukast. Nedocromil improved total asthma symptoms score and lung function. There was a reduction in the daytime and night-time symptom scores after treatment with all three drugs. Triamcinolone and montelukast had a stronger effect on asthma symptoms than nedocromil. There were statistically significant differences in reduction of nocturnal asthma symptoms between the triamcinolone and nedocromil groups (p < 0.001) and between montelukast and nedocromil (p = 0.001) groups, but not between the triamcinolone and montelukast groups. There was a reduction in beta-agonists use after treatment with all three drugs, with the strongest effect of triamcinolone. The study showed the strongest effect of low-dose inhaled steroids on clinical symptoms, lung function, bronchial hyper-reactivity and eosinophil blood count when compared to other asthma medications.     

标准化尘螨特异性皮下免疫治疗尘螨过敏性哮喘伴变应性鼻炎患儿的长期随访研究

目的：探讨标准化尘螨特异性皮下免疫治疗(SCIT)对尘螨过敏性哮喘伴变应性鼻炎患儿远期疗效的影响。 方法：本文为干预效果的长期随访的病例系列报告。对尘螨过敏性哮喘伴变应性鼻炎患儿,开始接受标准化SCIT治疗（T0）至疗程≥30个月治疗结束（T1）,在T0、T1、T2（T1后的3年）和T3（T1后的6年）,均在哮喘专科门诊或通过电话随访,分别以哮喘症状评分（ASS）、鼻炎症状评分（RSS）、鼻炎与哮喘症状总评分（TSS）、药物评分（TMS）、症状药物总评分（SMS）、视觉模拟量表(VAS)评价和病情改善自我评价量表进行病情估计,ASS、RSS、TSS、TMS评估时点为晚近4周内情况、VAS和病情改善自我评价为患儿或其家长自我感受评估时点为晚近1个月的情况。 结果：2006年4月至2011年6月在哮喘专科门诊诊断为尘螨过敏性哮喘伴变应性鼻炎患儿、且接受了标准化SCIT治疗≥30个月,T1时点56例,男41例,女15例,平均年龄7.1（5~12）岁。均回顾性收集到T0时点病情评估指标ASS、RSS、TSS和VAS,并计算TSS和SMS。随访至T2时点有51例（男38例）和T3时点有45例（男33例）采集到了本文全部病情评估指标。T1时点不同病情评估指标较T0时点差异均有统计学意义。反映病情评估的2个组合指标（TSS和SMS）前后相临时点差异均有统计学意义。病情改善自我评价量表中,变应性鼻炎与哮喘T1时点（18.5% vs 75.0%）、T2时点（31.2% vs 84.0%）、T3时点（39.5% vs 80.0%）比较差异均有统计学意义,病情改善自我评价量表病情评估变应性鼻炎明显差于哮喘。T3时点女生的RSS、TSS、SMS明显低于男生,差异有统计学意义。 结论：标准化SCIT治疗能使尘螨过敏哮喘伴变应性鼻炎患儿的哮喘、鼻炎症状明显减轻,用药减少,VAS评分降低,在停止治疗后的6年仍能维持长期疗效。女性患儿比男性患儿在鼻炎哮喘症状以及症状用药评分方面疗效更加显著。     

High prevalence and young onset of allergic rhinitis in children with bronchial asthma

Bronchial asthma and allergic rhinitis often co-exist, and rhinitis is a major risk factor for the development of asthma. However, the reported incidence of allergic rhinitis in asthmatic children varies widely. The aim of this study was to elucidate the incidence of allergic rhinitis, the onset age of chronic upper and lower airway symptoms, and the correlation of these two symptoms in asthmatic children. A cohort of 130 consecutive children (ages 2–10) with asthma was evaluated. A questionnaire regarding upper and lower airway symptoms was filled out by the parents. Objective diagnosis of allergic rhinitis was also made on the basis of rhinoscopy, nasal cytology, nasal challenge, and specific serum IgE (CAP-RAST). Persistent nasal symptoms were present in 83.8% of the asthmatic children. The incidence of allergic rhinitis was 77.7% based on the objective findings. The mean onset age of asthma was 2.8 yr, and that of rhinitis was 2.9 yr. Nasal symptoms started as early as the first year of life in 8.9% of the children. In children with comorbid asthma and allergic rhinitis, rhinitis preceded in 33.7%, asthma preceded in 31.7%, and both started in the same year in 26.7%. In 7.9%, rhinitis was asymptomatic. Concomitant exacerbation of the upper and lower airways occurred in 34.6% of the total 130 children. These results demonstrate that allergic rhinitis manifested early in life in the majority of the asthmatic children. Persistent nasal symptoms in infancy may point to subsequent development of asthma and possible early intervention.     

The effects of grass pollen allergoid immunotherapy on clinical and immunological parameters in children with allergic rhinitis

Allergoid immunotherapy is a new form of allergen immunotherapy allowing safe administration of high allergen doses. There is limited information on the effects of allergoid immunotherapy in children with allergic rhinitis. To investigate the immunological and clinical effects of allergoid immunotherapy in children with allergic rhinitis due to grass pollen allergy. Children with allergic rhinitis were assigned to allergoid immunotherapy (n = 27) or control (n = 26, no immunotherapy) groups. Children in the immunotherapy group received seven injections of grass pollen allergoid immunotherapy before grass pollen season and continued to receive maintenance immunotherapy for 27 months. All patients were offered a pharmacotherapy regimen to be used on demand during the pollen seasons. Clinical and laboratory parameters were compared between the immunotherapy and control groups. The rhinoconjunctivitis symptom-medication score and asthma symptom score were lower in the immunotherapy group after 1 yr of maintenance immunotherapy (p < 0.01 for both). Skin test reactivity and nasal reactivity as determined by nasal provocation testing for grass pollen were significantly decreased after 1 yr of immunotherapy (p < 0.001 for both). The seasonal increase in bronchial reactivity and nasal lavage eosinophil cationic protein levels were prevented after the first year of immunotherapy (p < 0.05 for both). The seasonal increase in immunoglobulin (Ig)E decreased (p < 0.05) and grass-specific IgG, IgG(1) and IgG(4) increased significantly already at the end of the seven-injection build-up therapy (p < 0.001, for all). Interleukin (IL)-4 levels in the culture supernatants showed a steady decline from baseline at first and second year of immunotherapy (p < 0.001) but remained unchanged in the control group. Allergoid immunotherapy is an effective method in the treatment of grass pollen-induced allergic rhinitis in children and prevents the seasonal increase in bronchial hyper-reactivity. Changes in specific IgE and IgG levels and decreased IL-4 production in peripheral blood mononuclear cell culture supernatants may account for the observed clinical effects.     

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目的观察白三烯(LTs)受体拮抗剂(孟鲁司特钠)在儿童腺样体肥大(AH)治疗中的疗效,探讨LTs受体拮抗剂用于治疗儿童AH的临床可行性。方法收集2007年1月至2010年12月在广州医学院第二附属医院就诊的上气道咳嗽综合征合并腺样体肥大和(或)并有过敏性鼻炎的患儿,分为观察组116例和对照组52例,各组均予对症治疗及按需使用抗生素,在此基础上观察组给予LTs受体拮抗剂(孟鲁司特钠)治疗16周。观察治疗前后各组患儿咳嗽持续天数、呼吸相关睡眠障碍症状指标评分及腺样体/鼻咽比值(A/N比值)的改变。结果治疗16周后:(1)观察组呼吸相关睡眠障碍症状指标评分、咳嗽天数,A/N比值分别由(12.31±2.58)分、(52.59±11.87)d、0.77±0.04下降至(5.68±3.30)分、(19.99±11.14)d、0.64±0.07,治疗前后差异有统计学意义(P<0.001)。对照组治疗前后上述各指标差异无统计学意义(P>0.05)。观察组与对照组在治疗前上述各指标差异无统计学意义,治疗后各指标间差异有统计学意义(P<0.001);(2)对观察组中的上气道咳嗽综合征合并单纯AH及AH合并过敏性鼻炎(AH-AR)...     

Three-year follow-up of clinical and inflammation parameters in children monosensitized to mites undergoing sub-lingual immunotherapy

Parallel follow-up of clinical and inflammatory markers during sub-lingual immunotherapy (SLIT) is highly beneficial. Twenty-four children (age 4-16) monosensitized to house dust mite were randomized to receive either active or placebo SLIT for 1 yr in a double-blind placebo controlled design (Marcucci et al., Allergy 2003: 58: 657-62). Thereafter, for 2 yr they all received active treatment. Symptom scores for rhinitis, asthma, and drug usage were daily recorded. Eosinophil cationic protein (ECP) and tryptase in sputum and nasal secretions, serum and nasal mite-specific immunoglobulin E (IgE) were recorded before treatment and at 10-12 months intervals. Nasal ECP and nasal tryptase after specific nasal provocation tests were significantly reduced as compared to baseline values (p = 0.0043 and 0.0195, respectively) in the third year of active treatment. None of the other inflammatory parameters was increased. In placebo treated patients all these parameters tended to decrease only after switching to active treatment. Clinical scores did not improve in treated vs. placebo patients in the double-blind placebo-controlled phase of the study. In both cohorts a clinical benefit was observed as intra-group score reduction as compared to baseline. A significant difference was reached in patients treated for 2 yr for rhinitis and asthma (p = 0.0009 and 0.0019, respectively) but not for drug usage and in patients treated for 3 yr for rhinitis, asthma, and drug usage (p = 0.0105, 0.0048, and 0.02, respectively). SLIT in children monosensitized to mites reverted the spontaneous increase in nasal IgE and in local parameters of allergic inflammation. These outcomes were followed by a consolidated clinical improvement in the second and third year of treatment.     

孟鲁司特治疗儿童支气管哮喘的临床疗效观察

目的孟鲁司特联合布地奈德气雾剂吸入治疗合并过敏性鼻炎的轻、中度哮喘儿童临床疗效的前瞻性研究。方法将80例合并有过敏性鼻炎的轻、中度哮喘儿童随机分为治疗组和对照组。治疗组在吸入布地奈德气雾剂的同时加用孟鲁司特片,对照组则在吸入布地奈德气雾剂基础上加安慰剂,其余治疗相同。两组布地奈德气雾剂递减至最适有效剂量(无哮喘症状体征,β2激动剂吸入量无增加,呼气峰流速达预计值的80%以上,或变异率小于20%),并进行统计学分析。结果治疗组在加用孟鲁司特前后布地奈德吸入量减少差异有统计学意义(P<0.05),对照组在加用安慰剂前后布地奈德吸入量减少差异有统计学意义(P<0.05),而且两组比较差异亦有统计学意义(P<0.05)。结论孟鲁司特片联合布地奈德气雾剂治疗儿童合并过敏性鼻炎的哮喘,不仅能明显缓解哮喘和鼻炎的症状,还可以减少糖皮质激素、β2激动剂吸入量,取得了满意的疗效且无明显的不良反应。     

Safety and efficacy of oral fexofenadine in children with seasonal allergic rhinitis – a pooled analysis of three studies

Allergic rhinitis is one of the most common clinical conditions in children; however, data regarding the safety of antihistamines in children with seasonal allergic rhinitis are limiting. To evaluate the safety and efficacy of fexofenadine in children with seasonal allergic rhinitis, data were pooled from three, double-blind, randomized, placebo-controlled, parallel-group, 2-week trials in children (6-11 year) with seasonal allergic rhinitis. All studies assessed fexofenadine HCl 30 mg b.i.d.; two studies included fexofenadine HCl at 15 and 60 mg b.i.d. Patients (and investigators) reported any adverse events during the trial. Physical examinations, including measurements of vital signs and laboratory tests, were performed. Efficacy assessments (total symptom score and individual symptom scores) were evaluated. Exposure to fexofenadine HCl 30 mg b.i.d. and to any fexofenadine dose exceeded 10,000 and 17,000 patient days, respectively. Incidences of adverse events, and discontinuations because of adverse events, were low and similar across treatment groups. In the placebo group, 24.4% of subjects reported adverse events compared with 24.1% for fexofenadine HCl 30 mg b.i.d., and 28.4% for all fexofenadine-treated groups. The most common adverse event overall was headache (4.3% placebo; 5.8% fexofenadine HCl 30 mg b.i.d.; and 7.2% any fexofenadine doses). Treatment-related adverse events were similar across treatment groups with no sedative effects. Fexofenadine HCl 30 mg b.i.d. was significantly superior to placebo in reducing the total symptom score and all individual seasonal allergic rhinitis symptoms, including nasal congestion (p < 0.05). Fexofenadine, at doses of up to 60 mg b.i.d., is safe and non-sedating, and fexofenadine HCl 30 mg b.i.d. effectively reduces all seasonal allergic rhinitis symptoms in children aged 6-11 years.     

A randomized controlled trial on the effect of montelukast on sputum eosinophil cationic protein in children with corticosteroid-dependent asthma

Previous adult studies demonstrated the clinical efficacy of an additional treatment with leukotriene receptor antagonists on steroid-dependent asthma, but there is little knowledge about anti-inflammatory add-on effects within the lung. In this study, we hypothesized that steroid-treated children exhibit a decrease in bronchial inflammation in induced sputum under additional treatment with montelukast. Twenty-five asthmatic children aged 6 to 14 y, who had been taking inhaled corticosteroids (400-800 microg/d budesonide) regularly for at least 12 wk, were randomized to receive additional treatment with either montelukast (5 mg orally, once daily) or placebo over a 4-wk period. As primary efficacy variable, eosinophil cationic protein (ECP) in induced sputum as direct measurement of bronchial inflammation was assessed before and after treatment. To assure a baseline level of inflammation, an ECP concentration above 100 microg/L was required. Sputum eosinophil count, concentration of exhaled nitric oxide, urinary excretion of eosinophil protein X, and quality-of-life items were considered as secondary outcome variables. After treatment with montelukast, ECP in sputum was significantly reduced (montelukast: median -975 microg/L [5 to 95% confidence interval: -4295 to 583 microg/L]; placebo: 561 microg/L [-1335 to 3320 microg/L]; p < 0.01) and the quality-of-life score had significantly improved (p < 0.05) compared with placebo. Partly explained by low baseline levels, no statistically significant change in concentration of exhaled nitric oxide (p > 0.05), urinary excretion of eosinophil protein X (p > 0.05), or eosinophil count (p > 0.05) was found. In conclusion, add-on treatment with montelukast can suppress sputum ECP in children with steroid-dependent asthma, while at the same time an improvement in quality of life items occurs.     

Perennial rhinitis in the under 4s: A difficult problem to treat safely and effectively? A comparison of intranasal fluticasone propionate and ketotifen in the treatment of 2–4‐year‐old children with perennial rhinitis

To compare the safety and efficacy of fluticasone propionate aqueous nasal spray (FPANS) and oral ketotifen in children aged 2-4 years with perennial rhinitis. A randomized, multicentre, double-blind, double dummy, placebo-controlled study. Paediatric patients between the ages of 2-4 years with perennial rhinitis. Rhinitis symptoms score (parent-rated), clinical evaluation of symptoms (investigator-rated) and adverse event profiles during the treatment period. Patients treated with FPANS had a significant reduction in both the total night-time rhinitis symptom assessment for weeks 4-6 (p-value 0.036), and the total daytime rhinitis symptom score over the same period (p-value 0.049). Generally, except for nasal itching/rubbing over weeks 1-3, the patients taking FPANS had lower recorded symptom scores for all individual symptoms measured. Nasal blockage, in particular, was significantly reduced over the 4-6 week period (p-value 0.027). The overall investigator-rated clinical evaluation showed substantial improvement or improvement in nine of 12 of the children taking FPANS compared with four of 14 taking ketotifen. Finally, there were no reports of serious adverse events, the incidence of drug-related adverse events was low and there was no statistical difference between the groups. FPANS may be an appropriate treatment to control the symptoms of rhinitis in children between 2 and 4 years old.