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Objective:To assess the clinical effectiveness and safety of Omalizumab for treating pediatric allergic asthma in real world in China.Methods:The clinical data of children aged 6 to 11 years with allergic asthma who received Omalizumab treatment in 17 hospitals in China between July 6, 2018 and September 30, 2020 were retrospectively analyzed.Such information as the demographic characteristics, allergic history, family history, total immunoglobulin E (IgE) levels, specific IgE levels, skin prick test, exhaled nitric oxide (FeNO) levels, eosinophil (EOS) counts, and comorbidities at baseline were collected.Descriptive analysis of the Omalizumab treatment mode was made, and the difference in the first dose, injection frequency and course of treatment between the Omalizumab treatment mode and the mode recommended in the instruction was investigated.Global Evaluation of Treatment Effectiveness (GETE) analysis was made after Omalizumab treatment.The moderate-to-severe asthma exacerbation rate, inhaled corticosteroid (ICS) dose, lung functions were compared before and after Omalizumab treatment.Changes in the Childhood Asthma Control Test (C-ACT) and Pediatric Asthma Quality of Life Questionnaire (PAQLQ) results from baseline to 4, 8, 12, 16, 24, and 52 weeks after Omalizumab treatment were studied.The commodity improvement was assessed.The adverse event (AE) and serious adverse event (SAE) were analyzed for the evaluation of Omalizumab treatment safety.The difference in the annual rate of moderate-to-severe asthma exacerbation and ICS reduction was investigated by using t test.The significance level was set to 0.05.Other parameters were all subject to descriptive analysis.A total of 200 allergic asthma patients were enrolled, including 75.5% ( n=151) males and 24.5% ( n=49) females.The patients aged (8.20±1.81) years. Results:The median total IgE level of the 200 patients was 513.5 (24.4-11 600.0) IU/mL.Their median treatment time with Omalizumab was 112 (1-666) days.Their first dose of Omalizumab was 300 (150-600) mg.Of the 200 cases, 114 cases (57.0%) followed the first Omalizumab dosage recommended in the instruction.After 4-6 months of Omalizumab treatment, 88.5% of the patients enrolled ( n=117) responded to Omalizumab.After 4 weeks of treatment with Omalizumab, asthma was well-controlled, with an increased C-ACT score [from (22.70±3.70) points to (18.90±3.74) points at baseline]. Four-six months after Omalizumab administration, the annual rate of moderate-to-severe asthma exacerbation had a reduction of (2.00±5.68) per patient year( t=4.702 5, P<0.001), the median ICS daily dose was lowered [0 (0-240) μg vs. 160 (50-4 000) μg at baseline] ( P<0.001), the PAQLQ score was improved [(154.90±8.57) points vs. (122.80±27.15) points at baseline], and the forced expiratory volume in one second % predicted (FEV 1%pred) was increased [(92.80±10.50)% vs. (89.70±18.17)% at baseline]. In patients with available evaluations for comorbidities, including allergic rhinitis, atopic dermatitis or eczema, urticaria, allergic conjunctivitis and sinusitis, 92.8%-100.0% showed improved symptoms.A total of 124 AE were reported in 58 (29.0%) of the 200 patients, and the annual incidence was 0(0-15.1) per patient year.In 53 patients who suffered AE, 44 patients (83.0%) and 9 patients (17.0%) reported mild and moderate AE, respectively.No severe AE were observed in patients.The annual incidence of SAE was 0(0-1.9) per patient year.Most common drug-related AE were abdominal pain (2 patients, 1.0%) and fever (2 patients, 1.0%). No patient withdrew Omalizumab due to AE. Conclusions:Omalizumab shows good effectiveness and safety for the treatment of asthma in children.It can reduce the moderate-to-severe asthma exacerbation rate, reduce the ICS dose, improve asthma control levels, and improve lung functions and quality of life of patients.
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Objective:To evaluate the outcome and stability of control statuses in children under 6 years old with bronchial asthma(abbreviated asthma)who were received long-term standardized treatment and management, and to analyze the factors affecting the control stability.Methods:Using the case registration study, a total of 173 asthmatic children under 6 years old were selected from January 2014 to December 2020 in the department of allergy of Beijing Children′s Hospital.All the patients were received asthma long-term standardized treatment and management for 1 year to 2 years.Control statuses were evaluated at 1 year and 2 years follow up visits respectively.According to the changes of stage evaluations of control statuses, the control stabilities were decided, and patients were divided into stable control group and unstable control group.The parameters of exacerbation, repeated respiratory tract infection, pneumonia, concomitant diseases, allergen sensitization, pulmonary function, initial treatment level, delivery mode, feeding method and family history of allergic diseases were compared between the two groups at 1 year and 2 years respectively.Results:Of the 173 patients included, 17.9%(31/173)were younger than 3 years old and 82.1%(142/173)were 3 to 5 years old.After treatment and management for 1 year and 2 years, the proportions of asthma control levels assessed as good control were 51.6%(16/31)and 70.0%(21/30)respectively in the patients younger than 3 years old, and they were 74.6%(106/142)and 76.7%(79/103)respectively in the patients aged 3 to 5 years old.At 1 year and 2 years of treatment and management, the proportions of stable control and unstable control in 173 patients were 28.9%(50/173), 71.1%(123/173)and 26.3%(35/133), 73.7%(98/133), respectively.Asthma control stability status assessment and analysis showed that in the stable control group than that in the unstable control group, at 1 year and 2 years follow up visits, the percentages of exacerbations were lower(28.0% and 54.3% vs 64.2% and 72.4%), and the differences were statistically significant( χ2=18.768 and 3.889, all P<0.05).At 1 year follow up visits, the egg sensitization rate was higher(53.1% vs 32.9%), and the difference was statistically significant( χ2=3.921, P<0.05); the initial treatment level was higher, and the proportions of level 2, 3, 4 initial treatment were(4.0%, 22.0% and 74.0% vs 20.3%, 34.1% and 45.5%), and the difference was statistically significant( Z=-3.608, P<0.05).At 2 years follow up visits, the egg and milk sensitization rates were higher(61.9% and 42.9% vs 26.2% and 18.0%), and the differences were statistically significant( χ2=8.698 and 5.220, all P<0.05).There were no significant differences on the distributions in repeated respiratory tract infection, pneumonia, concomitant diseases, pulmonary function, delivery mode, feeding method and family history of allergic diseases. Conclusion:Stable asthma control is more likely to be achieved in children aged under 6 years with asthma who are manifesting no asthma exacerbation, presenting food sensitization and using the initial treatment at a high level.
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Objective:To analyze the factors related to the control and stability of asthma and allergic rhinitis in children.Methods:Children with airway allergic diseases who visited Department of Allergy and Department of Otorhinolaryngology of Beijing Children′s Hospital from April to December 2015 were enrolled in the prospective study. Patients underwent baseline assessment and regular management every three months. The stability of disease control was evaluated after one year of treatment; according to the control level, children were divided into stable control group and unstable group. The gender, age, history of asthma, allergic rhinitis and eczema, family history, allergen sensitization, pulmonary function, fractional exhaled nitric oxide were compared between the two group.Results:A total of 147 children with airway allergic diseases were included and 106 children were followed up for 12 months. According to the control level at 12 months, there were 60 cases(56.6%)in stable group and 46 cases(43.4%)in unstable group. The proportion of children with eczema history in the unstable group was significantly higher than that in the stable group [88.9%(32/46) vs. 71.7%(43/60), χ 2=3.91, P=0.048]. The allergic rhinitis VAS in the unstable group was significantly higher than that in the stable group at the baseline [(4.7±1.9) vs.(3.7±2.3), t=2.12, P=0.037]. The serum T-IgE level in unstable group was significantly higher than that in the stable group at the baseline [269.0(163.0, 578.5)kU/L vs. 195.5(69.7, 420.8)kU/L, Z=2.01, P=0.044]. The sensitivity rate to dust mite in the unstable group was significantly higher than that in the stable group [76.1%(35/46) vs.55.0%(33/60), χ 2=5.19, P=0.025]. The improvement rate of forced expiratory volume in one second (FEV 1) in the unstable group was significantly higher than that in the stable group[(14.2±11.5) vs.(7.3±5.9), t=2.42, P=0.018]. Conclusion:Eczema history, the severity of allergic rhinitis, serum T-IgE level, atopy and pulmonary physiology are associated with unstable status of airway allergic diseases in children.
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Objective:To investigate the distribution characteristics and clinical significance of aeroallergen sensitization in children with airway allergic diseases.Methods:The information of children who were diagnosed with airway allergic diseases and performed with skin prick test(SPT)of aeroallergens was collected and retrospectively analyzed from Beijing Children′s Hospital from January to December, 2019.A total of 2557 patients were divided into ≤5 years of age group, 6-11 years of age group and ≥12 years of age group according to age, and allergic rhinitis group, asthma group, allergic rhinitis combined with asthma group according to diseases.The differences in the distribution of positive rates of 18 kinds of aeroallergens in age group and disease group were compared.Results:The positive rates of SPT in 2557 children from high to low were weeds pollens in summer and autumn, molds, trees pollens in spring, dust mites, etc..The top five strong positive rates from high to low were Artemisia pollen, Humulus pollen, Dermatophagoides farina, Betula pollen and Fraxinus pennsylvanica pollen.The positive rate was 71.5%(539/754)in the ≤5 years of age group, 78.5%(1241/1581)in 6-11 years of age group, and 81.1%(180/222)in ≥12 years of age group.The difference in positive rates of SPT among different age groups was statistically significant( χ2=16.825, P<0.05). In the group of ≤5 years of age group, the main aeroallergens were Chenopodium pollen(310/754, 41.1%), Alternaria alternate(307/754, 40.7%), Humulus pollen(295/754, 39.1%), Artemisia pollen(293/754, 38.9%)and Fraxinus pennsylvanica pollen(258/754, 34.2%). The main aeroallergens in the 6-11 years of age group were Chenopodium pollen(853/1581, 54.0%), Humulus pollen(769/1581, 48.6%), Artemisia pollen(768/1581, 48.6%), Alternaria alternate(751/1581, 47.5%)and Fraxinus pennsylvanica pollen(724/1581, 45.8%). The main aeroallergens in the ≥12 years of age group were Chenopodium pollen(131/222, 59.0%), Humulus pollen(119/222, 53.6%), Artemisia pollen(113/222, 50.9%), Alternaria alternate(112/222, 50.5%)and Dermatophagoides farina(103/222, 46.4%). The positive rate of allergic rhinitis group was 73.6%(1164/1582), asthma group was 72.4%(234/323), allergic rhinitis combined with asthma group was 86.0%(561/652). The positive rate of SPT was significantly different among different disease groups( χ2=43.408, P<0.05). The main aeroallergen of allergic rhinitis, asthma and allergic rhinitis combined with asthma was Chenopodium pollen.The positive rates of 18 kinds of aeroallergens were significantly different among the three disease groups(all P<0.05). The positive rate of each aeroallergen in allergic rhinitis combined with asthma was higher than that in single airway allergic disease. Conclusion:In children with airway allergic disease, the sensitization spectrum of aeroallergen varies among different age groups and disease groups.Clinicians should monitor allergens regularly and give preventive treatment to children with airway allergic disease.
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Objective:To compare the difference on the positive detection rate of the main aeroallergens and food allergens specific IgE measured with the systems between fluorescence enzyme immunoassay(FEIA, referred to as ImmunoCAP system)and western blot(referred to as Allergy Screen system), in order to provide a basis for the rational application of methods and interpretation of the test results.Methods:The clinical information and sIgE test results data were collected from a total of 458 cases of allergic diseases from October 2017 to April 2019 in the outpatient clinic of Allergy Department in Beijing Children′s Hospital.All of the 458 cases were detected for a panel of common aeroallergens and food allergens sIgE level in their serum with the Allergy Screen system.Simultaneously, the above 141 cases were detected main aeroallergen and food allergen sIgE with ImmunoCAP system, while 303 cases only for aeroallergens and 14 cases only for food allergens.All of the cases were divided into three different phenotype groups according to the main target organ and diagnosis such as airway allergic disease group( N=293), skin allergic disease group( N=14)and multi-system allergic disease group( N=151). Meanwhile, three different age groups were referred to as <3 years old group( N=97), 3 to 6 years old group(3 years and 6 years included)( N=186)and >6 years old group( N=175). The same kinds of the allergens included in the two systems were house dust mite(HDM), cat dander, dog dander, egg white, milk, crab, shrimp, therefore data of sIgE to those seven allergens were compared. Results:In all the enrolled cases, the positive detection rate of HDM, egg white and milk sIgE detected by ImmunoCAP system were significantly higher than those by Allergy Screen system(30.6%, 36.1% and 43.2% vs 21.2%, 21.3% and 21.3%). Among the disease groups, the positive detection rate of HDM sIgE detected by ImmunoCAP system was significantly higher in the airway allergic disease group and multi-system allergic disease group than those by Allergy Screen system, respectively(33.7% and 24.6% vs 23.4% and 16.2%). The positive detection rate of egg white and milk sIgE detected by ImmunoCAP system in the multi-system allergic disease group was significantly higher than those by Allergy Screen system, respectively(47.6% and 47.6% vs 26.2% and 25.2%). There was no significant difference in the positive detection rate of cat dander, dog dander, crab and shrimp sIgE among the disease groups.The positive detection rate of HDM sIgE detected by ImmunoCAP system in all of the age groups were significantly higher than those by Allergy Screen system, respectively(14.9%, 26.9% and 42.3% vs 5.7%, 17.6% and 32.6%). The positive detection rate of cat dander sIgE detected by ImmunoCAP system in <3 years old group was significantly lower than that by Allergy Screen system(6.9% vs 16.1%). The positive detection rate of egg white sIgE detected by ImmunoCAP system in the <3 years old group and the 3 to 6 years old group were higher than those by Allergy Screen system, respectively(47.1% and 33.3% vs 32.4% and 15.0%). The difference in the positive detection rate of milk sIgE detected by these two methods in the <3 years old group and the 3 to 6 years old group was similar to the egg white.Conclusion:According to the analysis of seven kinds of major aeroallergen and food allergen sIgE results, there are differences between the two methods to detect HDM, cat dander, egg white and milk sIgE.It depends on the type of allergic disease and age.The positive detection rates of dog dander, crab, and shrimp sIgE detected by the two methods are consistent.In clinical application, comprehensive analysis should be made, testing methods should be selected rationally, and the results should be interpreted scientifically.
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Objective:To explore the change in the cerebral natriuretic peptide (BNP) levels in the premature infants with hemodynamically significant patent dectus arteriosus (hsPDA) and its relationship with hemodynamics, and to further clarify the clinical significance of BNP in the judgement of illness condition and treatment in the premature infants with hsPDA.Methods:A total of 106cases of premature infants within 6hof birth whose gestational age was no more than 32weeks were selected and divided into hsPDA group (43cases) and PDA with no hemodynamic significance group (nhsPDA group, 27cases) and no PDA group (nPDA group, 36cases) .The patients in HsPDA group were divided into hsPDA treatment group (33cases) and hsPDA non-treatment group (10cases) according to whether ibuprofen was administrated or not.Echocardiography was performed in the patients in hsPDA treatment group, 7dafter oral ibuprofen administration, and the patients in hsPDA treatment group were divided into hsPDA close group (15cases) and hsPDA non-close group (18cases) .The left atrium (LA) /aortic root diameter (VO) value, diameter of patent arterial duct, left ventricular ejection fraction (LVEF) , shortening fraction, left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) were recorded at 1, 3, 7dafter birth of the premature infants in various groups with echocardiography.The level of BNP in plasma was determined by electrochemiluminescence.The correlation analysis was performed between the hemodynamic indexes of echocardiography and the level of BNP in plasma.Results:Compared with nhsPDA group, the LA/VO value, arterial catheter diameter and LVEDD were significantly increased (P＜0.05) .The plasma BNP levels of premature infants in hsPDA close and non-close groups at 1and 3dafter birth were significantly higher than those in nPDA group (P＜0.05) ;the plasma BNP level of the premature infants in hsPDA close group at 7dafter birth was significantly lower than that at 3dafter birth (P＜0.05) .Compared with hsPDA non-treatment group, the LA/VO value, arterial catheter diameter, LEVDD and the plasma BNP level of the premature infants in hsPDA treatment group at 7dafter birth were significantly decreased (P＜0.05) .The plasma BNP level was positively correlated with the LA/VO value and arterial catheter diameter (r=0.727, P＜0.05;r=0.780, P＜0.05) of the premature infants in hsPDA group at 3dafter birth.Conclusion:The level of plasma BNP of premature infants 3 dafter birth is positively correlated with the hemodynamic indexes, and the detection of the changes of the plasma BNP levels is helpful to judge the condition of preterm infants with hsPDA and to provide basis for its diagnosis.
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The damage of pulmonary function starts early in children for airway allergic diseases and increasing the risk of chronic obstructive pulmonary disease (COPD).The prevalence of airway allergic diseases in children is rising year by year,and easily recurrent on-set.It is clear that low lung function in infancy can precede the development of subsequent asthma in childhood and childhood asthma may persist to teenagers and even in the adults and the impairment of pulmonary function also starts early in life and continue to exist.Children with allergic rhinitis suffer from impaired lung function.Allergic rhinitis may impact the recovery of pulmonary function testing after moderate/severe asthma exacerbation in children.Pulmonary function testing can be used to determine the growth and Trajectory of children lung function and the effect of diseases.Pulmonary function testing is an important index to evaluate the status of asthma control and remission,meanwhile,children with allergic rhinitis suffer from impaired lung function to varying degrees.
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Objective To analyze the effects on control rate and the outcome of pulmonary function in children with bronchial asthma (abbreviated asthma) who were received the two years standardized treatment and management,and to explore the sensitive parameters of control effects in children with asthma.Methods Using the retrospective analysis,asthmatic children were selected from January 2014 to January 2015 in Beijing Children's Hospital,allergy and asthma outpatient clinics.All the patients were received asthma control treatment and management according to GINA guidelines (2014 version).They were assessed on asthma control level at one year and two years follow up visits respectively and their pulmonary function were evaluated at the same time.According to response status to therapy and adjustment of step up and down,children were divided into two groups,the stable control group and the difficult to control group.The parameters of sex,age,asthma,combined with rhinitis,allergen sensitization and pulmonary function were compared between the two groups.Results A total of 149 patients were enrolled in this study.The treatment levels were 20.2％,67.1％ and 12.7％ respectively at grade 2,grade 3 and ≥ 4 grade.After Treatment management for one year and two years,the asthma control level were assessed as good control was 81.8％ and 83.2％ respectively (P ＜ 0.05) Each parameter of pulmonary function excepted FEV1/FVC at the one year visit point after treatment and management was significantly higher than that at enrollment (P ＜ 0.05).After two years of treatment and management,PEF％ pred and FEF25 ％ pred was higher than that at first follow up visit (P ＜ 0.05).There were no significantly different on the distribution of sex,age,course of asthma,allergic rhinitis,allergen sensitization and initial control treatment level between the stable control and the difficult to control groups.Asthma control stability status assessment and analysis at the one year follow up visits showed that PEF％ pred was significantly higher in the group of stable control than that in group of difficult to control (97.3 ± 14.3 vs 93.1 ± 15.1,P ＜ 0.05).Asthma control stability starus assessment and analysis at two years follow up visits showed that the positive rate of allergen sensitization was significantly lower in the group of stable control than that in group of difficult to control (P ＜ 0.05),while FEV1/FVC was significantly higher in the group of stable control than that in group of difficult to control (81.0 ± 9.47vs77.4 ± 8.95,P＜0.05).Conclusion School age children asthma control level were improved with longer time regular treatment and management as well as the pulmonary function improvement.Multiple allergenic sensitization and lower PEF％ pred value and FEV1/FVC are suggestive parameters for children with difficult to control asthma.
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Objective To investigate the changes in percentage and function of CD4+CD25+regu-latory T cells ( Tregs) in peripheral blood of patients with hay fever. Methods A total of 20 patients with hay fever, 20 patients with house dust mite-induced allergic asthma and 20 healthy subjects were enrolled in this study. Peripheral blood samples were collected from all subjects to isolate PBMCs. Percentages of Tregs in PBMCs were measured by flow cytometry. CD4+CD25+ Tregs and CD4+CD25-T cells ( Teffs) were isola-ted by immunomagnetic cell sorting. Effects of CD4+CD25+Tregs on the proliferation of Teffs were evaluated by MTT assay. Expression of Foxp3 and TGF-β1 at mRNA level was analyzed by RT-PCR. Results During the pollen season, the percentage of circulating Tregs in patients with hay fever [(1. 82+0. 82)％] was sig-nificantly lower than that in patients with house dust mite-induced allergic asthma [(2. 96±1. 34)％] and health subjects [(5. 78±2. 29)％] (both P<0. 05). Expression of Foxp3 at mRNA level was significantly reduced in patients with hay fever (0. 46±0. 25) as compared with that of the house dust mite-induced aller-gic asthma (0. 64±0. 31) and healthy control (1. 04±0. 21) groups (both P<0. 05). Expression of TGF-β1 at mRNA level in both hay fever (0. 34±0. 27) and house dust mite-induced allergic asthma (0. 43±0. 31) groups was lower than that of the healthy control group (0. 99±0. 34). Treg-mediated suppression of Teff proliferation was significantly decreased in patients with hay fever [(17. 1±8. 4)％] as compared with that in patients with house dust mite-induced allergic asthma [(21. 4±9. 1)％]) and healthy subjects [(36. 0± 13. 9)％] (P<0. 05). Conclusion Decreased percentage and defective function of Tregs might be one of the major causes for the occurrence and development of hay fever in children during the pollen season.
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Objective To investigate the levels and significance of Th17 cells and regulatory T cells (Treg) in peripheral blood of children with allergic rhinitis during pollen and non-pollen seasons.Methods Thirteen children with hay fever, 10 children with house dust mite(HDM)-allergic asthma and 10 healthy children were recruited into this study.Percentages of Th17 and Treg cells were detected by flow cytometry.Levels of IL-17, IL-10 and TGF-β in cell culture supernatants were measured by ELISA.Results (1) The percentages of Th17 cells in children with allergic rhinitis [(3.4±2.4)%] were significantly higher than those in HDM-allergic asthmatics [(2.1±1.6)%] and those in healthy children [(0.5±0.3)%] during pollen season (both P<0.05).The levels of Treg cells in allergic rhinitis group [(2.1±1.3)%] and in HDM-allergic asthma group [(3.6±1.9)%] were significantly lower than those in healthy control group [(5.5±2.8)%] (both P<0.05).The levels of Th17 cells [(3.0±1.9)% vs (3.4±2.4)%, P<0.05] and ratios of Th17/Treg cells [(1.4±1.0)% vs (1.7±1.5)%, P<0.05] in children with allergic rhinitis were significantly decreased during non-pollen season as compared with those during pollen season, but the levels of Treg cells were up-regulated [(2.4±1.6)% vs (2.1±1.3)%, P<0.05].(2) Correlation analysis revealed that the ratios of Th17/Treg cells were positively correlated with the concentrations of FeNO (fractional concentration of exhaled NO) (r=0.321, P<0.05) and the counts of circulating eosinophils (r=0.198, P<0.05) in children with allergic rhinitis during pollen season.Conclusion The imbalanced Th17 and Treg cells in children with allergic rhinitis during pollen season might play a vital role in the regulation of allergic airway inflammation.
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Objective To systematically evaluate the influence of TNF-α and NSE levels in cerebrospinal fluid on Chinese children with viral encephalitis (VE).Methods Literature about the influence of TNF-α and NSE levels in cerebrospinal fluid on Chinese children with VE,which were published before Nov.1,2016,were searched in databases including CNKI,Wanfang Data,Cochrane Library and PubMed.And the case-control study about the TNF-α and NSE levels in cerebrospinal fluid between Children with VE (VE group) and children without VE (control group) were included in this study,and the quality evaluation was implemented and the data were extracted.And then the RevMan 5.3 was used to carry out the meta-analysis.Results Nine case-control studies were included in this study,involving 536 cases in the VE group and 284 cases in the control group.The results showed that the level of TNF-α and NSE in cerebrospinal fluid of the VE group were all significantly higher than that of the control group,and the differences was statistically significant [SMD=1.75,95%CI:1.56-1.93,P<0.01;SMD=1.34,95%CI:1.17-1.51,P<0.01].Conclusion The levels of TNF-α and NSE in cerebrospinal fluid are positively correlated with the incidence of VE in Chinese children.
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Objective To investigate the changes in percentage and function of CD4+CD25+regu-latory T cells ( Tregs) in peripheral blood of patients with hay fever. Methods A total of 20 patients with hay fever, 20 patients with house dust mite-induced allergic asthma and 20 healthy subjects were enrolled in this study. Peripheral blood samples were collected from all subjects to isolate PBMCs. Percentages of Tregs in PBMCs were measured by flow cytometry. CD4+CD25+ Tregs and CD4+CD25-T cells ( Teffs) were isola-ted by immunomagnetic cell sorting. Effects of CD4+CD25+Tregs on the proliferation of Teffs were evaluated by MTT assay. Expression of Foxp3 and TGF-β1 at mRNA level was analyzed by RT-PCR. Results During the pollen season, the percentage of circulating Tregs in patients with hay fever [(1. 82+0. 82)％] was sig-nificantly lower than that in patients with house dust mite-induced allergic asthma [(2. 96±1. 34)％] and health subjects [(5. 78±2. 29)％] (both P<0. 05). Expression of Foxp3 at mRNA level was significantly reduced in patients with hay fever (0. 46±0. 25) as compared with that of the house dust mite-induced aller-gic asthma (0. 64±0. 31) and healthy control (1. 04±0. 21) groups (both P<0. 05). Expression of TGF-β1 at mRNA level in both hay fever (0. 34±0. 27) and house dust mite-induced allergic asthma (0. 43±0. 31) groups was lower than that of the healthy control group (0. 99±0. 34). Treg-mediated suppression of Teff proliferation was significantly decreased in patients with hay fever [(17. 1±8. 4)％] as compared with that in patients with house dust mite-induced allergic asthma [(21. 4±9. 1)％]) and healthy subjects [(36. 0± 13. 9)％] (P<0. 05). Conclusion Decreased percentage and defective function of Tregs might be one of the major causes for the occurrence and development of hay fever in children during the pollen season.