粉尘螨滴剂舌下免疫治疗儿童过敏性哮喘的临床研究

发布时间：2018-08-29 10:52

【摘要】：目的观察和评价2年粉尘螨滴剂(Dermatophagoides Farinae Drops,DFD)舌下脱敏免疫治疗(Sublingual immunotherapy,SLIT)儿童过敏性哮喘的疗效和安全性。方法选取2012年3月-6月福建省福州儿童医院哮喘专科门诊110例6-14岁非急性发作期轻-中度过敏性哮喘儿童,随机分成实验组和对照组各55例。实验组按照全球哮喘防治创议(Global INitiative for Asthma,GINA)方案常规治疗和舌下含服DFD,对照组按照GINA方案常规治疗。通过2年随访,每个月评估日、夜间哮喘症状(Daytime nighttime asthma symptom,DNAS)评分、儿童哮喘控制测试(Children asthma control test,C-ACT)评分及安全性,每6个月复查肺功能第1秒用力呼气容积(forced expiratory volume in one secon,FEV1)占用力肺活量(forced vital capacity,FVC)的百分比即1秒率(FEV1/FVC,FEV1%)、用力呼气流量25%(forced expiratory flow25%,FEF25%)、用力呼气流量50%(forced expiratory flow50%,FEF50%)、呼气峰流量(peak expiratory flow,PEF),每12个月复查特异性免疫球蛋白G4(Specific immunoglobulin G4,s Ig G4)、特异性免疫球蛋白E(Specific Immunoglobulin E,s Ig E)、皮肤点刺检测(Skin Prick Test,SPT),并记录2年期间两组患儿呼吸道感染次数、哮喘发作次数、儿童误学天数和吸入型糖皮质激素(inhaled corticosteroid,IC)剂量。结果1.治疗24个月实验组肺功能FEV1%、FEF25%、FEF50%、Ig G4值、C-ACT评分较对照组升高(t=-2.146 P=0.005,t=-2.185 P=0.031,t=-3.098 P=0.003,t=-7.583 P=0.0001,t=-2.146 P=0.034),DAS、NAS评分较对照组降低(t=2.183 P=0.035,t=2.103 P=0.03),差异有统计学意义。2.治疗24个月实验组粉尘螨皮试等级变化、s Ig E、肺功能PEF值与对照组比较无差异(χ2=0.510 P=0.185,t=-0.183 P=0.855,t=-1.877P=0.063)。3.实验组治疗24个月后肺功能各指标FEV1%、FEF25%、FEF50%较治疗前明显升高(t=-5.973 P=0.0001,t=-2.431 P=0.019,t=-3.957P=0.0001),差异有统计学意义。4.对照组治疗24个月后肺功能FEV1%较治疗前明显升高(t=-6.201P=0.0001),FEF25%、FEF50%与治疗前比较差异无统计学意义(t=1.461P=0.150,t=-1.770 P=0.083)。5.实验组s Ig G4值在治疗12个月和治疗24个月逐年升高,差异有统计学意义(F=44.722 P=0.0001)。6.治疗24个月后实验组呼吸道感染次数、哮喘发作次数、儿童误学天数较对照组明显减少(t=-2.409 P=0.020,t=-3.194 P=0.002,t=-2.304P=0.026),差异有统计学意义。7.治疗24个月后实验组IC剂量较对照组明显减少(χ2=9.072 P=0.028)。结论1.DFD SLIT可以改善过敏性哮喘患儿的肺功能指标FEV1%、FEF25%、FEF50%和临床症状如DNAS、C-ACT评分。2.DFD SLIT可以减少呼吸道感染次数、哮喘发作次数、儿童误学天数和IC剂量。3.DFD SLIT可以产生特异性封闭抗体s Ig G4,并在2年治疗中呈现逐年显著升高,减轻过敏症状。4.DFD是一种安全、有效治疗过敏性哮喘儿童的特异性免疫药物。
[Abstract]:Objective to observe and evaluate the efficacy and safety of sublingual desensitization immunotherapy (Sublingual immunotherapy,SLIT) for 2 years with dermatophagoides farinae drop (Dermatophagoides Farinae Drops,DFD) in children with allergic asthma. Methods from March to June, 2012, 110 children with mild to moderate allergic asthma aged 6-14 years were randomly divided into two groups: experimental group (n = 55) and control group (n = 55). The experimental group was treated according to global asthma prevention and treatment regimen (Global INitiative for Asthma,GINA) and the sublingual DFD, group was treated with GINA regimen. After 2 years follow-up, each month assessment day, night asthma symptom (Daytime nighttime asthma symptom,DNAS) score, childhood asthma control test (Children asthma control test,C-ACT) score and safety, The percentage of forced expiratory volume (forced expiratory volume in one secon,FEV1) in forced vital capacity (forced vital capacity,FVC) was 1 second (FEV1/FVC,FEV1%), forced expiratory flow (25% (forced expiratory flow25%,FEF25%), forced expiratory flow (50% (forced expiratory flow50%,FEF50%), peak expiratory flow (peak expiratory flow,PEF) every 12 months. The specific immunoglobulin G _ 4 (Specific immunoglobulin G _ 4s Ig G4) and the specific immunoglobulin E (Specific Immunoglobulin Eros Ig E), skin prick were examined for (Skin Prick Test,SPT). The respiratory tract infection times of the two groups were recorded during the 2-year period. Asthma attacks, school days and inhaled glucocorticoid (inhaled corticosteroid,IC) doses in children. Result 1. After 24 months of treatment, the FEV1%,FEF25%,FEF50%,Ig G4 scores and C-ACT scores in the experimental group were significantly higher than those in the control group (t = 2.146, P ~ (0.005), t ~ (-2.185) ~ (0.031) ~ (-3.098), P ~ (0.003) ~ (-7.583) P ~ (0.0001) ~ (0.0001) ~ (2.146) P ~ (0.034), and the DASNAS score was significantly lower than that in the control group (t ~ (2.183) P ~ (0.035) P ~ (2.103) P ~ (0.03). After 24 months of treatment, there was no significant difference in the grade of dermatophagoides farinae and the PEF value of lung function between the experimental group and the control group (蠂 ~ 2 ~ (2) 0. 510 P ~ (0. 185) P ~ (- 0.183) P ~ (-1) P ~ (-1) P ~ + 0.85 ~ (7) P ~ 0. 063). After 24 months of treatment, the FEV1%,FEF25%,FEF50% of lung function in the experimental group was significantly higher than that before treatment (t _ (-5.973) P ~ (0.0001) ~ (0.0001) ~ (-2.431) P ~ (-1) (t ~ (-5.973) P ~ (0.000) ~ (-2.431) ~ (0.019) ~ (3.957) P ~ (-1). After 24 months of treatment, the pulmonary function of the control group was significantly higher than that before treatment (t=-6.201P=0.0001). There was no significant difference in 50% of FEF25 and before treatment (t = 1.461) or 0.150 ~ (-1.770) P0. 083) .5. The value of Ig G4 in the experimental group increased year by year after 12 months of treatment and 24 months of treatment, and the difference was statistically significant (FF4 44.722 P0. 0001) .6. After 24 months of treatment, the number of respiratory tract infection, the number of asthma attacks and the number of days of school error in children in the experimental group were significantly lower than those in the control group (t _ (2.409) P ~ (0.020) P ~ (-3.194) P ~ (-1). The difference was statistically significant (t ~ (2) -2.304 P ~ (+) P ~ (0.026). After 24 months of treatment, the dose of IC in the experimental group was significantly lower than that in the control group (蠂 ~ 2 / 9.072 P ~ (0.028). Conclusion 1.DFD SLIT can improve the pulmonary function index FEV1%,FEF25%,FEF50% and clinical symptoms such as DNAS,C-ACT score. 2. DFD SLIT can reduce the number of respiratory tract infections and asthma attacks in children with allergic asthma. The days of school error in children and the dosage of IC. 3. DFD SLIT could produce specific blocking antibody s Ig G4, and increased significantly year by year during 2 years treatment. 4. DFD is a safe and effective specific immunotherapy for children with allergic asthma.
【学位授予单位】：福建医科大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R725.6

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