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粉塵螨滴劑舌下免疫治療兒童過(guò)敏性哮喘的臨床研究

發(fā)布時(shí)間:2018-08-29 10:52
【摘要】:目的觀察和評(píng)價(jià)2年粉塵螨滴劑(Dermatophagoides Farinae Drops,DFD)舌下脫敏免疫治療(Sublingual immunotherapy,SLIT)兒童過(guò)敏性哮喘的療效和安全性。方法選取2012年3月-6月福建省福州兒童醫(yī)院哮喘?崎T(mén)診110例6-14歲非急性發(fā)作期輕-中度過(guò)敏性哮喘兒童,隨機(jī)分成實(shí)驗(yàn)組和對(duì)照組各55例。實(shí)驗(yàn)組按照全球哮喘防治創(chuàng)議(Global INitiative for Asthma,GINA)方案常規(guī)治療和舌下含服DFD,對(duì)照組按照GINA方案常規(guī)治療。通過(guò)2年隨訪,每個(gè)月評(píng)估日、夜間哮喘癥狀(Daytime nighttime asthma symptom,DNAS)評(píng)分、兒童哮喘控制測(cè)試(Children asthma control test,C-ACT)評(píng)分及安全性,每6個(gè)月復(fù)查肺功能第1秒用力呼氣容積(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%)、用力呼氣流量25%(forced expiratory flow25%,FEF25%)、用力呼氣流量50%(forced expiratory flow50%,FEF50%)、呼氣峰流量(peak expiratory flow,PEF),每12個(gè)月復(fù)查特異性免疫球蛋白G4(Specific immunoglobulin G4,s Ig G4)、特異性免疫球蛋白E(Specific Immunoglobulin E,s Ig E)、皮膚點(diǎn)刺檢測(cè)(Skin Prick Test,SPT),并記錄2年期間兩組患兒呼吸道感染次數(shù)、哮喘發(fā)作次數(shù)、兒童誤學(xué)天數(shù)和吸入型糖皮質(zhì)激素(inhaled corticosteroid,IC)劑量。結(jié)果1.治療24個(gè)月實(shí)驗(yàn)組肺功能FEV1%、FEF25%、FEF50%、Ig G4值、C-ACT評(píng)分較對(duì)照組升高(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評(píng)分較對(duì)照組降低(t=2.183 P=0.035,t=2.103 P=0.03),差異有統(tǒng)計(jì)學(xué)意義。2.治療24個(gè)月實(shí)驗(yàn)組粉塵螨皮試等級(jí)變化、s Ig E、肺功能PEF值與對(duì)照組比較無(wú)差異(χ2=0.510 P=0.185,t=-0.183 P=0.855,t=-1.877P=0.063)。3.實(shí)驗(yàn)組治療24個(gè)月后肺功能各指標(biāo)FEV1%、FEF25%、FEF50%較治療前明顯升高(t=-5.973 P=0.0001,t=-2.431 P=0.019,t=-3.957P=0.0001),差異有統(tǒng)計(jì)學(xué)意義。4.對(duì)照組治療24個(gè)月后肺功能FEV1%較治療前明顯升高(t=-6.201P=0.0001),FEF25%、FEF50%與治療前比較差異無(wú)統(tǒng)計(jì)學(xué)意義(t=1.461P=0.150,t=-1.770 P=0.083)。5.實(shí)驗(yàn)組s Ig G4值在治療12個(gè)月和治療24個(gè)月逐年升高,差異有統(tǒng)計(jì)學(xué)意義(F=44.722 P=0.0001)。6.治療24個(gè)月后實(shí)驗(yàn)組呼吸道感染次數(shù)、哮喘發(fā)作次數(shù)、兒童誤學(xué)天數(shù)較對(duì)照組明顯減少(t=-2.409 P=0.020,t=-3.194 P=0.002,t=-2.304P=0.026),差異有統(tǒng)計(jì)學(xué)意義。7.治療24個(gè)月后實(shí)驗(yàn)組IC劑量較對(duì)照組明顯減少(χ2=9.072 P=0.028)。結(jié)論1.DFD SLIT可以改善過(guò)敏性哮喘患兒的肺功能指標(biāo)FEV1%、FEF25%、FEF50%和臨床癥狀如DNAS、C-ACT評(píng)分。2.DFD SLIT可以減少呼吸道感染次數(shù)、哮喘發(fā)作次數(shù)、兒童誤學(xué)天數(shù)和IC劑量。3.DFD SLIT可以產(chǎn)生特異性封閉抗體s Ig G4,并在2年治療中呈現(xiàn)逐年顯著升高,減輕過(guò)敏癥狀。4.DFD是一種安全、有效治療過(guò)敏性哮喘兒童的特異性免疫藥物。
[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.
【學(xué)位授予單位】:福建醫(yī)科大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2014
【分類號(hào)】:R725.6

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