舌下含服粉尘螨滴剂治疗儿童过敏性哮喘和变应性鼻炎的临床评价  

Clinical evaluation for sublingual immunotherapy of allergic asthma and atopic rhinitis with Dermatophagoides Farinae Drops

作　　者：曹兰芳[1] 陆权[2] 顾洪亮[3] 陈燕萍[4] 张源[5] 陆敏[2] 钱耀琴[3] 李岚[5] 许以平[6] 

机构地区：[1]上海交通大学医学院附属仁济医院儿科,200001 [2]上海交通大学附属儿童医院呼吸科 [3]上海交通大学医学院附属第九人民医院儿科 [4]上海中医药大学附属岳阳中西医结合医院 [5]浙江省中医院儿科 [6]上海交通大学医学院附属仁济医院 过敏疾病防治中心,200001

出　　处：《中华儿科杂志》2007年第10期736-741,共6页Chinese Journal of Pediatrics

基　　金：浙江省重点技术创新计划;高新技术产业化专项[(2004)548号];科技型中小企业技术创新基金项目(713 05C26213300713);国家发展和改革委员会办公厅高科技产业化专项[发改办高技(2006)2352号]

摘　　要：目的评估舌下特异性免疫治疗药物"粉尘螨滴剂"治疗儿童过敏性哮喘及变应性鼻炎的疗效及安全性。方法采用随机双盲、安慰剂平行对照的研究方法,将278例年龄4～18岁粉尘螨过敏的哮喘和(或)鼻炎患儿随机分为治疗组(139例)和安慰剂组(139例),分别给予舌下含服"粉尘螨滴剂"或安慰剂,在治疗第2,3,4,6,10,14,18,22周进行随访,治疗第25周结束临床观察。对两组治疗前后的哮喘和鼻炎症状与体征评分、用药计分、肺功能及各项实验室指标、不良事件进行分析比较,并在试验结束前让患儿进行疾病转归的自我评价。结果 (1)278例研究对象中,共251例完成试验;(2)治疗组过敏性哮喘患者 PEF 日内变异率改变量-1.38,而安慰剂组仅为-0.90(P<0.05);(3)治疗结束后,过敏性哮喘治疗组应急用药改变量较基线有所下降(=-0.08),而安慰剂组用药则有所增加(=0.52),两组用药剂量较基线改变量的差异有显著性(W=-2.45,P<0.05);(4)治疗组鼻炎患者每日症状积分改变量为-1.96,而安慰剂组为-1.03(W=3.90,P<0.01);(5)鼻炎患者安慰剂组应急用药量较基线改变量为0.01,治疗组为-0.25,但两组差异无统计学意义(W=1.40,P>0.05);(6)用药25周以后,两组血清特异性 IgE(sIgE)水平较用药前无显著改变,而治疗组的血清特异性 IgG4平均水平显著增高(P<0.05);(7)试验期间未发生严重不良事件,与研究药物可能有关的不良反应主要表现为哮喘轻度发作和局部皮疹。结论"粉尘螨滴剂"是一种安全有效治疗儿童过敏性哮喘和变应性鼻炎的舌下特异性免疫治疗药物。Objective To evaluate the safety and efficacy of sublingual immunotherapy with ＇ Dermatophagoides Farinae Drops＇ in D. farinae allergic asthma and/or rhinitis patients. Methods A 25- week double-blind, placebo-controlled, multi-centered trail was conducted in 278 children （ aged 4 - 18 yr） with mite-induced asthma and/or rhinitis. Patients were randomly assigned to receive sublingual immunotherapy （SLIT） with ＇ Dermatophagoides Farinae Drops＇ （n = 139） or placebo （n = 139） for 25 weeks and the dosage and administration strictly followed the manufacturer＇s instructions. At the beginning of the 2nd, 3rd, 4th, 6th, 10th, 14th, 18th, 22nd week of the treatment, the patients were asked to accept follow-up visit, during the clinical trial all patients and parents were asked to keep a daily record of their asthma symptom scores, rescue medicine use, rhinitis symptom scores, morning and evening peak expiratory flow. Asthma symptom scores, reduction in use of rescue medicine, rhinitis symptom scores, lung function tests, skin sensitivity to mite, mite-specific immunoglobulin （Ig） E and IgG4, and quality of life and adverse effect were assessed during the study. Result （1） Of the 278 children, 27 dropped out before the study completion. （2） After 25 weeks of treatment, the median variability of PEFR was - 1.38 for SLIT group and - 0. 90 for the placebo （ P 〈 0. 05 ）. （ 3 ） Besides, the mean variability of medicine score of asthma was - 0. 08 for SLIT group and 0. 52 for the plcebo （ P 〈 0. 05 ）. （4） The median variability of rhinitis symptom score was - 1.96 for SLIT group and - 1.03 for the placebo （ P 〈 0. 01 ）. （ 5 ） The rescue medicine usage of SLIT reduced but did not show significant differences between SLIT and placebo. （6） After 25 weeks treatment, the increase of D. farinae specific IgE antibody of two groups were similar, while specific IgG4 increased significantly in SLIT compared to the patients in control one （ P 〈 0. 01 ） ; （7）

关 键 词：投药 舌下 免疫疗法 粉尘螨 哮喘 鼻炎 反应性 常年性 

分 类 号：R725.6[医药卫生—儿科] R765[医药卫生—临床医学]