标准化屋尘螨疫苗免疫治疗对变应性支气管哮喘的疗效  

Effect of 1-year specific immunotherapy with standardized house dust mite vaccine on mild to moderate allergic asthmatic patients

作　　者：王红玉[1] 林小平[2] 郝创利[3] 张纯青[4] 孙宝清[1] 郑劲平[1] 陈萍[2] 盛锦云[3] 邬扬源[5] 钟南山[1] 

机构地区：[1]广州医学院第一附属医院广州呼吸疾病研究所,510120 [2]沈阳军区总医院呼吸内科及变态反应疾病诊治中心 [3]苏州儿童医院呼吸内科 [4]广州医学院第一附属医院 儿科,510120 [5]香港大学玛丽医院内科

出　　处：《中华结核和呼吸杂志》2006年第10期679-687,共9页Chinese Journal of Tuberculosis and Respiratory Diseases

基　　金：广东省卫生厅基金(A2003295)

摘　　要：目的评价标准化屋尘螨疫苗治疗变应性支气管哮喘(简称哮喘)的临床疗效和安全性。方法按照多中心、随机、双盲、安慰剂平行对照的方法,2001年10月至2002年3月将来自广州医学院第一附属医院、沈阳军区总医院、苏州儿童医院的轻至中度变应性哮喘患者132例分为治疗组和对照组,每组66例。治疗组皮下注射标准化氢氧化铝吸附的缓释型屋尘螨疫苗,对照组皮下注射二盐酸组胺,治疗时间为1年。从各组药物的起始浓度开始,按4个以10倍递增的浓度每周注射1次(治疗组:100、1 000、10 000、100 000 SQ-U/ml,对照组:0.01、0.1、1.0、10μg/ml。100 000 SQ-U/ml的屋尘螨疫苗含9.8μg/ml 主要致敏蛋白 Der P1)。前3个浓度的每种浓度每周依次注射剂量为0.2、0.4、0.8 ml,共9周,第10~14周每周依次注射最高浓度的0.1、0.2、0.4、0.6、0.8 ml,第15周达1 ml,并以此剂量渐延长注射间隔,按每2、4、6周各注射1次,1至26周末为剂量递增阶段(第1阶段,简称 H_1),之后保持每6周注射1次至治疗结束,进入剂量维持阶段(第2阶段,简称 H_2)。患者在每次注射后,必须在诊室留观30 min。结果 132例患者入选,129例(治疗组64例,对照组65例)完成1年的治疗,其中3例中途退出。两组基线期的所有临床及实验室指标具有可比性。对每4周计算的日均哮喘症状计分观察,从第29~32周开始两组患者症状计分开始出现差异,治疗组日均哮喘症状计分为(0.17±0.33)分,对照组为(0.39±0.74)分,两组比较差异有统计学意义(Z=2.031,P<0.05),至治疗结束。治疗组 H_2的症状计分为(0.19±0.27)分,与 H_1[(0.29±0.39)分]比较差异有统计学意义(Z=2.923,P<0.01),而对照组 H_2的症状计分为(0.40±0.68)分,与 H_1[(0.45±0.62)分]比较差异无统计学意义(Z=1.885,P>0.05)。哮喘总体病情、发作严重程度、发作频率的自我评估改善率,治疗组分别为96.9%、95.3%、95.4%,对照组分别为80.0%、75.4%、83.1Objective To evaluate the clinical efficacy and safety of specific immunotherapy(SIT) with standardized house dust mite (HDM) vaccine on allergic asthmatic patients. Methods The investigation was a multicentre, randomized, double-blind, placebo-controlled clinical study. 132 patients with mild to moderate asthma who were allergic to HDM, recruited from three hospitals of China ( The First Affiliated Hospital of Guangzhou Medical College, Shenyang General Military Hospital, Suzhou Children' s Hospital) , were randomly allocated to the active group ( n = 66 ) or the control group ( n = 66 ) respectively. The active group received SIT with a standardized depot Dermatophagoides pteronyssinus ( Der p ) extract absorbed to aluminium hydroxide (Alutard SQ, ALK-Abell6, Denmark) , while the control group received a placebo containing histamine dihydrochloride by subcutaneous injections for 1 year. Treatment of each group was started from the initial concentration. Updosing was performed with weekly injections from four 10-fold dose-increase vials( active group : 100,1 000,10 000,100 000 SQ-U/ml, control group: 0. 01,0. 1,1.0,10 μg/ml. 100 000 SQ-U/ml of Der p extract contains 9. 8 μg/ml of the majoy allergen Der pl ) . The singledose was injected weekly with 0. 2,0.4,0. 8 ml of each concentration in turn from the preceding 3 vials, totally for 9 weeks. Subsequently, the dose with 0. 1,0. 2,0.4,0. 6,0. 8 ml of the highest concentration was injected weekly from the 10th-14th week and a maintenance dose with 1 ml was reached at the 15th week. The dosing interval was then gradually increased to 2,4,6 weeks until the end of the first 26-weeks updosing phase (phase Ⅰ , H1 ). Thereafter, the dosing continued at 6-week intervals for maintenance phase (phase Ⅱ , H2 ) till the end of the complete treatment. The patient was observed for at least 30 minutes in the clinic after each injection. Results A total of 132 subjects were randomized and 129 subjects (64 in the active group,65 in the control group) completed the whole st

关 键 词：螨 易感性与特异性 免疫法 哮喘 支气管高反应性 

分 类 号：R562.25[医药卫生—呼吸系统]