淋巴免疫治疗过敏性哮喘的临床疗效

Clinical Efficacy of Intralymphatic Immunotherapy for Allergic Asthma

目的评价标准化屋尘螨过敏原淋巴免疫治疗过敏性哮喘的临床疗效及安全性。方法 72例屋尘螨致敏性哮喘患者,随机分为治疗组和对照组,每组各36例,对照组给予布地奈德气雾剂和沙丁胺醇气雾剂治疗;治疗组在上述药物治疗同时,行超声引导下分别于0、4、8、12、16和20周行腹股沟淋巴结内注射屋尘螨过敏原制剂,除0周用药剂量为100 SQ-U外,其余5次应用剂量均为1000 SQ-U。治疗前后两组患者分别进行血清屋尘螨特异性IgE(sIgE)检测、哮喘控制测试(asthma control test,ACT),药物用量评分、肺功能[第1秒用力呼气容积占预计值的百分比(percentage of forced expiratory volume in first second to predicted value,FEV1%)、第1秒用力呼气容积与用力肺活量比值(ratio of forced expiratory volume in first second to forced vital capacity,FEV1/FVC)和峰流速占预计值的百分比(percentage of peak expiratory flow to predicted value,PEF%)]检测并记录患者疗程中的不良反应。结果治疗组32例患者完成了淋巴免疫治疗,2例因怀孕退出,2例失访;对照组32例按要求完成了对照观察,4例失访。治疗组患者治疗后4、8、12、16和20周ACT评分分别为(15.72±2.00)、(16.44±2.06)、(18.88±1.29)、(20.16±1.43)、(23.97±1.03),高于治疗前(0)周(15.34±2.15),差异有统计学意义(P<0.01);12、16和20周ACT评分均高于对照组同时间ACT评分[(16.63±2.12)、(16.81±2.10)、(16.87±2.30)],差异有统计学意义(P<0.01)。治疗后肺功能检测(FEV1%、FEV1/FVC和PEF%)分别为(74.81±5.91)、(77.31±5.43)、(74.09±4.71),均明显高于治疗前各项[(57.06±7.49)、(60.31±7.04)、(50.81±6.57)]及治疗后对照组水平[(54.91±7.79)、(59.44±8.77)、(50.38±8.13)],差异有统计学意义(P<0.01)。治疗组治疗后药物用量评分(0.66±0.43)和血清屋尘螨sIgE浓度(1.69±0.92)kU/L明显低于治疗前[(2.19±0.78)、(2.73±1.09)kU/L],且明显低于对照组[(1.92±0.77)、(3.09±1.29)kU/L],差异均有统计学差异(P<0.01)。32例淋巴免疫治疗患者进行了192次浅表淋巴结注射,未发生局部不良反应和全身不良反应。结论过敏原淋巴免疫治疗不仅临床疗效显著,而且大大缩短了疗程,减少了变应原剂量、注射次数和不良反应的发生,为安全、有效的病因治疗方法。

Objective To evaluate the clinical efficacy and safety of intralymphatic immunotherapy with standardized Dermatophagoides pteronyssinus allergen vaccine for Dermatophagoides pteronyssinus-induced allergic asthma. Methods 72 patients with Dermatophagoides pteronyssinus-induced allergic asthma were randomly divided into intralymphatic immunotherapy treatment group and control group, 36 cases were enrolled in each group. Patients in control group were prescribed budesonide and salbutamol aerosol while patients in intralymphatic immunotherapy treatment group were prescribed above medications and also received 6 ultrasound-guided intra-superficial lymph node injections by using standardized aluminum-adsorbed Dermatophagoides pteronyssinus allergen vaccine （ Alutard ALK, Denmark） every four weeks. The evaluation of clinical efficacy was based on serum Dermatophagoides pteronyssinus slgE, asthma control test （ACT）, pulmonary function test [ FEVI% , FEV1/FVC and PEF% ], medication score on baseline and after treatment, comparing with control group. Adverse reactions were also recorded. Results 32 cases in treatment group completed the study, 2 cases dropped out due to pregnancy and another 2 cases lost. 32 cases in control group completed the study and 4 cases lost. ACT scores, FEV1%, FEV1/FVC sand PEF % values of patients＇ in intralymphatic immunotherapy group increased significantly, comparing with that of patients in control group. Medication scores and serum Dermatophagoides pteronyssinus slgE of patients in treatment group decreased significantly, comparing with that of pre-treatment and that of in control group. There was no local and systemic adverse reaction in 192 intralymphatic injections among 32 patients. Conclusions Allergen specific ntralymphatie immunotherapy is not only very effective, but also can remarkably shorten the duration of immunotherapy, reduce the number and dose of injection and decrease adverse reaction. Intralymphatic immunotherapy with standardized Dermatophagoides pteronyssinus allergen vaccine is an effective and safe causative treatment for Dermatophagoides pteronyssinus allergic asthma.