皮下免疫和舌下免疫治疗尘螨变应性鼻炎的安全性及依从性分析

目的 评价标准化尘螨变应原疫苗皮下免疫疗法(subcutaneous immunotherapy,SCIT)和舌下免疫疗法(sublingual immunotherapy,SLIT)治疗中-重度持续性变应性鼻炎(allergic rhinitis,AR)的安全性及依从性.方法 160例中-重度持续性AR患者分为两组,分别采用SCIT和SLIT的治疗方案.其中,SCIT组81例,年龄7～62岁,平均((x)±s,以下同)年龄为(21.5 ±14.6)岁;SLIT组79例,年龄6～53岁,平均年龄(15.1±10.3)岁.所有患者均对屋尘螨和粉尘螨过敏.随访6个月至2年,观察免疫治疗过程中的局部和全身不良反应发生情况,同时评价患者的依从性及相关影响因素.采用SPSS13.0软件对数据进行分析.结果 局部不良反应:SCIT组所有患者在免疫治疗的不同阶段均出现过局部反应,占注射总次数的62.9%,表现为注射部位周围皮肤肿胀;SLIT组有4例(5.1%)出现局部反应,表现为口腔局部瘙痒不适.两组患者的局部不良反应均属于轻度,可耐受并自行缓解.全身不良反应:SCIT组有11例患者(13.6%)发生全身反应,共18例次(占注射总次数0.9%),多为速发性反应,多见于维持治疗阶段,临床主要表现为胸闷、呼吸困难、哮喘发作和荨麻疹.SLIT组有11例患者(13.9%)发生全身反应,包括胃肠道反应、荨麻疹和鼻炎症状加重等,主要发生在剂量递增阶段.两组全身不良反应的发生率差异无统计学意义(x2=0.004,P>0.05).SCIT组有1例为非致命性严重全身反应(严重哮喘),两组患者其余的全身反应均属于轻到中度,未发生过敏性休克.依从性:160例患者对免疫治疗的总体依从性为83.1%,其中SCIT组和SLIT组的依从性分别为86.4%和79.7%,两者之间差异无统计学意义(x2-0.84,P>0.05).患者不依从(提前退出治疗)的首要原因均为自觉疗效不满意,SCIT组和SLIT组分别占6.2%和10.1%.结论 尘螨AR患者采用皮下注射或舌下含服途径进行特异性免疫治疗均有良好的安全性,两种治疗方式的全身不良反应发牛率和患者依从性无明显差异.

Compliance and safety evaluation of subcutaneous versus sublingual immunotherapy in mite-sensitized patients with allergic rhinitis

Objective To investigate the safety profile of subcutaneous immunotherapy (SCIT) versus sublingual immunotherapy (SLIT) in patients with allergic rhinitis (AR) caused by house dust mites. The treatment compliance and related factors were also evaluated. Methods A total of 160 patients with AR were enrolled in this study and received either SCIT (Alutard SQ, ALK-Abell6) or SLIT (ChanL Lergen-Df drops, WoLwo Pharma). All subjects were divided into two groups; SCIT group consisted of 81 patients aged 7 to 62 years [(21.5 ± 14. 6) years, x ± s] , and SLIT group consisted of 79 patients aged 6 to 53 years [(15. 1 ±10.3) years]. The selected patients were persistent and moderate to severe AR sensitized to Dermatophagoides pteronyssinus and Dermatophagoides farinae. Local and systemic reactions, as well as patient's adherence to the treatment, were carefully recorded and analyzed during the immunotherapy schedules (followed up for 6 months to 2 years). Statistical analysis was performed using a SPSS13. 0 software. Results Local swelling commonly occurred following injections throughout the treatment duration (62. 9% of overall injections) in the SCIT group. Oral itching associated with drop intakes was reported by 4 subjects (5. 1% ) in the SLIT group. All local reactions were mild, well tolerated and self-limiting in both groups. A total of 11 patients (13. 6% ) with 18 injections (0. 9% ) experienced systemic reactions in the SCIT group, involving respiratory distress, asthmatic attacks, and urticaria These adverse effects were mostly immediate reactions, and occurred more frequently in patients during the maintenance phase of treatment. There were also 11 patients (13.9%) who experienced systemic reactions in the SLIT group, including gastrointestinal symptoms, urticaria, and rhinitis exacerbations. However, systemic reactions to SLIT were mainly observed in patients during the up-dosing phase of treatment No significant difference in the overall incidence of systemic adverse effects was found between the SCIT and SLIT groups (13. 6% and 13.9% respectively, X2 =0. 004, P > 0.05). There was only one case of non-life-threatening systemic reaction (severe asthma) in the SCIT group. Others were mild or moderate and no anaphylactic shock occurred in any group. No significant difference in treatment compliance was found between the SCIT and SLIT groups (86. 4% and 79. 7% respectively, X2 =0. 84, P >0. 05) , with an overall rate of compliance (83.1%) among 160 patients. The most common cause for treatment withdrawal was insufficient ineffectiveness, in both groups of SCIT (6. 2% ) and SLIT (10. 1% ). Conclusion The results suggest that the frequency of systemic adverse effects of SCIT is not significantly different from SLIT in mite sensitized patients with AR, and both treatments are well tolerated and had favorable compliance during the study period.