粉尘螨滴剂治疗过敏性哮喘和变应性鼻炎的临床研究

目的评估舌下特异性免疫治疗药物粉尘螨滴剂治疗过敏性哮喘及变应性鼻炎的疗效和安全性。方法采用多中心、随机、双盲、安慰剂平行对照的研究方法,对300例粉尘螨过敏的哮喘和(或)鼻炎患者进行为期25周的临床观察,试验组(150例)和对照组(150例)分别舌下含服粉尘螨滴剂和安慰剂。结果试验组过敏性哮喘患者的呼气峰流速值和自我疗效评估以及变应性鼻炎患者的每日症状评分和自我疗效评估较对照组均有显著改善(P值均<0．05)。试验组过敏性哮喘患者应急用药量较对照组明显减少(P<0．05)。试验期间未发生严重不良事件。用药25周后,两组血清粉尘螨特异性IgE水平的差异无显著性(P>0．05),而试验组的血清粉尘螨特异性IgG4水平升幅显著高于对照组(P<0．01)。结论粉尘螨滴剂是治疗过敏性哮喘和变应性鼻炎安全、有效的舌下特异性免疫治疗药物。

Dermatophagoides farinae drops in treatment of allergic asthma and atopic rhinitis

Objective To evaluate the safety and efficacy of sublingual immunotherapy(SLIT) with dermatophagoides farinae drops on patients with D. farinae allergic asthma and rhinitis. Methods A double-blind clinical trial was performed in 300 patients, with allergic asthma and/or rhinitis due to D. farinae, age ranged 4-60 years; and randomly assigned to either a test or a control group. Patients in the test group(n = 150) received dermatophagoides farinae drops, and those in the control group(n = 150) received placebo. The trial lasted 25 weeks for both groups and the dosage and administration were strictly referred to the manufacturer's manual. At the beginning of the 2nd, 3rd, 4th, 6th, 10th, 14th, 18th, 22nd week of the treatment, patients came to the hospital to accept follow-up surveys; while physicians made clinical evaluation for them. All patients were asked to record the symptoms and dosages of quick-relief medicine etc, and gave self-evaluation of their symptoms. Results There were 29 patients (9.67%) dropped out before the end of the study. The test group showed a significant improvement comparing to the control group with regard to PEF, PEF variability and subjective evaluation of asthma patients; improvement of daily symptom score and subjective evaluation of rhinitis patients(P < 0.05). Instant relief drug intake of asthma patients decreased (P<0.05). After 25 weeks treatment, the level of D. farinae specific IgE of the two groups were similar, while the specific IgG4 increased significantly in the test group comparing to the patients in the control group (P<0.01). No severe adverse events occurred in the trial. Besides, asthma scores, FEV1 and its percentage of prognostic value changed insignificantly. Conclusion Dermatophagoides farinae drops is relatively safe and effective in treating allergic asthma and atopic rhinitis.