Bousquet J, Scheinmann P, Guinnepain M T, Perrin-Fayolle M, Sauvaget J, Tonnel A B, Pauli G, Caillaud D, Dubost R, Leynadier F, Vervloet D, Herman D, Galvain S, André C
Hôpital Arnaud de Villeneuve, Service des Maladies Respiratoires, Montpellier, France.
Allergy. 1999 Mar;54(3):249-60. doi: 10.1034/j.1398-9995.1999.00916.x.
A double-blind, placebo-controlled study was carried out in 85 patients with a well-documented history of perennial asthma caused by house-dust mites. Patients received either placebo or sublingual immunotherapy (SLIT) with a standardized Dermatophagoides pteronyssinus (DP)-D. farinae (DF) 50/50 extract. After a run-in period, patients received increasing doses up to 300 IR every day for 4 weeks and then three times a week for the following 24 months. The cumulative dose was about 104000 IR, equivalent to 4.2 mg Der p 1 and 7.3 mg Der f 1. Symptom and medication scores and respiratory function were assessed throughout the trial. Serum specific IgE and IgG4 were determined before SLIT (t0) and after 6 (t1), 11 (t2), 17 (t3), and 25 months (t4) of SLIT. Mite exposure was evaluated at t0, t2, and t4 by semiquantitative guanine determinations. Patients aged 15 years and older were asked to assess their quality of life (QoL) by completing the SF20 (Short Form Health Status Survey) plus two items at t0, t2, and t4. Use of inhaled corticosteroids and beta2-agonists was significantly decreased after 25 months of treatment in both groups (P<0.03). SLIT patients showed significant improvements in respiratory function at t4 (% predicted FEV1 (P = 0.01), VC (P = 0.002), morning (P = 0.01) and evening (P = 0.03) PEFR), and reduction in daytime asthma score (P = 0.02). In the SLIT group, the post-treatment PD20 was 1.75 times higher than the baseline value. There was no change in PD20 in the placebo group. Compared to the placebo group, the SLIT group showed a significant increase in specific IgE DP(P = 0.05), IgE DF(P = 0.02), IgG4 DP(P = 0.001), and IgG4 DF (P = 0.001) levels after SLIT. QoL scores were similar in both groups at t0 and t2. At t4, all scores were better in the SLIT group than in the placebo group, with the differences being most marked for the general perception of health (P = 0.01) and physical pain (P = 0.02). Adverse events were similar in the two groups. This study shows that SLIT in house-dust-mite-related asthma has a good safety profile and improves respiratory function, bronchial hyperreactivity, and QoL.
对85例有充分记录的由屋尘螨引起的常年性哮喘患者进行了一项双盲、安慰剂对照研究。患者接受安慰剂或舌下免疫疗法（SLIT），使用标准化的粉尘螨（DP）- 户尘螨（DF）50/50提取物。在导入期后，患者每天接受递增剂量直至300国际反应单位，持续4周，然后在接下来的24个月每周三次。累积剂量约为104000国际反应单位，相当于4.2毫克Der p 1和7.3毫克Der f 1。在整个试验过程中评估症状和药物评分以及呼吸功能。在SLIT前（t0）以及SLIT 6个月（t1）、11个月（t2）、17个月（t3）和25个月（t4）后测定血清特异性IgE和IgG4。在t0、t2和t4通过半定量鸟嘌呤测定评估螨暴露情况。15岁及以上的患者在t0、t2和t4通过完成SF20（简短健康状况调查问卷）加两个项目来评估他们的生活质量（QoL）。两组在治疗25个月后吸入糖皮质激素和β2激动剂的使用均显著减少（P<0.03）。SLIT组患者在t4时呼吸功能有显著改善（预测FEV1百分比（P = 0.01）、VC（P = 0.002）、早晨（P = 0.01）和晚上（P = 0.03）的PEFR），白天哮喘评分降低（P = 0.02）。在SLIT组，治疗后的PD20比基线值高1.75倍。安慰剂组的PD20没有变化。与安慰剂组相比，SLIT组在SLIT后特异性IgE DP（P = 0.05）、IgE DF（P = 0.02）、IgG4 DP（P = 0.001）和IgG4 DF（P = 0.001）水平显著升高。两组在t0和t2时QoL评分相似。在t4时，SLIT组的所有评分均优于安慰剂组，在总体健康感知（P = 0.01）和身体疼痛（P = 0.02）方面差异最为明显。两组的不良事件相似。这项研究表明，舌下免疫疗法治疗与屋尘螨相关的哮喘具有良好的安全性，可改善呼吸功能、支气管高反应性和生活质量。
