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特异性免疫疗法对屋尘螨诱发的重度常年性变应性鼻炎患者的疗效:一项双盲、随机、安慰剂对照试验。

Usefulness of specific immunotherapy in patients with severe perennial allergic rhinitis induced by house dust mite: a double-blind, randomized, placebo-controlled trial.

作者信息

Varney V A, Tabbah K, Mavroleon G, Frew A J

机构信息

RCMB Research Division, University Medicine, Southampton General Hospital, Southampton, UK.

出版信息

Clin Exp Allergy. 2003 Aug;33(8):1076-82. doi: 10.1046/j.1365-2222.2003.01735.x.

DOI:10.1046/j.1365-2222.2003.01735.x
PMID:12911781
Abstract

OBJECTIVES

To evaluate the effectiveness of specific immunotherapy (SIT) in patients with severe house dust mite (HDM)-induced perennial allergic rhinitis using diary cards and objective endpoints.

PATIENTS AND METHODS

Thirty-six adult patients were selected with moderate to severe allergic rhinitis due to HDM allergy uncontrolled by regular anti-allergic drugs. Twenty-eight patients completed the study, 22 of these patients also had mild asthma. Subjects were stratified for HDM sensitivity on the basis of their 4-week diary card score and the size of their immediate and late-phase skin reaction to HDM. The groups were well matched for all relevant parameters. Patients were randomized to receive active preparation (Alutard(R)-SQ, ALK, Dermatophagoides pteronyssinus extract) or an identical placebo preparation. Increasing doses were administered until the maintenance dose was reached. This dose was then given once a month for 12 months.

RESULTS

Clinical efficacy was evaluated by symptom medication diary cards recorded for 4 weeks after 12 months of continuous treatment and compared with pre-treatment scores. Skin test reactivity was re-measured after 12 months of treatment to HDM, cat dander and codeine phosphate. After 1 year of treatment, the actively treated group showed a 58% reduction in diary card symptom scores (P<0.002) and a 20% reduction in the use of rescue medication. The placebo group had a 32% reduction in symptom scores (P=NS), but no reduction in rescue medication requirements. The active group showed 36% reduction in skin prick test sensitivity to D. pteronyssinus (P=0.006), while the placebo group values were unchanged. Skin reactivity to codeine was unchanged in both groups. No significant adverse reactions to SIT were encountered.

CONCLUSIONS

One year of SIT for D. pteronyssinus in patients with poorly controlled rhinitis (+/-mild asthma) produced clinically useful improvement as shown by symptom-medication diary cards and reductions in immediate skin reactions compared with placebo treatment.

摘要

目的

使用日记卡和客观终点指标评估特异性免疫疗法(SIT)对重度屋尘螨(HDM)诱发的常年性变应性鼻炎患者的疗效。

患者与方法

选取36例因HDM过敏导致中度至重度变应性鼻炎且常规抗过敏药物无法控制症状的成年患者。28例患者完成了研究,其中22例患者还患有轻度哮喘。根据患者4周的日记卡评分以及对HDM的速发和迟发皮肤反应大小对HDM敏感性进行分层。两组在所有相关参数上匹配良好。患者被随机分为接受活性制剂(阿罗格(R)-SQ,ALK,粉尘螨提取物)或相同的安慰剂制剂。逐渐增加剂量直至达到维持剂量。然后每月给予该剂量,持续12个月。

结果

通过连续治疗12个月后记录的4周症状用药日记卡评估临床疗效,并与治疗前评分进行比较。治疗12个月后,重新测量对HDM、猫毛屑和磷酸可待因的皮肤试验反应性。治疗1年后,积极治疗组的日记卡症状评分降低了58%(P<0.002),急救药物使用减少了20%。安慰剂组症状评分降低了32%(P=无显著性差异),但急救药物需求无减少。积极治疗组对粉尘螨的皮肤点刺试验敏感性降低了36%(P=0.006),而安慰剂组的值未改变。两组对可待因的皮肤反应性均未改变。未遇到对SIT的明显不良反应。

结论

对于鼻炎控制不佳(±轻度哮喘)的患者,针对粉尘螨进行1年的SIT治疗,与安慰剂治疗相比,症状用药日记卡显示临床症状有明显改善,速发皮肤反应也有所降低。

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