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乳胶诱导性荨麻疹患者舌下免疫疗法的双盲、安慰剂对照研究:一项为期12个月的研究。

Double-blind, placebo-controlled study of sublingual immunotherapy in patients with latex-induced urticaria: a 12-month study.

作者信息

Nettis E, Colanardi M C, Soccio A L, Marcandrea M, Pinto L, Ferrannini A, Tursi A, Vacca A

机构信息

Department of Clinical Medicine, Immunology and Infectious Deseases, University of Bari, Bari, Italy.

出版信息

Br J Dermatol. 2007 Apr;156(4):674-81. doi: 10.1111/j.1365-2133.2006.07738.x.

Abstract

BACKGROUND

Natural rubber latex (NRL) allergy is a worldwide problem. Although prevention is sufficient to reduce sensitization, prolonged avoidance is needed to prevent resensitization or adverse reactions on re-exposure.

OBJECTIVES

This double-blind, placebo-controlled study was conducted to determine the efficacy of sublingual immunotherapy (SLIT) with latex.

METHODS

Forty patients with NRL allergy were enrolled. At diagnosis, 30 presented urticaria and 10 asthma. Patients were evaluated on their clinical history and an allergological assessment: skin prick test with latex extract, serum-specific IgE and provocation tests. Patients were subdivided by complaint (asthma or urticaria), and randomized to receive SLIT with latex extract (ALK-Abelló, Lainate, Milan, Italy) or placebo.

RESULTS

The evaluable population consisted of 35 patients, 18 treated with SLIT and 17 with placebo. The results show that 12 months of SLIT improved the symptoms score and reduced the medication score in all subjects. The subjective evaluation was corroborated by improved bronchial and glove provocation test results. The latex-specific IgE levels increased slightly in the SLIT group, and skin sensitization was reduced at the end of the trial in all the patients treated with SLIT. The immunotherapy was not complicated by any severe adverse reactions.

CONCLUSIONS

This is the first double-blind, placebo-controlled evaluation of the efficacy of SLIT with latex extract conducted in adult patients allergic to NRL. SLIT with latex can be proposed for subjects with latex allergy, especially those for whom complete avoidance of latex exposure may be very difficult or even impossible. More studies are needed to evaluate the efficacy of SLIT in the treatment of subjects with latex allergy who are sensitized to inhalant allergens.

摘要

背景

天然橡胶乳胶(NRL)过敏是一个全球性问题。尽管预防措施足以降低致敏率,但仍需要长期避免接触以防止再次致敏或再次接触时出现不良反应。

目的

本双盲、安慰剂对照研究旨在确定乳胶舌下免疫疗法(SLIT)的疗效。

方法

招募了40名NRL过敏患者。诊断时,30例出现荨麻疹,10例出现哮喘。根据患者的临床病史和过敏学评估进行评估:用乳胶提取物进行皮肤点刺试验、血清特异性IgE检测和激发试验。患者按主诉(哮喘或荨麻疹)分组,并随机接受乳胶提取物(ALK-Abelló,意大利米兰莱纳特)的SLIT治疗或安慰剂治疗。

结果

可评估人群包括35名患者,18名接受SLIT治疗,17名接受安慰剂治疗。结果显示,12个月的SLIT治疗改善了所有受试者的症状评分并降低了用药评分。支气管和手套激发试验结果的改善证实了主观评估。SLIT组中乳胶特异性IgE水平略有升高,在试验结束时,所有接受SLIT治疗的患者皮肤致敏性均降低。免疫疗法未出现任何严重不良反应。

结论

这是首次在对NRL过敏的成年患者中进行的关于乳胶提取物SLIT疗效的双盲、安慰剂对照评估。对于乳胶过敏患者,尤其是那些完全避免接触乳胶可能非常困难甚至不可能的患者,可以考虑使用乳胶SLIT。需要更多研究来评估SLIT在治疗对吸入性过敏原致敏的乳胶过敏患者中的疗效。

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