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采用整群给药方案,对改良的猪毛菜(俄罗斯刺蓟)治疗性疫苗进行双盲、安慰剂对照研究。

Double-blind, placebo-controlled study with a modified therapeutic vaccine of Salsola kali (Russian thistle) administered through use of a cluster schedule.

作者信息

Colás Carlos, Monzón Susana, Venturini Mónica, Lezaun Apolinar

机构信息

Servicio de Alergia, Hospital Clínico Lozano Blesa, Zaragoza, Spain.

出版信息

J Allergy Clin Immunol. 2006 Apr;117(4):810-6. doi: 10.1016/j.jaci.2005.11.039. Epub 2006 Feb 8.

DOI:10.1016/j.jaci.2005.11.039
PMID:16630938
Abstract

BACKGROUND

The inhalation of Salsola kali pollen is a common cause of respiratory diseases in Europe and North America.

OBJECTIVE

To evaluate the efficacy and safety of a depigmented and glutaraldehyde-polymerized therapeutic vaccine of S kali.

METHODS

The trial was randomized, double-blind, and placebo-controlled using a rush protocol in the build-up phase. Sixty patients with rhinoconjunctivitis (19 also had mild asthma) were randomly allocated to receive either active treatment (polymerized extract) or placebo. The final distribution was 41 patients in the active and 19 in the placebo group. Side effects were registered. Symptom and medication scores and the number of days free of symptoms during the pollen season were assessed to evaluate the clinical efficacy. A Rhinoconjunctivitis Quality of Life Questionnaire was completed in the previous pollen season (before treatment) and during the pollen season 1 year later (in the trial). Dose-response skin tests were performed at baseline and at the end of the trial.

RESULTS

There was a significant difference (P < .05) in symptom and medication scores between both groups during the pollen season, with the active group the one that had fewer symptoms and lower intake of medication. The number of days without symptoms was higher in the active group (P < .05). This group also had a significant improvement in the Rhinoconjunctivitis Quality of Life Questionnaire and a reduction in skin sensitivity. No moderate or severe systemic reactions were registered.

CONCLUSION

Immunotherapy with this modified vaccine of S kali pollen is safe and efficacious to treat patients clinically sensitive to this pollen.

CLINICAL IMPLICATIONS

Patients allergic to S kali (Russian thistle) can be successfully treated with immunotherapy to improve symptoms of allergic rhinitis and asthma, reduce medication use, and improve quality of life parameters.

摘要

背景

在欧洲和北美,吸入猪毛菜花粉是呼吸系统疾病的常见病因。

目的

评估一种经脱色和戊二醛聚合处理的猪毛菜治疗性疫苗的疗效和安全性。

方法

在诱导期采用快速方案进行随机、双盲、安慰剂对照试验。60例鼻结膜炎患者(其中19例还患有轻度哮喘)被随机分配接受活性治疗(聚合提取物)或安慰剂。最终分配结果为活性治疗组41例患者,安慰剂组19例患者。记录副作用情况。评估症状和用药评分以及花粉季节无症状天数以评价临床疗效。在之前的花粉季节(治疗前)和1年后的花粉季节(试验期间)完成鼻结膜炎生活质量问卷。在基线和试验结束时进行剂量反应性皮肤试验。

结果

在花粉季节,两组之间的症状和用药评分存在显著差异(P<0.05),活性治疗组症状较少且用药量较低。活性治疗组的无症状天数更多(P<0.05)。该组在鼻结膜炎生活质量问卷方面也有显著改善,皮肤敏感性降低。未记录到中度或重度全身反应。

结论

用这种改良的猪毛菜花粉疫苗进行免疫治疗对临床上对该花粉敏感的患者安全有效。

临床意义

对猪毛菜(俄罗斯刺蓟)过敏的患者可通过免疫治疗成功改善过敏性鼻炎和哮喘症状,减少药物使用,并改善生活质量参数。

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