J Allergy Clin Immunol Pract:柳杉花粉SLIT药片的长期效果和剂量测试试验

2018-12-20 AlexYang MedSci原创

在日本,柳杉(JC)花粉症是一种用常见的过敏性鼻炎。JC花粉SLIT药片是使用高浓度的的JC花粉提取物制成的。最近,有研究人员进行了一个随机的、双盲的和案例对照阶段2/3试验来调查JC花粉SLIT药片的最优剂量,并且调查了选择剂量情况下3年的效果和安全性,并进行了2年的跟踪调查研究。研究包括了1042名患有JC过敏症的患者(年龄在5-64岁),并随机的分配到4个小组中接受不同的治疗,每天分别接受2

在日本,柳杉(JC)花粉症是一种用常见的过敏性鼻炎。JC花粉SLIT药片是使用高浓度的的JC花粉提取物制成的。最近,有研究人员进行了一个随机的、双盲的和案例对照阶段2/3试验来调查JC花粉SLIT药片的最优剂量,并且调查了选择剂量情况下3年的效果和安全性,并进行了2年的跟踪调查研究。

研究包括了1042名患有JC过敏症的患者(年龄在5-64岁),并随机的分配到4个小组中接受不同的治疗,每天分别接受2000、5000或者10000 JAU或者安慰剂。主要结果是第一个季节症状峰值时的总鼻症状和药物评分(TNSMS)。关键次要结果为花粉散落季节中的TNSMS,以及症状峰值时期和JC花粉散落时期的总鼻和眼部症状以及药物评分(TNOSMS)。研究发现,对主要结果来讲,TNSMS的绝对减少和相对均值减少在 2000、5000和10000 JAU时分别为1.50和21.4%, 2.24和32.1%以及2.18和31.2%(p值均小于0.001)。对所有的关键次级结果,所有的剂量均有效(p值均小于0.001)。另外,治疗具有良好的耐受性。5000 JAU表现出了超过3年的良好效果。

最后,研究人员指出,JC花粉SLIT药片的最后剂量为5000 JAU。持续的效果依赖于治疗持续的时间。

原始出处:

Gotoh M, Yonekura S, Imai T et al. Long-term efficacy and dose-finding trial of Japanese cedar pollen SLIT table. J Allergy Clin Immunol Pract. 8 Dec 2018.

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    2018-12-22 膀胱癌
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    2018-12-21 CHANGE

    疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的

    0

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