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首页> 外文期刊>Clinical and experimental allergy : >A comparative analysis of symptom and medication scoring methods used in clinical trials of sublingual immunotherapy for seasonal allergic rhinitis.
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A comparative analysis of symptom and medication scoring methods used in clinical trials of sublingual immunotherapy for seasonal allergic rhinitis.

机译：舌下免疫疗法治疗季节性变应性鼻炎的临床症状和药物评分方法的比较分析。

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Symptom and medication use are the key outcomes for assessing the efficacy of subcutaneous (SCIT) and sublingual allergen immunotherapy (SLIT). Our objective was to explore the similarities and differences between existing scoring mechanisms used in clinical trials of SLIT for seasonal allergens and characterize the impact that such differences may have on efficacy reporting. Randomized, double-blind, placebo-controlled clinical trials investigating the efficacy of SLIT for seasonal allergic rhinitis (2009-2013) were selected for review. Simulated and published data were used to demonstrate differences in scoring methods. Symptom and medication scoring methods across trials, although all designed to achieve the same objective, included important differences. The maximum daily symptom score (DSS) can vary widely depending on the number of symptoms assessed, and terminology of symptoms is not consistent. Similarly, daily medication scoring (DMS) methods differ greatly among studies and are dependent on medications allowed and weighting of scores assigned to each medication. When published DSS and DMS scores were used to calculate simulated daily combined scores (DCSs) based on various published methods, changes from placebo ranged from 19% to 29% when assuming all variables other than the DSS and DMS methods were equal. Variations in trial design, analysis, and seasonal characteristics also have effects on symptom and medication scoring outcomes. We identified multiple differences in trial scoring methods and design that make comparison among trials difficult. Symptom, medication, or combined scores cannot be indirectly compared among trials without taking the methods of scoring and other trial differences into account.
机译：症状和药物使用是评估皮下（SCIT）和舌下变应原免疫疗法（SLIT）疗效的关键结果。我们的目的是探讨用于季节性变应原的SLIT临床试验中现有评分机制之间的异同，并描述这种差异可能对疗效报告产生的影响。选择随机，双盲，安慰剂对照的临床试验研究SLIT对季节性变应性鼻炎的疗效（2009-2013年），以进行回顾。模拟和公开的数据用于证明评分方法的差异。尽管所有试验旨在实现相同目标，但症状和药物评分方法均存在重要差异。每日最大症状评分（DSS）可能会有所不同，具体取决于所评估症状的数量，并且症状的术语不一致。同样，每日药物评分（DMS）方法在研究之间也有很大差异，并且取决于所允许的药物和分配给每种药物的评分权重。当使用已发布的DSS和DMS分数基于各种已发布的方法计算模拟的每日综合分数（DCS）时，如果假设除DSS和DMS方法之外的所有其他变量均相等，则安慰剂的变化范围为19％至29％。试验设计，分析和季节特征的变化也会对症状和药物评分结果产生影响。我们在试验评分方法和设计中发现了多个差异，这些差异使试验之间的比较变得困难。如果不考虑评分方法和其他试验差异，则不能在试验之间间接比较症状，药物或综合评分。

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