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Measurement of oral chronic GVHD: Results from the Chronic GVHD Consortium

机译:口服慢性GVHD的测量:慢性GVHD联盟的结果

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摘要

Oral chronic GVHD (cGVHD) is a serious complication of alloSCT. Scales and instruments to measure oral cGVHD activity and severity have not been prospectively validated. The objective of this study was to describe the characteristics of oral cGVHD and determine the measures most sensitive to change. Patients enrolled in the cGVHD Consortium with oral involvement were included. Clinicians scored oral changes according to the National Institutes of Health (NIH) criteria, and patients completed symptom and quality-of-life measures at each visit. Both rated change on an eight-point scale. Of the 458 participants, 72% (n=331) had objective oral involvement at enrollment. Lichenoid change was the most common feature (n=293; 89%). At visits where oral change could be assessed, 50% of clinicians and 56% of patients reported improvement, with worsening reported in 4-5% for both the groups (weighted kappa=0.41). Multivariable regression modeling suggested that the measurement changes most predictive of perceived change by clinicians and patients were erythema and lichenoid, NIH severity and symptom scores. Oral cGVHD is common and associated with a range of signs and symptoms. Measurement of erythema and lichenoid changes and symptoms may adequately capture the activity of oral cGVHD in clinical trials but require prospective validation.
机译:口服慢性GVHD(cGVHD)是alloSCT的严重并发症。尚未评估过用于测量口服cGVHD活性和严重程度的量表和仪器。这项研究的目的是描述口服cGVHD的特征并确定对变化最敏感的措施。纳入参加cGVHD联合会且口腔受累的患者。临床医生根据美国国立卫生研究院(NIH)的标准对口腔变化进行评分,并且患者每次就诊都完成了症状和生活质量的测量。两者均以八分制衡量变化。在458名参与者中,有72%(n = 331)在入组时有客观的口头参与。苔藓样变化是最常见的特征(n = 293; 89%)。在可以评估口腔变化的访视中,两组的50%的临床医生和56%的患者报告有改善,而两组的恶化都在4-5%之间(加权kappa = 0.41)。多变量回归模型表明,测量变化最能预测临床医生和患者的感知变化,包括红斑和地衣样,NIH严重程度和症状评分。口服cGVHD很常见,并伴有一系列体征和症状。在临床试验中,红斑和苔藓样变化和症状的测量可能足以捕获口服cGVHD的活性,但需要进行前瞻性验证。

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