Damage caused by Wegener's granulomatosis and its treatment - Prospective data from the Wegener's Granulomatosis Etanercept Trial (WGET)
Damage caused by Wegener's granulomatosis and its treatment - Prospective data from the Wegener's Granulomatosis Etanercept Trial (WGET)
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DOI：
10.1002/art.21117
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发表时间：
2005-07-01
影响因子：
--
通讯作者：
Stone, JH
中科院分区：
文献类型：
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作者：
Seo, P;Min, YI;Stone, JH
目标。分析参加韦格纳肉芽肿试验(WGET)的韦格纳肉芽肿(WG)患者所发生的损害，并将这种损害与疾病活动性、不良事件和生活质量相关联。脉管炎损伤指数(VDI)在试验开始时和试验期间每6个月应用于所有180名患者。损伤项目按假定病因(即继发于WG、继发于治疗或两者兼而有之)和发生时间进行分析。计算VDI评分与BVAS/WG的伯明翰血管炎活动评分(BVAS/WG)、闪光频率、不良事件次数和患者生活质量评估之间的Spearman等级相关系数。VDI的平均得分在研究登记时为1.3，在试验结束时为1.8。这一增长是由于在接受治疗的情况下(或由于治疗)造成的损害，包括视力障碍、听力损失、鼻塞、肺纤维化、高血压、肾功能不全、周围神经病变、性腺功能衰竭和糖尿病。只有11%的入选患者在入选一年后没有持续任何VDI项目。当调整基线VDI值时，基线BVAS/WG与第1年的VDI值有较好的相关性(r=0.2，P=0.015)。调整后VDI评分的增加也与不良事件的数量相关，特别是在WG有限的患者(P=0.06)。活动期疾病的损害及其治疗仍然是WG患者面临的重要问题。尽管在过去的几十年里，患者的存活率有了显著的改善，但只有少数WG患者从活动期疾病中脱颖而出，而没有受到疾病本身、其治疗或两者兼而有之的损害。未来治疗方法的一个重要衡量标准将是它们减少随时间积累的损害的能力。
Objective. To analyze damage occurring in patients with Wegener's granulomatosis (WG) enrolled in the WG Etanercept Trial (WGET) and to correlate that damage with disease activity, adverse events, and quality of life.Methods. The Vasculitis Damage Index (VDI) was applied to all 180 patients at trial entry and every 6 months throughout the trial. Items of damage were analyzed by presumed etiology (i.e., secondary to WG, to therapy, or both) and time of occurrence. Spearman's rank correlation coefficients were calculated between VDI scores and the Birmingham Vasculitis Activity Score for WG (BVAS/WG), frequency of flares, number of adverse events, and the patients' quality-of-life assessments.Results. The mean VDI score was 1.3 at the study enrollment and 1.8 at the end of the trial. This increase was due to damage that occurred despite (or because of) therapy, including visual impairment, hearing loss, nasal blockade, pulmonary fibrosis, hypertension, renal insufficiency, peripheral neuropathy, gonadal failure, and diabetes mellitus. Only 11% of the enrolled patients had not sustained a single VDI item after 1 year of enrollment. When adjusted for baseline VDI, the baseline BVAS/WG correlated moderately well with the VDI score at I year (r = 0.20, P = 0.015). Increases in adjusted VDI scores also correlated with the number of adverse events, particularly among patients with limited WG (P = 0.06).Conclusion. Damage from both active disease and its treatment remain important problems for patients with WG. Despite the dramatic improvements in patient survival achieved over the last several decades, only a few patients with WG emerge from a period of active disease without sustaining some damage from the disease itself, its treatment, or both. An important measure future therapeutic approaches will be their ability to reduce the damage accrued over time.