Mouthon Luc, Carpentier Patrick H, Lok Catherine, Clerson Pierre, Gressin Virginie, Hachulla Eric, Bérezné Alice, Diot Elisabeth, Van Kien Aurélie Khau, Jego Patrick, Agard Christian, Duval-Modeste Anne-Bénédicte, Sparsa Agnès, Puzenat Eve, Richard Marie-Aleth
Department of Internal Medicine, Assistance Publique-Hôpitaux de Paris, Cochin Hospital, Paris Descartes University, 27, Rue du Faubourg Saint-Jacques, 75679 Paris, France.
Department of Vascular Medicine, University Hospital Grenoble, Grenoble, France.
Semin Arthritis Rheum. 2017 Jun;46(6):759-766. doi: 10.1016/j.semarthrit.2017.01.001. Epub 2017 Jan 13.
Ischemic digital ulcers (DU) represent a major complication of systemic sclerosis (SSc). We investigated the impact of controlling the ulcerative disease on disability, pain, and quality of life in SSc patients receiving bosentan.
ECLIPSE (Study AC-052-517) is a 2-year prospective, multicenter, and observational study. Patients with SSc who experienced at least 1 DU in the previous year and received bosentan were included between October 2009 and March 2011. Disability scores [Cochin Hand Function Scale (CHFS) and Health Assessment Questionnaire Disability Index (HAQ-DI)], pain scores (visual analog scale), and quality-of-life scores (SF-36) were collected at inclusion and 1 year later (primary endpoint). A controlled ulcerative disease was defined by the absence of ongoing/new DU episode between inclusion and 1-year follow-up.
Data were available at 1 year for 120 patients out of 190 included. During follow-up, 46 (38.3%) patients experienced a new DU episode. The number of DU per patient decreased from 1.4 ± 1.8 at inclusion to 0.6 ± 1.6 (p < 0.0001) at 1 year. Disability scores decreased from 1.0 ± 0.7 to 0.9 ± 0.7 (p = 0.04) for the HAQ-DI and from 29 ± 20 to 25 ± 20 (p = 0.005) for the CHFS; the pain score decreased from 4.3 ± 3.1 to 2.9 ± 2.8 (p < 0.0001). This improvement was attributed to patients with a controlled ulcerative disease (48.3%), who significantly improved HAQ-DI (p = 0.04), CHFS (p = 0.04), and pain score (p = 0.046).
In patients with SSc, control of the ulcerative disease for 1 year was associated with significant attenuation of hand disability.
缺血性指端溃疡（DU）是系统性硬化症（SSc）的主要并发症。我们研究了控制溃疡性疾病对接受波生坦治疗的SSc患者的残疾、疼痛和生活质量的影响。
ECLIPSE（研究AC - 052 - 517）是一项为期2年的前瞻性、多中心观察性研究。2009年10月至2011年3月期间纳入了前一年至少经历过1次DU且接受波生坦治疗的SSc患者。在纳入时和1年后（主要终点）收集残疾评分[科钦手功能量表（CHFS）和健康评估问卷残疾指数（HAQ - DI）]、疼痛评分（视觉模拟量表）和生活质量评分（SF - 36）。溃疡性疾病得到控制定义为从纳入到1年随访期间无持续/新发DU发作。
纳入的190例患者中有120例在1年时可获得数据。随访期间，46例（38.3%）患者出现新的DU发作。每位患者的DU数量从纳入时的1.4±1.8降至1年时的0.6±1.6（p<0.0001）。HAQ - DI的残疾评分从1.0±0.7降至0.9±0.7（p = 0.04），CHFS的残疾评分从29±20降至25±20（p = 0.005）；疼痛评分从4.3±3.1降至2.9±2.8（p<0.0001）。这种改善归因于溃疡性疾病得到控制的患者（48.3%），他们的HAQ - DI（p = 0.04）、CHFS（p = 0.04）和疼痛评分（p = 0.046）有显著改善。
在SSc患者中，溃疡性疾病控制1年与手部残疾的显著减轻相关。
