Department of Experimental and Clinical Medicine, Department of Geriatric Medicine, Division of Rheumatology and Scleroderma Unit AOUC, University of Florence, Florence, Italy.
Rheumatology Institute of Lucania (IReL), Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Potenza, Italy.
Clin Rheumatol. 2020 Jan;39(1):27-36. doi: 10.1007/s10067-019-04564-8. Epub 2019 May 20.
DeSScipher is the first European multicentre study on management of systemic sclerosis (SSc), and its observational trial 1 (OT1) evaluated the efficacy of different drugs for digital ulcer (DU) prevention and healing. The aim of this study was to assess current use of vasoactive/vasodilating agents for SSc-related DU in the expert centres by analysing the baseline data of the DeSScipher OT1.
Baseline characteristics of patients enrolled in the OT1 and data regarding DU were analysed.
The most commonly used drugs, in both patients with and without DU, were calcium channel blockers (CCBs) (71.6%), followed by intravenous iloprost (20.8%), endothelin receptor antagonists (ERAs) (20.4%) and phosphodiesterase 5 (PDE-5) inhibitors (16.5%). Of patients, 32.6% with DU and 12.8% without DU received two drugs (p < 0.001), while 11.5% with DU and 1.9% without DU were treated with a combination of three or more agents (p < 0.001). Sixty-five percent of the patients with recurrent DU were treated with bosentan and/or sildenafil. However, 64 out of 277 patients with current DU (23.1%) and 101 (23.6%) patients with recurrent DU were on CCBs alone.
Our study shows that CCBs are still the most commonly used agents for DU management in SSc. The proportion of patients on combination therapy was low, even in patients with recurrent DU: almost one out of four patients with current and recurrent DU was on CCBs alone. Prospective analysis is planned to investigate the efficacy of different drugs/drug combinations on DU healing and prevention. Key Points • The analysis of DeSScipher, the first European multicentre study on management of SSc, has shown that the most commonly used vasoactive/vasodilating drugs for DU were CCBs, followed by intravenous Iloprost, ERAs and PDE-5 inhibitors. • More than half of the patients with recurrent DU received bosentan and/or sildenafil. • However, the proportion of patients on combination therapy of more than one vasoactive/vasodilating drug was low and almost one out of four patients with current and recurrent DU was on CCBs alone.
DeSScipher 是第一项针对系统性硬化症（SSc）管理的欧洲多中心研究，其观察性试验 1（OT1）评估了不同药物预防和治疗手指溃疡（DU）的疗效。本研究的目的是通过分析 DeSScipher OT1 的基线数据，评估专家中心中用于 SSc 相关 DU 的血管活性/血管扩张剂的当前使用情况。
分析了 OT1 入组患者的基线特征和 DU 数据。
最常使用的药物，无论患者是否患有 DU，都是钙通道阻滞剂（CCBs）（71.6%），其次是静脉注射伊洛前列素（20.8%）、内皮素受体拮抗剂（ERAs）（20.4%）和磷酸二酯酶 5（PDE-5）抑制剂（16.5%）。患有 DU 的患者中有 32.6%和没有 DU 的患者中有 12.8%接受了两种药物治疗（p<0.001），而患有 DU 的患者中有 11.5%和没有 DU 的患者中有 1.9%接受了三种或更多药物的联合治疗（p<0.001）。65%的复发性 DU 患者接受了波生坦和/或西地那非治疗。然而，277 名有当前 DU 的患者中有 64 名（23.1%）和 101 名（23.6%）有复发性 DU 的患者仅使用 CCB 治疗。
我们的研究表明，CCBs 仍然是 SSc 中 DU 管理最常用的药物。联合治疗的患者比例较低，即使是复发性 DU 患者：几乎四分之一的当前和复发性 DU 患者仅使用 CCB 治疗。计划进行前瞻性分析，以研究不同药物/药物组合对 DU 愈合和预防的疗效。 关键点 • DeSScipher 的分析，第一项针对 SSc 管理的欧洲多中心研究，表明用于 DU 的最常用血管活性/血管扩张药物是 CCBs，其次是静脉注射 Iloprost、ERAs 和 PDE-5 抑制剂。 • 超过一半的复发性 DU 患者接受了波生坦和/或西地那非治疗。 • 然而，使用两种以上血管活性/血管扩张药物的患者比例较低，几乎四分之一的当前和复发性 DU 患者仅使用 CCB 治疗。
