Division of Rheumatology, Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan.
Division of Rheumatology, Department of Internal Medicine, Hanyang University Hospital for Rheumatic Diseases, Seoul.
Rheumatology (Oxford). 2021 Dec 1;60(12):5814-5819. doi: 10.1093/rheumatology/keab147.
To assess the efficacy of an endothelin receptor antagonist (ERA) and phosphodiesterase type5 inhibitors (PDE5is) for treating SSc-related digital ulcers (DUs).
This prospective, multicentre, observational cohort study recruited patients with active SSc-related DUs from 13 medical centres in South Korea. The primary outcome was time to cardinal ulcer (CU) healing. A secondary outcome was time to new DU occurrence. Patients were followed up 4, 8, 12 and 24 weeks after treatment initiation.
Sixty-three patients were analysed. Their mean age was 49.9 years (s.d. 11.4) and 49 were female. Twenty-eight had limited SSc. Forty-nine patients received ERA, 11 received a PDE5i (9 sildenafil, 1 udenafil and 1 tadalafil) and 3 received other medication. The hazard ratio (HR) for time to CU healing in the ERA group vs the PDE5i group was 0.75 (95% CI 0.35, 1.64; P = 0.47) in an unadjusted model and 0.80 (95% CI 0.36, 1.78; P = 0.59) in a model adjusted for age, sex, use of calcium channel blockers (CCBs), total DU number and initial CU area. The HR for new DU development in the ERA group vs the PDE5i group was 0.39 (95% CI 0.16, 0.93; P = 0.03) in an unadjusted model and 0.32 (95% CI 0.13, 0.81; P = 0.02) in an adjusted model. No patients receiving CCBs developed new DUs at 24 weeks.
Time to CU healing is comparable for ERA and PDE5i. ERAs are more effective in reducing new DU occurrence than PDE5is. CCBs may be effective as a background medication.
评估内皮素受体拮抗剂（ERA）和磷酸二酯酶 5 抑制剂（PDE5i）治疗系统性硬化症相关手指溃疡（DU）的疗效。
这是一项前瞻性、多中心、观察性队列研究，在韩国的 13 家医疗中心招募了患有活动期系统性硬化症相关 DU 的患者。主要结局是主要溃疡（CU）愈合时间。次要结局是新 DU 发生时间。患者在治疗开始后 4、8、12 和 24 周进行随访。
共分析了 63 例患者，其平均年龄为 49.9 岁（标准差 11.4），49 例为女性，28 例为局限型系统性硬化症。49 例患者接受 ERA 治疗，11 例接受 PDE5i（9 例西地那非、1 例乌地那非和 1 例他达拉非）治疗，3 例接受其他药物治疗。在未调整模型中，ERA 组与 PDE5i 组 CU 愈合时间的风险比（HR）为 0.75（95%CI 0.35, 1.64；P=0.47），在调整年龄、性别、钙通道阻滞剂（CCB）使用、总 DU 数量和初始 CU 面积后，HR 为 0.80（95%CI 0.36, 1.78；P=0.59）。在未调整模型中，ERA 组与 PDE5i 组新 DU 发生率的 HR 为 0.39（95%CI 0.16, 0.93；P=0.03），在调整模型中，HR 为 0.32（95%CI 0.13, 0.81；P=0.02）。在 24 周时，未使用 CCB 的患者均未出现新的 DU。
ERA 和 PDE5i 治疗 CU 愈合时间相当，ERA 在减少新 DU 发生方面比 PDE5i 更有效。CCB 可能是一种有效的背景治疗药物。
