CTU Bern and Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.
Swiss Health Insurance Service, Bern, Switzerland.
Arthritis Res Ther. 2020 Mar 24;22(1):59. doi: 10.1186/s13075-020-2141-2.
To investigate the effect of ACE inhibitors (ACEi) on the incidence of scleroderma renal crisis (SRC) when given prior to SRC in the prospectively collected cohort from the European Scleroderma Trial and Research Group (EUSTAR).
SSc patients without prior SRC and at least one follow-up visit were included and analyzed regarding SRC, arterial hypertension, and medication focusing on antihypertensive medication and glucocorticoids (GC).
Out of 14,524 patients in the database, we identified 7648 patients with at least one follow-up. In 27,450 person-years (py), 102 patients developed SRC representing an incidence of 3.72 (3.06-4.51) per 1000 py. In a multivariable time-to-event analysis adjusted for age, sex, disease severity, and onset, 88 of 6521 patients developed SRC. The use of ACEi displayed an increased risk for the development of SRC with a hazard ratio (HR) of 2.55 (95% confidence interval (CI) 1.65-3.95). Adjusting for arterial hypertension resulted in a HR of 2.04 (95%CI 1.29-3.24). There was no evidence for an interaction of ACEi and arterial hypertension (HR 0.83, 95%CI 0.32-2.13, p = 0.69). Calcium channel blockers (CCB), angiotensin receptor blockers (ARB), endothelin receptor antagonists, and GC-mostly in daily dosages below 15 mg of prednisolone-did not influence the hazard for SRC.
ACEi in SSc patients with concomitant arterial hypertension display an independent risk factor for the development of SRC but are still first choice in SRC treatment. ARBs might be a safe alternative, yet the overall safety of alternative antihypertensive drugs in SSc patients needs to be further studied.
在欧洲硬皮病试验和研究组（EUSTAR）前瞻性收集的队列中，研究 ACE 抑制剂（ACEi）在硬皮病肾危象（SRC）之前给药时对 SRC 发生率的影响。
纳入无 SRC 既往史且至少有一次随访的 SSc 患者，并对 SRC、动脉高血压和药物（重点是降压药物和糖皮质激素（GC））进行分析。
在数据库中的 14524 名患者中，我们确定了至少有一次随访的 7648 名患者。在 27450 人年（py）中，102 名患者发生了 SRC，发病率为每 1000 py 3.72（3.06-4.51）。在调整年龄、性别、疾病严重程度和发病时间的多变量时间事件分析中，6521 名患者中有 88 名发生了 SRC。ACEi 的使用与 SRC 的发生风险增加相关，风险比（HR）为 2.55（95%置信区间（CI）1.65-3.95）。调整动脉高血压后，HR 为 2.04（95%CI 1.29-3.24）。ACEi 和动脉高血压之间没有交互作用的证据（HR 0.83，95%CI 0.32-2.13，p=0.69）。钙通道阻滞剂（CCB）、血管紧张素受体阻滞剂（ARB）、内皮素受体拮抗剂和 GC-主要在每日剂量低于 15mg 泼尼松龙的情况下-并未影响 SRC 的危险度。
伴有动脉高血压的 SSc 患者中 ACEi 是 SRC 发展的独立危险因素，但仍是 SRC 治疗的首选。ARB 可能是一种安全的替代药物，但 SSc 患者替代降压药物的总体安全性仍需进一步研究。
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