Department of Rheumatology, Patras University Hospital, University of Patras Medical School, Patras, Greece.
North Sector Health Center, Patras, Greece.
Rheumatol Int. 2022 Jun;42(6):949-958. doi: 10.1007/s00296-022-05128-x. Epub 2022 Apr 21.
The management of acute gout in the hospital setting may be challenging since most patients are elderly with multiple unstable comorbidities. However, there are no prospective clinical trials for hospitalized patients with gout to guide optimal management. Evidence indicates that steroids or adrenocorticotropic hormone (ACTH) may be effective and safe therapeutic options for these patients. This study aimed at directly comparing the efficacy and safety of ACTH vs betamethasone for the treatment of gout in hospitalized patients. This is the first prospective clinical trial for hospitalized patients with gout. We designed a randomized, open label study to assess the efficacy and safety of a single intramuscular injection of either ACTH or betamethasone in hospitalized patients with acute gout. Primary efficacy endpoints were the change in intensity of pain as recorded using a Visual Analogue Scale (VAS) at baseline compared to 24 h (ΔVAS24h), and 48 h. Moreover, we assessed safety and effects on the hypothalamic-pituitary-adrenal (HPA) axis, glucose and lipid homeostasis, bone metabolism, electrolytes and renal function. 38 patients were recruited. Both treatments were highly effective. The mean ± SE ΔVAS24h and ΔVAS48h for ACTH was 4.48 ± 0.29 and 5.58 ± 0.26, respectively. The mean ± SE ΔVAS24h and ΔVAS48h for betamethasone was 4.67 ± 0.32 and 5.67 ± 0.28, respectively. Direct comparison between the two groups at 24 h and 48 h did not show statistically significant differences. Both treatments were well tolerated and safe. The effects on all metabolic parameters were mostly minimal and transient for both treatments. However, ACTH may affect less the HPA axis and bone metabolism compared to betamethasone, thus leading to the conclusion that. ACTH and betamethasone are effective and safe for the management of acute gout in hospitalized patients but that ACTH may associate with less disturbance of the HPA axis and bone metabolism. Our data support the use of both drugs as first line treatments for hospitalized patients with gout.Clinical trial registration: ClinicalTrials.gov NCT04306653.
在医院环境中管理急性痛风可能具有挑战性，因为大多数患者是患有多种不稳定合并症的老年人。然而，尚无针对住院痛风患者的前瞻性临床试验来指导最佳治疗。有证据表明，类固醇或促肾上腺皮质激素（ACTH）可能是这些患者有效且安全的治疗选择。本研究旨在直接比较 ACTH 与倍他米松治疗住院痛风患者的疗效和安全性。这是第一项针对住院痛风患者的前瞻性临床试验。我们设计了一项随机、开放标签研究，以评估住院急性痛风患者单次肌内注射 ACTH 或倍他米松的疗效和安全性。主要疗效终点是基线时与 24 小时（ΔVAS24h）和 48 小时相比，视觉模拟量表（VAS）记录的疼痛强度变化（ΔVAS24h）。此外，我们评估了安全性以及对下丘脑-垂体-肾上腺（HPA）轴、血糖和脂质稳态、骨代谢、电解质和肾功能的影响。共招募了 38 名患者。两种治疗方法均非常有效。ACTH 的平均±SEΔVAS24h 和ΔVAS48h 分别为 4.48±0.29 和 5.58±0.26。倍他米松的平均±SEΔVAS24h 和ΔVAS48h 分别为 4.67±0.32 和 5.67±0.28。两组在 24 小时和 48 小时的直接比较未显示出统计学上的显著差异。两种治疗方法均耐受良好且安全。两种治疗方法对所有代谢参数的影响大多是最小和短暂的。然而，与倍他米松相比，ACTH 可能对 HPA 轴和骨代谢的影响较小，因此得出结论，ACTH 和倍他米松可有效且安全地治疗住院痛风患者，但 ACTH 可能与 HPA 轴和骨代谢的干扰较小有关。我们的数据支持将这两种药物用作住院痛风患者的一线治疗药物。临床试验注册：ClinicalTrials.gov NCT04306653。
