PDF(Pubmed)
Abstract：
UNASSIGNED: This study aimed to assess the effectiveness of iguratimod (IGU) as an alternative treatment for systemic sclerosis (SSc), especially in the prevention of ischemic digital ulcers (DUs).
UNASSIGNED: We constructed two cohorts from the Renji SSc registry. In the first cohort, SSc patients receiving IGU were observed prospectively with effectiveness and safety. In the second cohort, we picked up all the DU patients with at least a 3-month follow-up to investigate the prevention of IGU on ischemic DU.
UNASSIGNED: From 2017 to 2021, 182 SSc patients were enrolled in our SSc registry. A total of 23 patients received IGU. With a median follow-up of 61 weeks (IQR: 15-82 weeks), the drug persistence was 13/23. In total, 91.3% of the patients (21/23) became free of deterioration in the last visit with IGU. Of note, 10 patients withdrew from the study due to the following reasons: two patients withdrew due to deterioration, three due to incompliance, and five due to mild-to-moderate side effects. All the patients with side effects recovered fully after stopping IGU. Of note, 11 patients had ischemic DU, and 8 out of 11 (72.7%) patients had no new occurrence of DU during the follow-up. In the second cohort of 31 DU patients receiving a combination of vasoactive agents with a median follow-up of 47 weeks (IQR, 16-107 weeks), IGU treatment was protective of new DU occurrence (adjusted risk ratio = 0.25; 95% CI, 0.05-0.94; adjusted odds ratio = 0.07; and 95% CI, 0.01-0.49).
UNASSIGNED: Our study for the first time describes the potential of IGU possibly as an alternative treatment for SSc. To our surprise, this study provides a hint that IGU treatment can be used for the prevention of the occurrence of ischemic DU and merits further investigation.
UNASSIGNED: We constructed two cohorts from the Renji SSc registry. In the first cohort, SSc patients receiving IGU were observed prospectively with effectiveness and safety. In the second cohort, we picked up all the DU patients with at least a 3-month follow-up to investigate the prevention of IGU on ischemic DU.
UNASSIGNED: From 2017 to 2021, 182 SSc patients were enrolled in our SSc registry. A total of 23 patients received IGU. With a median follow-up of 61 weeks (IQR: 15-82 weeks), the drug persistence was 13/23. In total, 91.3% of the patients (21/23) became free of deterioration in the last visit with IGU. Of note, 10 patients withdrew from the study due to the following reasons: two patients withdrew due to deterioration, three due to incompliance, and five due to mild-to-moderate side effects. All the patients with side effects recovered fully after stopping IGU. Of note, 11 patients had ischemic DU, and 8 out of 11 (72.7%) patients had no new occurrence of DU during the follow-up. In the second cohort of 31 DU patients receiving a combination of vasoactive agents with a median follow-up of 47 weeks (IQR, 16-107 weeks), IGU treatment was protective of new DU occurrence (adjusted risk ratio = 0.25; 95% CI, 0.05-0.94; adjusted odds ratio = 0.07; and 95% CI, 0.01-0.49).
UNASSIGNED: Our study for the first time describes the potential of IGU possibly as an alternative treatment for SSc. To our surprise, this study provides a hint that IGU treatment can be used for the prevention of the occurrence of ischemic DU and merits further investigation.
摘要：
■本研究旨在评估iguratimod（IGU）作为系统性硬化症（SSc）的替代疗法的有效性，特别是在缺血性数字溃疡（DU）的预防。
■我们从RenjiSSc注册表中构建了两个队列。在第一个队列中，前瞻性观察接受IGU的SSc患者的有效性和安全性。在第二个队列中，我们对所有DU患者进行了至少3个月的随访，以研究IGU对缺血性DU的预防。
■从2017年到2021年，182名SSc患者纳入了我们的SSc注册。共有23名患者接受了IGU。中位随访时间为61周（IQR：15-82周），药物持久性为13/23.总的来说,91.3%的患者(21/23)在最后一次访问IGU时没有恶化。值得注意的是，10例患者因以下原因退出本研究：2例患者因病情恶化退出，三是由于违规，和五个由于轻度至中度的副作用。所有有副作用的患者在停止IGU后完全恢复。值得注意的是，11例患者有缺血性DU，11例患者中有8例(72.7%)在随访期间没有出现新的DU。在接受血管活性剂组合治疗的第二组31名DU患者中，中位随访时间为47周（IQR，16-107周），IGU治疗对新的DU发生具有保护作用（调整后的风险比=0.25；95％CI，0.05-0.94；调整后的比值比=0.07；95％CI，0.01-0.49）。
■我们的研究首次描述了IGU可能作为SSc替代治疗的潜力。令我们惊讶的是，本研究提示IGU治疗可用于预防缺血性DU的发生,值得进一步研究.
■我们从RenjiSSc注册表中构建了两个队列。在第一个队列中，前瞻性观察接受IGU的SSc患者的有效性和安全性。在第二个队列中，我们对所有DU患者进行了至少3个月的随访，以研究IGU对缺血性DU的预防。
■从2017年到2021年，182名SSc患者纳入了我们的SSc注册。共有23名患者接受了IGU。中位随访时间为61周（IQR：15-82周），药物持久性为13/23.总的来说,91.3%的患者(21/23)在最后一次访问IGU时没有恶化。值得注意的是，10例患者因以下原因退出本研究：2例患者因病情恶化退出，三是由于违规，和五个由于轻度至中度的副作用。所有有副作用的患者在停止IGU后完全恢复。值得注意的是，11例患者有缺血性DU，11例患者中有8例(72.7%)在随访期间没有出现新的DU。在接受血管活性剂组合治疗的第二组31名DU患者中，中位随访时间为47周（IQR，16-107周），IGU治疗对新的DU发生具有保护作用（调整后的风险比=0.25；95％CI，0.05-0.94；调整后的比值比=0.07；95％CI，0.01-0.49）。
■我们的研究首次描述了IGU可能作为SSc替代治疗的潜力。令我们惊讶的是，本研究提示IGU治疗可用于预防缺血性DU的发生,值得进一步研究.
