Department of Medicine and Rheumatology, University of Melbourne at St Vincent's Hospital, Melbourne, Victoria, Australia.
Department of Medicine, Division of Rheumatology, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.
Rheumatology (Oxford). 2023 Dec 1;62(12):3785-3800. doi: 10.1093/rheumatology/kead289.
To evaluate the evidence concerning systemic pharmacological treatments for SSc digital ulcers (DUs) to inform the development of evidence-based treatment guidelines.
A systematic literature review of seven databases was performed to identify all original research studies of adult patients with SSc DUs. Randomized controlled trials (RCTs) and prospective longitudinal observational studies (OBSs) were eligible for inclusion. Data were extracted, applying the patient, intervention, comparison, outcome framework, and risk of bias (RoB) was assessed. Due to study heterogeneity, narrative summaries were used to present data.
Forty-seven studies that evaluated the treatment efficacy or safety of pharmacological therapies were identified among 4250 references. Data from 18 RCTs of 1927 patients and 29 OBSs of 661 patients, at various RoB (total 2588 patients) showed that i.v. iloprost, phosphodiesterase-5 inhibitors and atorvastatin are effective for the treatment of active DUs. Bosentan reduced the rate of future DUs in two RCTs (moderate RoB) and eight OBSs at low to high RoB. Two small studies (moderate RoB) indicate that Janus kinase inhibitors may be effective for the treatment of active DUs, otherwise there are no data to support the use of immunosuppression or anti-platelet agents in the management of DUs.
There are several systemic treatments, across four medication classes, that are effective therapies for the management of SSc DUs. However, a lack of robust data means it is not possible to define the optimal treatment regimen for SSc DUs. The relatively low quality of evidence available has highlighted further areas of research need.
评估系统性药物治疗系统性硬化症（SSc）手指溃疡（DU）的证据，为制定基于证据的治疗指南提供信息。
对七个数据库进行系统文献检索，以确定所有患有 SSc DU 的成年患者的原始研究。合格的研究包括随机对照试验（RCT）和前瞻性纵向观察性研究（OBS）。提取数据，应用患者、干预、比较、结局框架，并评估偏倚风险（RoB）。由于研究存在异质性，采用叙述性总结呈现数据。
在 4250 篇参考文献中，共确定了 47 项评估药物治疗疗效或安全性的研究。来自 18 项 RCT（1927 例患者）和 29 项 OBS（661 例患者）的数据，存在不同的 RoB（共 2588 例患者），表明静脉内伊洛前列素、磷酸二酯酶-5 抑制剂和阿托伐他汀治疗活动性 DU 有效。博森坦在两项 RCT（中度 RoB）和八项 OBS（低至高度 RoB）中降低了未来 DU 的发生率。两项小型研究（中度 RoB）表明，Janus 激酶抑制剂可能对治疗活动性 DU 有效，否则没有数据支持在 DU 管理中使用免疫抑制或抗血小板药物。
有几种系统性治疗方法，涉及四种药物类别，对 SSc DU 的管理是有效的治疗方法。然而，由于缺乏强有力的数据，无法确定 SSc DU 的最佳治疗方案。现有证据质量相对较低，突出了进一步的研究需求。
