系统性文献综述,为葡萄牙关于系统性硬化症和其他结缔组织疾病中雷诺现象和数字溃疡的管理建议提供参考。

IF 1.4 4区 医学 Q3 RHEUMATOLOGY
ARP Rheumatology Pub Date : 2024-07-01 DOI:10.63032/YHBL8967
Emanuel Costa, Filipe Cunha-Santos, Eduardo Dourado, Daniela Oliveira, Louise Falzon, Vasco Romão, Ana Catarina Duarte, Ana Cordeiro, Tânia Santiago, Alexandre Sepriano
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引用次数: 0

摘要

目的进行一项系统性文献综述(SLR),旨在评估系统性硬化症(SSc)和其他结缔组织疾病(CTD)患者雷诺现象(RP)和数字溃疡(DU)的药物和非药物治疗的有效性和安全性,从而为葡萄牙提出的治疗这些患者雷诺现象和数字溃疡的建议提供参考:在 2022 年 5 月之前进行了一次 SLR,以确定评估药物和非药物干预对 SSc 和其他 CTD 患者 RP 和 DU 的疗效和安全性的研究。符合条件的研究设计包括用于评估干预措施疗效和安全性的随机对照试验(RCT)、对照临床试验及其扩展研究。还包括有比较对象的观察性研究,用于评估非药物干预措施的疗效和安全性以及药物干预措施的安全性。使用标准工具对每项研究的偏倚风险进行了评估:在符合纳入标准的 71 篇出版物中,59 篇对药物干预措施进行了评估,12 篇对非药物干预措施进行了评估。我们发现中等质量的证据支持钙通道阻滞剂、磷酸二酯酶-5抑制剂和静脉注射前列环素类似物在减少RP发生频率、严重程度和持续时间方面的疗效。静脉注射伊洛前列素在改善 DU 愈合方面具有小到中等程度的效果。磷酸二酯酶-5抑制剂可有效减少DU总数、新DU发生率,并促进DU愈合。波生坦可有效预防 SSc 患者出现新的 DU。这些治疗方法没有引起新的安全问题。非药物干预研究的质量普遍较低,样本量也较小。保暖措施减少了RP发作的频率和持续时间;激光疗法改善了RP相关的预后;局部氧-臭氧疗法作为一种附加疗法改善了RP预后;骨髓单核细胞植入改善了DU相关的疼痛;动脉周围交感神经切除术和血管旁路术减少了DU的数量和手指截肢的风险:现有证据支持药物干预(即硝苯地平、西地那非、伊洛前列素和波生坦)治疗 SSc 和其他 CTD 患者 RP 和 DU 的有效性和安全性。稀少且低质量的证据确实支持使用一些非药物干预措施,但其效果并不显著。该 SLR 强调,用于确定最佳治疗方法的高质量证据非常有限。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Systematic literature review to inform the Portuguese recommendations for the management of Raynaud's phenomenon and digital ulcers in systemic sclerosis and other connective tissue diseases.

Objective: To perform a systematic literature review (SLR) aimed at evaluating the efficacy and safety of pharmacological and non-pharmacological treatments for Raynaud's phenomenon (RP) and digital ulcers (DU) in patients with systemic sclerosis (SSc) and other connective tissue diseases (CTD), in order to inform the Portuguese recommendations for managing RP and DU in these patients.

Methods: A SLR was conducted until May 2022 to identify studies assessing the efficacy and safety of pharmacological and non-pharmacological interventions for RP and DU in SSc and other CTD. Eligible study designs included randomized controlled trials (RCTs), controlled clinical trials, and their extensions for assessing efficacy and safety of interventions. Observational studies with a comparator were included for evaluating the efficacy and safety of non-pharmacological interventions and safety of pharmacological interventions. The risk of bias of each study was assessed using standard tools.

Results: Out of 71 publications meeting the inclusion criteria, 59 evaluated pharmacological and 12 non-pharmacological interventions. We found moderate quality evidence supporting the efficacy of calcium channel blockers, phosphodiesterase-5 inhibitors, and intravenous prostacyclin analogues in reducing RP frequency, severity, and duration. Intravenous iloprost had a small to moderate effect size in improving DU healing. Phosphodiesterase-5 inhibitors were effective in reducing total DU count, new DU occurrence, and enhancing DU healing. Bosentan effectively prevented new DU in SSc patients. No new safety concerns were associated with these treatments. The studies on non-pharmacological interventions were, in general, of low quality, and had a small sample size. Warming measures decreased frequency and duration of RP attacks; laser therapy improved RP-related outcomes; local oxygen-ozone therapy improved RP outcomes as an add-on therapy; bone marrow mononuclear cell implantation improved DU-associated pain; periarterial sympathectomy and vascular bypass reduced DU number and finger amputation risk.

Conclusion: The available evidence supports the efficacy and safety of pharmacological interventions, namely nifedipine, sildenafil, iloprost, and bosentan in treating RP and DU in patients with SSc and other CTD. Scarce and low-quality evidence does support the use of some non-pharmacological interventions but with only a modest effect size. This SLR underscores the limited availability of high-quality evidence for determining the optimal treatment.

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