[结缔组织疾病和血管病的正面研究]。

IF 0.9 4区 医学 Q4 RHEUMATOLOGY Zeitschrift fur Rheumatologie Pub Date : 2024-10-01 Epub Date: 2024-07-17 DOI:10.1007/s00393-024-01537-4
Bernhard Hellmich, Johanna Mucke, Martin Aringer
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引用次数: 0

摘要

头对头(H2H)研究能够直接比较几种可供选择的治疗方法,从而为一种治疗方法与其他治疗方法在特定适应症中的相对地位提供循证依据。这些试验是对安慰剂对照临床试验的重要补充。在非制药行业进行的对照临床试验中,有大量针对结缔组织病(CTD)和血管炎的 H2H 试验,尤其是针对系统性红斑狼疮(SLE)、系统性硬化症(SSc)和抗中性粒细胞胞浆抗体(ANCA)相关性血管炎(AAV)的试验。本文回顾了针对 CTD 和血管炎的 H2H 试验,并讨论了这些试验与当前治疗方案的相关性。就系统性红斑狼疮而言,H2H 试验主要用于治疗狼疮性肾炎,证明了小剂量环磷酰胺和霉酚酸盐以及硫唑嘌呤对维持治疗的影响。在最近的 H2H 试验中,利妥昔单抗被确定为 AAV 的诱导和维持疗法,现已被纳入当前的治疗指南。为了从个性化医疗的角度为每位患者选择最有效、最安全的治疗方法,有必要进一步开展比较试验。
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[Head-to-head studies on connective tissue diseases and vasculitides].

Head-to-head (H2H) studies enable the direct comparison of several alternative therapeutic approaches and thus provide the evidence-based foundation for the relative position of one treatment as compared to others for a specific indication. These trials constitute an important addition to placebo-controlled clinical trials. Among the controlled clinical trials not performed by the pharmaceutical industry, there are a relevant number of H2H trials for connective tissue diseases (CTDs) and vasculitides, particularly for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). This article encompasses a review of the H2H trials for CTDs and vasculitides and discusses their relevance for current treatment algorithms. For SLE the H2H trials were predominantly performed for the treatment of lupus nephritis, demonstrating the impact of low-dose cyclophosphamide and mycophenolate as well as azathioprine for maintenance therapy. In recent H2H trials rituximab could be established as induction and maintenance therapy for AAV, which has now been incorporated into current treatment guidelines. Further comparative trials will be necessary in order to select the most effective and safest treatment for every patient, in the sense of personalized medicine.

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来源期刊
Zeitschrift fur Rheumatologie
Zeitschrift fur Rheumatologie 医学-风湿病学
CiteScore
2.20
自引率
20.00%
发文量
150
审稿时长
6-12 weeks
期刊介绍: Die Zeitschrift für Rheumatologie ist ein international angesehenes Publikationsorgan und dient der Fortbildung von niedergelassenen und in der Klinik tätigen Rheumatologen. Die Zeitschrift widmet sich allen Aspekten der klinischen Rheumatologie, der Therapie rheumatischer Erkrankungen sowie der rheumatologischen Grundlagenforschung. Umfassende Übersichtsarbeiten zu einem aktuellen Schwerpunktthema sind das Kernstück jeder Ausgabe. Im Mittelpunkt steht dabei gesichertes Wissen zu Diagnostik und Therapie mit hoher Relevanz für die tägliche Arbeit – der Leser erhält konkrete Handlungsempfehlungen. Frei eingereichte Originalien ermöglichen die Präsentation wichtiger klinischer Studien und dienen dem wissenschaftlichen Austausch.
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