Trial of intravenous immunoglobulin in dermatomyositis: a critically appraised research paper.
Trial of intravenous immunoglobulin in dermatomyositis: a critically appraised research paper.
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静脉注射免疫球蛋白治疗皮肌炎的试验：一篇经过严格评价的研究论文。
DOI：
10.1093/bjd/ljad044
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发表时间：
2023
期刊：
影响因子：
--
通讯作者：
Werth,VictoriaP
中科院分区：
文献类型：
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作者：
Pandya,Rachita;Kleitsch,Julianne;Werth,VictoriaP
阿格瓦莱特等人。最近报告了第一个成功的 III 期试验的结果，该试验研究静脉注射免疫球蛋白 (IVIG) 治疗皮肌炎 (DM) 的效果。该研究表明，接受 IVIG 治疗的患者疾病活动度的改善在临床上和统计学上均显着高于接受安慰剂的患者，这使得美国食品和药物管理局批准将 IVIG 用于治疗糖尿病。尽管取得了成功，这项研究也强调了必须解决的几个问题，以便为该领域的未来试验提供信息，特别是纳入皮肤为主/无肌病和肌病后糖尿病患者。
Aggarwalet al. recently reported results from the first successful phase III trial studying intravenous immunoglobulin (IVIG) in dermatomyositis (DM). The study showed that improvement in disease activity was clinically and statistically significantly greater in those who received IVIG than in those who received placebo, allowing US Food and Drug Administration approval for use of IVIG in DM. Despite its success, this study also highlights several concerns that must be addressed to inform future trials in the field, particularly the inclusion of patients with skin-predominant/amyopathic and post-myopathic DM.