在第一线治疗 (TAILOR研究):一个研究协议的第三阶段,开放标签,多中心,随机对照试验
Anna E C Stoelinga1, Maarten E Tushuizen2, Wilbert B van den Hout3
1Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands. a.e.c.stoelinga@lumc.nl.
Trials
|January 17, 2024
概括
这项研究比较了塔克罗利斯 (TAC) 和菌酸莫菲蒂尔 (MMF) 作为自身免疫性肝炎 (AIH) 的二线治疗方法. 它旨在确定哪种疗法在实现完整的生化反应方面更有效,并评估它们在AIH患者中的安全性.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 免疫学 免疫学 免疫学
- 临床药理学 临床药理学
背景情况:
- 自身免疫性肝炎 (AIH) 是一种罕见的慢性肝炎,需要有效的治疗来预防纤维化和肝硬化.
- 一线AIH治疗包括阿扎西奥普林和普雷迪尼索隆,但有些患者需要二线选择.
- 对初始治疗的不完全反应是肝移植和死亡的关键风险因素.
研究的目的:
- 为了比较tacrolimus (TAC) 和mycophenolate mofetil (MMF) 作为二线治疗AIH的疗效和安全性.
- 评估TAC与MMF之间实现完整生化反应 (CR) 的患者比例.
- 评估二次结果,包括时间到CR,不良事件,纤维化,生活质量和成本效益.
主要方法:
- TAILOR研究是一项IIIB期,多中心,随机对照试验 (RCT),对AIH患者的TAC和MMF进行比较.
- 86名患有AIH且对一线治疗反应不完全的患者被随机分配 (1:1) 接受TAC或MMF.
- 主要终点是12个月后CR率的差异,以肝硬化存在为分层.
主要成果:
- 这个部分不在所提供的摘要中.
- 对TAILOR研究结果的进一步分析正在等待.
- 这项研究是第一个直接比较AIH的TAC和MMF的RCT.
结论:
- 这是第一个比较两种二线AIH治疗方法的RCT,解决了当前治疗指南中的差距.
- 结果将为临床实践提供信息,并可能更新管理AIH的国际指南.
- AIH的稀有性对临床研究提出了挑战,这使得这项试验具有重要意义.
相关概念视频
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
166
Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
166
Cell-mediated Immune Responses
68.3K
Overview
68.3K
Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids
120
Glucocorticoids, a class of anti-inflammatory drugs, are pivotal in treating moderate to severe Crohn's disease by inducing remission. They exhibit their anti-inflammatory action by inhibiting the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α, interleukin (IL)-1, and chemokines like IL-8. In addition, they reduce the expression of inflammatory cell adhesion molecules and inhibit gene transcription of nitric oxide synthase, phospholipase A2, cyclooxygenase-2...
120
Tissue Transplantation
372
Tissue transplantation is a significant medical procedure involving the transfer of cells, tissues, or organs from a donor to a recipient, with the primary aim of restoring lost functions. This procedure is crucial in treating a broad spectrum of diseases, including kidney diseases, liver failure, heart disease, and certain types of cancers.
The Biology of Tissue Transplantation
The biology of tissue transplantation hinges on the Major Histocompatibility Complex (MHC) molecules. These molecules...
The Biology of Tissue Transplantation
The biology of tissue transplantation hinges on the Major Histocompatibility Complex (MHC) molecules. These molecules...
372
Tumor Immunotherapy
527
Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
527
Myasthenia Gravis: Overview and Treatment
1.5K
Myasthenia gravis is a neuromuscular transmission disorder characterized by weakness and increased fatigability of skeletal muscles. It is an autoimmune disease affecting approximately one in 2000 people, where antibodies against the α1 subunit of nicotinic acetylcholine receptors are produced.
These antibodies interfere with the function of the nicotinic receptors in three ways: by binding to the receptor and disrupting acetylcholine binding; by causing cross-linking of receptors which...
These antibodies interfere with the function of the nicotinic receptors in three ways: by binding to the receptor and disrupting acetylcholine binding; by causing cross-linking of receptors which...
1.5K


