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Comparison of Mycophenolate Mofetil Plus Methotrexate versus Cyclophosphamide with Sequential Azathioprine for Active Takayasu's Arteritis: An Open-Label, Randomized-Controlled Trial

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机构: [1]Peking Union Med Coll Hosp, Beijing, Peoples R China [2]Nanchang Univ, Affiliated Hosp 2, Nanchang, Peoples R China [3]Shanxi Bethune Hosp, Taiyuan, Peoples R China [4]Jiaozuo Peoples Hosp, Jiaozuo, Henan, Peoples R China [5]Zhejiang Univ, Sch Med, Affiliated Hosp 2, Hangzhou, Peoples R China [6]Fourth Mil Med Univ, Xijing Hosp, Xian, Peoples R China [7]Xuanwu Hosp, Beijing, Peoples R China [8]Peoples Hosp Xinjiang Uygur Autonomous Reg, Xinjiang, Peoples R China [9]Dalian Med Univ, Affiliated Hosp 1, Dalian, Peoples R China [10]Peking Union Med Coll Hosp PUMCH, Chinese Acad Med Sci, Natl Clin Res Ctr Dermatol & Immunol Dis, Dept Rheumatol, Beijing, Peoples R China [11]Univ Penns, Philadelphia, PA USA [12]Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Beijing, Peoples R China
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关键词: Intervention Randomized Trial Takayasu s arteritis

摘要:
Background/Purpose: The management of Takayasu’s arteritis (TAK) is challenging for lack of largescale, high-quality clinical trials. Cyclophosphamide (CYC) is a conventional rst-line immunosuppressant but is associated with reproductive toxicity and increased risk of malignancy. This study evaluated the ecacy and safety of mycophenolate mofetil (MMF) combined with methotrexate (MTX) compared to CYC followed by azathioprine (AZA) in treating active TAK. Methods: Patients aged 18 or older with active TAK were randomized 2:1 to receive MMF+MTX or CYC/AZA. All subjects received high-dose glucocorticoids (GCs) with a predened tapering plan. MMF was dosed at 750mg or 1000mg twice daily based on body weight (< 50kg or ≥50kg), and MTX was given at 15mg weekly. CYC was administered intravenously at 15mg/kg for 10 infusions over 28 weeks, followed by oral AZA at 100mg daily. Patients were followed for 52 weeks to evaluate treatment ecacy and safety. The primary endpoint was the overall response rate at 52 weeks. Secondary endpoints included complete and partial response rates at 28 and 52 weeks. Complete response was dened as the resolution of active disease signs, normalization of ESR and CRP, no progression on imaging, and GCs dose < 15mg daily of prednisone or equivalent.

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出版当年[2023]版:
大类 | 1 区 医学
小类 | 1 区 风湿病学
最新[2023]版:
大类 | 1 区 医学
小类 | 1 区 风湿病学
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出版当年[2022]版:
Q1 RHEUMATOLOGY
最新[2023]版:
Q1 RHEUMATOLOGY

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第一作者机构: [1]Peking Union Med Coll Hosp, Beijing, Peoples R China
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