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Combining Traditional Chinese Herbs and csDMARDs for the Treatment of Rheumatoid Arthritis Involves Tapering and Discontinuing Glucocorticoids: Protocol for a Two-Stage Non-Randomized Controlled Trial

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机构: [1]Yunnan Univ Tradit Chinese Med, Affiliated Hosp 1, Dept Rheumatol, Kunming 650021, Yunnan, Peoples R China [2]Yunnan Prov Hosp Tradit Chinese Med, Yunnan Prov Clin Med Res Ctr Rheumatism TCM, Kunming 650021, Yunnan, Peoples R China [3]Yunnan Univ Chinese Med, Sch Clin Med 1, Kunming 650021, Yunnan, Peoples R China [4]Lijiang Hosp Tradit Chinese Med, Dept Integrat Internal Med, Lijiang 674100, Yunnan, Peoples R China [5]Kunming Univ Sci & Technol, Peoples Hosp Yunnan Prov 1, Dept Rheumatol & Immunol, Kunming 650034, Yunnan, Peoples R China [6]Kunming Univ Sci & Technol, Affiliated Hosp, Kunming 650034, Yunnan, Peoples R China
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关键词: rheumatoid arthritis glucocorticoids tapering clinical trial traditional Chinese medicine Yupingfeng Guizhi Decoction Juanbi Decoction

摘要:
Glucocorticoids (GC) are crucial in the treatment of rheumatoid arthritis (RA), but discontinuing GC effectively in RA patients poses a significant challenge for rheumatologists. In this two -stage, single -center, non -randomized controlled trial, we investigated the benefits of combining Chinese traditional herbal treatment with csDMARDs to aid GC discontinuation in terms of GC tapering, disease control, and safety. A total of 231 participants were enrolled, of which 150 eligible subjects were included in the first phase and allocated to three groups (control group, treatment group 1, and treatment group 2) based on their willingness to take traditional Chinese medicine and syndrome differentiation, in a 1:1:1 ratio. All groups received basic treatment consisting of methotrexate tablets (10 mg, qw), leflunomide (10 mg, qd), and stratified GC bridging therapy and tapering regimen (The intervention regimen was developed based on rigorous adherence to available evidence). Treatment group 1 received basic treatment combined with Juanbi Granule, while treatment group 2 received basic treatment combined with Yupingfeng Guizhi Decoction Granule. Efficacy was evaluated after a 12 -week follow-up, with slightly adjustments to the treatment group based on efficacy and change of syndrome, followed by continued observation until 24 weeks to complete the study. The efficacy evaluation and data analysis were conducted in a blinded manner, including group label concealment, data cleaning, confounder and control regimen analysis, and outcome analysis. This project has received ethical approval from the Ethics Committee of Yunnan Provincial Hospital of Traditional Chinese Medicine (YLZ [2022] Ethical Review No. (006)-01) and has been registered with the China Clinical Trials Registry (Registration number: ChiCTR2300067676, Registered 17 January 2023, https://www. chictr.org.cn/showproj.html?proj=184908). This trial was the first to evaluate the clinical efficacy of combining Chinese herbal medicines with standard Western medicines to facilitate the discontinuation of glucocorticoid (GC) therapy in patients with rheumatoid arthritis (RA).

基金:

基金编号: 81960863 82160901 82360924 202102AA310006 131 85 202305AF150175 202101AT070230 2019FF002 (-082) 2019FF002 (-031) 202101AZ070001- 072) 2018TGZ01 2018NS0045 2018NS0046

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大类 | 4 区 医学
小类 | 3 区 医学:内科
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出版当年[2023]版:
Q2 MEDICINE, GENERAL & INTERNAL
最新[2023]版:
Q2 MEDICINE, GENERAL & INTERNAL

影响因子: 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

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第一作者机构: [1]Yunnan Univ Tradit Chinese Med, Affiliated Hosp 1, Dept Rheumatol, Kunming 650021, Yunnan, Peoples R China [2]Yunnan Prov Hosp Tradit Chinese Med, Yunnan Prov Clin Med Res Ctr Rheumatism TCM, Kunming 650021, Yunnan, Peoples R China
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通讯机构: [1]Yunnan Univ Tradit Chinese Med, Affiliated Hosp 1, Dept Rheumatol, Kunming 650021, Yunnan, Peoples R China [2]Yunnan Prov Hosp Tradit Chinese Med, Yunnan Prov Clin Med Res Ctr Rheumatism TCM, Kunming 650021, Yunnan, Peoples R China
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