研究疾病:
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类风湿关节炎
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研究疾病代码:
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Target disease:
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Rheumatoid Arthritis
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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其它
Others
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研究目的:
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类风湿关节炎是一种慢性全身性炎性自身免疫性疾病,其主要特征为慢性进行性的关节炎症、软骨和骨侵蚀。类风湿关节炎骨破坏是本病最常见的临床表现之一,严重影响患者生活质量。研究表明全球类风湿关节炎患病率为0.5%-1%,我国约有300万患者。类风湿关节炎骨破坏发生在病程早期,累及手、足小关节最为常见。骨破坏不仅导致疼痛丧失功能,还增加畸形和残疾的风险。目前关于类风湿关节炎骨破坏的发病机制研究尚不清楚,药物治疗以控制症状为主,无法完全修复和恢复受损骨骼。因此,亟需开展类风湿关节炎骨破坏的药物治疗研究,以减轻患者痛苦、提高生活质量。补肾通络方在临床治疗类风湿关节炎骨破坏效果确切,但其真实世界研究尚少。因此,有必要开展真实世界研究,评价其治疗效果和安全性。
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Objectives of Study:
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Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease characterized by chronic progressive joint inflammation, cartilage, and bone erosion. Bone damage in rheumatoid arthritis is one of the most common clinical manifestations, significantly impacting the quality of life of patients. Studies have indicated a global prevalence of rheumatoid arthritis between 0.5% to 1%, with approximately 3 million patients in China alone. Bone destruction in rheumatoid arthritis occurs early in the disease course, often affecting small joints in the hands and feet. Bone erosion not only leads to pain and functional loss but also increases the risk of deformities and disabilities.
The underlying mechanism of bone destruction in rheumatoid arthritis remains unclear, and current drug treatments primarily focus on symptom control, lacking the ability to fully restore and repair damaged bones. Thus, there is an urgent need for research into drug therapies targeting bone damage in rheumatoid arthritis to alleviate patient suffering and enhance their quality of life.
Bushen Tongluo Decoction has shown promising effects in the clinical treatment of bone damage in rheumatoid arthritis; however, real-world research in this area remains limited. Therefore, it is essential to conduct real-world studies to comprehensively evaluate the treatment efficacy and safety of Bushen Tongluo Decoction.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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(1)符合上述西医诊断、中医疾病及证候诊断;
(2)年龄 35-60 岁;
(3)关节功能分级属I、II、III级,双手 X 线分期属于 I、II、III期者;
(4)RA 疾病活动度为轻度及中度患者;
(5)近期间未服用或注射非甾体抗炎药、改善病情抗风湿药、生物制剂、糖皮质激素类药等;
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Inclusion criteria
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(1) Meets the aforementioned Western medical diagnosis, traditional Chinese disease classification, and syndrome diagnosis.
(2) Age range between 35 and 60 years.
(3) Classified with joint function levels I, II, or III, and hand X-ray staging falls under stages I, II, or III.
(4) RA disease activity is mild to moderate.
(5) Has not recently taken or been administered non-steroidal anti-inflammatory drugs, disease-modifying anti-rheumatic drugs (DMARDs), biologics, glucocorticoids, or similar medications intended to alleviate symptoms or improve rheumatoid arthritis condition.
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排除标准:
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(1)不符合诊断标准的患者;
(2)近半年以来连续使用糖皮质激素类药物(如口服的强的松、甲泼尼龙,静滴的甲强龙等)超过1月者;
(3)合并有其他风湿性疾病患者;
(4)近1年服用或注射过有助于促进骨形成及吸收的药物,如钙片、骨化三醇或依降钢素等;
(5)急性心脑血管病患者;
(6)有合并明显其它系统疾病的患者;有严重外伤者,或有计划接受手术及存在严重感染患者;
(7)有药物滥用史者;本研究所用药物过敏者;精神疾病病史者;
(8)妊娠期或哺乳期以及备孕期的女性;
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Exclusion criteria:
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(1) Patients who do not meet the diagnostic criteria.
(2) Patients who have used glucocorticoid medications continuously for more than one month in the last six months (such as oral prednisone, methylprednisolone, or intravenous methylprednisolone).
(3) Patients with concomitant other rheumatic diseases.
(4) Patients who have taken medications in the past year that promote bone formation or absorption, such as calcium supplements, calcitriol, or teriparatide.
(5) Patients with acute cardiovascular or cerebrovascular diseases.
(6) Patients with significant concurrent systemic diseases, severe trauma, planned surgery, or severe infections.
(7) Patients with a history of drug abuse, allergies to the medications used in this study, or a history of mental illness.
(8) Women who are pregnant, breastfeeding, or in the preconception period.
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研究实施时间:
Study execute time:
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从From
2024-07-01
至To
2026-08-31
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征募观察对象时间:
Recruiting time:
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从From
2024-07-01
至To
2026-06-30
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