EFFECTS OF NSAIDs ON CLINICAL OUTCOMES, SYNOVIAL FLUID CYTOKINE CONCENTRATION AND SIGNAL TRANSDUCTION PATHWAYS IN KNEE OSTEOARTHRITIS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster universities (WOMAC) osteoarthritis index score
研究概览
简要总结
Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local inflammation (which involves production of pro-inflammatory cytokines such as interleukin (IL) 4 TNF-alpha, IL-6 and IL-8) is considered to be a major source of pain.
Certain therapies that specifically interfere with the expression or actions of pro-inflammatory cytokines have been explored. NSAIDs have analgesic, antipyretic and anti-inflammatory properties and are extensively prescribed for several musculoskeletal disorders. Indeed, the Osteoarthritis Research Society International (OARSI) recently recommended the use of NSAIDs for management of knee and hip OA in symptomatic patients. These drugs have been shown to influence cytokine metabolism in the synovial fluid of OA patients with satisfactory relief of painful osteoarthritic joints.
The aim of the current study was to explore whether NSAID treatment inhibits TNF-alpha, IL-6, IL-8, and VEGF secretion in the synovial fluid of osteoarthritic joints. In particular, diclofenac, ibuprofen and celecoxib were studied. Under the hypothesis that relationships between proinflammatory cytokines and the clinical status of OA patients are possible, we also evaluated the association between the concentration of these molecules in the osteoarthritic knee synovial fluid and the pain and functional status of patients with OA. The effects of NSAIDS on signal transduction pathways in the synovial membrane were also investigated.
详细描述
not desired
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for the study were:
- •older than 50 years and
- •had primary knee OA diagnosed according to the clinical and radiological criteria of the American Rheumatism Association.
- •Further inclusion criteria were:
- •clinical signs of joint inflammation (warmth, swelling or effusion) and
- •a disease severity grade 2 or 3 according to the Kellgren-Lawrence classification
排除标准
- •allergy to NSAIDs,
- •progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease),
- •history of gastrointestinal ulcer or bleeding,
- •a hemoglobin concentration lower than 11.5 g/dL,
- •renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values), or
- •liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values).
研究组 & 干预措施
diclofenac 75 mg/day
diclofenac 75 mg once day slow release
干预措施: Diclofenac (Drug)
diclofenac 150 mg/day
diclofenac 75 mg bid
干预措施: Diclofenac (Drug)
ibuprofen 1200 mg/day
ibuprofen 600 mg bid
干预措施: Ibuprofen (Drug)
ibuprofen 1800 mg/day
ibuprofen 600 mg tid
干预措施: Ibuprofen (Drug)
celecoxib 200 mg/day
celecoxib 200 mg once day
干预措施: Celecoxib (Drug)
celecoxib 400 mg/day
celecoxib 200 mg bid
干预措施: Celecoxib (Drug)
结局指标
主要结局
Western Ontario and McMaster universities (WOMAC) osteoarthritis index score
时间窗: 0-14 days
Womac was used to 77 measure the disease-specific health status of patients before and after the pharmacological treatment.
次要结局
- Naranjo probability scale(14 days)
研究者
Luca Gallelli
MD
University of Catanzaro