The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 主要终点
- Changes from baseline in Carotid intima-media thickness at 24 weeks
研究概览
简要总结
The purpose of this study is to access the effect (week 12/week 24) of puerarin injection on carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients despite routine anti-rheumatic treatment.
详细描述
- Controlled, randomized trial
- RA patients under routine anti-rheumatic care were randomized to receive the treatment with or without 400 mg puerarin injection
- Assessments were made at entry, 12 and 24 weeks
- The overall sample size was assessed before the enrollment
- Randomization was performed using concealed random allocation method
- The collected data was processed and assessed by two reviewers
- All the measurement and analysis procedures concerning CIMT were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment
- The reproducibility of the ultrasonographic method was test before the trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010
- •aged from 18 to 75 years
- •without conflict to the written, informed consent signed prior to the enrollment
- •no severe hepatic or renal disorders
- •no known carotid artery stenosis
- •no coagulation disorders
- •no hypertension
排除标准
- •being in pregnancy, lactation period or under a pregnancy plan
- •being allergic to the test drug
- •not compatible for the trial medication
- •without full legal capacity
研究组 & 干预措施
Puerarin injection 400 mg
Patients were administrated with 400 mg intravenously infused puerarin injection once a day. Puerarin injection was prepared in 250 mL 0.9% sodium chloride injection before the use. The treatment course consisted of 2 weeks followed by a 15-day interval for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.
干预措施: Puerarin injection 400 mg (Drug)
Control
Patients receive routine anti-rheumatic care only. Patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.
干预措施: Control (Drug)
结局指标
主要结局
Changes from baseline in Carotid intima-media thickness at 24 weeks
时间窗: At 0 week, 12 weeks, 24 weeks
Carotid intima-media thickness (CIMT) was using a high-resolution B-mode ultrasound machine (iU22 xMATRIX, Philips, Germany). CIMT was measured twice by a single experienced operator using an 10-MHz linear vascular probe. Patients were let resting in a relaxed supine position, with the head turned gently to the contralateral side when the electrocardiogram was recorded. The imaging system (QLab 6.0, Philips, Germany) was applied to measure the CIMT signals from the proximal internal carotid artery (the arterial segment 10 mm distal to the carotid bifurcation), the carotid bulb and the distal common carotid artery (the arterial segment 10 mm proximal to the carotid bulb). The mean CIMT was calculated from the value of five arterial segments. All the measurement and analysis procedures were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment.
次要结局
- low-density lipoprotein cholesterol (LDL-C)(at 0 week, 12 weeks, 24 weeks)
- erythrocyte sedimentation rate (ESR)(at 0 week, 12 weeks, 24 weeks)
- C reactive protein (CRP)(at 0 week, 12 weeks, 24 weeks)
- Total cholesterol (TC)(at 0 week, 12 weeks, 24 weeks)
- triglycerides (TGs)(at 0 week, 12 weeks, 24 weeks)
- tumor necrosis factor (TNFα)(at 0 week，12 weeks, 24 weeks)
- interleukin-8 (IL-8)(at 0 week，12 weeks, 24 weeks)
- interleukin-1 (IL-1)(at 0 week，12 weeks, 24 weeks)
- interleukin-6 (IL-6)(at 0 week，12 weeks, 24 weeks)
- disease activity score in 28 joints (DAS28)(at 0 week，12 weeks, 24 weeks)
- homeostasis model assessment (HOMA-IR)(at 0 week，12 weeks, 24 weeks)
研究者
Yang Min
Dr.
Chengdu PLA General Hospital