Treatment of Refractory Gout With Adrenocorticotropic Hormone or Methylprednisolone
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Arthritis score
研究概览
简要总结
To clarify the therapeutic effect and safety evaluation of ACTH in refractory gouty arthritis and special population, and to explore its mechanism of action.
详细描述
When patients with acute gout have multiple comorbidities and complications , traditional treatment methods are often contraindicated . From the current clinical research evidence , we have seen the non-inferior effect of ACTH on glucocorticoids and non-steroidal anti-inflammatory drugs in the treatment of acute gout , as well as the good safety and extensive anti-inflammatory effect in addition to efficacy . Therefore , we designed this study to update and improve the treatment of acute gout attacks , and to try to clarify the mechanism of action .
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(123 items and 1 item from 4-7 are met simultaneously) :
- •Meet the 2015 ACR/EULAR classification diagnostic criteria for gout
- •Acute gouty arthritis
- •Repeated attacks and prolonged pain (more than 1 month);
- •poor response or intolerance to colchicine or NSAIDs;
- •Liver and kidney dysfunction;
排除标准
- •History of gastrointestinal bleeding and active ulcer 2) The application history of glucocorticoids and ACTH in 1 month before screening 3) Pregnancy and lactation 4) Drug and alcohol abuse 5) Malignant tumor (treated or untreated within 5 years) 6) Mental illness inability to communicate or have language barriers and inability to fully understand and cooperate 7) negligent compensatory heart failure, unstable angina pectoris, stroke, transient ischemic attack, myocardial infarction, and severe arrhythmia occurred within 6 months 8) The investigator did not consider it appropriate to participate in the study
研究组 & 干预措施
ACTH
Adrenocorticotropic Hormone
干预措施: Adrenocorticotropic Hormone (Drug)
Methylprednisolone
Methylprednisolone
干预措施: Methylprednisolone Injection (Drug)
结局指标
主要结局
Arthritis score
时间窗: 7 days
Arthritis (redness and swelling fever 0-3) score
Measurement of pain
时间窗: 7 days
Visual analogue scale (VAS 0-10)
次要结局
- Recurrence rate(1 month)
研究者
Zhang Manna
Professor
Shanghai 10th People's Hospital