Investigation of Pain Incidence After FK506 Immunosuppressive Therapy in Liver Transplantation Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- pain incidence
研究概览
简要总结
FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation, and to treat T cell-mediated diseases such as eczema and atopic dermatitis. FK506 treatment often accompanies pain sensation in patients with atopic dermatitis or after organ transplantation. In previous studies, the investigators confirmed that FK506 treatment increased neuronal activity of primary afferent neurons and causes pain behavior in naïve mice. In order to further search for objective clinical evidence, the investigators proposed to investigate pain incidence after FK506 immunosuppressive therapy in liver transplantation patients. The investigators will investigate pain incidence and pain intensity in patients who underwent liver transplant from September of 2011 to May of 2018 in the Liver Health Rehabilitation Association. The patients who were divided into two groups based on whether or not FK506 was used in the immunosuppressive therapy. The patients in control group (without FK506 treatment) and FK506-treated group report pain sensation 3 months and 12 months after liver transplant. The investigators will compare the pain incidence between the two groups at both time points. On the other hand, the investigators will further investigate changes in pain sensation after 1st and 2nd reductions of FK506 dose. Pain is reported subjectively by the patient using the visual analogue scale (VAS) 1 month after dose reduction. In our study, 1st and 2nd reductions of FK506 dose refers to the first two dose-adjustments (approximately 6 months apart) that occurred 3-6 months after the liver transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •had liver transplantation for end-stage liver disease
- •was ≥18 years of age at the time of liver transplantation -
排除标准
- •liver cancer
- •acute (fulminant) liver failure
- •multiorgan transplant
- •chronic postsurgical pain
- •fibromyalgia, osteoarthritis, low back pain and inflammatory pain of any origin
- •peripheral and central neuropathic pain of any origin
- •chronic secondary visceral pain
- •chronic cancer-related pain that is due to cancer or its treatment -
研究组 & 干预措施
FK506-treated group
In FK506-treated group, the patients who underwent liver transplant are treated with FK506 immunosuppressive therapy.
干预措施: FK506 (Drug)
结局指标
主要结局
pain incidence
时间窗: within 2 years after liver transplantation
Pain is defined as painful sensation that lasts or recurs for 1-3 months within 3 months after liver transplantation, or for longer than 3 months within 12 months after liver transplantation.
pain intensity
时间窗: within 2 years after liver transplantation
Pain is reported subjectively by the patient using the visual analogue scale (VAS)
次要结局
未报告次要终点
