Department of Infectious Diseases, People's Hospital of Xinjiang Uygur Autonomous Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- UDCA response: Paris I criteria
研究概览
简要总结
The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis.
详细描述
A prospective analysis will be conducted on 60 patients with primary PBC who were admitted to our Infectious Diseases Department and outpatient clinic. All patients will take UDCA capsules orally and divide into two groups: the experimental group, which received UDCA combined with Vitamin D(1200 IU per day) treatment, and the control group. The control group will receive UDCA treatment alone for one year, selected through a random number table method. After one year, the control group will be further divided into two groups using the same method. One group will continue to receive UDCA alone, while the other will receive a combination of UDCA and vitamin D for an additional year. Clinical data, clinical manifestations, blood tests, and imaging tests will be collected during the initial and subsequent treatments. The efficacy will be evaluated using the Paris I and Barcelona standards.
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
- •The patient must meet the diagnostic criteria for PBC ;
- •The patient must have been diagnosed at the age of 18 or older;
- •The patient must have completed at least 2 years of treatment and have complete and accessible clinical data;
- •The patient must have strictly followed the doctor's prescription during the treatment period and not have interrupted the treatment arbitrarily.
排除标准
- •The study excluded patients with autoimmune hepatitis or primary sclerosing cholangitis.
- •Patients with other acute and chronic liver diseases were also excluded.
- •Patients with serious cardiopulmonary diseases were excluded as well.
- •Pregnant or lactating women were not included in the study.
- •Patients who randomly interrupted or adjusted their medication during the treatment period were excluded.
- •Patients who lacked follow-up were also excluded.
研究组 & 干预措施
experimental group
experimental group received UDCA(Losan Pharma GmbH, registration number H20181059, 13-15 mg/day/kg) combined with Vitamin D3 (1200 IU per day) treatment for 1year
干预措施: Vitamin D (Drug)
结局指标
主要结局
UDCA response: Paris I criteria
时间窗: 1 year
The ALP levels should be no more than three times the upper limit of normal (3xULN), while the AST levels should be no more than two times the ULN, and bilirubin levels should be normal after one year of standard treatment.
UDCA response: Barcelona criteria
时间窗: 1 year
After one year of standard treatment, the ALP levels should decrease by more than 40% or reach normal levels.
次要结局
未报告次要终点
研究者
Yilihamu·Abilitifu
People's Hospital of Xinjiang Uygur Autonomous Region
People's Hospital of Xinjiang Uygur Autonomous Region