Department of Urology, Shanghai Xu-hui Central Hospital
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stone burdern stone burdern
研究概览
简要总结
The purpose of this study was to explore the effects of uric acid control on stone recurrence and renal function in patients with calculi of hyperuricemia through a prospective controlled study.
详细描述
2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). The patients were followed up for 3 months, 6 months, 12 months and 18 months after operation.
Informations as age, sex, height, weight, calculation BMI, past medical history, history of gout, diabetes, hyperthyroidism, calcium supplements will be recorded.
Rapid blood glucose, serum total cholesterol, high density cholesterol, thyroid hormone detection, androgen, estrogen detection, serum sodium, potassium, chlorine, calcium, magnesium, phosphorus, serum uric acid will be tested.
Renogram test to evaluate the change of single renal function. The stones burden will be followed-up with ultrasound or kub or CT plain scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Make a random table, and the patients are divided into the group according to the random table according to the order of enrollment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.Over 18 years old, under 70 years old, regardless of sex .The subjects had no mental illness or language dysfunction, could understand the situation of this study and had signed an informed consent form.
- •.No clinical manifestations of urinary tract infection, urinary routine examination showed urinary tract infection, but urinary etiology test was negative (urinary routine leukocytosis), treated with broad-spectrum antibiotics for more than 3 days.
- •.Clinical manifestations of urinary tract infection, urine routine examination showed urinary tract infection, and patients with positive urinary etiology were treated with sensitive antibiotics for more than 7 days.
- •Serum uric acid value ≥480 µmol / L
- •urinary stones
排除标准
- •Transplanted kidney
- •Fever or urinary tract infection is not treated according to the inclusion criteria
- •Pregnant women and female menstruation
- •Unable to tolerate anesthesia or surgery due to severe systemic disease, heart disease, pulmonary insufficiency and important organ failure
- •Patients with renal insufficiency Clcr <30 mL/min
- •Those who take side effects of febuxostat，Patients with side effects of febuxostat, patients with a previous history of coronary heart disease
研究组 & 干预措施
Uric acid drug control group
For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week
干预措施: Febuxostat 40mg Tab (Drug)
Non-drug control group
They are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly.
干预措施: Non-drug control group (Behavioral)
结局指标
主要结局
Stone burdern stone burdern
时间窗: Change from the base line of the stone's volume and quantity at 18 months.
Use ultrasound or kub or CT plain scan to follow up the patients.
次要结局
- Renal function(Change from the base line of GFR at 18 months after the operation.)
研究者
Zhao Hong
Department of Urology
Xuhui Central Hospital, Shanghai