Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Recovery rate
研究概览
简要总结
Application of multi-center, prospective study on the severity of postoperative cholangitis biliary atresia classification, according to the degree of cholangitis targeted therapy, to improve the therapeutic effect of postoperative cholangitis biliary atresia, decrease the overuse of antibiotics related complications.
详细描述
Cholangitis patients post-kasai Portoenterostomy were grouped by cholangitis severity score, according to the severity was divided into mild, moderate, severe cholangitis, all levels of cholangitis patients were divided into subgroups by age and post-kasai Portoenterostomy jaundice matching design of experiment, then they were randomly divided into control group and experimental group, and all the control group unified antibiotic treatment, the experimental group was graded antibiotic treatment according to the severity cholangitis, after three days treatment，evaluate each treatment effect, average hospitalization days, the average hospitalization expenses, antimicrobial drug use strength to evaluate the therapeutic effect of postoperative cholangitis biliary atresia.
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
- 3 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3 months to 2 years old, gender is not limited.
- •Patients with cholangitis post-kasai Portoenterostomy.
- •No other treatment before entering the group.
- •The patient must sign an informed consent form and can actively cooperate with the treatment and follow-up.
排除标准
- •Patients with other infectious lesions.
- •Patients with other severe deformity.
- •Patients with end-stage liver failure.
- •Patientsn with liver transplantation.
- •Patients with mental symptoms or other disease.
研究组 & 干预措施
moderate cholangitis
Meropenem injection, iv. drip,20mg/Kg，Q12h; Tinidazole injection, iv. drip,20mg/Kg,Qd.
干预措施: Sulperazon (Drug)
severe cholangitis
Meropenem injection, iv. drip,20mg/Kg，Q8h; Teicoplanin injection, iv. drip,10mg/Kg,Qd; Tinidazole injection, iv. drip,20mg/Kg,Qd.
干预措施: Teicoplanin (Drug)
control group
Sulperazon, iv.,drip,100mg/Kg,Bid; Tinidazole injection, iv. drip,20mg/Kg,Qd
干预措施: Meropenem Injection (Drug)
结局指标
主要结局
Recovery rate
时间窗: 7 days
The cure indicator including:1.Temperature:T≤37.5℃; 2. Infection index:WBC\<10x109/L, CRP\<10mg/L. After 7days treatment, we calculate the cure number and recovery rate of each group to evaluate the efficiency.
次要结局
- Recurrence rate(1 year)
研究者
J.X. Feng
Chief in Department
Tongji Hospital