A Study of 100 Thousand Cases of Pediatric Patients of Clinical Safety Monitoring and Characteristic Observation and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)in Hospitals in China
试验速览
- 阶段
- 不适用
- 入组人数
- 100,000
- 主要终点
- Incidence of Adverse Drug Reaction
研究概览
简要总结
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in February 2018.
The purpose of this study is to make a monitoring of adverse reactions in 100 thousand children aged 14 years and below to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.
详细描述
In order to observe the clinical characteristics and adverse reactions of patients aged 14 and below using Reduning injection in hospital,registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of anaphylaxis. Calculating the incidence of adverse drug reactions is one of the main aims for this study. 100000 cases need to be registered at least. The aim population is who using Reduning injection from February 2018 to December 2018.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 14 and below using Reduning injection from February 2018 to December 2018.
排除标准
- 未提供
结局指标
主要结局
Incidence of Adverse Drug Reaction
时间窗: 3 days
Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction
次要结局
- The Ratio of Body Temperature to Normal(3 days)
- The Ratio of WBC to Normal(3 days)
- The Ratio of The Antibiotic Used(3 days)
研究者
Yanming Xie
Deputy Director
China Academy of Chinese Medical Sciences