Epidemiological Study on Drug-induced Coagulation Disorder Caused by Cefoperazone Sulbactam Sodium and Construction of Prediction Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Coagulation disorder
研究概览
简要总结
The incidence rate of drug-induced blood diseases accounts for about 10% of all drug-induced diseases, most of which are serious at the time of onset, and the mortality rate can be as high as 32.5%. In this study, cefoperazone sulbactam sodium, which is commonly used in clinic, was selected as the target drug, and the epidemiological characteristics of drug-induced coagulation dysfunction and the construction of risk factor models were studied by single factor and multiple factor Logistic regression analysis.
详细描述
Investigators selected inpatients from Qianfoshan Hospital of Shandong Province from January 1, 2018 to December 30, 2021, extracted the cohort according to the inclusion and exclusion criteria, and divided it into exposure group and control group to find out the risk factors of cefoperazone sulbactam sodium causing coagulation disorders, and build a risk factor model of drug-induced coagulation disorders caused by cefoperazone sulbactam sodium.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All inpatients who used cefoperazone sulbactam sodium during hospitalization;
- •Hospital stay ≥ 48h
- •Age ≥ 18 years old
排除标准
- •Age < 18 years
- •Severe liver and kidney dysfunction
- •Patients with vitamin K deficiency
- •Patients with hematological diseases
- •Patients with advanced malignant tumor or mental disease
- •Patients with incomplete clinical data
研究组 & 干预措施
Occurrence of coagulation disorder
- All inpatients who used cefoperazone sulbactam sodium during hospitalization；
- Hospital stay ≥ 48h;
- Age ≥ 18 years old;
- Prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and platelet (PLT) were detected twice or more during hospitalization
干预措施: cefoperazone sulbactam sodium (Drug)
No coagulation disorder
- Inpatients who did not use cefoperazone sulbactam sodium during hospitalization;
- Hospital stay ≥ 48h;
- Age ≥ 18 years old;
- Prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and platelet (PLT) were detected twice or more during hospitalization
干预措施: cefoperazone sulbactam sodium (Drug)
结局指标
主要结局
Coagulation disorder
时间窗: Through study completion,up to half a year.
Coagulation disorder occurred after cefoperazone sulbactam sodium was used in the patient's hospitalization.
次要结局
未报告次要终点
研究者
Xiao Li，MD
Director
Qianfoshan Hospital