Establishment of Risk Factors Model of Drug-induced Coagulation Disorder Caused by Cefoperazone Sulbactam Sodium

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Epidemiological Study on Drug-induced Coagulation Disorder Caused by Cefoperazone Sulbactam Sodium and Construction of Prediction Model

Conditions
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Risk Factors

Intervention / Treatment
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* Drug: cefoperazone sulbactam sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All inpatients who used cefoperazone sulbactam sodium during hospitalization; Hospital stay ≥ 48h Age ≥ 18 years old Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Occurrence of coagulation disorder<br>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 | Drug: cefoperazone sulbactam sodium<br>* Cefoperazone sodium and Sulbactam Sodium for injection (1; 1) are white or almost white powder drugs, and the components are cefoperazone sodium and sulbactam sodium<br>|
| No coagulation disorder<br>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 | Drug: cefoperazone sulbactam sodium<br>* Cefoperazone sodium and Sulbactam Sodium for injection (1; 1) are white or almost white powder drugs, and the components are cefoperazone sodium and sulbactam sodium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coagulation disorder | Coagulation disorder occurred after cefoperazone sulbactam sodium was used in the patient's hospitalization. | Through study completion,up to half a year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coagulation disorder, Epidemiological study, Risk factors, Building models