Study of the Clinical Benefits of Different Formulations of Amphotericin B

Study Overview
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Brief Summary
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This project intends to carry out a multi-center retrospective observational real-world study to understand the current status of amphotericin B use by formulation type, compare the differences in safety and efficacy of each formulation in domestic clinical application, provide real-world evidence for clinical drug selection, and provide evidence-based evidence in support of rational clinical drug use.

Detailed Description
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The researchers selected patients with amphotericin B use records discharged from five tertiary hospitals across the country from January 1, 2020 to the present, extracted data according to the inclusion and exclusion criteria, and divided them into experimental and control groups, in order to understand the current status of amphotericin B use in each preparation type, compare the differences in the safety and efficacy of the various preparations in the domestic clinical application, and provide real-world evidence of the choice of clinical medication.

Official Title
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Study of the Clinical Benefits of Different Formulations of Amphotericin B

Conditions
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Efficacy, Safety

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients discharged from January 1, 2020 to the present; Patients with a record of amphotericin B use. Exclusion Criteria: 1.Key information missing from patient studies.
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 |
| --- | --- |
| Experimental Group<br>Liposomal Amphotericin B for Injection (Ampicillin®) | |
| Control Group<br>Liposome of Amphotericin B for Injection (Fungoxone®), Cholesteryl Sulfate Complex of Amphotericin B for Injection (Amphotericin®), Amphotericin B for Injection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Adverse Reaction Rate | The incidence of total adverse reactions was analyzed to assess the difference in safety of amphotericin B by formulation type in domestic clinical application, to provide real-world evidence for clinical drug selection, and to provide evidence-based evidence in support of rational clinical drug use. | Through study completion,up to half a year. | 
| Pathogen clearance rate | To assess the differences in effectiveness of amphotericin B by formulation type in domestic clinical application by analyzing the pathogen clearance rate, to provide real-world evidence for clinical dosing selection, and to provide evidence-based evidence to support rational clinical dosing. | 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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Liposomal Amphotericin B for Injection, Amphotericin B Cholesteryl Sulfate Complex for Injection, Amphotericin B for Injection, Safety, Efficacy