This study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin B cholesterol-sulfate complex (ABCD) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. Patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with ABCD antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Patients were eligible for enrollment on antifungal therapy with injectable amphotericin B cholesterol-sulfate complex (ABCD) at the same time as a treatment for underlying disease. Dosage: According to the patient's condition and the investigator's judgment, the initial dose of ABCD can be 0.5-1.0mg/kg/d, and the dose can be increased daily according to the situation, and the therapeutic dose can be increased to 3.0-4.0mg/kg/d on the third day. Course of treatment: ≥ 14 days (whether to continue to receive trial drug treatment after 14 days is decided by the investigator according to the patient's condition).
Treatment is effective
A patient is considered successful if they meet the following five criteria: Starting antifungal treatment until no new fungal infections occur within 7 days after discontinuation of medication; Patient survival within 7 days after discontinuation of treatment; During the treatment period, the drug was not stopped due to side effects or lack of efficacy; After starting antifungal therapy, patients experience fever reduction during neutropenia (defined as body temperature\<38 ℃ for more than 48 hours); Invasive fungal diseases diagnosed or clinically diagnosed (baseline fungal infection refers to fungal infection confirmed within 24-48 hours after initiation of antifungal treatment) achieve complete or partial efficacy at the end of treatment. Refer to the "Diagnostic Criteria and Treatment Principles for Invasive Fungal Disease in Patients with Hematological Diseases/Malignant Tumors (Sixth Revised Edition)" for the evaluation criteria for the treatment efficacy.
Time frame: 12 months
Incidence of the single index in the five criteria of treatment success
The incidence of a single indicator among the five criteria for treatment success mentioned in "Outcome 1"
Time frame: 12 months
Completion rate of ABCD treatment for at least 14 days
Completion rate of ABCD treatment for at least 14 days
Time frame: 12 months
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