Itraconazole Oral Solution versus Fluconazole Syrup for Prevention of Invasive Fungal Infections in Patients Receiving Hematopoietic Stem Cell Transplantation: Prospective, Randomized, Comparative Clinical Trial.
- Author:
Su Mi CHOI
1
;
Dong Gun LEE
;
Jung Hyun CHOI
;
Sun Hee PARK
;
Ki Seong EOM
;
Yoo Jin KIM
;
Hee Je KIM
;
Chang Ki MIN
;
Jin Hong YOO
;
Dong Wook KIM
;
Jong Wook LEE
;
Woo Sung MIN
;
Wan Shik SHIN
;
Chun Choo KIM
Author Information
1. Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. fire@catholic.ac.kr
- Publication Type:Clinical Trial ; Original Article ; Randomized Controlled Trial
- Keywords:
Itraconazole;
Fluconazole;
Neutropenia;
Hematopoietic stem cell transplantation;
Invasive fungal infection
- MeSH:
Adult;
Aspergillus;
Bilirubin;
Biological Availability;
Diarrhea;
Fluconazole*;
Hematopoietic Stem Cell Transplantation*;
Hematopoietic Stem Cells*;
Humans;
Incidence;
Itraconazole*;
Mortality;
Nausea;
Neutropenia;
Prospective Studies;
Transplantation;
Vomiting
- From:
Infection and Chemotherapy
2005;37(2):71-78
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND: Though fluconazole is widely used for antifungal prophylaxis, it is ineffective against mould infections including Aspergillus species. Itraconazole has a broader spectrum than fluconazole but the capsule form shows erratic bioavailability in neutropenic patients. In this study, we compared itraconazole oral solution (ITZS) with fluconazole syrup (FCZS) for the prevention of invasive fungal infection (IFI) in allogeneic hematopoietic stem cell transplant recipients. MATERIALS AND METHODS: Adults receiving allogeneic hematopoietic stem cell transplantation (HSCT) from september 2001 to June 2002, were randomly allocated to either the ITZS group or the FCZS group. We prospectively evaluated the safety and efficacy of each drug. RESULTS: Out of 78 patients (40 patients in the ITZS group and 38 patients in the FCZS group) who were eligible for this study, 37 patients completed the course of prophylaxis without any evidence of IFI. The mean duration of prophylaxis was 16.4 days for the ITZS group and 21.9 days for the FCZS group (P<0.006). Drug-related adverse events occurred in 28 patients (70.0%) and 19 patients (50.0%) in the ITZS group and the FCZS group, respectively. Common adverse events of ITZS were nausea, vomiting, and diarrhea. Drug-related reversible hepatotoxicity occurred in 4 patients in the ITZS group. There was a significant elevation of total bilirubin level in the ITZS group. The incidence of suspected IFI occurred in 5 patients (12.5%) who received ITZS, compared with 8 (21.1%) who received FCZS (P=0.372). There were no proven IFIs or superficial (oral/vaginal) fungal infections in both groups. Overall mortality was not different between the two groups (2.5% in the ITZS group versus 5.3% in the FCZS group, P=0.610). CONCLUSION: ITZS and FCZS showed similar protection against IFI during pre-engraftment period. Poor tolerability due to gastrointestinal troubles of ITZS might limit its success as prophylactic therapy. Well matched controlled study with large number of patients will be required in the future.
