Adverse effects of antifungal therapies in invasive fungal infections: review and meta-analysis
Tóm tắt
Amphotericin B is the main therapeutic agent for the treatment of invasive fungal infections; however, it is associated with significant toxicities that limit its use. Other systemic antifungal agents have been developed to improve tolerability while maintaining the efficacy profile of conventional amphotericin B. Fifty-four studies involving 9,228 patients were assessed for the frequency of adverse effects of the main systemic antifungal agents. While the results suggest that liposomal amphotericin B is the least nephrotoxic of the lipid formulations (14.6%), that conventional amphotericin B is the most nephrotoxic (33.2%), and that itraconazole is the most hepatotoxic (31.5%), the lack of standard definitions of antifungal-related adverse effects limits the validity of these results. Furthermore, heterogeneous patient pools and differing protocols make it difficult to draw direct comparisons between studies. With the advent of newer classes of systemic antifungal agents, future trials should conform to definitions that are universally applicable and clinically relevant to allow for such comparisons and to enable evidence-based decision-making.
Tài liệu tham khảo
Le Dictionnaire Vidal (2000) Vidal. Issy les Moulineaux, France
Hay RJ (1994) Liposomal amphotericin B. AmBisome. J Infect 28(Suppl 1):35–43
Hiemenz JW, Walsh TJ (1996) Lipid formulations of amphotericin B: recent progress and future directions. Clin Infect Dis 22 (Suppl 2):S133–S144
Lopez-Berestein G, Fainstein V, Hopfer R, Mehta K, Sullivan MP, Keating M, Rosenblum MG, Mehta R, Luna M, Hersh EM et al (1985) Liposomal amphotericin B for the treatment of systemic fungal infections in patients with cancer: a preliminary study. J Infect Dis 151:704–710
Wong-Beringer A, Jacobs RA, Guglielmo BJ (1998) Lipid formulations of amphotericin B: clinical efficacy and toxicities. Clin Infect Dis 27:603–618
Lister J (1996) Amphotericin B lipid complex (Abelcet) in the treatment of invasive mycoses: the North American experience. Eur J Haematol (Suppl 57):18–23
Herbrecht R, Letscher V, Andres E, Cavalier A (1999) Safety and efficacy of amphotericin B colloidal dispersion. An overview. Chemotherapy 45 (Suppl 1):67–76
Linden P, Williams P, Chan KM (2000) Efficacy and safety of amphotericin B lipid complex injection (ABLC) in solid-organ transplant recipients with invasive fungal infections. Clin Transplant 14:329–339
Ringden O, Meunier F, Tollemar J, Ricci P, Tura S, Kuse E, Viviani MA, Gorin NC, Klastersky J, Fenaux P et al(1991) Efficacy of amphotericin B encapsulated in liposomes (AmBisome) in the treatment of invasive fungal infections in immunocompromised patients. J Antimicrob Chemother 28 (Suppl B):73–82
Rapp RP, Gubbins PO, Evans ME (1997) Amphotericin B lipid complex. Ann Pharmacother 31:1174–1186
Product insert (2000) Sporanox (itraconazole). Janssen Pharmaceutica Products, Titusville NJ
Cucherat M (1997) Méta-analyse des essais thérapeutiques. Collection évaluation et statistique. Masson, Paris, p 390
Waller JL, Addy CL, Jackson KL, Garrison CZ (1994) Confidence intervals for weighted proportions. Stat Med 13:1071–1082
van’t Wout JW, Novakova I, Verhagen CA, Fibbe WE, de Pauw BE, van der Meer JW (1991) The efficacy of itraconazole against systemic fungal infections in neutropenic patients: a randomised comparative study with amphotericin B. J Infect 22:45–52
Rex JH, Bennett JE, Sugar AM, Pappas PG, van der Horst CM, Edwards JE, Washburn RG, Scheld WM, Karchmer AW, Dine AP et al (1994) A randomized trial comparing fluconazole with amphotericin B for the treatment of candidemia in patients without neutropenia. N Engl J Med 331:1325–1330
Anaissie EJ, White MH, Uzun O, Singer C, Bodey GP, Azarnia N, Lopez-Berestein G, Matzke D (1995) Abelcet (Amphotericin B lipid complex) vs amphotericin B for treatment of invasive candidiasis: a prospective, randomized multicenter trial. In: Program and abstracts of the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy. Abstract number LM-21
Abele-Horn M, Kopp A, Sternberg U, Ohly A, Dauber A, Russwurm W, Buchinger W, Nagengast O, Emmerling P (1996) A randomized study comparing fluconazole with amphotericin B/5-flucytosine for the treatment of systemic Candida infections in intensive care patients. Infection 24:426–432
Viscoli C, Castagnola E, Van Lint MT, Moroni C, Garaventa A, Rossi MR, Fanci R, Menichetti F, Caselli D, Giacchino M, Congiu M (1996) Fluconazole versus amphotericin B as empirical antifungal therapy of unexplained fever in granulocytopenic cancer patients: a pragmatic, multicentre, prospective and randomised clinical trial. Eur J Cancer 32A:814–820
Anaissie EJ, Darouiche RO, Abi-Said D, Uzun O, Mera J, Gentry LO, Williams T, Kontoyiannis DP, Karl CL, Bodey GP (1996) Management of invasive candidal infections: results of a prospective, randomized, multicenter study of fluconazole versus amphotericin B and review of the literature. Clin Infect Dis 23:964–972
Phillips P, Shafran S, Garber G, Rotstein C, Smaill F, Fong I, Salit I, Miller M, Williams K, Conly JM, Singer J, Ioannou S (1997) Multicenter randomized trial of fluconazole versus amphotericin B for treatment of candidemia in non-neutropenic patients. Eur J Clin Microbiol Infect Dis 16:337–345
Prentice HG, Hann IM, Herbrecht R, Aoun M, Kvaloy S, Catovsky D, Pinkerton CR, Schey SA, Jacobs F, Oakhill A, Stevens RF, Darbyshire PJ, Gibson BE (1997) A randomized comparison of liposomal versus conventional amphotericin B for the treatment of pyrexia of unknown origin in neutropenic patients. Br J Haematol 98:711–718
Ellis M, Spence D, de Pauw B, Meunier F, Marinus A, Collette L, Sylvester R, Meis J, Boogaerts M, Selleslag D, Krcmery V, von Sinner W, MacDonald P, Doyen C, Vandercam B (1998) An EORTC international multicenter randomized trial (EORTC no. 19923) comparing two dosages of liposomal amphotericin B for treatment of invasive aspergillosis. Clin Infect Dis 27:1406–1412
Schoffski P, Freund M, Wunder R, Petersen D, Kohne CH, Hecker H, Schubert U, Ganser A (1998) Safety and toxicity of amphotericin B in glucose 5% or intralipid 20% in neutropenic patients with pneumonia or fever of unknown origin: randomised study. BMJ 317:379–384
Silling G, Fegeler W, Roos N, Boes C, Schomaker R, Essink M, Buchner T (1998) Traitement empirique précoce chez des patients neutropéniques en hématologie: étude comparative randomisée fluconazole versus amphotéricine B/5-flucytosine. Hématologie 4 (Suppl II, No. 3):19–23
Leenders AC, Daenen S, Jansen RL, Hop WC, Lowenberg B, Wijermans PW, Cornelissen J, Herbrecht R, van der Lelie H, Hoogsteden HC, Verbrugh HA, de Marie S (1998) Liposomal amphotericin B compared with amphotericin B deoxycholate in the treatment of documented and suspected neutropenia-associated invasive fungal infections. Br J Haematol 103:205–212
Malik IA, Moid I, Aziz Z, Khan S, Suleman M (1998) A randomized comparison of fluconazole with amphotericin B as empiric antifungal agents in cancer patients with prolonged fever and neutropenia. Am J Med 105:478–483
White MH, Bowden RA, Sandler ES, Graham ML, Noskin GA, Wingard JR, Goldman M, van Burik JA, McCabe A, Lin JS, Gurwith M, Miller CB (1998) Randomized, double-blind clinical trial of amphotericin B colloidal dispersion vs amphotericin B in the empirical treatment of fever and neutropenia. Clin Infect Dis 27:296–302
Walsh TJ, Finberg RW, Arndt C, Hiemenz J, Schwartz C, Bodensteiner D, Pappas P, Seibel N, Greenberg RN, Dummer S, Schuster M, Holcenberg JS (1999) Liposomal amphotericin B for empirical therapy in patients with persistent fever and neutropenia. N Engl J Med 340:764–771
Timmers GJ, Zweegman S, Simoons-Smit AM, van Loenen AC, Touw D, Huijgens PC (2000) Amphotericin B colloidal dispersion (Amphocil) vs fluconazole for the prevention of fungal infections in neutropenic patients: data of a prematurely stopped clinical trial. Bone Marrow Transplant 25:879–884
Sandler ES, Mustafa MM, Tkaczewski I, Graham ML, Morrison VA, Green M, Trigg M, Abboud M, Aquino VM, Gurwith M, Pietrelli L (2000) Use of amphotericin B colloidal dispersion in children. J Pediatr Hematol Oncol 22:242–246
Wingard JR, White MH, Anaissie E, Raffalli J, Goodman J, Arrieta A (2000) A randomized, double-blind comparative trial evaluating the safety of liposomal amphotericin B versus amphotericin B lipid complex in the empirical treatment of febrile neutropenia. Clin Infect Dis 31:1155–1163
Winston DJ, Hathorn JW, Schuster MG, Schiller GJ, Territo MC (2000) A multicenter, randomized trial of fluconazole versus amphotericin B for empiric antifungal therapy of febrile neutropenic patients with cancer. Am J Med 108:282–289
Boogaerts M, Winston DJ, Bow EJ, Garber G, Reboli AC, Schwarer AP, Novitzky N, Boehme A, Chwetzoff E, De Beule K (2001) Intravenous and oral itraconazole versus intravenous amphotericin B deoxycholate as empirical antifungal therapy for persistent fever in neutropenic patients with cancer who are receiving broad-spectrum antibacterial therapy. A randomized, controlled trial. Ann Intern Med 135:412–422
Fleming RV, Kantarjian HM, Husni R, Rolston K, Lim J, Raad I, Pierce S, Cortes J, Estey E (2001) Comparison of amphotericin B lipid complex (ABLC) vs AmBisome in the treatment of suspected or documented fungal infections in patients with leukemia. Leuk Lymphoma 40:511–520
De Beule K, De Doncker P, Cauwenbergh G, Koster M, Legendre R, Blatchford N, Daunas J, Chwetzoff E (1988) The treatment of aspergillosis and aspergilloma with itraconazole: clinical results of an open international study (1982–1987). Mycoses 31:476–485
Baddour L (1999) Dosing experience with amphotericin B lipid complex (ABLC). In: Program and abstracts of the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. Poster presentation
Meunier F, Prentice HG, Ringden O (1991) Liposomal amphotericin B (AmBisome): safety data from a phase II/III clinical trial. J Antimicrob Chemother 28 (Suppl B):83–91
Ringden O, Tollemar J, Dahllof G, Tyden G (1994) High cure rate of invasive fungal infections in immunocompromised children using AmBisome. Transplant Proc 26:175–177
Ringden O, Andstrom E, Remberger M, Svahn BM, Tollemar J (1994) Safety of liposomal amphotericin B (AmBisome) in 187 transplant recipients treated with cyclosporin. Bone Marrow Transplant 14 (Suppl 5):S10–S14
Mills W, Chopra R, Linch DC, Goldstone AH (1994) Liposomal amphotericin B in the treatment of fungal infections in neutropenic patients: a single-centre experience of 133 episodes in 116 patients. Br J Haematol 86:754–760
Denning DW, Lee JY, Hostetler JS, Pappas P, Kauffman CA, Dewsnup DH, Galgiani JN, Graybill JR, Sugar AM, Catanzaro A et al (1994) NIAID Mycoses Study Group multicenter trial of oral itraconazole therapy for invasive aspergillosis. Am J Med 97:135–144
Andstrom EE, Ringden O, Remberger M, Svahn BM, Tollemar J (1996) Safety and efficacy of liposomal amphotericin B in allogeneic bone marrow transplant recipients. Mycoses 39:185–193
Anaissie EJ, Vartivarian SE, Abi-Said D, Uzun O, Pinczowski H, Kontoyiannis DP, Khoury P, Papadakis K, Gardner A, Raad II, Gilbreath J, Bodey GP (1996) Fluconazole versus amphotericin B in the treatment of hematogenous candidiasis: a matched cohort study. Am J Med 101:170–176
Noskin G, Pietrelli L, Gurwith M, Bowden R (1999) Treatment of invasive fungal infections with amphotericin B colloidal dispersion in bone marrow transplant recipients. Bone Marrow Transplant 23:697–703
Wingard JR, Kubilis P, Lee L, Yee G, White M, Walshe L, Bowden R, Anaissie E, Hiemenz J, Lister J (1999) Clinical significance of nephrotoxicity in patients treated with amphotericin B for suspected or proven aspergillosis. Clin Infect Dis 29:1402–1407
Emminger W, Graninger W, Emminger-Schmidmeier W, Zoubek A, Pillwein K, Susani M, Wasserer A, Gadner H (1994) Tolerance of high doses of amphotericin B by infusion of a liposomal formulation in children with cancer. Ann Hematol 68:27–31
Lister J (1994) Amphotericin B lipid complex in the management of serious systemic mycoses in patients intolerant to amphotericin B therapy. In: Program and abstracts of the 36th Annual Meeting & Exposition of the American Society of Hematology. Poster number 1209
De Pauw BE, Raemaekers JM, Donnelly JP, Kullberg BJ, Meis JF (1995) An open study on the safety and efficacy of fluconazole in the treatment of disseminated Candida infections in patients treated for hematological malignancy. Ann Hematol 70:83–87
Oppenheim BA, Herbrecht R, Kusne S (1995) The safety and efficacy of amphotericin B colloidal dispersion in the treatment of invasive mycoses. Clin Infect Dis 21:1145–1153
Bowden RA, Cays M, Gooley T, Mamelok RD, van Burik JA (1996) Phase I study of amphotericin B colloidal dispersion for the treatment of invasive fungal infections after marrow transplant. J Infect Dis 173:1208–1215
Troke PF (1997) Large-scale multicentre study of fluconazole in the treatment of hospitalised patients with fungal infections. Eur J Clin Microbiol Infect Dis 16:287–295
Mehta J, Kelsey S, Chu P, Powles R, Hazel D, Riley U, Evans C, Newland A, Treleaven J, Singhal S (1997) Amphotericin B lipid complex (ABLC) for the treatment of confirmed or presumed fungal infections in immunocompromised patients with hematologic malignancies. Bone Marrow Transplant 20:39–43
Wingard JR (1997) Efficacy of amphotericin B lipid complex injection (ABLC) in bone marrow transplant recipients with life-threatening systemic mycoses. Bone Marrow Transplant 19:343–347
Kruger WH, Kroger N, Russmann B, Renges H, Kabisch H, Zander AR (1998) Treatment of mycotic infections after haemopoietic progenitor cell transplantation with liposomal amphotericin-B. Bone Marrow Transplant 22 (Suppl 4):S10–S13
Anaissie EJ, Mattiuzzi GN, Miller CB, Noskin GA, Gurwith MJ, Mamelok RD, Pietrelli LA (1998) Treatment of invasive fungal infections in renally impaired patients with amphotericin B colloidal dispersion. Antimicrob Agents Chemother 42:606–611
Walsh TJ, Yeldandi V, McEvoy M, Gonzalez C, Chanock S, Freifeld A, Seibel NI, Whitcomb PO, Jarosinski P, Boswell G, Bekersky I, Alak A, Buell D, Barret J, Wilson W (1998) Safety, tolerance, and pharmacokinetics of a small unilamellar liposomal formulation of amphotericin B (AmBisome) in neutropenic patients. Antimicrob Agents Chemother 42:2391–2398
Walsh TJ, Hiemenz JW, Seibel NL, Perfect JR, Horwith G, Lee L, Silber JL, DiNubile MJ, Reboli A, Bow E, Lister J, Anaissie EJ (1998) Amphotericin B lipid complex for invasive fungal infections: analysis of safety and efficacy in 556 cases. Clin Infect Dis 26:1383–1396
Martino R, Subira M, Domingo-Albos A, Sureda A, Brunet S, Sierra J (1999) Low-dose amphotericin B lipid complex for the treatment of persistent fever of unknown origin in patients with hematologic malignancies and prolonged neutropenia. Chemotherapy 45:205–212
Walsh TJ, Seibel NL, Arndt C, Harris RE, Dinubile MJ, Reboli A, Hiemenz J, Chanock SJ (1999) Amphotericin B lipid complex in pediatric patients with invasive fungal infections. Pediatr Infect Dis J 18:702–708
Caillot D, Bassaris H, McGeer A, Arthur C, Prentice HG, Seifert W, De Beule K (2001) Intravenous itraconazole followed by oral itraconazole in the treatment of invasive pulmonary aspergillosis in patients with hematologic malignancies, chronic granulomatous disease, or AIDS. Clin Infect Dis 33:e83–e90
Lequaglie C (2002) Liposomal amphotericin B (AmBisome): efficacy and safety of low-dose therapy in pulmonary fungal infections. J Antimicrob Chemother 49 (Suppl 1):49–50
Tollemar J, Andersson S, Ringden O, Tyden G (1992) A retrospective clinical comparison between antifungal treatment with liposomal amphotericin B (AmBisome) and conventional amphotericin B in transplant recipients. Mycoses 35:215–220
Clark AD, McKendrick S, Tansey PJ, Franklin IM, Chopra R (1998) A comparative analysis of lipid-complexed and liposomal amphotericin B preparations in haematological oncology. Br J Haematol 103:198–204
Popp AI, White MH, Quadri T, Walshe L, Armstrong D (1999) Amphotericin B with and without itraconazole for invasive aspergillosis: a three-year retrospective study. Int J Infect Dis 3:157–160
Ringden O, Jonsson V, Hansen M, Tollemar J, Jacobsen N (1998) Severe and common side-effects of amphotericin B lipid complex (Abelcet). Bone Marrow Transplant 22:733–734
Furebring M, Oberg G, Sjolin J (2000) Side-effects of amphotericin B lipid complex (Abelcet) in the Scandinavian population. Bone Marrow Transplant 25:341–343
Utili R, Zampino R, De Vivo F, Maiello C, Andreana A, Mormone G, Marra C, Tripodi MF, Sarnataro G, Cione P, Cuccurullo S, Cotrufo M (2000) Improved outcome of pulmonary aspergillosis in heart transplant recipients with early diagnosis and itraconazole treatment. Clin Transplant 14:282–286
Barquist E, Fein E, Shadick D, Johnson J, Clark J, Shatz D (1999) A randomized prospective trial of amphotericin B lipid emulsion versus dextrose colloidal solution in critically ill patients. J Trauma 47:336–340
Kontoyiannis DP, Andersson BS, Lewis RE, Raad II (2001) Progressive disseminated aspergillosis in a bone marrow transplant recipient: response with a high-dose lipid formulation of amphotericin B. Clin Infect Dis 32:e94–e96
Ellis M, Shamoon A, Gorka W, Zwaan F, al-Ramadi B (2001) Severe hepatic injury associated with lipid formulations of amphotericin B. Clin Infect Dis 32:e87–e89
Gurwith M (1999) Clinical efficacy of amphotericin B colloidal dispersion against infections caused by Aspergillus spp. Chemotherapy 45 (Suppl 1):34–38
Kontoyiannis DP, Bodey GP, Mantzoros CS (2001) Fluconazole vs amphotericin B for the management of candidaemia in adults: a meta-analysis. Mycoses 44:125–135
Walker RJ, Duggin GG (1988) Drug nephrotoxicity. Annu Rev Pharmacol Toxicol 28:331–345
Cockroft DW, Gault MH (1976) Prediction of creatinine clearance from serum creatinine. Nephron 16:31–41