Academic Journal
Amphotericin B Colloidal Dispersion Is Effective and Safe for the Treatment of Invasive Aspergillosis in Chinese Patients with Hematologic Disease: A Multicenter, Prospective, Observational, Real-World Study.
| Τίτλος: | Amphotericin B Colloidal Dispersion Is Effective and Safe for the Treatment of Invasive Aspergillosis in Chinese Patients with Hematologic Disease: A Multicenter, Prospective, Observational, Real-World Study. |
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| Συγγραφείς: | Pang A; State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Hematopoietic Stem Cell Transplantation Center, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China., Gao G; Department of Hematology, Xijing Hospital, Air Force Medical University, Xi'an, People's Republic of China., Ren J; Department of Hematology, The Second Hospital of Hebei Medical University, Shijiazhuang, People's Republic of China., Zhang Y; Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China., Wang W; Department of Hematology, The Second Affiliated Hospital of Harbin Medical University, Harbin, People's Republic of China., Fu R; Department of Hematology, Tianjin Medical University General Hospital, Tianjin, People's Republic of China., Zhang H; Department of Hematology, The Second Affiliated Hospital of Shandong First Medical University, Taian, People's Republic of China., Liu B; State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Hematopoietic Stem Cell Transplantation Center, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China., Yan Z; State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Hematopoietic Stem Cell Transplantation Center, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China., Zheng X; State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Hematopoietic Stem Cell Transplantation Center, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China., Lyu M; State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Hematopoietic Stem Cell Transplantation Center, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China., Li G; State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Hematopoietic Stem Cell Transplantation Center, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China., Zhang Y; State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Hematopoietic Stem Cell Transplantation Center, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China., Yang D; State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Hematopoietic Stem Cell Transplantation Center, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China., Feng S; State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Hematopoietic Stem Cell Transplantation Center, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China. |
| Πηγή: | Drug design, development and therapy [Drug Des Devel Ther] 2026 Sep 16; Vol. 20, pp. 613724. Date of Electronic Publication: 2026 Sep 16 (Print Publication: 2026). |
| Τύπος έκδοσης: | Journal Article; Multicenter Study; Observational Study |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Dove Press Limited Country of Publication: New Zealand NLM ID: 101475745 Publication Model: eCollection Cited Medium: Internet ISSN: 1177-8881 (Electronic) Linking ISSN: 11778881 NLM ISO Abbreviation: Drug Des Devel Ther Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [Auckland, N.Z.] : Dove Press Limited |
| Ιατρικοί όροι (MeSH): | Antifungal Agents*/administration & dosage , Antifungal Agents*/therapeutic use , Antifungal Agents*/adverse effects , Amphotericin B*/administration & dosage , Amphotericin B*/therapeutic use , Amphotericin B*/adverse effects , Aspergillosis*/drug therapy , Hematologic Diseases*/drug therapy , Hematologic Diseases*/complications, Colloids/chemistry ; Humans ; Female ; Prospective Studies ; Male ; Middle Aged ; Adult ; Aged ; China ; Young Adult ; Adolescent ; Treatment Outcome ; East Asian People |
| Περίληψη: | Purpose: Invasive aspergillosis (IA) causes significant morbidity and mortality in hematologic patients. This study aimed to evaluate the efficacy and safety profile of amphotericin B colloidal dispersion (ABCD) for IA in this high-risk population. Patients and Methods: This multicenter, prospective, observational study enrolled hematologic patients with IA. Eligible patients received ABCD for up to 28 days or until investigator-assessed clinical response or intolerance. The primary outcome was clinical response rate, and the secondary outcome was 28-day all-cause mortality following the last dose of ABCD. Safety was assessed based on the incidence and severity of adverse events (AEs). Results: From January 2022 to May 2024, a total of 65 patients were included. The median duration of ABCD treatment was 19 days (range, 1 to 28 days). Across all patients in the full analysis set (FAS), the clinical response rate was 64.62% (42/65). Whereas, in the per-protocol set (PPS), which comprised patients who completed at least 7 days of therapy, the response rate increased to 80.39% (41/51). Notably, only two patients died (3.08%) within 28 days following the last dose of ABCD. Furthermore, exploratory subgroup analysis revealed higher response rates in patients with possible IA, Eastern Cooperative Oncology Group performance status score (ECOG) score of 0-2, baseline body temperature below 38°C, and acute lymphoblastic leukemia. Treatment-related AEs were predominantly grade 1-2, demonstrating a favorable safety profile. The absence of grade 3/4 elevated creatinine events indicated the low nephrotoxicity of ABCD. Univariate and multivariate analyses of clinical response identified longer duration of ABCD treatment as the only independent predictor of clinical response. Nevertheless, the study predominantly included patients with possible IA and employed an observational single-arm design, and the findings should therefore be interpreted cautiously and may not be directly generalizable to populations with microbiologically confirmed IA. Conclusion: Our findings support ABCD as an effective and well-tolerated treatment in hematologic patients with IA, thus providing a reliable therapeutic option for managing IA in this high-risk population. (© 2026 Pang et al.) |
| Competing Interests: | The authors have no competing interests to declare. |
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| Contributed Indexing: | Keywords: amphotericin B colloidal dispersion; efficacy; invasive aspergillosis; safety |
| Substance Nomenclature: | 0 (Antifungal Agents) 7XU7A7DROE (Amphotericin B) 0 (Colloids) |
| Entry Date(s): | Date Created: 20260922 Date Completed: 20260922 Latest Revision: 20260923 |
| Update Code: | 20260924 |
| PubMed Central ID: | PMC13590257 |
| DOI: | 10.2147/DDDT.S613724 |
| PMID: | 42769089 |
| Βάση Δεδομένων: | MEDLINE |
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