{"title":"异戊康唑治疗侵袭性真菌感染的疗效和安全性：随机对照试验的系统评价和荟萃分析。","authors":"Ayano Kawasaki, Ryuya Shintani, Risa Takao, Yuka Nakazawa, Takayuki Mihara, Shintaro Ikegami, Sora Shimada, Yuri Matsumoto, Yuko Okamoto, Yuki Igarashi, Yuki Enoki, Kazuaki Taguchi, Kazuaki Matsumoto","doi":"10.1093/mmy/myaf089","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Isavuconazole (ISA) is a treatment option for invasive fungal infections (IFIs) and is known for a favorable safety profile compared with other antifungal agents. However, comprehensive evidence regarding its efficacy and safety remains limited.</p><p><strong>Objectives: </strong>This study aimed to assess the efficacy and safety of ISA compared with other antifungal agents through a systematic review and meta-analysis restricted to randomized controlled trials (RCTs), to provide more reliable estimates of its clinical effects.</p><p><strong>Methods: </strong>Following Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines, a comprehensive literature search was conducted using PubMed, the Cochrane Library, Web of Science, and ClinicalTrials.gov to identify RCTs comparing ISA with other antifungal agents. The primary outcomes were clinical response and mortality. Secondary outcomes included the incidence of adverse events, including serious, drug-related, and organ-specific toxicities. A subgroup analysis was conducted focusing on filamentous fungal infections, comparing ISA and voriconazole.</p><p><strong>Results: </strong>Three RCTs met the inclusion criteria. No statistically significant differences were observed between ISA and comparator agents in terms of clinical response, mortality, or total and organ-specific adverse events. A trend toward fewer adverse events was noted in the ISA group. In the subgroup analysis, ISA and voriconazole showed similar efficacy and overall safety; however, the incidence of both drug-related adverse events and hepatobiliary disorders was significantly lower in the ISA group.</p><p><strong>Conclusions: </strong>ISA demonstrated efficacy comparable to that of other antifungal agents, with a favorable safety profile in patients with IFIs, including filamentous fungal infections. 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引用次数: 0
摘要
背景：Isavuconazole （ISA）是侵袭性真菌感染（IFIs）的治疗选择，与其他抗真菌药物相比，Isavuconazole具有良好的安全性。然而，关于其有效性和安全性的综合证据仍然有限。目的：本研究旨在通过随机对照试验（rct）的系统评价和荟萃分析，评估ISA与其他抗真菌药物的疗效和安全性，为其临床疗效提供更可靠的估计。方法：遵循PRISMA指南，使用PubMed、Cochrane图书馆、Web of Science和ClinicalTrials.gov进行全面的文献检索，以确定比较ISA与其他抗真菌药物的随机对照试验。主要结局是临床反应和死亡率。次要结局包括不良事件的发生率，包括严重、药物相关和器官特异性毒性。对丝状真菌感染进行亚组分析，比较ISA和伏立康唑。结果：3项rct符合纳入标准。在临床反应、死亡率、总不良事件和器官特异性不良事件方面，ISA和比较药物之间没有统计学上的显著差异。ISA组出现了不良事件减少的趋势。在亚组分析中，ISA和伏立康唑的疗效和总体安全性相似；然而，ISA组药物相关不良事件和肝胆疾病的发生率均显著降低。结论：ISA的疗效与其他抗真菌药物相当，在ifi患者（包括丝状真菌感染）中具有良好的安全性。本荟萃分析的随机对照试验提供了高质量的证据，支持抗真菌药物选择在临床实践中。
Efficacy and safety of isavuconazole for invasive fungal infections: A systematic review and meta-analysis of randomized controlled trials.
Background: Isavuconazole (ISA) is a treatment option for invasive fungal infections (IFIs) and is known for a favorable safety profile compared with other antifungal agents. However, comprehensive evidence regarding its efficacy and safety remains limited.
Objectives: This study aimed to assess the efficacy and safety of ISA compared with other antifungal agents through a systematic review and meta-analysis restricted to randomized controlled trials (RCTs), to provide more reliable estimates of its clinical effects.
Methods: Following Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines, a comprehensive literature search was conducted using PubMed, the Cochrane Library, Web of Science, and ClinicalTrials.gov to identify RCTs comparing ISA with other antifungal agents. The primary outcomes were clinical response and mortality. Secondary outcomes included the incidence of adverse events, including serious, drug-related, and organ-specific toxicities. A subgroup analysis was conducted focusing on filamentous fungal infections, comparing ISA and voriconazole.
Results: Three RCTs met the inclusion criteria. No statistically significant differences were observed between ISA and comparator agents in terms of clinical response, mortality, or total and organ-specific adverse events. A trend toward fewer adverse events was noted in the ISA group. In the subgroup analysis, ISA and voriconazole showed similar efficacy and overall safety; however, the incidence of both drug-related adverse events and hepatobiliary disorders was significantly lower in the ISA group.
Conclusions: ISA demonstrated efficacy comparable to that of other antifungal agents, with a favorable safety profile in patients with IFIs, including filamentous fungal infections. This meta-analysis of RCTs provides high-quality evidence to support antifungal drug selection in clinical practice.
期刊介绍：
Medical Mycology is a peer-reviewed international journal that focuses on original and innovative basic and applied studies, as well as learned reviews on all aspects of medical, veterinary and environmental mycology as related to disease. The objective is to present the highest quality scientific reports from throughout the world on divergent topics. These topics include the phylogeny of fungal pathogens, epidemiology and public health mycology themes, new approaches in the diagnosis and treatment of mycoses including clinical trials and guidelines, pharmacology and antifungal susceptibilities, changes in taxonomy, description of new or unusual fungi associated with human or animal disease, immunology of fungal infections, vaccinology for prevention of fungal infections, pathogenesis and virulence, and the molecular biology of pathogenic fungi in vitro and in vivo, including genomics, transcriptomics, metabolomics, and proteomics. Case reports are no longer accepted. In addition, studies of natural products showing inhibitory activity against pathogenic fungi are not accepted without chemical characterization and identification of the compounds responsible for the inhibitory activity.
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