四种两性霉素B静脉制剂抗真菌感染的疗效与安全性的网状Meta分析  

Efficacy and Safety of Four Kinds of Intravenous Preparations of Amphotericin B in the Treatment of Fungal Infections:A Network Meta-analysis

作　　者：王月玥 卢金淼[1] 张宇[3] 朱琳[1] 张俊琦 王艺 李智平[1] WANG Yueyue;LU Jinmiao;ZHANG Yu;ZHU Lin;ZHANG Junqi;WANG Yi;LI Zhiping(Dept.of Clinical Pharmacy,National Children’s Medical Center,Children’s Hospital of Fudan University,Shanghai 201102,China;Dept.of Pharmacy,Qidong Branch,Children’s Hospital of Fudan University,Qidong Women’s and Children’s Health,Jiangsu Qidong 226200,China;Dept.of Clinical Pharmacy,Nanyang Central Hospital,Affiliated Hospital of Zhengzhou University,Henan Nanyang 473000,China;Dept.of Neurology,National Children’s Medical Center,Children’s Hospital of Fudan University,Shanghai 201102,China)

机构地区：[1]国家儿童医学中心,复旦大学附属儿科医院临床药学部,上海201102 [2]复旦大学附属儿科医院启东分院/启东市妇幼保健院药学部,江苏启东226200 [3]郑州大学附属医院南阳市中心医院临床药学室,河南南阳473000 [4]国家儿童医学中心,复旦大学附属儿科医院神经内科,上海201102

出　　处：《中国医院用药评价与分析》2024年第3期327-332,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：中国-世界卫生组织双年合作项目(No.WPCHN1611348)。

摘　　要：目的:通过网状Meta分析,评价四种两性霉素B静脉剂型在治疗真菌感染方面的疗效和安全性。方法:检索中英文电子数据库(PubMed、Scopus、Web of Science、the Cochrane Library、Embase、中国知网、万方数据库、维普数据库和中国生物医学文献数据库),纳入比较两性霉素B与三唑类或棘白菌素类药物治疗真菌感染的随机对照试验(RCT)进行网状Meta分析。检索时间为建库至2023年8月5日,文献质量采用GRADE分级。结果:共纳入16篇文献,涉及4365例患者。在疗效方面,两性霉素B脂质体>两性霉素B脱氧胆酸盐>两性霉素B胶体分散体,差异有统计学意义(P<0.05),两性霉素B脂质体复合物与其他剂型相比差异暂无统计学意义(P>0.05);在总不良反应发生率方面,四种两性霉素B静脉剂型的差异无统计学意义(P>0.05)。亚组分析结果显示,两性霉素B脱氧胆酸盐相比两性霉素B胶体分散体具有更高的神经系统毒性,差异有统计学意义(P<0.05)。结论:四种两性霉素B静脉剂型中,脂质体剂型的疗效优于脱氧胆酸盐传统剂型;胶体分散体剂型的疗效显著低于传统剂型,同时神经系统毒性也较低。由于研究纳入文献数量有限,可能存在发表偏倚,故仍需更多大样本量、高质量的临床研究进一步证实本研究的结果和结论。OBJECTIVE:To evaluate the efficacy and safety of four kinds of intravenous preparations of amphotericin B in the treatment of fungal infections based on network Meta-analysis.METHODS:PubMed,Scopus,Web of Science,the Cochrane Library,Embase,CNKI,Wanfang Data,VIP and CBM were retrieved to collect the randomized controlled trial(RCT)of amphotericin B with triazole or echinocandins in the treatment of fungal infections for network Meta-analysis.The retrieval time was from the establishment of the database to Aug.5th,2023.The quality of literature was evaluated according to GRADE.RESULTS:A total of 16 literature with 4365 patients were included.In terms of efficacy,amphotericin B liposomes>amphotericin B deoxycholate>amphotericin B colloid dispersion,the difference was statistically significant(P<0.05),while amphotericin B liposomes complex had no statistical significance compared with other amphotericin B(P>0.05).There was no significant difference in the total incidence of adverse drug reactions among four kinds of intravenous preparations of amphotericin B(P>0.05).Subgroup analysis showed that amphotericin B deoxycholate had higher neurotoxicity than amphotericin B colloidal dispersion,with statistically significant differences(P<0.05).CONCLUSIONS:Among the four kinds of intravenous preparations of amphotericin B,efficacy of liposome dosage form is better than that of traditional dosage form of deoxycholate.The efficacy of colloid dispersion dosage form is significantly lower than that of traditional dosage form,with lower toxicity of nervous system.Due to the limited number of literature included in the study,there may be publication bias,more clinical literature with large sample size and high quality are needed to confirm the results and conclusions of this study.

关 键 词：两性霉素B 脱氧胆酸盐 脂质制剂 真菌感染 疗效 安全性 网状Meta分析 

分 类 号：R978.5[医药卫生—药品]