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Efficacy and safety of micafungin for invasive candida infections：a meta-analysis of randomized controlled trials

Chinese Medical Journal 2012年第2期125卷 345-351页

作者： Chen Qian Lin Mao-hu Chen Meng-li Liu Zhe-yuan Chai Dong Wang Rui Chinese Peoples Liberat Army Gen Hosp Dept Clin Pharmacol Beijing 100853 Peoples R China Chinese Peoples Liberat Army Gen Hosp Affiliated Hosp 1 Dept Urol Beijing 100853 Peoples R China

Background Invasive fungal infections such as candidiasis and mold infections cause significant morbidity and mortality in seriously ill *** is an echinocandin antifungal agent with potent activity against most species of Candida and *** did this meta-analysis to clarify whether micafungin offers superior efficacy and safety compared with other antifungal agent for treating infections associated with invasive *** We did a meta-analysis of randomized controlled trials to examine whether micafungin has superior efficacy and safety compared with other antifungal agents recommended by the treatment guidelines for fungal *** trials involving 2913 patients were included in this *** ratios （OR） and 95% confidence intervals （CI） were *** micafungin was associated with significantly better treatment success compared with the comparator antifungal agents （modified intention to treat,2851 patients; random-effects model,OR 1.20,95% CI 1.00-1.45,P=0.0487）.In addition,micafungin was more effective than the comparators for antifungal prophylaxis of neutropenic patients undergoing hematopoietic stem cell transplantation （OR 1.47,95% CI 1.08-2.00,P=0.01）.Although there was no significant difference between the compared regimens in terms of the incidence of adverse drug effects （OR 0.94,95% CI 0.77-1.11）,fewer patients treated with micafungin withdrew from the studies because of adverse events （OR 0.64,95% CI 0.44-0.94）.Conclusions micafungin has a good safety and tolerability profile,with an efficacy at least comparable to the other antifungal *** offers advantages over other agents for antifungal *** offers an appropriate alternative for antifungal prophylaxis rather than the treatment of invasive candida infections.

关键词： micafungin meta-analysis invasive candida infections antifungal agent

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Optimizing the Dosage Regimen of micafungin against <i>Candida spp</i>in HIV Positive Patients with EC Based on Mote Carlo Simulation

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Open Journal of Preventive Medicine 2020年第6期10卷 120-125页

作者： Ying Wang Jingyi Zhao Song Jiang Yinhui Yao Hainan Wen Department of Pharmacy The Affiliated Hospital of Chengde Medical College Chengde China Department of Functional Center Chengde Medical College Chengde China Department of Clinical Laboratory The Affiliated Hospital of Chengde Medical College Chengde China

The objective of our study was to explore the possibility of the antifungal efficacy of various micafungin dosage regimens against Candida spp in HIV positive patients with EC. According to pharmacokinetic/pharmacodynamics parameters of micafungin in HIV positive patients and MICs distribution of micafungin against Candida spp. in published studies, the dosage regimens of micafungin were 50, 100 and 150 mg QD iv. Monte Carlo Simulation analysed the probability of target attainment and cumulative fraction of response. The results showed that micafungin has good antifungal effect in treating HIV positive patients with EC when pathomycetes are Candida albicans, Candida glabrata or Candida tropicalis, in dosage at 100 mg QD and 150 mg QD.

关键词： Monte Carlo Simulation micafungin HIV Positive Patients Esophageal Candidiasis

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Based on PK/PD and Monte Carlo Simulation Analysis of the Dosing Regimens of micafungin in Children with Febrile Neutropenic

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Open Journal of Pediatrics 2022年第4期12卷 711-717页

作者： Jiuli Hu Ying Wang Junhui Hu Xiaolei Yu Xiaoqin Zhu Department of Clinic Pharmacy Affiliated of Chengde Medical College Chengde China Oncology Department The Affiliated Hospital of Chengde Medical College Chengde China

Neutropenia with fever is a special group of patients. Due to low immune function, inflammation-related clinical symptoms and signs are often not obvious, and pathogenic bacteria and infection focus are not clear. Fever may be the only sign of infection. If appropriate antimicrobial treatment is not given in time, infection-related mortality is high. In our study, we aimed to optimize the dosage regimen of micafungin in children with febrile neutropenic against Candida spp. by Mote Carlo Simulation (MCS). Pharmacokinetic parameters and microbiological data of micafungin were collected. Then we used MCS to calculate Probability of Target Attainment (PTA) and Cumulative Fraction of Response (CFR). With dosages of 0.5 mg/kg, 1 mg/kg, 1.5 mg/kg, 2 mg/kg, 3 mg/kg, and 4 mg/kg in oral group and dosages of 100 mg, and 200 mg in intravenous administration, all have different degree of antifungal effect. But when the dosage regimen was 50 mg IV, the therapeutic effect of micafungin against Candida spp. was not good.

关键词： PK/PD Model Mote Carlo Simulation micafungin Febrile Neutropenic

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Efficacy and Safety Assessment of Antifungal Sequential Therapy from micafungin to Liposomal Amphotericin B for Antibiotics-Refractory Febrile Neutropenia in Patients with Hematologic Malignancies

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Advances in Microbiology 2023年第6期13卷 315-322页

作者： Kazunori Nakase Koji Oka Keiki Kawakami Tetsuya Tsukada Shigehisa Tamaki Atsushi Fujieda Department of Personalized Cancer Immunotherapy Mie University Graduate School of Medicine Tsu Japan Department of Hematology and Oncology Mie University Hospital Tsu Japan Department of Internal Medicine Suzuka Kaisei Hospital Kameyama Japan Department of Internal Medicine Suzuka Chuo Hospital Suzuka Japan Department of Internal Medicine Takeuchi Hospital Tsu Japan Department of Internal Medicine Ise Red Cross Hospital Ise Japan

Invasive fungal infections are a major challenging problem in the management of febrile neutropenia (FN) in patients with hematologic malignancies. Liposomal amphotericin B (L-AmB) or micafungin (MCFG) has been widely used as a first-line empirical antifungal therapy for suspected fungal infection in such patients. However, there are several issues in patients receiving these agents: drug related toxicities for L-AmB and breakthrough fungal infections for MCFG. In order to make the best use of these 2 agents, we conducted a prospective study of sequential therapy from MCFG to L-AmB, and evaluated the efficacy and safety of this strategy in FN patients with hematologic malignancies. A total of 18 patients were enrolled, and 11 patients who fulfilled the protocol defined criteria were evaluated. Underlying diseases consisted of acute leukemia (n = 9), non-Hodgkin lymphoma (n = 1), and myelodysplastic syndrome (n = 1). Treatment success was achieved in 8 patients (72.7%). Drug-related adverse events occurred in 8 patients (72.7%). All of those adverse events except one case were below grade 2. Three patients required discontinuation of L-AmB. Although our empirical antifungal sequential therapy seems to be encouraging for antibiotics-refractory FN in patients with hematologic malignancies, further investigation in large-scale studies is warranted.

关键词： Empirical Antifungal Therapy micafungin Liposomal Amphotericin B Febrile Neutropenia Hematologic Malignancy

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Pharmacokinetics of micafungin in Adult Patients with Invasive Candidiasis and Candidemia

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Open Journal of Medical Microbiology 2012年第3期2卷 84-90页

作者： Nasrullah A. Undre Paul Stevenson Ernst-Rüdiger Kuse Ignace Demeyer Astellas Pharma Europe Ltd. Staines-upon-Thames UK Formerly of Astellas Pharma GmbH Munich Munich Germany Medizinische Hochschule Hannover Hannover Germany Onze Lieve Vrouw Ziekenhuis Aalst Belgium

micafungin is an efficacious and well-tolerated echinocandin with in vitro and in vivo activity against a broad range of Candida species. The objective of this randomized, double-blind study was to examine the pharmacokinetic parameters of micafungin and its metabolites in a subset of adult patients with invasive candidiasis or candidemia. The study was conducted at 27 sites in four countries, including eight in Europe. micafungin 100 mg/day or liposomal amphotericin B 3 mg/kg/day were administered once daily as a 1-hour infusion in a blinded manner. The minimum duration of therapy was 14 days. To define plasma analyte (micafungin and metabolites) concentration-time profiles, serial blood samples were collected after the first dose (Day 1), and at the end of therapy (EOT). For patients who received treatment for longer than 2 weeks, an additional profile was obtained during Week 2. To determine plasma trough analyte concentrations, blood samples were collected immediately prior to dosing on Day 2, Week 2, and EOT. In 20 evaluable, micafungin-treated patients, plasma micafungin concentrations peaked at completion of the 1-hour infusion and then declined biexponentially. Plasma concentrations of the micafungin metabolites (M-1, M-2, and M-5) remained low (micafungin were largely unchanged with repeated dosing up to 28 days, and no evidence of micafungin accumulation was observed. These data provide further support for the predictability of micafungin pharmacokinetics in adult patients with invasive candidiasis and candidemia.

关键词： micafungin Pharmacokinetics Invasive Candidiasis Candidemia

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抗真菌药micafungin

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药学进展 2002年第5期26卷 313-315页

作者：余华

据2002年3月的Marketletter杂志报道,日本藤泽(fujisawa)公司已经向美国FDA递交了其抗真菌药micafungin(代号FK-463)的新药申请书(NDA),以期获得该药单独或与其他全身性抗真菌药物合并用于对目前临床常用抗真菌药不能耐受或已产生耐药... 详细信息

据2002年3月的Marketletter杂志报道,日本藤泽(fujisawa)公司已经向美国FDA递交了其抗真菌药micafungin(代号FK-463)的新药申请书(NDA),以期获得该药单独或与其他全身性抗真菌药物合并用于对目前临床常用抗真菌药不能耐受或已产生耐药菌的病人的治疗以及造血干细胞移植病人的预防用药.

关键词：假丝酵母菌剂量真菌小鼠用药量小家鼠尼可霉素 FK micafungin 两性霉素烟曲霉菌抗真菌药抗霉菌药抗感染药

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FDA批准micafungin用于预防和治疗念珠菌感染

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世界临床药物 2005年第5期26卷 257-257页

2005年3月，FDA批准日本藤泽公司(Fujisawa)的micafungin sodlium注射液(Mycamirle)用于预防行造血干细胞移植术患者的念珠菌感染及治疗食道念珠菌感染。但本品对除念珠菌以外的其他真菌感染的疗效尚待验证。

关键词： micafungin 念珠菌感染 FDA批准预防和治疗造血干细胞移植术 2005年真菌感染注射液

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Endogenous aspergillus endophthalmitis after kidney transplantation

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International Journal of Ophthalmology(English edition) 2011年第5期4卷 567-571页

作者： Huan-Huan Cheng, Jin-Tang Xu Department of Ophthalmology the First Affiliated Hospital of Jinan University Guangzhou 510630 Guangdong Province China Zhongshan Ophthalmic Center Sun Yat-sen University Guangzhou 510060 Guangdong Province China

Endogenous aspergillus endophthalmitis(EAE) after kidney transplant is a rare but important clinical problem due to potentially devastating consequences. Early diagnosis of EAE, timely removal of affected vitreous by vitrectomy, proper anti-fungal treatment, all contributed to the successful control of the disease. Therapeutic success of EAE in post-transplant patients depends largely on prompt diagnosis. Definite diagnosis of EAE is based on positive culture results of vitreous specimen, while fundoscopy and B scan ultrasound may aid early diagnosis. In terms of anti-fungal medicine, amphotericin B has long been the first choice, but its systemic applicaiton has severe adverse reactions, especially for patients with impaired renal function. Herein, we report the treatment modality of EAE after kidney transplant with vitrectomy, systemic administration of micafungin plus voriconazole, topical application of fluconazol and amphotercin B.

关键词： aspergillus endophthalmitis kidney transplan-tation amphotercin B micafungin

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抗真菌药物echinocandins和pneumocandins类的研究进展

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中国抗生素杂志 2004年第7期29卷 439-442,i004页

作者：王栋海钱秀萍陈代杰上海师范大学生物系上海200234 上海来益生物药物研发中心上海201203

新型抗真菌药物 echinocandins与 pneumocandins类的作用机制是能够非竞争性的抑制真菌细胞壁中 β- 1,3-葡聚糖合成酶的活性 ,进而引起真菌细胞壁的裂解以及细胞内外渗透压的改变从而将真菌细胞彻底杀死。本文综述了这两类药物的研究进... 详细信息

新型抗真菌药物 echinocandins与 pneumocandins类的作用机制是能够非竞争性的抑制真菌细胞壁中 β- 1,3-葡聚糖合成酶的活性 ,进而引起真菌细胞壁的裂解以及细胞内外渗透压的改变从而将真菌细胞彻底杀死。本文综述了这两类药物的研究进展 ,主要包括它们的结构、分类、发现过程以及其中的三种上市或即将上市的药物 caspofungin、micafungin和

关键词：抗真菌药物 Echinocandins Pneumocandins Caspofungin micafungin Anidulafungin

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Astellas公司的一连串产品申请

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国外药讯 2006年第7期 49-49页

作者：张振华（摘）

Astellas药物公司已将他克莫司（tacromlimus）（每日一次）制剂的上市申请递交给欧洲药品管理局EMEA。该免疫抑制剂的主要适应症是用于器官移植的排斥反应。Astellas公司曾于去年12月份在美国提出相似的申请，且正在日本进行Ⅱ期临床... 详细信息

Astellas药物公司已将他克莫司（tacromlimus）（每日一次）制剂的上市申请递交给欧洲药品管理局EMEA。该免疫抑制剂的主要适应症是用于器官移植的排斥反应。Astellas公司曾于去年12月份在美国提出相似的申请，且正在日本进行Ⅱ期临床试验。Astellas公司在日本刚刚提交了5HT3拮抗剂雷莫司琼（ramosetron）和抗真菌药micafungin的申请，前者用于腹泻为主的肠易激综合征治疗，后者则用于预防造血干细胞移植中的曲霉菌及念珠菌感染等附加适应症。雷莫司琼在欧洲尚处于Ⅱ期临床试验阶段。

关键词：公司 micafungin Ⅱ期临床试验造血干细胞移植免疫抑制剂附加适应症产品肠易激综合征雷莫司琼药品管理局

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