Sganga G, Pepe G, Cozza V, Nure E, Lirosi M C, Frongillo F, Grossi U, Bianco G, Agnes S
Department of Surgery, Division of General Surgery and Organ Transplantation, Catholic University of Rome, Rome, Italy.
Transplant Proc. 2012 Sep;44(7):1982-5. doi: 10.1016/j.transproceed.2012.06.029.
In the last years, the incidence of Candida infections in liver transplant recipients has increased with still higher morbidity and mortality. Anidulafungin, a new echinocandin that does not interfere with cytochrome p450, shows no need for dosage adjustment based upon renal or hepatic function or weight.
To analyze tolerance to and microbiologic and clinical efficacy of Anidulafungin to treat Candida infections in liver transplant patients.
This phase 3b, prospective, open-label, single-center study focused on liver transplant patients with a suspected and/or diagnosed Candida infection. The patients received Anidulafungin intravenously, optionally followed by oral therapy with azoles. The primary endpoint was the global response at the end of therapy; secondary endpoints were the efficacy of intravenous therapy, 90-day survival, as well as tolerance for and interaction with immunosuppresants.
We considered 42 consecutive liver recipients transplanted between 2009 and 2010 among whom 13 (31%) were recruited for the study and four patients were treated with Anidulafungin as empirical therapy, six as preemptive therapy, and three as targeted treatment for documented candidemia (7.1%). The immunosuppressive regimen consisted of tacrolimus and low dose of steroids. The Candida species were: C albicans (50%), C glabrata (12.5%), C parapsilosis (12.5%), C krusei (12.5%), C lusitaniae (6.2%), C tropicalis (6.2%), and multiple others (25%). The principle site of isolation was the bile (53.8%), followed by the bloodstream (23.1%), central venous catheters (15.4%), bronchoalveolar lavage (15.4%), peritoneum (7.7%), and other locations (7.7%). Two patients (15.4%) died of severe sepsis with multiple organ failure. There was no alteration of hepatic enzymes, indices of cholestasis or changes in immunosuppressant drug levels.
Anidulafungin was an effective, safe, and well-tolerated drug. There were neither toxic effects to the grafts or adverse interactions with immunosuppresants.
在过去几年中,肝移植受者念珠菌感染的发生率有所上升,其发病率和死亡率仍然较高。阿尼芬净是一种新型棘白菌素,不干扰细胞色素P450,无需根据肾功能、肝功能或体重调整剂量。
分析阿尼芬净治疗肝移植患者念珠菌感染的耐受性、微生物学及临床疗效。
这项3b期、前瞻性、开放标签、单中心研究聚焦于疑似和/或确诊念珠菌感染的肝移植患者。患者静脉注射阿尼芬净,必要时随后接受唑类药物口服治疗。主要终点为治疗结束时的总体反应;次要终点为静脉治疗的疗效、90天生存率以及对免疫抑制剂的耐受性和相互作用。
我们纳入了2009年至2010年间连续接受肝移植的42例患者,其中13例(31%)被纳入研究,4例患者接受阿尼芬净经验性治疗,6例接受抢先治疗,3例接受确诊念珠菌血症的靶向治疗(7.1%)。免疫抑制方案包括他克莫司和低剂量类固醇。念珠菌种类包括:白色念珠菌(50%)、光滑念珠菌(12.5%)、近平滑念珠菌(12.5%)、克柔念珠菌(12.5%)、葡萄牙念珠菌(6.2%)、热带念珠菌(6.2%)以及其他多种(25%)。分离的主要部位是胆汁(53.8%),其次是血液(23.1%)、中心静脉导管(15.4%)、支气管肺泡灌洗(15.4%)、腹膜(7.7%)和其他部位(7.7%)。2例患者(15.4%)死于严重脓毒症伴多器官功能衰竭。肝酶、胆汁淤积指标无变化,免疫抑制剂药物水平也无改变。
阿尼芬净是一种有效、安全且耐受性良好的药物。对移植物既无毒性作用,也未与免疫抑制剂发生不良相互作用。