Emergency Surgery, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.
Huashan Hospital, Fudan University, Shanghai, China.
Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.
The incidence of nosocomial invasive fungal infections involving Candida spp. has increased markedly in recent years in patients undergoing abdominal surgery. This post hoc analysis aimed to determine the efficacy and safety of anidulafungin treatment in patients with intra-abdominal candidiasis (IAC) from five prospective studies (one comparative and four open-label) of adult surgical patients with microbiologically confirmed Candida intra-abdominal infection. Patients received an intravenous (IV) loading dose of anidulafungin 200 mg, followed by a daily 100-mg maintenance dose. Per study protocols, some patients could be switched to an oral azole after ≥ 5 or ≥ 10 days of IV treatment. Antifungal treatment was maintained for ≥ 14 days after the last positive Candida culture and resolution of symptoms. The global response rate (GRR) at the end of IV treatment (EOIVT) was the primary endpoint. GRR at the end of therapy (EOT), all-cause mortality at days 14 and 28, and safety was also evaluated. Seventy-nine patients had IAC from peritoneal fluid or hepatobiliary tract. C. albicans (72.2%) and C. glabrata (32.9%) were the most common pathogens. Overall GRR was 73.4% and 67.1% at EOIVT and EOT, respectively. All-cause mortality was 17.7% at day 14 and 24.1% at day 28 in the modified intent-to-treat population. Anidulafungin was well tolerated in this population, with most adverse events mild or moderate in severity. In these patients with IAC, anidulafungin showed a GRR at EOIVT similar to the anidulafungin registrational trial, and the results of our analysis confirmed the known safety profile of anidulafungin. ClinicalTrials.gov registration number NCT00496197, registered July 3, 2007, https://clinicaltrials.gov/ct2/show/study/NCT00496197 ; ClinicalTrials.gov registration number NCT00548262, registered October 19, 2007, https://clinicaltrials.gov/ct2/show/record/NCT00548262 ; ClinicalTrials.gov registration number NCT00537329, registered September 25, 2007, https://clinicaltrials.gov/ct2/show/record/NCT00537329 ; ClinicalTrials.gov registration number NCT00689338, registered May 29, 2008, https://clinicaltrials.gov/ct2/show/study/NCT00689338 ; ClinicalTrials.gov registration number NCT00805740, registered November 26, 2008, https://clinicaltrials.gov/ct2/show/NCT00805740.
近年来，接受腹部手术的患者中，涉及念珠菌属的医院获得性侵袭性真菌感染的发病率显著增加。本事后分析旨在确定安尼达fungin 在 5 项成人外科患者中微生物学确诊的腹腔内念珠菌感染的前瞻性研究（1 项对照和 4 项开放标签）中治疗腹腔内念珠菌病（IAC）的疗效和安全性。患者接受安尼达fungin 200mg 的静脉（IV）负荷剂量，随后每天给予 100mg 的维持剂量。根据研究方案，一些患者在 IV 治疗≥5 或≥10 天后可转为口服唑类药物。在最后一次阳性念珠菌培养和症状缓解后，至少持续 14 天进行抗真菌治疗。IV 治疗结束时的全球缓解率（GRR）（EOIVT）是主要终点。治疗结束时的 GRR（EOT）、第 14 天和第 28 天的全因死亡率以及安全性也进行了评估。79 例患者患有来自腹膜液或肝胆道的 IAC。最常见的病原体是白色念珠菌（72.2%）和光滑念珠菌（32.9%）。总的 GRR 分别为 EOIVT 时的 73.4%和 EOT 时的 67.1%。在修正意向治疗人群中，第 14 天和第 28 天的全因死亡率分别为 17.7%和 24.1%。在该人群中，安尼达fungin 耐受性良好，大多数不良事件为轻度或中度。在这些患有 IAC 的患者中，安尼达fungin 在 EOIVT 时的 GRR 与安尼达fungin 注册试验相似，我们的分析结果证实了安尼达fungin 的已知安全性特征。临床试验.gov 注册号 NCT00496197，于 2007 年 7 月 3 日注册，https://clinicaltrials.gov/ct2/show/study/NCT00496197；临床试验.gov 注册号 NCT00548262，于 2007 年 10 月 19 日注册，https://clinicaltrials.gov/ct2/show/record/NCT00548262；临床试验.gov 注册号 NCT00537329，于 2007 年 9 月 25 日注册，https://clinicaltrials.gov/ct2/show/record/NCT00537329；临床试验.gov 注册号 NCT00689338，于 2008 年 5 月 29 日注册，https://clinicaltrials.gov/ct2/show/study/NCT00689338；临床试验.gov 注册号 NCT00805740，于 2008 年 11 月 26 日注册，https://clinicaltrials.gov/ct2/show/NCT00805740。
