Department of Infectious Diseases, Christian Medical College, Vellore, Tamil Nadu, India.
Department of ENT 3 & Rhinology, Christian Medical College, Vellore, Tamil Nadu, India.
Clin Microbiol Infect. 2023 Oct;29(10):1298-1305. doi: 10.1016/j.cmi.2023.06.017. Epub 2023 Jun 20.
To evaluate the efficacy and safety of short-course intravenous amphotericin B followed by sustained release posaconazole tablets for diabetes or COVID-19-associated rhino-orbito-cerebral mucormycosis.
This prospective, pragmatic study included adults with diabetes or COVID-19-associated rhino-orbito-cerebral mucormycosis. Patients received short (7-14 days) or long (15-28 days) intravenous antifungal therapy (short intravenous antifungal treatment [SHIFT] or long intravenous antifungal treatment [LIFT], respectively) depending on the presence or absence of brain involvement. All patients received step-down posaconazole tablets, debridement, and glycemic control. The primary outcome was the treatment success at week 14, which was determined by assessing survival and the absence of disease progression through clinical evaluation and nasal endoscopy. Log-binomial regression analysis (risk ratio and 95% CI) was performed to assess factors associated with the primary outcome.
Intravenous therapy was administered to 251 participants: SHIFT, 205 (median duration, 13 days); LIFT, 46 (median duration, 22 days). Treatment success at 3 months was 88% (217/248; 95% CI, 83-91%): SHIFT group, 93% (189/203; 89-96%); LIFT group, 62% (28/45; 47-76%). All-cause mortality was 12% (30/251): SHIFT group, 6% (13/205); LIFT group, 37% (17/46). Age (aRR [95% CI]: 1.02 [1.00-1.05]; p 0.027), diabetic ketoacidosis at presentation (2.32 [1.20-4.46]; p 0·012), glycated haemoglobin A1c (1.19 [1.03-1.39]; p 0.019), stroke (3.93 [1.94-7.95]; p 0·0001), and brain involvement (5.67 [3.05-10.54]; p < 0.0001) were independently associated with unsuccessful outcomes.
Short intravenous amphotericin B with step-down posaconazole tablets should be further studied as primary treatment option for diabetes or COVID-19-associated mucormycosis in randomized controlled trials.
评估短期静脉注射两性霉素 B 序贯缓释泊沙康唑片治疗糖尿病或 COVID-19 相关 rhino-orbito-cerebral mucormycosis 的疗效和安全性。
本前瞻性、实用研究纳入了糖尿病或 COVID-19 相关 rhino-orbito-cerebral mucormycosis 成人患者。根据是否存在脑部受累，患者接受短（7-14 天）或长（15-28 天）疗程的静脉抗真菌治疗（短静脉抗真菌治疗 [SHIFT]或长静脉抗真菌治疗 [LIFT]）。所有患者均接受降阶梯泊沙康唑片、清创术和血糖控制。主要结局为第 14 周时的治疗成功率，通过临床评估和鼻内镜检查评估生存情况和疾病进展情况来确定。采用对数二项式回归分析（风险比和 95%CI）评估与主要结局相关的因素。
共对 251 名参与者进行了静脉治疗：SHIFT 组 205 名（中位疗程 13 天）；LIFT 组 46 名（中位疗程 22 天）。3 个月时的治疗成功率为 88%（217/248；95%CI，83-91%）：SHIFT 组为 93%（189/203；89-96%）；LIFT 组为 62%（28/45；47-76%）。全因死亡率为 12%（30/251）：SHIFT 组为 6%（13/205）；LIFT 组为 37%（17/46）。年龄（校正比值比 [95%CI]：1.02 [1.00-1.05]；p=0.027）、就诊时糖尿病酮症酸中毒（2.32 [1.20-4.46]；p=0.012）、糖化血红蛋白 A1c（1.19 [1.03-1.39]；p=0.019）、中风（3.93 [1.94-7.95]；p=0.0001）和脑部受累（5.67 [3.05-10.54]；p<0.0001）与治疗失败独立相关。
在随机对照试验中，短疗程静脉注射两性霉素 B 序贯降阶梯泊沙康唑片应进一步作为糖尿病或 COVID-19 相关 mucormycosis 的一线治疗选择进行研究。
