Safety and Feasibility of Photodynamic Therapy for Percutaneous Image-guided Abdominopelvic Abscess Drainage: Phase 1 Trial.
Safety and Feasibility of Photodynamic Therapy for Percutaneous Image-guided Abdominopelvic Abscess Drainage: Phase 1 Trial.
复制标题
经皮图像引导腹盆腔脓肿引流光动力疗法的安全性和可行性：第一阶段试验。
DOI：
10.1148/radiol.232667
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发表时间：
2024
期刊：
影响因子：
19.7
通讯作者：
Sharma,AshwaniK
中科院分区：
文献类型：
--
作者：
Baran,TimothyM;Bass,DavidA;Christensen,Laurie;Longbine,Erica;Favella,MariaD;Foster,ThomasH;Sharma,AshwaniK
背景：脓肿治疗的标准包括图像引导下经皮穿刺 引流和抗生素;然而，治愈率不同， 抗药性细菌正在增长。光动力疗法（PDT）， 它利用光激活染料产生细胞毒性活性氧 物种，可以通过消毒补充护理标准， 目的评价亚甲蓝PDT的安全性和可行性（以下简称PDT， MB-PDT）在经皮脓肿引流的时间。材料和方法这个前瞻性的，开放标签，剂量递增，首次在人类， 注册的MB-PDT 1期临床研究包括以下参与者： 接受经皮腹部或盆腔脓肿引流术，CT或 美国2015年1月至2020年3月和2022年9月至 2023年9月引流后，用激光进行MB-PDT 以20 mW/cm 2的通量率照射，其中通量 6、12、18、24、30和36 J/cm 2组（每组n= 3）。主要结果是安全性，即没有脂肪 栓塞，MB逃逸，脓肿壁损伤，需要手术切除 光纤初步疗效终点包括至 引流导管移除、引流导管输出量和临床 症状和发烧持续时间。注量和结局之间的关系 采用斯皮尔曼相关和线性回归分析， 组间采用普通单因素方差分析 结果MB-PDT在所有18例受试者（平均年龄60.1岁）中均安全可行 ± 18.3 [SD]; 10例女性），无不良安全性结局 观察任何参与者。未发生研究相关不良事件。 遇到，手术未增加报告的疼痛 （P= .1）。临床症状和发热持续时间 接受较高通量的参与者（30和36） J/cm 2 vs 6 J/cm 2）（P= .03）。 耐药菌的存在并不能预示 结论MB-PDT是一种安全、可行的辅助影像引导下经皮肺穿刺活检的方法 脓肿引流临床指标显示剂量依赖性反应 到PDT.ClinicalTrials.gov注册号：NCT 02240498 © RSNA，2024另见本期约翰斯顿和戈德堡的社论。
BackgroundStandard-of-care abscess management includes image-guided percutaneous drainage and antibiotics; however, cure rates vary, and concern for antibiotic-resistant bacteria is growing. Photodynamic therapy (PDT), which uses light-activated dyes to generate cytotoxic reactive oxygen species, could complement the standard of care by sterilizing the abscess at the time of drainage.PurposeTo evaluate safety and feasibility of PDT with methylene blue (hereafter, MB-PDT) at the time of percutaneous abscess drainage.Materials and MethodsThis prospective, open-label, dose-escalation, first-in-humans, registered phase 1 clinical study of MB-PDT included participants who underwent percutaneous abdominal or pelvic abscess drainage with CT or US guidance from January 2015 to March 2020 and September 2022 to September 2023. Following drainage, MB-PDT was performed with laser illumination at a fluence rate of 20 mW/cm2, with fluence groups of 6, 12, 18, 24, 30, and 36 J/cm2(n= 3 each). The primary outcome was safety, indicated by absence of fat embolism, MB escape, abscess wall damage, and need for surgery to remove optical fibers. Preliminary efficacy end points included the time to drainage catheter removal, drainage catheter output volume, and clinical symptom and fever duration. Relationships between fluence and outcomes were analyzed with Spearman correlation and linear regression analyses, and ordinary one-way analysis of variance was used for group comparisons.ResultsMB-PDT was safe and feasible in all 18 participants (mean age, 60.1 years ± 18.3 [SD]; 10 female), with no negative safety outcomes observed for any participant. No study-related adverse events were encountered, and the procedure did not increase reported pain (P= .1). Clinical symptom and fever duration was shorter in participants receiving higher fluences (30 and 36 J/cm2vs 6 J/cm2) (P= .03). The presence of antibiotic-resistant bacteria was not predictive of clinical symptom and fever duration (β = 0.13,P= .37).ConclusionMB-PDT was a safe and feasible adjunct to image-guided percutaneous abscess drainage. Clinical measures indicated a dose-dependent response to PDT.ClinicalTrials.gov registration no.: NCT02240498© RSNA, 2024See also the editorial by Johnston and Goldberg in this issue.