Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Department of Vascular and Oncological Interventional Radiology, 75015 Paris, France; Université Paris Cité, PARCC - INSERM Unité-970, 75015 Paris, France.
Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Department of Vascular and Oncological Interventional Radiology, 75015 Paris, France.
Diagn Interv Imaging. 2024 Apr;105(4):144-150. doi: 10.1016/j.diii.2023.12.003. Epub 2023 Dec 14.
The purpose of this study was to evaluate the safety and efficacy of transient genicular artery embolization (GAE) using an ethiodized oil-based emulsion for the treatment of knee osteoarthritis (KOA).
This prospective, single-arm, open-label, multicenter, first-in-human cohort trial was registered on ClinicalTrials.gov (NCT04733092). The main inclusion criterion was diagnosis of KOA according to a visual analogue scale (VAS) pain score ≥ 40 mm (score range: 0-100 mm), despite conservative treatment for at least three months. Treatment efficacy was assessed using changes in VAS pain score, Mean Western Ontario & McMaster Universities osteoarthritis (WOMAC) function score (normalized to 100; score ranging from 0 to100) and outcome measures in rheumatoid arthritis clinical trials (OMERACT)-Osteoarthritis Research Society (OARSI) set of responder criteria.
Twenty-two consecutive participants (13 women; mean age, 66 ± 9 [standard deviation (SD)]) were included and underwent GAE. Emulsion consisted in a mixture of ioversol and ethiodized oil (ratio 1:3, respectively) prepared extemporaneously. The rate of serious adverse events attributed to GAE within one month was 5% (1/22), corresponding to reversible worsening of renal function. Immediate technical success rate was 100%. Mean VAS pain score dropped from 74.4 ± 16.5 (SD) mm at baseline to 37.2 ± 26.7 (SD) mm at three months (P < 0.001). Mean WOMAC function score (normalized to 100: score ranging from 0 to 100) decreased from 57.3 ± 17.1 (SD) at baseline to 33.5 ± 25.9 (SD) at three months (P < 0.001). At three months, 16 out of 22 participants (73%) were considered responders according to the OMERACT-OARSI set of responder criteria, including high improvement in either pain or WOMAC function, or improvement in both pain and WOMAC function.
GAE using an ethiodized oil-based emulsion is safe and improves pain and function in participants with KOA for at least three months.
本研究旨在评估使用碘化油基乳剂进行瞬态关节囊动脉栓塞（GAE）治疗膝骨关节炎（KOA）的安全性和有效性。
这是一项前瞻性、单臂、开放标签、多中心、首次人体队列研究，在 ClinicalTrials.gov 上注册（NCT04733092）。主要纳入标准是根据视觉模拟评分（VAS）疼痛评分≥40mm（评分范围：0-100mm）诊断为 KOA，尽管经过至少三个月的保守治疗。治疗效果通过 VAS 疼痛评分、平均西安大略和麦克马斯特大学骨关节炎（WOMAC）功能评分（归一化为 100；评分范围为 0-100）和类风湿关节炎临床试验（OMERACT）-骨关节炎研究协会（OARSI）反应标准的测量指标变化进行评估。
连续纳入 22 名参与者（13 名女性；平均年龄 66±9[标准差（SD）]）并接受 GAE 治疗。乳剂由异碘醇和碘化油（分别为 1:3）混合制成，临时配制。一个月内与 GAE 相关的严重不良事件发生率为 5%（22 名参与者中有 1 名），对应肾功能可逆恶化。即刻技术成功率为 100%。平均 VAS 疼痛评分从基线时的 74.4±16.5（SD）mm降至三个月时的 37.2±26.7（SD）mm（P<0.001）。平均 WOMAC 功能评分（归一化为 100：评分范围为 0-100）从基线时的 57.3±17.1（SD）降至三个月时的 33.5±25.9（SD）（P<0.001）。三个月时，根据 OMERACT-OARSI 反应标准，22 名参与者中有 16 名（73%）被认为是反应者，包括疼痛或 WOMAC 功能的改善程度较高，或疼痛和 WOMAC 功能均改善。
使用碘化油基乳剂进行 GAE 治疗是安全的，可至少在三个月内改善 KOA 患者的疼痛和功能。
