Radiology and Diagnostic Imaging, Walter C. Mackenzie Health Sciences Centre, University of Alberta, 8440-112 Street, Edmonton, AB, T6G 2B7, Canada.
Cardiovasc Intervent Radiol. 2012 Jun;35(3):636-44. doi: 10.1007/s00270-011-0218-7. Epub 2011 Jul 6.
This study evaluated the safety, effectiveness, and biodegradation of a new embolic agent, Occlusin™ 503 Artificial Embolization Device (OCL 503). The agent consists of biodegradable poly-lactic-co-glycolic acid microspheres (150-212 μm) coated with type I bovine collagen and was compared with Embosphere® Microspheres (300-500 μm) in this controlled study of uterine artery embolization (UAE) in sheep.
Unilateral UAE was performed in 32 adult ewes randomly assigned. Vessels were embolized to effective stasis. The cohort was divided into four groups, which were sacrificed at 1, 3, 6, and 12 months.
Both agents were 100% effective in achieving stasis. At 6 months, all OCL 503-treated arteries were occluded, the microspheres degraded with time, and at 12 months all four animals examined demonstrated recanalization. OCL 503 was found in the untreated uterine artery in one animal with no other evidence of non target embolization. In the Embosphere-treated group, all vessels remained occluded and microspheres were detected in the contralateral uterine artery in 6 of 15 examined vessels and in 10 vaginal, 2 ovarian, and 1 vesical artery. No procedural-related complications were seen in either group.
OCL 503 is as effective an embolic agent as Embosphere® Microspheres when embolizing ovine uterine arteries and resorbs with time, allowing recanalization of the treated arteries. No device-related issues or adverse events were observed.
本研究评估了一种新型栓塞剂 Occlusin™ 503 人工栓塞装置（OCL 503）的安全性、有效性和生物降解性。该制剂由可生物降解的聚乳酸-共-羟基乙酸微球（150-212μm）组成，表面涂覆 I 型牛胶原蛋白，与 Embosphere®微球（300-500μm）在本研究中进行了比较，这是一项羊子宫动脉栓塞术（UAE）的对照研究。
32 只成年母羊进行单侧 UAE，随机分组。栓塞血管至有效止血。将队列分为四组，在 1、3、6 和 12 个月时处死。
两种制剂在实现止血方面均达到 100%有效。6 个月时，所有 OCL 503 治疗的动脉均闭塞，微球随时间降解，12 个月时，所有 4 只检查动物均显示再通。一只未处理的子宫动脉中发现了 OCL 503，但没有其他非目标栓塞的证据。在 Embosphere 治疗组中，所有血管均保持闭塞，在 15 个检查的血管中，有 6 个在对侧子宫动脉中发现了微球，在 10 个阴道动脉、2 个卵巢动脉和 1 个膀胱动脉中发现了微球。两组均未发生与操作相关的并发症。
OCL 503 作为栓塞剂在栓塞羊子宫动脉时与 Embosphere®微球同样有效，随着时间的推移可吸收，允许治疗后的动脉再通。未观察到与器械相关的问题或不良事件。
