背景:涉及填充物的美学程序越来越受欢迎,生物刺激器,和神经毒素引起了人们对患者安全的担忧。为了解决这些问题,成立了全球安全工作队(STF)。
目标:首届STF会议将血管折衷预防和管理列为优先事项,指导未来会议的临床试验设计和材料,并从专家那里收集有关当前安全方法的数据。
方法:STF由来自9个不同国家的16名专家组成,每个人都在与美学注射剂相关的各个领域拥有不同的专业知识。当前安全数据,协议,对知识差距和未来研究重点进行了讨论和投票。
结果:建立用于跟踪填充剂相关不良事件的全球数据库受到了93%的参与者的青睐。讨论围绕数据库的范围展开,数据标准化,以及是否应包括非医疗贡献者。作为一种安全技术,灵感得到了73%参与者的支持。大约43%的参与者在注射中使用超声波,与AE管理相比,其作为实践标准的影响和潜力存在分歧。工作队中的大多数医生都使用套管进行一些注射(93%)。对血管不良事件(VAE)的治疗有不同的看法,主要原因,以及在该领域采用新的议定书。
结论:STF会议强调需要协调努力解决与HA填充剂相关的并发症,包括VAE管理和透明质酸酶方案。评估了可靠的治疗终点,但需要改进的测量方法。今后的会议将侧重于解决延迟并发症,进一步加强这一领域的安全。
BACKGROUND: The growing popularity of aesthetic procedures involving fillers, biostimulators, and
neurotoxins has prompted concerns about patient safety. To address these concerns, a global Safety Task Force (STF) was formed.
OBJECTIVE: The inaugural STF meeting prioritized vascular compromise prevention and management, guiding clinical trial design and materials for future meetings, and collecting data from experts on current safety methods.
METHODS: The STF was formed and consisted of 16 experts from nine different countries, with each possessing distinct expertise in various fields related to aesthetic injectables. Current safety data, protocols, knowledge gaps and future research priorities were discussed and voted upon.
RESULTS: The establishment of a global database for tracking filler-related AEs was favored by 93% of participants. Discussions revolved around the database\'s scope, data standardization, and whether non-medical contributors should be included. Aspiration as a safety technique garnered support from 73% of participants. Approximately 43% of participants incorporate ultrasound in their injections, with divergent opinions on its impact and potential when used as a standard of practice versus in AE management. Most physicians on the task force incorporated cannula use for some of their injections (93%). There were varying perspectives on treatments for vascular adverse events (VAE), the primary causes, and the adoption of new protocols in the field.
CONCLUSIONS: The STF meeting underscored the need for a coordinated effort to address complications related to HA fillers, including VAE management and hyaluronidase protocols. Reliable treatment endpoints were evaluated, but improved measurement methods are needed. Future meetings will focus on addressing delayed complications, furthering safety in this field.