Lohman Mary E, Ghobadi Comeron W, Xu Shuai
Department of Medicine, McGaw Medical Center, Northwestern University, Chicago, Illinois.
Department of Radiology, University of Chicago Medical Center, Chicago, Illinois.
JAMA Facial Plast Surg. 2017 Sep 1;19(5):421-429. doi: 10.1001/jamafacial.2017.0082.
The US Food and Drug Administration (FDA) recently issued a safety warning regarding soft-tissue fillers (STFs) based on the risk of blindness and facial necrosis.
To examine the quality of evidence leading to FDA approval of STFs.
All original approvals for STFs were mined using the publicly available FDA database. The Cochrane Collaboration's risk of bias assessment tool was applied to all randomized clinical trials (RCTs).
A total of 14 STF approvals were identified. Of those, 10 pivotal studies (71%) were RCTs and 9 (60%) were masked. The median number of patients per trial was 144 (range, 30-439). Eleven of 12 studies (92%) met their primary end point. Ten of 14 trials (71%) involved injections solely of the nasolabial folds or cheeks; only 4 trials involved treatment of other facial regions. All 10 RCTs had an unclear risk of selection bias. Only 2 RCTs reported exclusions and attrition.
Safety warnings relate more to the off-label use of STFs, which has not been sufficiently studied prospectively. Although STFs remain a safe device, with approval based mostly on RCT outcomes, implementation of unique device identifiers and greater use of physician-led registries would ensure physician, consumer, and regulatory confidence in STF safety.
美国食品药品监督管理局（FDA）近期基于失明和面部坏死风险发布了关于软组织填充剂（STF）的安全警告。
审查促使FDA批准STF的证据质量。
利用公开可用的FDA数据库挖掘所有STF的原始批准信息。将Cochrane协作网的偏倚风险评估工具应用于所有随机临床试验（RCT）。
共确定了14项STF批准。其中，10项关键研究（71%）为RCT，9项（60%）采用了盲法。每项试验的患者中位数为144例（范围30 - 439例）。12项研究中的11项（92%）达到了主要终点。14项试验中的10项（71%）仅涉及鼻唇沟或脸颊注射；只有4项试验涉及其他面部区域的治疗。所有10项RCT的选择偏倚风险均不明确。只有2项RCT报告了排除标准和损耗情况。
安全警告更多地与STF的标签外使用有关，而这方面尚未进行充分的前瞻性研究。尽管STF仍是一种安全的器械，其批准主要基于RCT结果，但实施独特器械标识符以及更多地使用医生主导的注册系统将确保医生、消费者和监管机构对STF安全性的信心。
