PDF(Pubmed)
Abstract：
The LipiFlow Thermal Pulsation System received its first marketing clearance for the treatment of meibomian gland dysfunction (MGD) 13 years ago. Since then, the evidence evaluating the effectiveness and safety of LipiFlow as a treatment for MGD has grown significantly. The objective of this comprehensive review was to summarize all clinical reports evaluating the effectiveness and safety of LipiFlow over the past 15 years. The literature was systematically reviewed, and 55 unique articles had subjective (patient-reported outcomes) and objective (meibomian gland function, tear production, and ocular staining) outcomes for extraction. Data were collected from 2101 patients and 3521 eyes treated with LipiFlow. Of these, effectiveness was evaluated in 2041 patients and 3401 eyes, and safety was evaluated in 1448 patients and 2443 eyes. Taken together, the studies demonstrate that a single 12-min treatment with LipiFlow safely improves signs and symptoms of MGD and associated evaporative dry eye disease (DED), and the benefits persist up to 3 years in some cases. The findings are corroborated by multiple meta-analyses and consensus guidelines. While some studies showed that daily eyelid hygiene, warm compress, and/or massage had a similar benefit to a single LipiFlow, these treatments were limited by inconvenience, discomfort, and non-compliance. The majority of studies evaluating safety reported no discomfort or pain associated with LipiFlow treatment, which supports the patient acceptability of LipiFlow therapy. All adverse events (AEs) related to LipiFlow were transient, non-vision-threatening, and did not require treatment. No studies reported serious AEs. The data obtained from 55 studies conducted globally overwhelmingly show that LipiFlow is effective and safe for the treatment of MGD and associated evaporative DED. The conclusions are supported by the diversity of the patient populations (geography, race, disease severity, and diagnosis), the large population treated with LipiFlow, the meta-analyses, and that this review analyzed all published clinical studies to date.
摘要：
LipiFlow热脉动系统在13年前首次获得了用于治疗睑板腺功能障碍（MGD）的市场许可。从那以后,评价LipiFlow作为MGD治疗的有效性和安全性的证据显著增加.本综述的目的是总结过去15年来评估LipiFlow有效性和安全性的所有临床报告。对文献进行了系统回顾，55篇独特文章具有主观(患者报告的结果)和客观(睑板腺功能，泪液生产,和眼部染色)提取结果。数据来自用LipiFlow治疗的2101名患者和3521只眼。其中,在2041例患者和3401只眼中评估了有效性，对1448例患者和2443只眼进行了安全性评估.一起来看,研究表明，用LipiFlow治疗12分钟可以安全地改善MGD和相关蒸发性干眼病（DED）的体征和症状，在某些情况下，收益持续长达3年。这些发现得到了多个荟萃分析和共识指南的证实。虽然一些研究表明，日常眼睑卫生，热敷，和/或按摩具有与单一LipiFlow相似的益处，这些治疗方法受到不便的限制，不适,和不遵守。大多数评估安全性的研究报告没有与LipiFlow治疗相关的不适或疼痛。这支持了患者对LipiFlow治疗的可接受性。所有与LipiFlow相关的不良事件（AE）都是短暂的，无视力威胁,并且不需要治疗。没有研究报告严重的AE。从全球进行的55项研究获得的数据压倒性地表明，LipiFlow对于MGD和相关蒸发DED的治疗是有效和安全的。这些结论得到了患者人群多样性的支持(地理，种族,疾病严重程度,和诊断），用LipiFlow治疗的大量人口，荟萃分析，这篇综述分析了迄今为止所有已发表的临床研究。
