睑板腺热脉动系统治疗睑板腺功能障碍的临床观察

Clinical evaluation of a thermodynamic treatment system for meibomian gland dysfunction

目的评价睑板腺热脉动系统治疗睑板腺功能障碍（MGD）的临床效果及安全性。方法回顾性系列病例研究。本研究对48例（96只眼）MGD患者进行12rain的睑板腺热脉动系统治疗，在治疗前、治疗后4周及12周进行包括主观症状、泪膜稳定性、脂质层厚度（LLT）、睑板腺缺失情况等方面的临床评估，不同时间点有效性评估参数的变化采用独立样本t检验进行分析。结果48例MGD患者进行睑板腺热脉动系统治疗后随访12周，患者主观症状明显缓解，眼表疾病评分指数（OSDI）由治疗前（45．36±19．34）分降至4周后的（23．82±11．94）分及12周的（25．66±14．12）分，差异有统计学意义（t=-2．009，1．976；P=0．035，0．038）。睑板腺开口数量由治疗前（2．91±1．13）个增加至治疗后4周的（6．27±2．37）个（f=3．505，P〈0．001）及12周的（5．15±2．08）个（t=2．004，P=0．027）；睑板腺分泌物性状由治疗前（6．18±2．48）分增至4周后的（13．55±3．46）分0=2．689，P=0．005）及12周后的（12．67±3．41）分（f=2．403，P=0．009）。患者LLT较治疗前（42．13±9．67）nm明显增加，分别为治疗后4周的（59．02±16．39）nm（t=2．971，P=0．002）及12周的（54．65±12．52）nm（t=2．021，P=0．021），差异有统计学意义。不完全瞬目比率也由治疗前的0．37±0．30降至4周后的0．15±0．140=3．428，P=0．035）及12周后的0．12±0．13（t=1．986，P=0．026）。BUT在经过睑板腺热脉动系统的治疗后得到明显缓解，由治疗前的（4．73±2．34）S增至4周后的（9．32±2．18）s（t=3．385，P〈0．001）及12周后的9．91±3．01S（t=3．253，P〈0．001），差异有统计学意义。治疗1d后进行安全性评估，与基线相比：最佳矫正视力、角膜染色及眼压无明显变化（P=0．141，O．376，0．421）。结论12周的临床观察表明，睑板腺热脉动系统是一种有效且安全的MGD治疗方法.

[Abstract] Objective To evaluate the effectiveness and safety of a single thermodynamic treatment system （LipiFlow） for meibomian gland dysfunction （MGD）. Methods Retrospective series case study. Forty-eight subjects with meibomian gland dysfunction were analyzed before and after 12 minutes LipiFlow system treatment. All subjects were examined before, 4 weeks and 12 weeks after this treatment. Subjective symptoms, lipid layer thickness （LLT）, expressible meibomian gland, tear break-up time, meibomian gland assessment and ocular surface staining were measured. Statistical analysis was performed using SPSS 11.5 software. Analysis included those independent sample two-tailed t-tests for comparison of the mean change from baseline to 4 weeks and baseline to 12 weeks after Lipiflow treatment. Statistically significant difference was based on α=0.05 （P〈0.05）. Results A total of 48 cases completed the 12-week follow-up. MGD patients with LipiFlow treatment had a significant reduction in the Ocular Surface Disease Index （OSDI） scores with 45.36±19.34 before treatment, 23.82± 11.94 at 4 weeks （t=2.009, P=0.035） and 25.66± 14.12 at 12 weeks （t=1.976 P=0.038）. LipiFlow resulted in a higher number of expressible glands from 2.91±1.13 （baseline） to 6.27±2.37 （4 weeks, t=3.505, P〈0.001） and 5,15±2.08 （12 weeks, t=2.004, P= 0.027） and change of secretion quality from 6.18-±2.48 （baseline） to 13.55±3.46 （4 weeks, t=2.698, P=0.005） and 12.67±3.41 （12 weeks, t=2.403, P=0.009）. In addition, a single thermodynamic treatment increase the LET from （42.13 ± 9.67）nm （baseline） to （59.02± 16.39）nm （4 weeks, t=2.971, P=0.002 ） and （54.65 ± 12.52）nm （ 12 weeks, t=2.021, P=0.021 ）. The rate of partial blink was relieved from 0.37±0.30 （baseline） to 0.15-±0.14 （4 weeks, t=3.428, P=0.035）and 0.12±0.13 （ 12 weeks, t=1.986, P=0.026）. BUT was increased from （4.73± 2.34）s （baseline） to （9.32 ± 2.18）s （4 weeks, t=3.385, P〈O.001）and （9.91 ± 3.01）s （12 weeks, t=3.253, P〈 0.001）. There were no unanticipated or serious device-related adverse events reported. Compared with baseline, there was no statistically significant difference in BCVA, corneal staining and intraoeular pressure （P=0.141, 0.376, 0.421）. Coneluslon The LipiFlow system was a safety and effeetiveness treatment of MGD in the 12-week study.