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经向量热脉动系统(Lipiflow®)治疗睑板腺功能障碍的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of a vectored thermal pulsation system (Lipiflow®) in the treatment of meibomian gland dysfunction: a systematic review and meta-analysis.

机构信息

Department of Integrative Medicine, Huashan Hospital North, Fudan University, Shanghai, 201907, China.

Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, 200040, China.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2022 Jan;260(1):25-39. doi: 10.1007/s00417-021-05363-1. Epub 2021 Aug 10.

Abstract

PURPOSE

To investigate the efficacy and safety of a vectored thermal pulsation system (Lipiflow®) in the treatment of dry eye disease resulting from meibomian gland dysfunction (MGD).

METHODS

We searched for randomized clinical trials (RCTs) in Embase, MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Web of Science, and ClinicalTrials.gov up to 4 January 2021. The subjective symptoms, objective tests of dry eye, meibomian gland function, and the incidence of adverse events were evaluated.

RESULTS

Ten qualified RCTs incorporating 761 patients were analyzed. In the comparison of Lipiflow® treatment and lid hygiene, the subgroup with inconsistent units of randomization and analysis showed that the Lipiflow® treatment brought slight improvement in corneal fluorescein staining (mean difference (MD), - 0.42; 95% CI, - 0.75 to - 0.1), significant improvements in ocular surface disease index (OSDI) score (MD, - 7.4; 95% CI, - 11.06 to - 3.74), Standard Patient Evaluation of Eye Dryness (SPEED) score (MD, - 2.7; 95% CI, - 3.95 to - 1.45), meibomian glands yielding liquid secretion (MGYLS) (MD, 1.3; 95% CI, 0.78 to 1.82), and meibomian glands yielding secretion score (MGYSS) (MD, 4.09; 95% CI, 1.18 to 6.99). Meanwhile, significant improvements were detected in OSDI score, SPEED score, MGYLS, and MGYSS with patients who received Lipiflow® treatment compared with those who received nontreatment. The adverse events were comparable in the two control groups.

CONCLUSIONS

Lipiflow® treatment can improve the subjective and objective outcomes of MGD and does not increase the incidence of adverse events. The improper choice of units of analysis may be the leading cause of heterogeneity, which should be noted in the design of future ophthalmology research. Additional well-designed, large-scale RCTs are required to reach a firmer conclusion.

摘要

目的

研究向量热脉冲系统(Lipiflow®)治疗睑板腺功能障碍(MGD)引起的干眼症的疗效和安全性。

方法

我们在 Embase、MEDLINE、Cochrane 中央对照试验注册中心(CENTRAL)、PubMed、Web of Science 和 ClinicalTrials.gov 上检索了截至 2021 年 1 月 4 日的随机对照试验(RCT)。评估了主观症状、干眼客观检查、睑板腺功能和不良事件的发生率。

结果

纳入了 10 项合格的 RCT 共 761 例患者。在 Lipiflow®治疗与眼睑卫生的比较中,亚组分析显示,随机分组和分析的单位不一致,提示 Lipiflow®治疗可轻度改善角膜荧光素染色(平均差值(MD),-0.42;95%置信区间(CI),-0.75 至-0.1),眼表面疾病指数(OSDI)评分(MD,-7.4;95%CI,-11.06 至-3.74),标准患者眼干评估(SPEED)评分(MD,-2.7;95%CI,-3.95 至-1.45),睑板腺分泌液体(MGYLS)(MD,1.3;95%CI,0.78 至 1.82)和睑板腺分泌评分(MGYSS)(MD,4.09;95%CI,1.18 至 6.99)有显著改善。同时,与未接受治疗的患者相比,接受 Lipiflow®治疗的患者的 OSDI 评分、SPEED 评分、MGYLS 和 MGYSS 均有显著改善。两组不良反应发生率相当。

结论

Lipiflow®治疗可改善 MGD 的主观和客观结果,且不增加不良反应发生率。分析单位选择不当可能是异质性的主要原因,在未来的眼科研究设计中应予以注意。需要更多设计良好、规模较大的 RCT 来得出更确定的结论。

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