Lee S, Dausch S, Maierhofer G, Dausch D
Praxis Prof. Dr. Dieter Dausch, Amberg, Germany.
Klin Monbl Augenheilkd. 2004 Oct;221(10):825-36. doi: 10.1055/s-2004-813715.
Most of the eye drops currently used replace only the aqueous phase of the tear film. But, due to the fact that, with approximately 80 % of the patients with a dry eye, a disturbance of the lipid phase is present, an approach for new treatment methods needed to be found. We examined a new therapy concept with an eye spray containing liposomes for the therapy of the "dry eye" in a long-term study.
An examination of the effectiveness of a liposome eye spray (TEARS AGAIN, Optima Pharmaceutical GmbH, Germany) in patients with "dry eye" compared with a spray containing a balanced salt solution was carried out.
Between August 2003 and May 2004 a double-blind study with 382 patients was accomplished. The treatment group (V; n = 191) was compared with the control group (K; n = 191) for a period of 6 months regarding the following examination criteria: eyelid edge parallel conjunctival folds (LIPCOF), BREAK UP time (BUT), Schirmer I test, best corrected visual acuity, as well as slit lamp findings of the cornea and conjunctiva. Follow-up was after 4 weeks and 6 months. The statistical analysis was performed with the statistical program SPSS v.11.5.
The examined parameters such as LIPCOF, BUT and Schirmer were significantly better in the treatment group than in the control group. We found likewise significant improvements of the inflammations of the edge of eyelid with a remarkable decrease of around 89.5 %. Questioning of the patients resulted in, among other things, the belief that the liposome eye spray led altogether to a clear subjective improvement of the symptoms in 72 % of the cases, although an initial burning sensation was mentioned after the application. All patients were of the opinion that application with a spray is more favourably and more pleasant than teardrops.
The liposome tear substitute shows statistically significant advantages against a balanced salt solution. This new liposome eye spray represents a new, revolutionary and effective procedure in the therapy of the "dry eye". Considering the disturbance of the lipid phase in 80 % of the patients, TEARS AGAIN ought to be a first choice treatment.
目前使用的大多数眼药水仅替代泪膜的水相。但是，由于约80%的干眼症患者存在脂质相紊乱，因此需要找到新的治疗方法。我们在一项长期研究中，用含脂质体的眼喷雾对“干眼症”治疗进行了一种新的治疗理念研究。
对脂质体眼喷雾（TEARS AGAIN，德国奥普蒂玛制药有限公司）与含平衡盐溶液的喷雾相比，在“干眼症”患者中的有效性进行了研究。
在2003年8月至2004年5月期间，完成了一项针对382例患者的双盲研究。治疗组（V；n = 191）与对照组（K；n = 191）在6个月的时间内，就以下检查标准进行比较：睑缘平行结膜皱襞（LIPCOF）、泪膜破裂时间（BUT）、Schirmer I试验、最佳矫正视力，以及角膜和结膜的裂隙灯检查结果。随访在4周和6个月后进行。使用统计软件SPSS v.11.5进行统计分析。
治疗组中如LIPCOF、BUT和Schirmer等检查参数明显优于对照组。我们同样发现睑缘炎症有显著改善，显著降低了约89.5%。对患者的询问结果显示，除其他情况外，72%的患者认为脂质体眼喷雾总体上使症状有明显主观改善，尽管应用后最初提到有烧灼感。所有患者都认为喷雾应用比眼药水更方便、更舒适。
脂质体泪液替代物与平衡盐溶液相比具有统计学上的显著优势。这种新的脂质体眼喷雾代表了“干眼症”治疗中的一种新的、革命性的有效方法。考虑到80%的患者存在脂质相紊乱，TEARS AGAIN应该是首选治疗方法。
