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植物雌激素补充治疗绝经后干眼症的随机临床试验。

Effects of phytoestrogen supplementation in postmenopausal women with dry eye syndrome: a randomized clinical trial.

机构信息

Ophthalmic Clinic II, University of Rome La Sapienza"San't Andrea Hospital, Rome, Italy.

出版信息

Can J Ophthalmol. 2012 Dec;47(6):489-92. doi: 10.1016/j.jcjo.2012.08.019.

DOI:10.1016/j.jcjo.2012.08.019
PMID:23217501
Abstract

OBJECTIVE

To evaluate the correlation between tear osmolarity and blood levels of 17-β estradiol, estrone, and testosterone in postmenopausal women with dry eye syndrome, and to assess the efficacy and safety of oral supplementation with phytoestrogens, lipoic acid, and eicosapentaenoic acid in this population.

DESIGN

Cross-sectional study including 66 postmenopausal women with dry eye syndrome.

METHODS

Sixty-six postmenopausal women with dry eye syndrome were enrolled in a randomized, double-blind, placebo-controlled, crossover study. Patients were divided into 2 groups (groups A and B) and treated, respectively, with phytoestrogen (Bioos, Montegiorgio, Italy) tablets or placebo tablets for 30 days. The 2 treatment periods were separated by a 30-day washout. Patients were examined on days 0 and 30 of each period. Assessments included blood levels of sex hormones, the Schirmer test for tear production, and measurement of tear osmolarity and tear film break-up time.

RESULTS

At baseline, all patients had low sex hormone levels, which were correlated with high tear film osmolarity values (r = -0.59,-0.61,-0.58, respectively). After 30 days of therapy, the group treated with Lacrisek® (Bioos) had significantly decreased tear osmolarity (P<0.005) and significantly increased tear production evaluated with the Schirmer test and tear film break-up time values (P<0.001) compared with the placebo-treated group.

CONCLUSIONS

Our study confirms that steroid hormones play an important role in ocular surface equilibrium and functions. Consequently, reduced blood levels of these hormones can produce changes at the ocular surface. Phytoestrogen supplementation can significantly improve the signs and symptoms of dry eye syndrome in postmenopausal women.

摘要

目的

评估绝经后干眼症患者泪液渗透压与血 17-β 雌二醇、雌酮和睾酮水平的相关性,并评估植物雌激素、硫辛酸和二十碳五烯酸口服补充剂对此类患者的疗效和安全性。

设计

包括 66 例绝经后干眼症患者的横断面研究。

方法

66 例绝经后干眼症患者纳入随机、双盲、安慰剂对照、交叉研究。患者分为 2 组(A 组和 B 组),分别给予植物雌激素(意大利蒙特格里奥的 Bioos)片或安慰剂片治疗 30 天。两个治疗期之间有 30 天的洗脱期。患者在每个时期的第 0 天和第 30 天接受检查。评估包括性激素水平、泪液分泌的 Schirmer 试验以及泪液渗透压和泪膜破裂时间的测量。

结果

基线时,所有患者的性激素水平均较低,与高泪膜渗透压值相关(r 值分别为-0.59、-0.61、-0.58)。治疗 30 天后,与安慰剂组相比,使用 Lacrisek®(Bioos)治疗的组泪液渗透压显著降低(P<0.005),Schirmer 试验评估的泪液分泌量和泪膜破裂时间显著增加(P<0.001)。

结论

本研究证实甾体激素在眼表平衡和功能中发挥重要作用。因此,这些激素的血液水平降低会导致眼表发生变化。植物雌激素补充可以显著改善绝经后妇女干眼症的症状和体征。

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