Onischenko A L, Dimaksyan M V, Kolbasko A V, Zilina N M
Novokuznetsk State Institute of Postgraduate Medicine, Ministry of Health of the Russian Federation, 5 Stroiteley prospekt, Novokuznetsk, Kemerovo Oblast, Russian Federation, 654005.
Vestn Oftalmol. 2015 Mar-Apr;131(2):76-80. doi: 10.17116/oftalma2015131276-80.
To evaluate ocular surface changes in patients with primary open-angle glaucoma (POAG) as well as the hypotensive effect of preservative-free betaxolol eye drops.
A total of 22 patients (42 eyes) aged 55-83 with POAG stage I-II were examined. All of them were switched from betaxolol b.i.d. to its preservative-free analogue (Xonef BK). The baseline examination included visual acuity measurement, Morisky-Green test (questionnaire), Norn test, Schirmer's test, lissamine green staining, and ocular tonometry. The latter was repeated 2 and 4 weeks after the drug had been switched, while the whole complex--2 months after the beginning of the study.
The total tear production in POAG patients under betaxolol therapy was 19.1 ± 10.6 mm. After the 2 months of preservative-free betaxolol use there were no statistically significant changes in Schirmer's test results (p = 0.248). Tear film break-up time (Norn test) improved from 7.8 ± 0.5 secto 9.8 ± 0.8 sec (p = 0.067) as well as the results of lissamine green staining (W = 90.0, p < 0.022). In the Morisky-Green Test betaxolol patients scored only 2.6 ± 0.05 points on average, thus showing non-compliance. After the 2 months of preservative-free betaxolol instillations the scores increased up to 3.1 ± 0.07 (p = 0.04). According to Dunnett's test, used for multiple comparisons, intraocular pressure did not change significantly in either of the study periods (baseline and follow-up measurements at weeks 2, 4, and 8 were taken into account).
The study proves Xonef BK safe, effective, and appropriate in all types of glaucoma.
评估原发性开角型青光眼(POAG)患者的眼表变化以及不含防腐剂的倍他洛尔滴眼液的降压效果。
对22例年龄在55 - 83岁、处于I - II期POAG的患者(42只眼)进行检查。所有患者均从每日两次使用倍他洛尔转换为使用其不含防腐剂的类似物(Xonef BK)。基线检查包括视力测量、Morisky - Green测试(问卷)、诺恩测试、泪液分泌试验、丽丝胺绿染色和眼压测量。在换药后2周和4周重复进行眼压测量,而在研究开始2个月后进行整个综合检查。
接受倍他洛尔治疗的POAG患者的总泪液分泌量为19.1±10.6毫米。使用不含防腐剂的倍他洛尔2个月后,泪液分泌试验结果无统计学显著变化(p = 0.248)。泪膜破裂时间(诺恩测试)从7.8±0.5秒改善至9.8±0.8秒(p = 0.067),丽丝胺绿染色结果也有所改善(W = 90.0,p < 0.022)。在Morisky - Green测试中,使用倍他洛尔的患者平均得分仅为2.6±0.05分,显示出用药依从性不佳。使用不含防腐剂的倍他洛尔滴眼2个月后,得分增加至3.1±0.07(p = 0.04)。根据用于多重比较的Dunnett检验,在任何一个研究阶段(考虑基线以及第2、4和8周的随访测量)眼压均无显著变化。
该研究证明Xonef BK在所有类型的青光眼中安全、有效且适用。