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西班牙多中心他氟前列素耐受性研究。

Spanish multicenter tafluprost tolerability study.

机构信息

Glaucoma and Genetics Unit, Institut Comtal d'Oftalmologia, Via Augusta 48-54, 2n 08006 BCN Barcelona, Spain.

出版信息

Br J Ophthalmol. 2012 Jun;96(6):826-31. doi: 10.1136/bjophthalmol-2011-301015. Epub 2012 Mar 7.

DOI:10.1136/bjophthalmol-2011-301015
PMID:22399693
Abstract

AIM

To evaluate the ocular surface symptoms and signs associated with preservative-free 0.0015% tafluprost in patients with glaucoma or ocular hypertension (OHT).

METHODS

Prospective non-interventional, multicentre, observational study on 134 patients, naive or on previous treatment with another prostaglandin analogue. In each visit (V1 baseline visit, V2 at 1 month and V3 at 3 months), patients evaluated five ocular surface symptoms as: absent, mild, moderate and severe. Parallelly, the ophthalmologist assessed the tear break-up time, keratitis, conjunctival hyperaemia, blepharitis, Schirmer test and tear meniscus.

RESULTS

Patients with OHT (n=71, 53%) experienced a statistically significant improvement of all symptoms: stinging/burning/irritation, itching, foreign body sensation, tearing and dryness sensation at V3, while glaucoma patients improved all symptoms at both V2 and V3. In patients with OHT, all signs except Schirmer test improved and the decrease in hyperaemia was statistically significant. Eyes with glaucoma ameliorated the keratitis, hyperaemia and tear meniscus at V2 and V3 and the break-up time and blepharitis at V3. In the subset of patients with previous treatment (n=79, 58.9%), patients with OHT presented significant improvement of hyperaemia, yet the rest of signs did not decrease significantly or remained unchanged, while in patients with glaucoma all signs improved significantly at both visits. The intraocular pressure (IOP) drop in naive eyes was 22.2% (24.7-19.7 mm Hg) in OHT and 29.5% (33.7-25.3 mm Hg) in glaucoma eyes. In previously treated eyes, no statistically significant change in IOP was found.

CONCLUSION

Preservative-free tafluprost is a well tolerated hypotensive agent that can be used in eyes with surface problems and in naive eyes.

摘要

目的

评估与不含防腐剂的 0.0015%他氟前列素相关的青光眼或高眼压症(OHT)患者的眼表症状和体征。

方法

前瞻性、非干预性、多中心、观察性研究,纳入 134 名患者,均为初次治疗或正在使用其他前列腺素类似物治疗。在每次就诊(V1 基线就诊、V2 就诊 1 个月后和 V3 就诊 3 个月后)时,患者评估了 5 种眼表症状:无、轻度、中度和重度。同时,眼科医生评估了泪膜破裂时间、角膜炎、结膜充血、睑缘炎、泪液分泌试验和泪膜新月形。

结果

OHT 患者(n=71,53%)的所有症状(刺痛/烧灼感/刺激感、瘙痒、异物感、流泪和干燥感)在 V3 时均有统计学意义的改善,而青光眼患者在 V2 和 V3 时均改善了所有症状。OHT 患者的所有体征(除了泪液分泌试验)均得到改善,充血程度的下降具有统计学意义。青光眼患者的角膜炎、充血和泪膜新月形在 V2 和 V3 时得到改善,泪膜破裂时间和睑缘炎在 V3 时得到改善。在有既往治疗史的患者亚组(n=79,58.9%)中,OHT 患者的充血程度有显著改善,但其余体征无明显下降或保持不变,而青光眼患者的所有体征在两次就诊时均显著改善。在初次治疗的眼中,OHT 患者的眼内压(IOP)下降了 22.2%(24.7-19.7mmHg),青光眼患者的眼内压下降了 29.5%(33.7-25.3mmHg)。在有既往治疗史的眼中,IOP 无统计学意义的变化。

结论

不含防腐剂的他氟前列素是一种耐受性良好的降压药物,可用于有表面问题的眼睛和初次治疗的眼睛。

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