0.0015%他氟前列素与0.5%噻吗洛尔无防腐剂固定组合用于开角型青光眼和高眼压症患者：一项开放标签观察性研究的结果

Preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% in patients with open-angle glaucoma and ocular hypertension: results of an open-label observational study.

作者信息

Pillunat Lutz E, Erb Carl, Ropo Auli, Kimmich Friedemann, Pfeiffer Norbert

机构信息

Department of Ophthalmology, University Hospital Carl Gustav Carus, Dresden.

Augenklinik am Wittenbergplatz, Berlin, Germany.

出版信息

Clin Ophthalmol. 2017 Jun 2;11:1051-1064. doi: 10.2147/OPTH.S128453. eCollection 2017.

BACKGROUND

Efficacy, tolerability and safety of the novel preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% (Taptiqom) were investigated in an observational study in Germany.

OBJECTIVE

To assess efficacy, tolerability and safety of the preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% in a real-life setting.

METHODS

Intraocular pressure (IOP) was recorded for each eye at baseline (any previous therapy or untreated) and 4-16 weeks after changing medical treatment to or initiating treatment with the preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5%. Change in IOP was evaluated over the study period for all patients and for specific pretreatment subgroups. Clinical signs such as conjunctival hyperemia and lid-parallel conjunctival folds (LIPCOF) were recorded using standardized comparative photographs. Corneal staining, subjective symptoms and local comfort were measured using a four-step scale. All adverse events were recorded.

RESULTS

Among 1,157 patients enrolled, 1,075 patients were treated with the preservative-free fixed combination as the only medication at the final visit. Medical treatment was initiated in 741 patients because of an insufficient IOP-lowering effect of the prior medication. In 343 patients, medication was changed because of tolerability issues. The preservative-free fixed combination lowered IOP significantly in the subgroup of naïve patients, all subgroups with prior monotherapy and patients with prior fixed combinations: naïve patients: -8.9 mmHg, alpha- 2-agonists: -6.4 mmHg, beta-blockers: -5.7 mmHg, carbonic anhydrase inhibitors: -5.2 mmHg, prostaglandins: -4.7 mmHg, fixed-combination prostaglandins/timolol: -2.4 mmHg. At the final visit, clinical signs and subjective symptoms were improved in patients with prior medical therapy. Local comfort was rated as "very good" or "good" by 89.1% of patients at the final visit. Only few adverse events occurred during the treatment period.

CONCLUSION

The preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% was effective, well tolerated and showed a good safety profile.

背景

在德国进行的一项观察性研究中，对新型不含防腐剂的他氟前列素0.0015%/噻吗洛尔0.5%（Taptiqom）固定组合的疗效、耐受性和安全性进行了研究。

目的

在实际应用中评估不含防腐剂的他氟前列素0.0015%/噻吗洛尔0.5%固定组合的疗效、耐受性和安全性。

方法

在基线时（任何先前治疗或未治疗）以及改用或开始使用不含防腐剂的他氟前列素0.0015%/噻吗洛尔0.5%固定组合进行治疗后4 - 16周，记录每只眼睛的眼压。在研究期间，对所有患者以及特定的预处理亚组评估眼压变化。使用标准化对比照片记录结膜充血和睑结膜皱褶（LIPCOF）等临床体征。使用四步量表测量角膜染色、主观症状和局部舒适度。记录所有不良事件。

结果

在纳入的1157例患者中，1075例患者在最后一次就诊时仅接受不含防腐剂的固定组合治疗。741例患者因先前药物降眼压效果不佳而开始治疗。343例患者因耐受性问题更换药物。不含防腐剂的固定组合在初治患者亚组、所有先前接受单一疗法的亚组以及先前接受固定组合治疗患者中均显著降低眼压：初治患者：-8.9 mmHg，α - 2激动剂：-6.4 mmHg，β受体阻滞剂：-5.7 mmHg，碳酸酐酶抑制剂：-5.2 mmHg，前列腺素：-4.7 mmHg，前列腺素/噻吗洛尔固定组合：-2.4 mmHg。在最后一次就诊时，先前接受治疗的患者临床体征和主观症状有所改善。89.1%的患者在最后一次就诊时将局部舒适度评为“非常好”或“好”。治疗期间仅发生少数不良事件。