Costa Vital Paulino, Moreira Hamilton, Paolera Mauricio Della, de Moraes Silva Maria Rosa Bet
Universidade Estadual de Campinas - UNICAMP, São Paulo.
Clin Ophthalmol. 2012;6:699-706. doi: 10.2147/OPTH.S30717. Epub 2012 May 7.
To assess the safety and efficacy of transitioning patients whose intraocular pressure (IOP) had been insufficiently controlled on prostaglandin analog (PGA) monotherapy to treatment with travoprost 0.004%/timolol 0.5% fixed combination with benzalkonium chloride (TTFC).
This prospective, multicenter, open-label, historical controlled, single-arm study transitioned patients who had primary open-angle glaucoma, pigment dispersion glaucoma, or ocular hypertension and who required further IOP reduction from PGA monotherapy to once-daily treatment with TTFC for 12 weeks. IOP and safety (adverse events, corrected distance visual acuity, and slit-lamp biomicroscopy) were assessed at baseline, week 4, and week 12. A solicited ocular symptom survey was administered at baseline and at week 12. Patients and investigators reported their medication preference at week 12.
Of 65 patients enrolled, 43 had received prior travoprost therapy and 22 had received prior nontravoprost therapy (n = 18, bimatoprost; n = 4, latanoprost). In the total population, mean IOP was significantly reduced from baseline (P = 0.000009), showing a 16.8% reduction after 12 weeks of TTFC therapy. In the study subgroups, mean IOP was significantly reduced from baseline to week 12 (P = 0.0001) in the prior travoprost cohort (19.0% reduction) and in the prior nontravoprost cohort (13.1% reduction). Seven mild, ocular, treatment-related adverse events were reported. Of the ten ocular symptom questions, eight had numerically lower percentages with TTFC compared with prior PGA monotherapy and two had numerically higher percentages with TTFC (dry eye symptoms and ocular stinging/burning). At week 12, TTFC was preferred over prior therapy for 84.2% of patients (48 of 57) by the patients themselves, and for 94.7% of patients (54 of 57) by their physicians.
When TTFC replaced PGA monotherapy in patients whose IOP had been uncontrolled, the outcome was a significant reduction in IOP and an acceptable safety and tolerability profile. Most patients and investigators preferred TTFC to prior PGA monotherapy.
评估将眼内压（IOP）在前列腺素类似物（PGA）单药治疗下控制不佳的患者转换为使用0.004%曲伏前列素/0.5%噻吗洛尔与苯扎氯铵的固定组合（TTFC）进行治疗的安全性和有效性。
这项前瞻性、多中心、开放标签、历史对照、单臂研究将患有原发性开角型青光眼、色素性青光眼或高眼压症且需要从PGA单药治疗进一步降低IOP的患者转换为每日一次使用TTFC治疗12周。在基线、第4周和第12周评估IOP和安全性（不良事件、矫正远视力和裂隙灯生物显微镜检查）。在基线和第12周进行了一项有关眼部症状的调查。患者和研究者在第12周报告了他们对药物的偏好。
在纳入的65例患者中，43例曾接受过曲伏前列素治疗，22例曾接受过非曲伏前列素治疗（n = 18，比马前列素；n = 4，拉坦前列素）。在总体人群中，平均IOP较基线有显著降低（P = 0.000009），在TTFC治疗12周后降低了16.8%。在研究亚组中，在既往使用曲伏前列素的队列中（降低19.0%）和既往未使用曲伏前列素的队列中（降低13.1%），平均IOP从基线到第12周均有显著降低（P = 0.0001）。报告了7例轻度、与治疗相关的眼部不良事件。在10个眼部症状问题中，与既往PGA单药治疗相比，8个问题中TTFC的数值百分比更低，2个问题中TTFC的数值百分比更高（干眼症状和眼部刺痛/灼烧感）。在第12周，84.2%的患者（57例中的48例）自己更倾向于TTFC而非既往治疗，94.7%的患者（57例中的54例）的医生也更倾向于TTFC。
当TTFC替代IOP控制不佳患者的PGA单药治疗时，结果是IOP显著降低，且安全性和耐受性良好。大多数患者和研究者更倾向于TTFC而非既往的PGA单药治疗。
