Lazreg Sihem, Assaf Ahmed Hassan, Abdelrahman Ahmed M, Hosny Mohamed, Shaheen Mohamed Shafik, Shawky Medhat Mohamed, El-Raggal Tamer Mohamed, Abou Samra Waleed Ali Moustafa, Mostafa Yehia Salah Eldin
Cornea and Ocular Surface Center Lazreg, 09000, Blida, Algeria.
Professor of Opthalmology, Ain Shams University, Consultant at Watany Eye Hospital, Cairo, Egypt.
Int Ophthalmol. 2025 Jan 20;45(1):30. doi: 10.1007/s10792-025-03411-x.
This study evaluated the efficacy, safety, and tolerability of a single-dose, preservative-free (PF) Dorzolamide/Timolol combination (Twinzol-SDU).
A 3-month single-arm, multicenter, prospective cohort study was conducted in Egypt between January 2021 and October 2022 on previously diagnosed and controlled patients with ocular hypertension and/or glaucoma. Efficacy was assessed using the change in intraocular pressure (IOP) after 6 and 12 weeks. Safety was identified through the change in the incidence of ocular side effects, ocular surface disease index (OSDI) scores and grades, and Time Break-Up time (TBUT).
A total of 382 patients were enrolled in the analysis. After the three-month period of therapy, a significant reduction in IOP was seen (mean change: -1.9, P < 0.001) after switching to PF Dorzolamide/Timolol combination. The rate of ocular abrasion decreased significantly from 30.6% to 1.3% (P < 0.001). The rate of normal aqueous tear production increased from 24.1% to reach 79.4% (P < 0.001). The OSDI scores decreased significantly throughout the study period, with a median score decreased from 41.7 (21.7) to 12.5 (12.5) (P < 0.001). Mild OSDI grades significantly increased from the baseline of 12.6% to reach 24.7%. Moderate OSDI grade decreased at the same rate, from 12.8% to 11.1%. The number of patients with severe OSDI grade substantially decreased from 64.4% to 4.5%, with a P < 0.001. TBUT increased from 9 (3.7) seconds to reach and 12.3 (4) seconds after 12 weeks of treatment (P < 0.001).
Generally, the PF dorzolamide/timolol combination was associated with a significant reduction in IOP and tolerability among glaucoma patients.
本研究评估了单剂量、无防腐剂（PF）的多佐胺/噻吗洛尔复方制剂（Twinzol-SDU）的疗效、安全性和耐受性。
2021年1月至2022年10月在埃及对先前诊断并得到控制的高眼压症和/或青光眼患者进行了一项为期3个月的单臂、多中心、前瞻性队列研究。通过6周和12周后眼压（IOP）的变化评估疗效。通过眼部副作用发生率、眼表疾病指数（OSDI）评分和分级以及泪膜破裂时间（TBUT）的变化确定安全性。
共有382例患者纳入分析。经过3个月的治疗期，改用PF多佐胺/噻吗洛尔复方制剂后，眼压显著降低（平均变化：-1.9，P < 0.001）。眼部擦伤率从30.6%显著降至1.3%（P < 0.001）。正常房水泪液分泌率从24.1%升至79.4%（P < 0.001）。在整个研究期间，OSDI评分显著降低，中位数评分从41.7（21.7）降至12.5（12.5）（P < 0.001）。轻度OSDI分级从基线的12.6%显著升至24.7%。中度OSDI分级以相同速率下降，从12.8%降至11.1%。重度OSDI分级的患者数量从64.4%大幅降至4.5%，P < 0.001。治疗12周后，TBUT从9（3.7）秒增至12.3（4）秒（P < 0.001）。
总体而言，PF多佐胺/噻吗洛尔复方制剂与青光眼患者眼压显著降低及耐受性良好相关。
