Department of Surgical Sciences, Unit of Ophthalmology, Ospedale Maggiore, Bologna, Italy.
Department of Biomedical Sciences, University of Ferrara, Ferrara, Italy.
PLoS One. 2021 Oct 1;16(10):e0257695. doi: 10.1371/journal.pone.0257695. eCollection 2021.
To suggest the safety and efficacy of preservative-free triamcinolone acetonide intravitreal injectable suspension (Taioftal) for the treatment of diabetic macular edema.
A prospective clinical study involved 49 patients (49 eyes), that were treated with Taioftal and followed-up for six months. Complete ophthalmic examination, including spectral domain optical coherence tomography, was performed at baseline, and at month 1, 3, 6 after the intravitreal injection. Accurate collection and analysis of best-corrected visual acuity (BCVA), central foveal thickness (CFT), intraocular pressure (IOP), and adverse events (AEs) were carried out in order to evaluate visual function and macular morphology before and after treatment.
Median BCVA value chosen as comparing statistics was significantly improved at every follow-up time points (gain of 6 letters at month 1, 12 at month 3 -improvement up to 24% at month 3 with stabilization until month 6) compared to baseline, as certified by Kruskal-Wallis rank sum test (P<0.05). Median CFT significantly waned at each follow-up times (decrease of about 65 μm at month 1, 155 at month 3 -reduction up to 28% at month 3 keeping good outcome until month 6) compared to baseline (P<0.05). IOP elevation, with no severe increases, was the most common among spotted AEs (median of 23 mmHg at month 1, 20 at month 3).
Intravitreal injection of preservative-free triamcinolone (Taioftal) is an effective, safe and inexpensive drug used to improve visual acuity and reduce central foveal thickness in eyes affected by diabetic macular edema during an average time of 6 months. Temporary, never severe, elevation of IOP is totally manageable with topical medications. No serious vision-threatening complications are related to the use of intravitreal triamcinolone injections.
评估不含防腐剂的曲安奈德(Taioftal)玻璃体腔内注射混悬剂治疗糖尿病性黄斑水肿的安全性和疗效。
本前瞻性临床研究共纳入 49 例(49 只眼)患者,采用 Taioftal 进行治疗并随访 6 个月。所有患者在基线时及注药后 1、3、6 个月进行全面眼科检查,包括频域光学相干断层扫描。准确采集和分析最佳矫正视力(BCVA)、中心凹视网膜厚度(CFT)、眼内压(IOP)和不良事件(AE),以评估治疗前后的视功能和黄斑形态。
采用 Kruskal-Wallis 秩和检验比较各随访时间点的中位数 BCVA 值,结果显示其均显著高于基线值(第 1 个月提高 6 个字母,第 3 个月提高 12 个字母,第 3 个月提高幅度高达 24%,第 6 个月时保持稳定)(P<0.05)。采用中位数 CFT 比较各随访时间点,结果显示其均显著低于基线值(第 1 个月降低约 65μm,第 3 个月降低 155μm,第 3 个月降低幅度高达 28%,第 6 个月时保持良好)(P<0.05)。注射后最常见的局部不良反应是眼压升高(第 1 个月的中位数为 23mmHg,第 3 个月为 20mmHg),但无严重升高。
在平均 6 个月的时间内,玻璃体腔内注射不含防腐剂的曲安奈德(Taioftal)可有效、安全且经济地改善糖尿病性黄斑水肿患者的视力和降低中心凹视网膜厚度。一过性、从不严重的眼压升高可通过局部药物治疗完全控制。玻璃体腔内注射曲安奈德不会导致严重威胁视力的并发症。