Rapisarda Antonio, Arpa Paolo, Fantaguzzi Paolo Maria, Faraldi Francesco, Ratiglia Roberto, Rizzo Stanislao, Vaona Paola, Iannacone Claudio, Papa Vincenzo
Department of Ophthalmology, Azienda Ospedaliera Garibaldi, Catania, Italy.
Department of Ophthalmology, Ospedale San Gerardo, Monza, Italy.
Clin Ophthalmol. 2020 Oct 14;14:3297-3303. doi: 10.2147/OPTH.S257541. eCollection 2020.
To evaluate the effect of dexamethasone/netilmicin (dexa/net) fixed combination in the treatment of ocular inflammation after sutureless micro-incisional vitreoretinal surgery (MIVS).
This multicenter, open, randomized, active-controlled, parallel-group, clinical trial was run in 6 sites in Italy. Treatment started the day of surgery and continued 4 times daily for 14 days. Patients were 1:1 randomized to dexa/net (eyedrops solution and eye gel) or dexamethasone/tobramycin (dexa/tobra) eyedrops suspension and ointment. Viscous formulations (gel or ointment) were used alone during the early post-operative phase; afterwards, a combination of eye drops during daytime and viscous formulations at bedtime was adopted. The primary efficacy parameter evaluated was bulbar conjunctival hyperemia. Additional efficacy and safety parameters (palpebral conjunctival hyperemia, anterior chamber flare and cells, symptoms of ocular discomfort and ocular tolerance, adverse events and intraocular pressure) were also evaluated. Control visits were performed at day 1, day 4 and day 14 after surgery; the endpoint of the study was set at 14±2 days after surgery.
A complete resolution of bulbar conjunctiva hyperaemia at the study end point was reached in 92.9% of patients treated with dexa/net and 75.0% of those treated with dexa/tobra (p=0.02, Fisher's exact test). No differences were observed between treatments for other efficacy parameters. Statistically significant differences in favour of dexa/net (p< 0.0001, ANOVA) were observed for most of subjective tolerance variables examined (blurred vision, foreign body sensation, stickiness, burning) starting day 1 after surgery when only the viscous formulations were used. No increase in intraocular pressure or adverse events was observed during the study.
The combination dexa/net is safe and effective in the treatment of post-operative inflammation following sutureless MIVS. In particular, the use of eye gel formulation is characterized by a great tolerability.
评估地塞米松/奈替米星（dexa/net）固定复方制剂在无缝合微切口玻璃体视网膜手术（MIVS）后治疗眼部炎症的效果。
这项多中心、开放、随机、活性对照、平行组临床试验在意大利的6个地点开展。治疗于手术当天开始，每天进行4次，持续14天。患者按1:1随机分为dexa/net组（滴眼液溶液和眼凝胶）或地塞米松/妥布霉素（dexa/tobra）滴眼液混悬液和眼膏组。在术后早期单独使用粘性制剂（凝胶或眼膏）；之后，采用白天滴眼药水、睡前使用粘性制剂的联合用药方式。评估的主要疗效参数为球结膜充血。还评估了其他疗效和安全性参数（睑结膜充血、前房闪光和细胞、眼部不适症状和眼部耐受性、不良事件和眼压）。术后第1天、第4天和第14天进行对照访视；研究终点设定为术后14±2天。
使用dexa/net治疗的患者中有92.9%在研究终点时球结膜充血完全消退，而使用dexa/tobra治疗的患者中这一比例为75.0%（p = 0.02，Fisher精确检验）。在其他疗效参数方面，各治疗组之间未观察到差异。在术后第1天仅使用粘性制剂时，对于所检查的大多数主观耐受性变量（视力模糊、异物感、粘性、烧灼感），观察到dexa/net组具有统计学显著优势（p < 0.0001，方差分析）。在研究期间未观察到眼压升高或不良事件。
dexa/net复方制剂在治疗无缝合MIVS术后炎症方面安全有效。特别是，眼凝胶制剂的使用具有良好的耐受性。
