Institute of Ocular Pharmacology, School of Ophthalmology and Optometry, Wenzhou Medical College, Wenzhou, Zhejiang, China.
Retina. 2012 Feb;32(2):364-74. doi: 10.1097/IAE.0b013e31821e1f7c.
To characterize the safety profile of triamcinolone acetonide (TA) for intraocular application.
In vitro cell viability assay was performed on 2 types of human ocular cells to evaluate the cytotoxicity of the simulated different vitreal concentrations (from a 1:15 dilution as if injected into 1.5 mL of rabbit vitreous to 1:50 dilution as if injected into 5 mL of human vitreous) of preservative and excipient (supernatant) from Kenalog-40. In vivo 35 guinea pigs were used for evaluating either a dose of intravitreal triamcinolone acetonide (Kenalog-40 and Triesence) or the supernatant of Kenalog-40. The animal eyes were monitored by biomicroscopy, ophthalmoscopy, tonometry, electroretinography, and histology.
A ≥ 1:15 dilution of triamcinolone acetonide supernatant from Kenalog-40 did not show cytotoxicity on cultured human pigment epithelial (retinal pigment epithelium) cells or Müller cells. In vivo, neither intravitreal 6 μL (0.248 mg, equivalent to 4 mg in 0.1 mL for human eyes) nor 18 μL (0.744 mg, equivalent to 4 mg in 0.1 mL for rabbit eyes and equivalent to 12 mg in 0.1 mL for human eyes) of triamcinolone acetonide suspension showed ocular toxicity. No significant difference was noted between Kenalog-40 and Triesence clinically and histopathologically.
The equivalent triamcinolone acetonide doses to 0.1 mL (4 or 12 mg) intravitreal injection for human eye were found safe in guinea pig eyes. No significant difference was noted for 0.1 mL intravitreal injection between Kenalog-40 and Triesence.
描述曲安奈德（TA）用于眼内应用的安全性概况。
通过体外细胞活力测定，评估模拟不同玻璃体内浓度（从相当于向 1.5 mL 兔玻璃体内注射的 1:15 稀释，到相当于向 5 mL 人玻璃体内注射的 1:50 稀释）的防腐剂和赋形剂（上清液）对 2 种人眼细胞的细胞毒性。将 35 只豚鼠用于评估玻璃体内曲安奈德（Kenalog-40 和 Triesence）的剂量或 Kenalog-40 的上清液。通过生物显微镜、眼底镜、眼压计、视网膜电图和组织学监测动物眼睛。
Kenalog-40 的曲安奈德上清液的 ≥1:15 稀释液在培养的人色素上皮（视网膜色素上皮）细胞或 Müller 细胞上没有显示细胞毒性。在体内，6 μL（0.248 mg，相当于 4 mg 在 0.1 mL 用于人眼）或 18 μL（0.744 mg，相当于 4 mg 在 0.1 mL 用于兔眼，相当于 12 mg 在 0.1 mL 用于人眼）的曲安奈德混悬液均未显示眼毒性。临床上和组织病理学上，Kenalog-40 和 Triesence 之间没有明显差异。
在豚鼠眼中，相当于 0.1 mL（4 或 12 mg）玻璃体内注射的曲安奈德剂量是安全的。0.1 mL 玻璃体内注射时，Kenalog-40 和 Triesence 之间没有明显差异。
