Ghassemi Fariba, Sheibani Shahab, Arjmand Mojtaba, Poorbaygi Hosein, Kouhestani Emad, Sabour Siamak, Samiei Farhad, Beiki-Ardakani Akbar, Jabarvand Mahmood, Sadeghi Tari Ali
Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, IR, Iran.
Retina & Vitreous Service, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, IR, Iran.
Clin Ophthalmol. 2020 Feb 4;14:339-346. doi: 10.2147/OPTH.S235265. eCollection 2020.
To compare iodine-125 (I) with ruthenium-106 (Ru) episcleral plaque radiation therapy in terms of the effectiveness and non-inferiority for choroidal melanoma treatment.
To report the non-inferiority of new made iodine-125 (I) compared with ruthenium-106 (Ru) episcleral plaque radiation.
A retrospective, non-randomized comparative case series. In this series the patients treated with I and Ru episcleral plaques for choroidal melanoma between September 2013 and August 2017 at Farabi Hospital are compared. Local control of choroidal melanomas after I and Ru plaques implantation and vision changes are the main outcome measures.
A total of 35 patients were identified (I = 15, Ru = 20). No significant difference between two groups in visual acuity, diameter and thickness changes were observed after treatment. Multivariate linear regression (MLR) analysis showed that final diameter was only, independently and significantly, correlated with the pre-treatment diameter of the tumor (β = 0.59, 95% confidence interval [CI]: 0.29, 1.34, P = 0.003). The same MLR analysis for the final thickness and visual acuity, after adjusting for age and sex showed no significant difference between two groups. A single patient treated with Ru had local tumor recurrence with no one in the I group. No statistical difference in the rate of ocular complications was observed.
The treatment with our I plaques is as effective as Ru plaques in controlling choroidal melanoma tumor and preserving the vision during the two and half year of follow-up. The complication rates are alike. It means that the effectiveness of I is not only comparable to Ru but also superior when the outcome of the interest is the thickness of the tumors.
比较碘 - 125（I）与钌 - 106（Ru）巩膜外斑块放射治疗脉络膜黑色素瘤的有效性和非劣效性。
报告新制备的碘 - 125（I）与钌 - 106（Ru）巩膜外斑块放射治疗的非劣效性。
一项回顾性、非随机对照病例系列研究。比较2013年9月至2017年8月在法拉比医院接受I和Ru巩膜外斑块治疗的脉络膜黑色素瘤患者。I和Ru斑块植入后脉络膜黑色素瘤的局部控制情况以及视力变化是主要观察指标。
共纳入35例患者（I组15例，Ru组20例）。治疗后两组在视力、肿瘤直径和厚度变化方面未观察到显著差异。多因素线性回归（MLR）分析显示，最终肿瘤直径仅独立且显著地与治疗前肿瘤直径相关（β = 0.59，95%置信区间[CI]：0.29，1.34，P = 0.003）。在调整年龄和性别后，对最终肿瘤厚度和视力进行的相同MLR分析显示两组之间无显著差异。Ru组有1例患者出现局部肿瘤复发，I组无复发。两组眼部并发症发生率无统计学差异。
在两年半的随访期间，我们使用I斑块进行治疗在控制脉络膜黑色素瘤肿瘤和保留视力方面与Ru斑块同样有效。并发症发生率相似。这意味着当关注的结果是肿瘤厚度时，I的有效性不仅与Ru相当，而且更优。
