Pacella E, Pacella F, La Torre G, Impallara D, Malarska K, Brillante C, Turchetti P, De Giusti M
Department of Sense Organs, Faculty of Medicine and Dentistry, Sapienza University of Rome, Italy.
Clin Ter. 2012 Nov;163(6):e413-22.
To determine the effectiveness and safety of treatment of intravitreal Ranibizumab for Central Retinal Vein Occlusion.
This non-randomized observational clinical study was comprised of a round of therapy with three IVI. Twenty eyes affected by CRVO were recruited. The average age was 65.06 +/- 15 years and criterion for inclusion: age >18 years, best Corrected Visual Acuity (BCVA) from 5 to 40 letters and macular edema with thickness greater than 275 micrometer. The criteria used for reinjection were: CMT> 150 micrometer, ETDRS <10 letters and LogMAR <0.2. The statistical analysis for continuous variables (ETDRS, logMar and CMT) was conducted calculating median and range (min-max), since these variables, due to sample size, were not normally distributed.Time trends of these variables were plotted with boxplot and differences. Events between T0 and T12 were assessed using the analysis of variance (ANOVA) for repeated measurements and the F test (Pillai's trace). The statistical significance was set at p <=0.05.
All of the patients showed improvement. In fact, the ETDRS went from a median of 20.00 to 28.50, LogMAR went from a median of 0.75 to 0.55 and the values for CMT went from a median of 556.00 micrometer to 390.00 micrometer. The drug reaches maximum effectiveness after two months of therapy, with T2 remaining constant from the third injection at T3 until the end of 12 months at T12.
The results produced by our study indicate that Ranibizumab is a valid treatment for CRVO.
确定玻璃体内注射雷珠单抗治疗视网膜中央静脉阻塞的有效性和安全性。
这项非随机观察性临床研究包括一轮三次玻璃体内注射的治疗。招募了20只受视网膜中央静脉阻塞影响的眼睛。平均年龄为65.06±15岁，纳入标准为：年龄>18岁，最佳矫正视力（BCVA）为5至40个字母，且黄斑水肿厚度大于275微米。再次注射的标准为：中心凹视网膜厚度（CMT）>150微米，早期糖尿病性视网膜病变研究（ETDRS）视力下降<10个字母，最小分辨角对数（LogMAR）<0.2。对连续变量（ETDRS、LogMAR和CMT）进行统计分析时计算中位数和范围（最小值-最大值），因为由于样本量的原因，这些变量不呈正态分布。用箱线图和差异图绘制这些变量的时间趋势。使用重复测量的方差分析（ANOVA）和F检验（Pillai迹）评估T0和T12之间的事件。统计学显著性设定为p<=0.05。
所有患者均有改善。实际上，ETDRS从中位数20.00提高到28.50，LogMAR从中位数0.75降至0.55，CMT值从中位数556.00微米降至390.00微米。药物在治疗两个月后达到最大疗效，从第三次注射时的T2到12个月结束时的T12一直保持稳定。
我们的研究结果表明，雷珠单抗是治疗视网膜中央静脉阻塞的有效药物。
