Real J P, Luna J D, Palma S D
Unidad de Investigación y Desarrollo en Tecnología Farmacéutica (UNITEFA), CONICET and Departamento de Ciencias Farmacéuticas, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Ciudad Universitaria, 5000, Córdoba, Argentina.
Vitreo-Retinal Department, Centro Privado de Ojos Romagosa SA - Fundación VER, Deán Funes 429/432, Córdoba, Argentina.
Graefes Arch Clin Exp Ophthalmol. 2018 Jun;256(6):1079-1087. doi: 10.1007/s00417-018-3974-0. Epub 2018 Apr 19.
Summarize and compare the available evidence on the reactivation times in patients with age-related macular degeneration treated with Ranibizumab (RNB).
Systematic review of studies that reported the reactivation time of patients (direct method) or the number of injections received in a certain period of follow-up (indirect method).
Only 18 of 89 selected studies reported the average reactivation time of patients in a manifest form, without the need of any calculation. The average calculated, weighted reactivation time was 101.8 days with the direct method and 99.8 days in the indirect method (84 studies included). With both methods, it was found that the average reactivation time of the RCTs was between 2 and 3 weeks less than the average time identified in the observational studies. These differences are also reflected in the clinical results, there being a correlation between the number of doses received and the change in BCVA. The analysis of 11 comparative studies showed a difference in reactivation times between patients treated with RNB or Bevacizumab (BVZ).
There are few direct studies of reactivation time, but calculation from the PRN dose number turns out to be a good approximation for retrospective study of the variable. The use of the PRN, with criteria not based on optical coherence tomography scans, delays the application of doses between 2 or 3 weeks, and patients suffer loss of clinical benefits. RNB enables patients to receive less injections than BVZ throughout treatment.
总结并比较使用雷珠单抗（RNB）治疗的年龄相关性黄斑变性患者再激活时间的现有证据。
对报告患者再激活时间（直接法）或特定随访期内注射次数（间接法）的研究进行系统评价。
在89项入选研究中，只有18项以明确形式报告了患者的平均再激活时间，无需任何计算。直接法计算的加权平均再激活时间为101.8天，间接法为99.8天（纳入84项研究）。两种方法均发现，随机对照试验的平均再激活时间比观察性研究确定的平均时间少2至3周。这些差异也反映在临床结果中，即接受的剂量数与最佳矫正视力变化之间存在相关性。对11项比较研究的分析显示，接受RNB或贝伐单抗（BVZ）治疗的患者在再激活时间上存在差异。
关于再激活时间的直接研究较少，但根据按需给药剂量数进行计算对于该变量的回顾性研究是一个很好的近似值。使用不基于光学相干断层扫描的标准按需给药会使给药延迟2至3周，患者会因此失去临床获益。在整个治疗过程中，RNB使患者接受的注射次数比BVZ少。
