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阿柏西普与雷珠单抗治疗并延长方案治疗中心性视网膜静脉阻塞的注射频率:一项随机临床试验。

INJECTION FREQUENCY OF AFLIBERCEPT VERSUS RANIBIZUMAB IN A TREAT-AND-EXTEND REGIMEN FOR CENTRAL RETINAL VEIN OCCLUSION: A Randomized Clinical Trial.

机构信息

Karolinska Institutet, St. Erik Eye Hospital, Stockholm, Sweden.

出版信息

Retina. 2019 Jul;39(7):1370-1376. doi: 10.1097/IAE.0000000000002171.

Abstract

PURPOSE

To prospectively investigate the injection frequency of aflibercept and ranibizumab in the treatment of macular edema in central retinal vein occlusion.

METHODS

Patients with treatment-naive central retinal vein occlusion and macular edema were randomized to receive intravitreal injections with aflibercept (n = 22) or ranibizumab (n = 23) in a treat-and-extend regimen with a follow-up time of 18 months. After 3 loading doses, the treatment intervals were extended by 2 weeks to a maximum of 12 weeks. Intervals were shortened by 2 weeks if macular edema recurred.

RESULTS

The number of injections was significantly lower in the aflibercept group with a mean of 10.9 injections (95% confidence interval, 9.6-12.3) compared with 14.4 in the ranibizumab group (95% confidence interval 12.7-16.1) at study completion (P = 0.0017). The mean treatment interval was significantly longer in the aflibercept group compared with the ranibizumab group 10.0 (95% confidence interval, 8.7-11.3) and 6.6 (95% confidence interval, 5.2-8.0) weeks, respectively (P < 0.001). No significant difference between the groups regarding visual acuity or central retinal thickness was observed.

CONCLUSION

Patients with macular edema secondary to central retinal vein occlusion required significantly fewer intravitreal injections of aflibercept compared with ranibizumab when treated with a treat-and-extend regimen. This may reduce the treatment burden and, to some extent, the need for close monitoring of patients.

摘要

目的

前瞻性研究玻璃体内注射阿柏西普和雷珠单抗治疗视网膜中央静脉阻塞性黄斑水肿的注射频率。

方法

将未经治疗的视网膜中央静脉阻塞伴黄斑水肿患者随机分为玻璃体内注射阿柏西普(n = 22)或雷珠单抗(n = 23)组,均采用治疗和延长方案,随访时间为 18 个月。在 3 个负荷剂量后,将治疗间隔延长 2 周,最长可达 12 周。如果黄斑水肿复发,则将间隔缩短 2 周。

结果

与雷珠单抗组(95%置信区间 12.7-16.1)相比,阿柏西普组的注射次数明显减少,平均为 10.9 次(95%置信区间 9.6-12.3),研究结束时差异具有统计学意义(P = 0.0017)。与雷珠单抗组相比,阿柏西普组的平均治疗间隔明显延长,分别为 10.0(95%置信区间 8.7-11.3)和 6.6(95%置信区间 5.2-8.0)周,差异具有统计学意义(P < 0.001)。两组间视力或中心视网膜厚度无显著差异。

结论

与雷珠单抗相比,采用治疗和延长方案治疗视网膜中央静脉阻塞性黄斑水肿时,阿柏西普玻璃体内注射次数明显减少。这可能会降低治疗负担,并在一定程度上减少对患者的密切监测。

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