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雷珠单抗治疗糖尿病性黄斑水肿患者的长期疗效:一项为期4年的研究。

LONG-TIME OUTCOME IN PATIENTS TREATED WITH RANIBIZUMAB FOR DIABETIC MACULAR EDEMA: A 4-Year Study.

作者信息

Epstein David, Amrén Urban

机构信息

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

出版信息

Retina. 2018 Jan;38(1):183-186. doi: 10.1097/IAE.0000000000001501.

DOI:10.1097/IAE.0000000000001501
PMID:28323678
Abstract

PURPOSE

To investigate the long-time visual outcome in patients with diabetic macular edema treated with ranibizumab in an ordinary clinical setting.

METHODS

One hundred two eyes of 80 patients were followed for 4 years. All patients received a loading dose of 3 monthly ranibizumab 0.5-mg injections. From Month 3 to Month 48, patients received ranibizumab reinjections pro re nata based on disease activity.

RESULTS

Excluding deaths, the 4-year visit was completed by 82% of the study eyes. The best-corrected visual acuity improved by 6.6 Early Treatment Diabetic Retinopathy Study letters at 4 years (P < 0.001). The patients received a mean of 7.7 ± 3.4 ranibizumab injections for 4 years. The number of injections (mean ± SD) given were 4.7 (1.1), 1.4 (1.4), 0.7 (1.1), and 0.9 (1.4) during Years 1 to 4, respectively. No difference in the injections needed was seen between patients who had previously received focal/grid laser and treatment-naive subjects.

CONCLUSION

The gain in the best-corrected visual acuity achieved after the initial loading dose was sustained over time with a pro re nata regimen. The number of injections needed to maintain the best-corrected visual acuity was low during the study period.

摘要

目的

在普通临床环境中研究接受雷珠单抗治疗的糖尿病性黄斑水肿患者的长期视力预后。

方法

对80例患者的102只眼进行了4年的随访。所有患者均接受每月一次、每次0.5毫克雷珠单抗的负荷剂量注射。从第3个月到第48个月,根据疾病活动情况对患者进行雷珠单抗按需再注射。

结果

排除死亡病例后,82%的研究眼完成了4年随访。4年时最佳矫正视力提高了6.6个早期糖尿病性视网膜病变研究字母(P<0.001)。患者4年平均接受7.7±3.4次雷珠单抗注射。第1年至第4年期间,注射次数(平均值±标准差)分别为4.7(1.1)、1.4(1.4)、0.7(1.1)和0.9(1.4)。既往接受过局部/格栅样激光治疗的患者与未接受过治疗的患者在所需注射次数上未见差异。

结论

初始负荷剂量后获得的最佳矫正视力改善随着按需治疗方案随时间得以维持。在研究期间,维持最佳矫正视力所需的注射次数较少。

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