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康柏西普与雷珠单抗治疗糖尿病性黄斑水肿12个月的疗效比较:一项真实世界临床实践研究

Comparison of 12-month therapeutic effect of conbercept and ranibizumab for diabetic macular edema: a real-life clinical practice study.

作者信息

Xu Yule, Rong Ao, Xu Wei, Niu Yunli, Wang Zhen

机构信息

Department of Ophthalmology, Tongji Hospital, Tongji University School of Medicine, 389 Xincun Road, Shanghai, 200065, China.

出版信息

BMC Ophthalmol. 2017 Aug 25;17(1):158. doi: 10.1186/s12886-017-0554-8.

Abstract

BACKGROUND

To compare the efficacy of intravitreal conbercept and ranibizumab in the treatment of diabetic macular edema (DME) in a real-life clinical practice.

METHODS

This was a retrospective study. Among 62 Chinese patients with DME, 32 patients (36 eyes) received intravitreal conbercept (IVC) injections and 30 patients (32 eyes) received intravitreal ranibizumab (IVR) injections, once a month for 3 months followed by as needed therapy. All participants had at least 12 months of follow-up. We compared the changes in best-corrected visual acuity (BCVA) letter score and central retinal thickness (CRT) between groups, as well as the number of intravitreal injections delivered. Safety was assessed with the incidence of adverse events (AEs).

RESULTS

At month 12, the mean BCVA letter score improved by 9.3 ± 5.2 with conbercept, and by 8.9 ± 4.4 with ranibizumab, the mean CRT reduction was 138.4 ± 97.7 μm and 145.2 ± 72.5 μm, respectively. There was no statistically significant difference of improvement in BCVA (P = 0.756) and decrease in CRT (P = 0.748) between the two groups. The number of intravitreal injections delivered was significantly higher (P = 0.027) in the IVR group (7.2 ± 1.0 per eye) than in the IVC group (6.6 ± 0.9 per eye). There were no severe ocular adverse reactions or systemic adverse events.

CONCLUSIONS

Both conbercept and ranibizumab are effective in the treatment of DME, achieving the similar clinical efficacy. In comparison to ranibizumab, conbercept shows a longer treatment interval and fewer intravitreal conbercept injections are needed.

摘要

背景

在实际临床实践中比较玻璃体内注射康柏西普和雷珠单抗治疗糖尿病性黄斑水肿(DME)的疗效。

方法

这是一项回顾性研究。62例中国DME患者中,32例患者(36只眼)接受玻璃体内注射康柏西普(IVC),30例患者(32只眼)接受玻璃体内注射雷珠单抗(IVR),每月注射1次,共3个月,之后按需治疗。所有参与者均接受至少12个月的随访。我们比较了两组之间最佳矫正视力(BCVA)字母评分和中心视网膜厚度(CRT)的变化,以及玻璃体内注射次数。通过不良事件(AE)发生率评估安全性。

结果

在第12个月时,康柏西普组的平均BCVA字母评分提高了9.3±5.2,雷珠单抗组提高了8.9±4.4,平均CRT分别降低了138.4±97.7μm和145.2±72.5μm。两组之间BCVA改善情况(P = 0.756)和CRT降低情况(P = 0.748)无统计学显著差异。IVR组(每只眼7.2±1.0次)的玻璃体内注射次数显著高于IVC组(每只眼6.6±0.9次)(P = 0.027)。未发生严重眼部不良反应或全身不良事件。

结论

康柏西普和雷珠单抗治疗DME均有效,临床疗效相似。与雷珠单抗相比,康柏西普治疗间隔更长,所需玻璃体内注射次数更少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c893/6389086/307cf1097589/12886_2017_554_Fig1_HTML.jpg

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