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比较阿柏西普、贝伐单抗和雷珠单抗治疗糖尿病性黄斑水肿的随机临床试验中血压和尿白蛋白/肌酐比值的变化。

Changes in Blood Pressure and Urine Albumin-Creatinine Ratio in a Randomized Clinical Trial Comparing Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema.

机构信息

Jaeb Center for Health Research Tampa, Florida, United States.

Feinberg School of Medicine, Northwestern University, Chicago, Illinois, United States.

出版信息

Invest Ophthalmol Vis Sci. 2018 Mar 1;59(3):1199-1205. doi: 10.1167/iovs.17-22853.

Abstract

PURPOSE

To compare blood pressure and urine albumin-creatinine ratio over time for participants receiving aflibercept, bevacizumab, or ranibizumab.

METHODS

Preplanned secondary analyses from a randomized trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME). The Diabetic Retinopathy Clinical Research Network (DRCR.net) enrolled 660 participants with DME and visual acuity 20/32 or worse in at least one eye. Eyes received intravitreous injections of 2.0 mg aflibercept, 1.25 mg bevacizumab, or 0.3 mg ranibizumab based on a structured retreatment protocol over 2 years. Main outcome measures were (1) a change in blood pressure at 2 years, and (2) a change in urine albumin-creatinine ratio (UACR) at 1 year.

RESULTS

At baseline, 95 participants (14%) had normal blood pressure, 220 (33%) had borderline blood pressure elevation, 206 (31%) had mild blood pressure elevation, and 139 (21%) had moderate blood pressure elevation. Average change in mean arterial pressure from baseline to 2 years was -1.2 ± 15, -1.8 ± 13.5, -2.6 ± 14.4 mm Hg in the aflibercept, bevacizumab, and ranibizumab groups, respectively (global P = 0.69). At baseline 247 participants (38%) had no albuminuria (<30 mg/g), 195 (30%) had microalbuminuria (30-300 mg/g), and 212 (32%) had macroalbuminuria (>300 mg/g). Changes in UACR category were not different among treatment groups at the 52-week visit (global P = 0.29).

CONCLUSIONS

There do not appear to be treatment group differences for changes in blood pressure or UACR as a reflection of kidney function in patients with DME treated with aflibercept, bevacizumab, or ranibizumab.

摘要

目的

比较接受阿柏西普、贝伐珠单抗或雷珠单抗治疗的患者的血压和尿白蛋白/肌酐比值随时间的变化。

方法

这是一项比较糖尿病黄斑水肿(DME)中阿柏西普、贝伐珠单抗和雷珠单抗疗效的随机试验的预先计划的二次分析。DRCR.net 共纳入了 660 例患有 DME 且至少一眼视力在 20/32 或更差的患者。根据 2 年的结构化再治疗方案,这些眼分别接受玻璃体腔内注射 2.0mg 阿柏西普、1.25mg 贝伐珠单抗或 0.3mg 雷珠单抗。主要观察指标为:(1)2 年时血压的变化;(2)1 年时尿白蛋白/肌酐比值(UACR)的变化。

结果

在基线时,95 例(14%)患者血压正常,220 例(33%)患者血压边缘升高,206 例(31%)患者血压轻度升高,139 例(21%)患者血压中度升高。从基线到 2 年时平均动脉压的平均变化分别为:阿柏西普、贝伐珠单抗和雷珠单抗组分别为-1.2±15、-1.8±13.5、-2.6±14.4mmHg(总体 P=0.69)。在基线时,247 例(38%)患者无白蛋白尿(<30mg/g),195 例(30%)患者微量白蛋白尿(30-300mg/g),212 例(32%)患者大量白蛋白尿(>300mg/g)。在 52 周时,各组之间 UACR 类别的变化无差异(总体 P=0.29)。

结论

在接受阿柏西普、贝伐珠单抗或雷珠单抗治疗的 DME 患者中,血压或 UACR 的变化似乎没有治疗组差异,这反映了肾功能的变化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6874/5837671/658eabad8be7/i1552-5783-59-3-1199-f01.jpg

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