当前位置: X-MOL 学术Ophthalmology › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
A Dosing Study of Bevacizumab for Retinopathy of Prematurity
Ophthalmology ( IF 13.7 ) Pub Date : 2018-06-07 , DOI: 10.1016/j.ophtha.2018.05.001
David K. Wallace , Trevano W. Dean , Mary Elizabeth Hartnett , Lingkun Kong , Lois E. Smith , G. Baker Hubbard , Mary Lou McGregor , Catherine O. Jordan , Iason S. Mantagos , Edward F. Bell , Raymond T. Kraker

Purpose

Intravitreal bevacizumab is increasingly used to treat severe retinopathy of prematurity (ROP), but it enters the bloodstream, and there is concern that it may alter development of other organs. Previously we reported short-term outcomes of 61 infants enrolled in a dose de-escalation study, and we report the late recurrences and additional treatments.

Design

Masked, multicenter, dose de-escalation study.

Participants

A total of 61 premature infants with type 1 ROP.

Methods

If type 1 ROP was bilateral at enrollment, then the study eye was randomly selected. In the study eye, bevacizumab intravitreal injections were given at de-escalating doses of 0.25 mg, 0.125 mg, 0.063 mg, or 0.031 mg; if needed, fellow eyes received 1 dose level higher: 0.625 mg, 0.25 mg, 0.125 mg, or 0.063 mg, respectively. After 4 weeks, additional treatment was at the discretion of the investigator.

Main Outcome Measures

Early and late ROP recurrences, additional treatments, and structural outcomes after 6 months.

Results

Of 61 study eyes, 25 (41%; 95% confidence interval [CI], 29%–54%) received additional treatment: 3 (5%; 95% CI, 1%–14%) for early failure (within 4 weeks), 11 (18%; 95% CI, 9%–30%) for late recurrence of ROP (after 4 weeks), and 11 (18%; 95% CI, 9%–30%) for persistent avascular retina. Re-treatment for early failure or late recurrence occurred in 2 of 11 eyes (18%; 95% CI, 2%–52%) treated with 0.25 mg, 4 of 16 eyes (25%; 95% CI, 7%–52%) treated with 0.125 mg, 8 of 24 eyes (33%; 95% CI, 16%–55%) treated with 0.063 mg, and 0 (0%; 95% CI, 0%–31%) of 10 eyes treated with 0.031 mg. By 6 months corrected age, 56 of 61 study eyes had regression of ROP with normal posterior poles, 1 study eye had developed a Stage 5 retinal detachment, and 4 infants had died of preexisting medical conditions.

Conclusions

Retinal structural outcomes are very good after low-dose bevacizumab treatment for ROP, although many eyes received additional treatment.



中文翻译:

贝伐单抗治疗早产儿视网膜病变的剂量研究

目的

玻璃体内贝伐单抗已被越来越多地用于治疗严重的早产儿视网膜病变(ROP),但它进入血液,并且可能会改变其他器官的发育。以前,我们报告了参加降剂量研究的61例婴儿的短期结局,并报告了晚期复发和其他治疗方法。

设计

屏蔽的多中心剂量降低研究。

参加者

共有61名1型ROP早产儿。

方法

如果1型ROP在入组时是双侧的,则随机选择研究用眼。在研究眼中,贝伐单抗玻璃体内注射的降级剂量为0.25 mg,0.125 mg,0.063 mg或0.031 mg;如果需要,另一只眼睛的剂量要高1级:分别为0.625 mg,0.25 mg,0.125 mg或0.063 mg。4周后,研究者可以决定是否接受其他治疗。

主要观察指标

6个月后早期和晚期ROP复发,其他治疗和结构性结局。

结果

在61只研究眼中,有25只(41%; 95%可信区间[CI],29%–54%)接受了额外的治疗:3只(5%; 95%CI,1%–14%)因早期衰竭(在4周内) ),晚期ROP复发(4周后)为11(18%; 95%CI,9%–30%),而持久性无血管视网膜则为11(18%; 95%CI,9%–30%)。0.25 mg,16眼中的4眼(25%; 95%CI,7%–52)经0.25 mg治疗的11眼中有2眼(18%; 95%CI,2%–52%)发生了早期失败或晚期复发的再治疗%)用0.125 mg治疗,用0.063 mg治疗24只眼中的8只(33%; 95%CI,16%–55%),用10只眼睛治疗0(0%; 95%CI,0%–31%)与0.031毫克。到校正后的6个月大时,61只研究眼中有56只具有后极正常的ROP消退,1只研究眼已发展为5期视网膜脱离,4例婴儿死于既往疾病。

结论

小剂量贝伐单抗治疗ROP后的视网膜结构结局非常好,尽管许多眼睛接受了额外的治疗。

更新日期:2018-06-07
down
wechat
bug