OPHTHALMOLOGY:雷珠单抗后早期或后期激光治疗的比较
2012-11-29 OPHTHALMOLOGY OPHTHALMOLOGY
11月《眼科学》Ophthalmology发表的一篇文章提到:糖尿病视网膜病变临床研究网络的 3 年结果表明,与后期(至少 24 周以后)激光治疗相比,糖尿病性黄斑水肿(DME) 中央凹受累视力下降的患者接受玻璃体腔注射 ranibizumab 后,早期(注射后7到10天)局灶/格栅样激光的视力恢复效果并不优于后期激光治疗,
11月《眼科学》Ophthalmology发表的一篇文章提到:糖尿病视网膜病变临床研究网络的 3 年结果表明,与后期(至少 24 周以后)激光治疗相比,糖尿病性黄斑水肿(DME) 中央凹受累视力下降的患者接受玻璃体腔注射 ranibizumab 后,早期(注射后7到10天)局灶/格栅样激光的视力恢复效果并不优于后期激光治疗,甚至可能更差。这项研究包括 361 例累及中央凹的 DME 患者,视力 20/32~20/320。3 年随访后,后期激光治疗组平均预期视力提高,积分比早期激光组高 2.9 个字母。早期和后期激光组视力提高 ≥10 个字母的比率分别为 42% 和 56%,视力下降10 个字母的比率分别为 10% 和 5%。2 组间视力恢复的差异,可能与早期激光组需要的 ranibizumab 累计注射次数较少相关。这些患者还将随访到第 5 年。(aaojournal)
Objective
To report the 3-year follow-up results within a previously reported randomized trial evaluating prompt versus deferred (for ≥24 weeks) focal/grid laser treatment in eyes treated with intravitreal 0.5 mg ranibizumab for diabetic macular edema (DME).
Design
Multicenter, randomized clinical trial.
Participants
Three hundred sixty-one participants with visual acuity of 20/32 to 20/320 (approximate Snellen equivalent) and DME involving the fovea.
Methods
Ranibizumab every 4 weeks until no longer improving (with resumption if worsening) and random assignment to prompt or deferred (≥24 weeks) focal/grid laser treatment.
Main Outcome Measures
Best-corrected visual acuity and safety at the 156-week (3-year) visit.
Result
The estimated mean change in visual acuity letter score from baseline through the 3-year visit was 2.9 letters more (9.7 vs. 6.8 letters; mean difference, 2.9 letters; 95% confidence interval, 0.4–5.4 letters; P = 0.02) in the deferral group compared with the prompt laser treatment group. In the prompt laser treatment group and deferral group, respectively, the percentage of eyes with a ≥10-letter gain/loss was 42% and 56% (P = 0.02), whereas the respective percentage of eyes with a ≥10-letter gain/loss was 10% and 5% (P = 0.12). Up to the 3-year visit, the median numbers of injections were 12 and 15 in the prompt and deferral groups, respectively (P = 0.007), including 1 and 2 injections, respectively, from the 2-year up to the 3-year visit. At the 3-year visit, the percentages of eyes with central subfield thickness of 250 μm or more on time-domain optical coherence tomography were 36% in both groups (P = 0.90). In the deferral group, 54% did not receive laser treatment during the trial. Systemic adverse events seemed to be similar in the 2 groups.
Conclusions
These 3-year results suggest that focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better, and possibly worse, for vision outcomes than deferring laser treatment for 24 weeks or more in eyes with DME involving the fovea and with vision impairment. Some of the observed differences in visual acuity at 3 years may be related to fewer cumulative ranibizumab injections during follow-up in the prompt laser treatment group. Follow-up through 5 years continues.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found after the references.
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#光治疗#
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#激光#
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#激光治疗#
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#雷珠单抗#
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#THA#
68