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玻璃体内注射贝伐单抗(阿瓦斯汀)治疗持续性弥漫性糖尿病性黄斑水肿。

Intravitreal bevacizumab (Avastin) therapy for persistent diffuse diabetic macular edema.

作者信息

Haritoglou Christos, Kook Daniel, Neubauer Aljoscha, Wolf Armin, Priglinger Siegfried, Strauss Rupert, Gandorfer Arnd, Ulbig Michael, Kampik Anselm

机构信息

Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.

出版信息

Retina. 2006 Nov-Dec;26(9):999-1005. doi: 10.1097/01.iae.0000247165.38655.bf.

Abstract

PURPOSE

To evaluate the efficacy of bevacizumab (Avastin; Genentech, Inc., South San Francisco, CA) for the treatment of diabetic macular edema.

METHODS

This prospective, consecutive, noncomparative case series included 51 consecutive patients (26 females and 25 males; mean age, 64 years) with diffuse diabetic macular edema. Inclusion criteria were determined independently of the size of edema, retinal thickness, visual acuity, age, metabolic control, type of diabetes, or previous treatments beyond a 6-month period. At each visit, patients underwent complete eye examination, including determination of best-corrected visual acuity, slit-lamp examination, intraocular pressure measurement, stereoscopic biomicroscopy of the macula, retinal thickness measurement by optical coherence tomography, fluorescein angiography, and fundus photography. After written informed consent was obtained, all patients were treated with a 0.05-mL injection containing 1.25 mg of bevacizumab.

RESULTS

All patients completed 6 weeks of follow-up; 23 (45%) completed 12 weeks of follow-up. Sixteen patients (70%) had received at least two intravitreal injections. All patients had undergone previous treatments, such as focal laser therapy (35%), full-scatter panretinal laser therapy (37%), vitrectomy (12%), and intravitreal injection of triamcinolone (33%). The mean diameter of the foveal avascular zone was 503 micro m, with 49% with values of >500 micro m. At baseline, mean visual acuity +/- SD was 25.88 +/- 14.43 ETDRS letters (0.86 +/- 0.38 logMAR of Snellen letters). Mean central retinal thickness by optical coherence tomography +/- SD was 501 +/- 163 micro m (range, 252-1,031 micro m). Mean visual acuity +/- SD increased to 0.75 +/- 0.37 logMAR of Snellen letters at 6 weeks after injection (P = 0.001), with some regression to 0.84 +/- 0.41 logMAR of Snellen letters after 12 weeks. Changes in ETDRS letters were not significant throughout follow-up. Mean retinal thickness +/- SD decreased to 425 +/- 180 micro m at 2 weeks (P = 0.002), 416 +/- 180 micro m at 6 weeks (P = 0.001), and 377 +/- 117 micro m at 12 weeks (P = 0.001). Changes of retinal thickness and visual acuity correlated weakly (r = -0.480 and P = 0.03 at 6 weeks; r = -0.462 and P = 0.07 at 12 weeks). The increase of visual acuity after 6 weeks as measured by ETDRS charts could be predicted best by baseline visual acuity. No other factors investigated, such as age, thickness by optical coherence tomography, or previous treatments, were predictive for the increase in visual acuity.

CONCLUSION

Even in cases of diffuse diabetic macular edema not responding to previous treatments such as photocoagulation, intravitreal injection of triamcinolone, or vitrectomy, improvement of visual acuity and decrease of retinal thickness could be observed after intravitreal injection of bevacizumab. Although our follow-up period was too short to provide specific treatment recommendations, the short-term results encourage further prospective studies with different treatment groups and longer follow-up.

摘要

目的

评估贝伐单抗(阿瓦斯汀;基因泰克公司,加利福尼亚州南旧金山)治疗糖尿病性黄斑水肿的疗效。

方法

本前瞻性、连续性、非对照病例系列研究纳入了51例连续性弥漫性糖尿病性黄斑水肿患者(26例女性和25例男性;平均年龄64岁)。纳入标准的确定与水肿大小、视网膜厚度、视力、年龄、代谢控制情况、糖尿病类型或6个月以上的既往治疗无关。每次就诊时,患者均接受全面眼部检查,包括测定最佳矫正视力、裂隙灯检查、眼压测量、黄斑区立体生物显微镜检查、光学相干断层扫描测量视网膜厚度、荧光素血管造影及眼底照相。在获得书面知情同意后,所有患者均接受含1.25mg贝伐单抗的0.05mL注射治疗。

结果

所有患者均完成了6周的随访;23例(45%)完成了12周的随访。16例患者(70%)接受了至少两次玻璃体内注射。所有患者均接受过既往治疗,如局部激光治疗(35%)、全视网膜光凝(37%)、玻璃体切除术(12%)及玻璃体内注射曲安奈德(33%)。黄斑无血管区平均直径为503μm,49%的患者直径>500μm。基线时,平均视力±标准差为25.88±14.43 ETDRS字母(Snellen字母的0.86±0.38 logMAR)。光学相干断层扫描测量的平均中心视网膜厚度±标准差为501±163μm(范围252 - 1031μm)。注射后6周时,平均视力±标准差提高至Snellen字母的0.75±0.37 logMAR(P = 0.001),12周后部分回退至0.84±0.41 logMAR。整个随访期间ETDRS字母变化无统计学意义。平均视网膜厚度±标准差在2周时降至425±180μm(P = 0.002),6周时降至416±180μm(P = 0.001),12周时降至377±117μm(P = 0.001)。视网膜厚度和视力变化的相关性较弱(6周时r = -0.480,P = 0.03;12周时r = -0.462,P = 0.07)。ETDRS图表测量的6周后视力提高情况最好由基线视力预测。所研究的其他因素,如年龄、光学相干断层扫描测量的厚度或既往治疗,均不能预测视力提高情况。

结论

即使是对既往光凝、玻璃体内注射曲安奈德或玻璃体切除术等治疗无反应的弥漫性糖尿病性黄斑水肿病例,玻璃体内注射贝伐单抗后仍可观察到视力改善和视网膜厚度降低。尽管我们的随访期过短,无法提供具体的治疗建议,但短期结果鼓励开展不同治疗组和更长随访期的进一步前瞻性研究。

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