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联合药物手术治疗糖尿病性黄斑水肿:核心玻璃体切除术联合玻璃体内注射贝伐单抗和曲安奈德

[Combined pharmacosurgery as treatment for diabetic macular edema: core pars plana vitrectomy and intravitreal injection of bevacizumab and triamcinolone].

作者信息

Naser H, Koss M J, Singh P, Koch F

机构信息

Netzhaut- und Glaskörperchirurgie, Augenklinik der Goethe-Universität Frankfurt/Main.

出版信息

Klin Monbl Augenheilkd. 2011 Oct;228(10):910-4. doi: 10.1055/s-0029-1245965. Epub 2011 Oct 13.

DOI:10.1055/s-0029-1245965
PMID:21997827
Abstract

BACKGROUND

The aim of this work is to report the efficacy of a 1.5 mL core pars plana vitrectomy (cppV) combined with isovolumetric substitution with 1.25 mg bevacizumab and 8 mg triamcinolone for the treatment of diabetic macular edema (DME).

METHODS

Data of 73 eyes (60 patients; mean age: 65.4 ± 10.4 years) with diabetic macular edema were retrospectively analysed. Main outcome measures were changes in visual acuity, central macular thickness (CMT) and the need for re-intervention and further treatment modalities, i. e., laser photocoagulation (LPC) or pars plana vitrectomy (ppV). Study eyes were assigned to one of three groups: non-proliferative diabetic retinopathy without ischaemic maculopathy (NPDR I. M.; group I; n = 38 eyes); NPDR with I. M. (group II; n = 17 eyes); proliferative diabetic retinopathy with or without I. M. (group III; n = 18). Mean follow-up times were 9 weeks (T1), 25 weeks (T2) and 44 weeks.

RESULTS

Preoperative mean VA was 0.69 ± 0.4 logMAR. A statistically significant increase in mean VA was observed in all study eyes at 2 months after the initial operation (T1; 0.51 ± 0.22 logMAR; p < 0.01). This remained stable at T 2 (0.52 ± 0.33 logMAR; p = 0.6) and T 3 (0.55 ± 0.35 logMAR; p = 0.99). At baseline mean VA was 0.52 ± 0.21 logMAR in group I, 0.99 ± 0.5 logMAR in group II and 0.77 ± 0.42 logMAR in group III. At T 1 (2 months) the VA change was statistically significant in group II (0.64 ± 0.18 logMAR; p < 0.05) only. In contrast, group I had a highly significant VA gain after 6 months (0.36 ± 0.16; p < 0.01). Patients with PDR (group III) had a non-significant VA gain at T 1 (0.53 ± 0.24; p = 0.08) and remained stable at T 2 and T 3. The mean central macular thickness (CMT) in all study eyes decreased significantly from 393.7 ± 120.6 µm to 269.7 ± 100.2 µm (delta -28 %; p < 0.01) at T 1. Thereafter CMT slightly increased but, on the whole, remained stable at that level. Retreatment with the intravitreal combination therapy was performed in 20 of 73 eyes (27.4 %). Laser photocoagulation was only carried out in more than half of the eyes with PDR (10 / 18; 55.6 %). An increase in IOP was noted in 12 / 73 eyes (16.4 %) at different follow-up, and was controlled using topical medication. Systemic side effects were not reported.

CONCLUSION

Our data show that the majority of the study eyes maintained or improved their visual acuity after pharmacosurgical therapy. Furthermore we observed a reduction of the central macular thickness in almost all study eyes. Only few retreatments and other treatment modalities were needed during the follow-up period. This combind pharmacosurgical treatment may supplement current treatment standards like laser photocoagulation, classical pars plana vitrectomy or intravitreal monotherapy for DME.

摘要

背景

本研究旨在报告1.5毫升玻璃体切除术(cppV)联合1.25毫克贝伐单抗和8毫克曲安奈德等容置换治疗糖尿病性黄斑水肿(DME)的疗效。

方法

回顾性分析73例(60例患者;平均年龄:65.4±10.4岁)糖尿病性黄斑水肿患者的资料。主要观察指标为视力、黄斑中心厚度(CMT)的变化以及再次干预和进一步治疗方式的需求,即激光光凝(LPC)或玻璃体切除术(ppV)。研究眼分为三组:无缺血性黄斑病变的非增殖性糖尿病视网膜病变(NPDR I.M.;第一组;n = 38只眼);伴有I.M.的NPDR(第二组;n = 17只眼);伴有或不伴有I.M.的增殖性糖尿病视网膜病变(第三组;n = 18只眼)。平均随访时间分别为9周(T1)、25周(T2)和44周。

结果

术前平均视力为0.69±0.4 logMAR。在初次手术后2个月(T1;0.51±0.22 logMAR;p < 0.01),所有研究眼的平均视力均有统计学意义的提高。在T2(0.52±0.33 logMAR;p = 0.6)和T3(0.55±0.35 logMAR;p = 0.99)时保持稳定。基线时,第一组平均视力为0.52±0.21 logMAR,第二组为0.99±0.5 logMAR,第三组为0.77±0.42 logMAR。仅在T1(2个月)时,第二组的视力变化有统计学意义(0.64±0.18 logMAR;p < 0.05)。相比之下,第一组在6个月后视力有显著提高(0.36±0.16;p < 0.01)。增殖性糖尿病视网膜病变患者(第三组)在T1时视力提高不显著(0.53±0.24;p = 0.08),在T2和T3时保持稳定。所有研究眼的平均黄斑中心厚度(CMT)在T1时从393.7±120.6 µm显著降至269.7±100.2 µm(差值-28%;p < 0.01)。此后CMT略有增加,但总体保持在该水平稳定。73只眼中有20只(27.4%)接受了玻璃体腔联合治疗的再次治疗。仅一半以上的增殖性糖尿病视网膜病变眼(10 / 18;55.6%)进行了激光光凝。在不同随访期间,73只眼中有12只(16.4%)眼压升高,使用局部药物控制。未报告全身副作用。

结论

我们的数据表明,大多数研究眼在药物手术治疗后视力保持或改善。此外,我们观察到几乎所有研究眼的黄斑中心厚度都有所降低。随访期间仅需少量再次治疗和其他治疗方式。这种联合药物手术治疗可能补充当前治疗标准,如激光光凝、经典玻璃体切除术或玻璃体腔单一疗法治疗DME。

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