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玻璃体内注射贝伐单抗联合/不联合曲安奈德单次注射治疗糖尿病黄斑水肿。

Intravitreal bevacizumab combined with/without triamcinolone acetonide in single injection for treatment of diabetic macular edema.

机构信息

Department of Ophthalmology, the Eye Institute of People's Liberation Army, Xijing Hospital, Fourth Military Medical University, Xi'an, Shannxi 710032, China.

出版信息

Chin Med J (Engl). 2011 Feb;124(3):352-8.

Abstract

BACKGROUND

Diabetic macular edema (DME) is a common manifestation of diabetic retinopathy (DR) that forms the main cause of central visual impairment. This study aimed to compare the efficacy and safety of a single intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone acetonide in eyes with diabetic macular edema (DME).

METHODS

A total of 40 eyes in 40 Chinese patients (22 male and 18 female) diagnosed with diabetic macular edema were enrolled in this prospective, randomized, consecutive study. Among them, 21 patients in group 1 were treated with intravitreal injection of bevacizumab (1.25 mg/0.05 ml), and the other 19 patients in group 2 accepted intravitreal bavacizumab (1.25 mg/0.05 ml) combined with triamcinolone acetonide (2 mg/0.05 ml). All patients were examined at baseline and followed up at 4, 6 and 12 weeks after the injection. Changes in mean best correct visual acuity (BCVA) using ETDRS chart, central retina thickness (CRT) measured by optical coherence tomography (OCT), and intraocular pressure (IOP) were focused on.

RESULTS

In group 1, mean BCVA improved from (41.76 ± 15.59) letters (baseline) to (56.24 ± 18.56) letters, (52.57 ± 12.31) letters and (48.41 ± 17.90) letters at 4, 6 and 12 weeks post-injection, respectively (P = 0.004, P = 0.011 and P = 0.026, respectively). Mean CRT decreased from (525.76 ± 184.10) µm (baseline) to (270.33 ± 202.67)µm, (303.12 ± 168.43) µm and (402.26 ± 196.21) µm, respectively (P = 0.009, P = 0.016 and P = 0.030, respectively). In group 2, mean BCVA improved from (39.89 ± 12.27) letters (baseline) to (55.31 ± 19.27) letters, (51.25 ± 13.48) letters and (46.97 ± 16.23) letters at 4, 6 and 12 weeks after injection, respectively (P = 0.003, P = 0.010 and P = 0.027, respectively). Mean CRT decreased from (554.50 ± 169.05) µm (baseline) to (292.76 ± 196.05) µm, (323.46 ± 164.05) µm and (426.38 ± 169.05) µm, respectively (P = 0.009, P = 0.014 and P = 0.028, respectively). However, there was no significant difference between these two groups with regard to mean BCVA (F = 1.602, P = 0.216) and CRT (F = 0.412, P = 0.526). At 12 weeks after the injection, 11 of the patients in group 1 and nine patients in group 2 appeared recurrent macular edema and needed repeat injections. There was one patient in group 2 appeared transient intraocular pressure increases.

CONCLUSIONS

Intravitreal injection of bevacizumab combined with/without triamcinolone acetonide had a beneficial effect on DME. However, the significant effect was not permanent. Our results showed that no significant differences were detected between intravitreal bevacizumab combined with/without triamcinolone acetonide for the eyes with diabetic macular edema in Chinese patients.

摘要

背景

糖尿病性黄斑水肿(DME)是糖尿病性视网膜病变(DR)的常见表现,是中央视力损害的主要原因。本研究旨在比较单纯玻璃体内注射贝伐单抗与玻璃体内注射贝伐单抗联合曲安奈德治疗糖尿病性黄斑水肿(DME)的疗效和安全性。

方法

本前瞻性、随机、连续研究纳入了 40 名被诊断为糖尿病性黄斑水肿的中国患者(22 名男性和 18 名女性)的 40 只眼。其中,第 1 组 21 例患者接受玻璃体内注射贝伐单抗(1.25mg/0.05ml),第 2 组 19 例患者接受玻璃体内注射贝伐单抗(1.25mg/0.05ml)联合曲安奈德(2mg/0.05ml)。所有患者均在基线时进行检查,并在注射后 4、6 和 12 周进行随访。重点关注平均最佳矫正视力(BCVA)、光学相干断层扫描(OCT)测量的中心视网膜厚度(CRT)和眼压(IOP)的变化。

结果

第 1 组患者的平均 BCVA 从(41.76±15.59)个字母(基线)提高到(56.24±18.56)个字母、(52.57±12.31)个字母和(48.41±17.90)个字母,分别在注射后 4、6 和 12 周时(P=0.004,P=0.011,P=0.026)。平均 CRT 从(525.76±184.10)µm(基线)降低至(270.33±202.67)µm、(303.12±168.43)µm 和(402.26±196.21)µm,分别在注射后 4、6 和 12 周时(P=0.009,P=0.016,P=0.030)。第 2 组患者的平均 BCVA 从(39.89±12.27)个字母(基线)提高到(55.31±19.27)个字母、(51.25±13.48)个字母和(46.97±16.23)个字母,分别在注射后 4、6 和 12 周时(P=0.003,P=0.010,P=0.027)。平均 CRT 从(554.50±169.05)µm(基线)降低至(292.76±196.05)µm、(323.46±164.05)µm 和(426.38±169.05)µm,分别在注射后 4、6 和 12 周时(P=0.009,P=0.014,P=0.028)。然而,两组之间的平均 BCVA(F=1.602,P=0.216)和 CRT(F=0.412,P=0.526)没有显著差异。在注射后 12 周时,第 1 组的 11 例患者和第 2 组的 9 例患者出现复发性黄斑水肿,需要重复注射。第 2 组中有 1 例患者出现短暂性眼压升高。

结论

玻璃体内注射贝伐单抗联合/不联合曲安奈德对糖尿病性黄斑水肿均有有益的作用。然而,这种显著的效果并不持久。我们的结果表明,在中国患者的糖尿病性黄斑水肿眼中,玻璃体内注射贝伐单抗联合/不联合曲安奈德治疗没有显著差异。

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