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辅助玻璃体内注射贝伐单抗预防增生性糖尿病视网膜病变玻璃体切割术后出血的效果。

The effect of adjunctive intravitreal bevacizumab for preventing postvitrectomy hemorrhage in proliferative diabetic retinopathy.

机构信息

Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea.

出版信息

Ophthalmology. 2011 Nov;118(11):2218-26. doi: 10.1016/j.ophtha.2011.03.036. Epub 2011 Jul 2.

DOI:10.1016/j.ophtha.2011.03.036
PMID:21724263
Abstract

OBJECTIVE

To assess the effects of preoperative and intraoperative intravitreal bevacizumab (IVB) injection on the incidence of postoperative vitreous hemorrhage (VH) after vitrectomy for proliferative diabetic retinopathy (PDR).

DESIGN

Prospective, randomized, clinical trial.

PARTICIPANTS

One hundred seven eyes of 91 patients undergoing pars plana vitrectomy (PPV) for the management of PDR-related complications were enrolled.

METHODS

One hundred seven cases were assigned randomly to either group 1 (intravitreal 1.25 mg/0.05 ml bevacizumab injection 1 to 14 days before PPV), group 2 (intravitreal 1.25 mg/0.05 ml bevacizumab injection at the end of PPV), or group 3 (no IVB injection).

MAIN OUTCOME MEASURES

The primary outcome was the incidence of early (≤ 4 weeks) and late (> 4 weeks) recurrent VH. Secondary outcome measures were the initial time of vitreous clearing (ITVC) and best-corrected visual acuity (BCVA) at 6 months after surgery.

RESULTS

The incidences of early recurrent VH were 22.2%, 10.8%, and 32.4% in groups 1, 2, and 3, respectively (P = 0.087). A subgroup pairwise analysis showed significantly decreased early VH incidence in group 2 compared with that of group 3 (P = 0.026). The incidences of late recurrent VH were 11.1%, 16.2%, and 14.7% in groups 1, 2, and 3, respectively (P = 0.813). The ITVC in groups 1, 2, and 3 were 26.4 ± 42.5 days, 10.3 ± 8.2 days, and 25.2 ± 26.1 days, respectively. The ITVC was significantly shorter in group 2 compared with that in groups 1 and 3 (P = 0.045 and P = 0.015, respectively). The BCVA at 6 months after surgery did not differ significantly among the 3 groups (P = 0.418).

CONCLUSIONS

This study found no substantial evidence to support the adjunctive use of preoperative IVB to reduce postoperative recurrence of VH in vitrectomy for PDR. For select cases in which adjunctive IVB use is considered, intraoperative administration seems to be the better option for reducing postoperative VH.

FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

摘要

目的

评估增生性糖尿病视网膜病变(PDR)患者行玻璃体切除术(PPV)前和术中玻璃体内注射贝伐单抗(IVB)对术后玻璃体积血(VH)发生率的影响。

设计

前瞻性、随机、临床试验。

参与者

纳入 91 例 107 只眼,这些患者因 PDR 相关并发症行 PPV 治疗。

方法

107 例患者被随机分为 3 组:1 组(术前 1 至 14 天玻璃体腔内注射 1.25 mg/0.05 ml 贝伐单抗)、2 组(PPV 结束时玻璃体腔内注射 1.25 mg/0.05 ml 贝伐单抗)或 3 组(未行 IVB 注射)。

主要观察指标

主要结局为早期(≤4 周)和晚期(>4 周)复发性 VH 的发生率。次要结局指标为术后 6 个月时的初始玻璃体清除时间(ITVC)和最佳矫正视力(BCVA)。

结果

1 组、2 组和 3 组的早期复发性 VH 发生率分别为 22.2%、10.8%和 32.4%(P = 0.087)。亚组两两比较显示,2 组早期 VH 发生率明显低于 3 组(P = 0.026)。1 组、2 组和 3 组的晚期复发性 VH 发生率分别为 11.1%、16.2%和 14.7%(P = 0.813)。1 组、2 组和 3 组的 ITVC 分别为 26.4 ± 42.5 天、10.3 ± 8.2 天和 25.2 ± 26.1 天。2 组的 ITVC 明显短于 1 组和 3 组(P = 0.045 和 P = 0.015)。术后 6 个月时,3 组间 BCVA 差异无统计学意义(P = 0.418)。

结论

本研究未发现有充分证据支持在 PPV 治疗 PDR 中术前 IVB 辅助治疗可降低术后 VH 复发。对于考虑辅助 IVB 使用的特定病例,术中给药似乎是降低术后 VH 的更好选择。

利益冲突

作者未声明任何与本文内容相关的经济利益。

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