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Intracameral bevacizumab as an adjunct to trabeculectomy: A 1-year prospective, randomised study

机译:前房内贝伐单抗作为小梁切除术的辅助手段:一项为期1年的前瞻性随机研究

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Aims: To investigate the efficacy and safety of a single intracameral bevacizumab injection to improve the outcome of trabeculectomy. Methods: A 12-month, prospective, randomised, double-masked, placebo-controlled trial. Patients with medically uncontrolled open-angle glaucoma scheduled for a primary trabeculectomy were recruited and randomised to receive 50 mL of either bevacizumab (1.25 mg) or placebo (balanced salt solution) peroperatively. Absolute success was defined as intraocular pressure (IOP) ≤18 mm Hg and >5 mm Hg with at least 30% reduction from baseline and no loss of light perception. Success through the use of additional medical and/or surgical IOP-lowering treatments was defined as qualified success. Results: 138 patients completed a 12-month follow-up, 69 of whom were in the bevacizumab treated group. IOP at 1 year postoperatively was significantly lower than baseline ( placebo: 25.6±9.9 mm Hg vs 11.5 ±3.9 mm Hg, p<0.01; bevacizumab: 24.8±8.1 mm Hg vs 11.9±3.8 mm Hg, p<0.01), with no difference between treatment groups ( p=0.69). However, absolute success was higher in the bevacizumab group (71% vs 51%, p=0.02), with the need for IOP-lowering interventions (needlings) being lower in this group (12% vs 33%, p=0.003). Complication rates were low and comparable between groups. Conclusions: Peroperative administration of intracameral bevacizumab significantly reduces the need for additional interventions during the follow-up of patients undergoing trabeculectomy.
机译:目的:探讨单次前房贝伐单抗注射改善小梁切除术的疗效和安全性。方法:一项为期12个月的前瞻性,随机,双盲,安慰剂对照试验。招募计划进行原发性小梁切除术的医学上不受控制的开角型青光眼患者,并随机接受手术期间接受50 mL贝伐单抗(1.25 mg)或安慰剂(平衡盐溶液)。绝对成功定义为眼内压(IOP)≤18 mm Hg和> 5 mm Hg,与基线相比降低至少30%,并且不会损失光感。通过使用其他降低IOP的医疗和/或外科手术获得的成功被定义为合格的成功。结果:138例患者完成了12个月的随访,其中69例属于贝伐单抗治疗组。术后1年的IOP明显低于基线(安慰剂:25.6±9.9 mm Hg vs 11.5±3.9 mm Hg,p <0.01;贝伐单抗:24.8±8.1 mm Hg vs 11.9±3.8 mm Hg,p <0.01),无治疗组之间的差异(p = 0.69)。但是,贝伐单抗组的绝对成功率更高(71%比51%,p = 0.02),而降低IOP干预(针)的需要量较低(12%vs 33%,p = 0.003)。并发症发生率低,各组之间可比。结论:对小梁切除术患者进行随访时,术前给予腔内贝伐单抗可明显减少对其他干预措施的需求。

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