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单纯小梁切除术与小梁切除术联合玻璃体内注射贝伐单抗治疗的比较:一项为期 2 年的研究。

Trabeculectomy with mitomycin C alone or coupled with intracamerular bevacizumab? A 2-year comparative study.

机构信息

Ophthalmology, Centro Hospitalar Lisboa Norte, Lisboa, Portugal

Ophthalmology University Clinic, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.

出版信息

Br J Ophthalmol. 2022 Oct;106(10):1399-1405. doi: 10.1136/bjophthalmol-2021-319039. Epub 2021 Apr 30.

Abstract

PURPOSE

To compare outcomes of primary trabeculectomy using either mitomycin C (MMC) alone versus MMC augmented with intracamerular bevacizumab in patients with open-angle glaucoma.

METHODS

Retrospective, cohort, two-centre, comparative study. Patients' data were screened between October 2015 and March 2019, with inclusion requiring a minimum follow-up of 24 months. Primary outcome was intraocular pressure (IOP) lowering at 24 months, with surgical success defined with different maximum IOP targets (≤18, ≤16 and ≤14 mm Hg) and at least 30% reduction and higher than 5 mm Hg. Absolute success was achieved if no IOP-lowering medication was needed and a qualified success if otherwise. Safety outcomes were analysed.

RESULTS

A total of 110 eyes underwent trabeculectomy with MMC, 51 of these combined with intracamerular bevacizumab. Both strategies were effective in terms of IOP lowering (baseline vs 2 years postoperatively: 24.4 (8.0) mm Hg vs 12.1 (5.3) mm Hg in the MMC group; 25.1 (8.7) vs 10.8 (3.8) mm Hg in the MMC+bevacizumab group; p<0.001 in both comparisons). The MMC+bevacizumab group had a significant difference towards higher efficacy on absolute success rates at all targets (IOP≤14 or ≤16 or ≤18 mm Hg; p=0.010, p=0.039 and p=0.007, respectively). The large majority (93%) of the MMC+bevacizumab group was drop-free at 24 months, and 41% had IOP below 10 mm Hg. Complication rates were low and similar between groups, with no systemic adverse events.

CONCLUSIONS

Intracamerular bevacizumab in MMC-augmented primary trabeculectomy increases the chances of obtaining low IOP outcomes. This strategy may be useful when planning for surgeries aiming at target pressures in the low teens.

TRIAL REGISTRATION NUMBER

ISRCTN93098069.

摘要

目的

比较原发性小梁切开术中单独使用丝裂霉素 C(MMC)与 MMC 联合房内注射贝伐单抗治疗开角型青光眼的疗效。

方法

回顾性、队列、双中心比较研究。2015 年 10 月至 2019 年 3 月期间筛选患者数据,要求至少随访 24 个月。主要观察指标为 24 个月时眼压(IOP)降低情况,手术成功的定义为不同最大 IOP 目标(≤18mmHg、≤16mmHg 和≤14mmHg)下IOP 降低至少 30%,且至少降低 5mmHg。如果无需使用降眼压药物则判定为绝对成功,如果需要使用降眼压药物则判定为合格成功。分析安全性结果。

结果

共 110 只眼行小梁切开术联合 MMC,其中 51 只眼联合房内注射贝伐单抗。两种方法在降低 IOP 方面均有效(MMC 组:基线 vs 术后 2 年:24.4(8.0)mmHg vs 12.1(5.3)mmHg;MMC+贝伐单抗组:25.1(8.7)mmHg vs 10.8(3.8)mmHg;p<0.001,两组比较均如此)。在所有目标(IOP≤14mmHg、≤16mmHg 或≤18mmHg)下,MMC+贝伐单抗组的绝对成功率均显著更高(p=0.010、p=0.039 和 p=0.007)。24 个月时,MMC+贝伐单抗组绝大多数(93%)患者无需滴眼剂,41%患者的 IOP 低于 10mmHg。两组的并发症发生率均较低且相似,无全身不良事件。

结论

在 MMC 增强的原发性小梁切开术中房内注射贝伐单抗可增加获得低 IOP 结果的机会。当计划进行眼压目标为 10 年代的手术时,这种策略可能是有用的。

试验注册号

ISRCTN93098069。

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