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青光眼原发性小梁切除术术后辅助使用贝伐单抗与安慰剂的对比研究

Postoperative adjunctive bevacizumab versus placebo in primary trabeculectomy surgery for glaucoma.

作者信息

Muhsen Sana', Compan Javiera, Lai Tze, Kranemann Christoph, Birt Catherine

机构信息

Department of Ophthalmology, School of Medicine, The University of Jordan, Amman 11942, Jordan.

Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto ON M4N 3M5, Canada.

出版信息

Int J Ophthalmol. 2019 Oct 18;12(10):1567-1574. doi: 10.18240/ijo.2019.10.08. eCollection 2019.

Abstract

AIM

To compare the effectiveness of postoperative adjunctive use of subconjunctival bevacizumab in altering the outcome of primary trabeculectomy in terms of sustained lowering of intraocular pressure (IOP) and reduction of postoperative bleb vascularization and fibrosis.

METHODS

A prospective, one center, randomized, placebo-control study. Fifty-nine patients (59 eyes) with uncontrolled IOP under maximal tolerated medical treatment (MTMT) were recruited. A primary trabeculectomy with mitomycin C (MMC) was done and the patients were randomized to either postoperative subconjunctival injection of bevacizumab (1.25 mg/0.05 mL) or balanced salt solution (BSS). Forty-seven patients (47 eyes) completed at least one year of follow up and were included in the study. The main outcome measure was the IOP, and secondary outcome measures include bleb morphology, vascularization, and fibrosis, as well as the need for glaucoma medications and 5-fluorouracil (5-FU) needling.

RESULTS

At 1-year follow up, there was no significant difference between groups for IOP (=0.65), bleb morphology (=0.65), and the need for glaucoma medications (=0.65) or 5-FU needling requirements (=0.11). However, the bevacizumab group had a higher rate of success results, lower use of glaucoma medications after surgery, and optimal bleb aspect in more patients, but more 5-FU needling procedures required.

CONCLUSION

A bigger sample size is needed in order to determine whether the differences found in the bevacizumab group are statistically significant.

摘要

目的

比较结膜下注射贝伐单抗辅助原发性小梁切除术在持续降低眼压(IOP)、减少术后滤过泡血管化和纤维化方面改变手术效果的有效性。

方法

一项前瞻性、单中心、随机、安慰剂对照研究。招募了59例在最大耐受药物治疗(MTMT)下眼压控制不佳的患者(59只眼)。进行了丝裂霉素C(MMC)原发性小梁切除术,患者被随机分为术后结膜下注射贝伐单抗(1.25mg/0.05mL)或平衡盐溶液(BSS)两组。47例患者(47只眼)完成了至少一年的随访并纳入研究。主要观察指标为眼压,次要观察指标包括滤过泡形态、血管化、纤维化,以及青光眼药物需求和5-氟尿嘧啶(5-FU)针刺需求。

结果

在1年随访时,两组在眼压(P=0.65)、滤过泡形态(P=0.65)、青光眼药物需求(P=0.65)或5-FU针刺需求(P=0.11)方面无显著差异。然而,贝伐单抗组成功率更高,术后青光眼药物使用更少,更多患者的滤过泡外观最佳,但需要更多的5-FU针刺操作。

结论

需要更大样本量来确定贝伐单抗组中发现的差异是否具有统计学意义。

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