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奥洛根植入物与丝裂霉素C在原发性小梁切除术中的疗效与安全性:一项随机临床试验的荟萃分析

Efficacy and Safety of Ologen Implant Versus Mitomycin C in Primary Trabeculectomy: A Meta-analysis of Randomized Clinical Trials.

作者信息

Ji Qingshan, Qi Bing, Liu Lian, Guo Xiaoling, Zhong Jingxiang

机构信息

*Department of Ophthalmology, Affiliated Anhui Provincial Hospital of Anhui Medical University, Hefei †Department of Ophthalmology, the First Affiliated Hospital of Jinan University ‡Department of Cell Biology, the Cell Biology Institute of Jinan University, Guangzhou, China.

出版信息

J Glaucoma. 2015 Jun-Jul;24(5):e88-94. doi: 10.1097/IJG.0000000000000147.

DOI:10.1097/IJG.0000000000000147
PMID:25264995
Abstract

PURPOSE

To assess the efficacy and safety of trabeculectomy with Ologen implant versus trabeculectomy with mitomycin C (MMC) for treatment of glaucoma.

PATIENTS AND METHODS

Medline, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, and Google Scholar were searched for relevant randomized controlled trials. The outcome measures of efficacy were intraocular pressure and glaucoma medications reductions, and success rate. Safety estimates were measured by relative ratio for complications.

RESULTS

A total of 6 studies including 224 participants were included in this meta-analysis. Ologen implant was associated with a numerically lower but nonsignificant percentage reduction in IOP compared with MMC. The pooled absolute IOP decreases from baseline (95% confidence interval) were: 13.28 mm Hg (11.33-15.23 mm Hg) versus 15.8 mm Hg (13.21-18.38 mm Hg) at 1 month; 12.95 mm Hg (11.45-14.44 mm Hg) versus 13.87 mm Hg (11.77-15.97 mm Hg) at 3 months; 11.44 mm Hg (8.77-14.11 mm Hg) versus 13.34 mm Hg (11.48-15.20 mm Hg) at 6 months; 10.05 mm Hg (7.14-12.96 mm Hg) versus 11.59 mm Hg (10.27-12.91 mm Hg) at 12 months; and 12.17 mm Hg (8.88-15.47 mm Hg) versus 10.64 mm Hg (8.15-13.12 mm Hg) at 24 months for Ologen implant versus MMC, respectively. There was no significant difference in the reduction in glaucoma medications, success rate, and incidence of complications.

CONCLUSIONS

Trabeculectomy with an Ologen implant is comparable to the use of MMC with a similar long-term success rate. However, it does not seem to offer significant advantages of avoiding the potential complications related to MMC.

摘要

目的

评估采用Ologen植入物的小梁切除术与采用丝裂霉素C(MMC)的小梁切除术治疗青光眼的疗效和安全性。

患者与方法

检索Medline、EMBASE、科学引文索引、Cochrane对照试验中心注册库和谷歌学术,查找相关随机对照试验。疗效的结局指标为眼压降低、青光眼药物使用减少情况及成功率。安全性评估通过并发症的相对比率进行衡量。

结果

本荟萃分析共纳入6项研究,包括224名参与者。与MMC相比,Ologen植入物使眼压降低的百分比在数值上更低,但差异无统计学意义。Ologen植入物与MMC相比,术后1个月时,眼压从基线下降的合并绝对值(95%置信区间)分别为:13.28 mmHg(11.33 - 15.23 mmHg)与15.8 mmHg(13.21 - 18.38 mmHg);3个月时为12.95 mmHg(11.45 - 14.44 mmHg)与13.87 mmHg(11.77 - 15.97 mmHg);6个月时为11.44 mmHg(8.77 - 14.11 mmHg)与13.34 mmHg(11.48 - 15.20 mmHg);12个月时为10.05 mmHg(7.14 - 12.96 mmHg)与11.59 mmHg(10.27 - 12.91 mmHg);24个月时为12.17 mmHg(8.88 - 15.47 mmHg)与10.64 mmHg(8.15 - 13.12 mmHg)。青光眼药物使用减少情况、成功率及并发症发生率方面无显著差异。

结论

采用Ologen植入物的小梁切除术与使用MMC的小梁切除术效果相当,长期成功率相似。然而,它似乎并未在避免与MMC相关的潜在并发症方面具有显著优势。

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