He Miao, Wang Wei, Zhang Xiulan, Huang Wenyong
Zhongshan Ophthalmic Center, State Key Laboratory of Ophthalmology, Sun Yat-Sen University, Guangzhou, People's Republic of China.
PLoS One. 2014 Jan 20;9(1):e85782. doi: 10.1371/journal.pone.0085782. eCollection 2014.
To evaluate the application of the Ologen implant compared to mitomycin C (MMC) on the outcome of trabeculectomy and to examine the balance of risks and benefits.
A systematic literature search (Pubmed, Embase, the Cochrane Library, and the Chinese Biomedicine Database) was performed. Randomized controlled trials comparing the Ologen implant with MMC in trabeculectomy were selected. The efficacy measures were the weighted mean differences (WMDs) for the intraocular pressure reduction (IOPR), the reduction in glaucoma medications, and the relative risks (RRs) for success rates. The tolerability measures were RRs for adverse events. The pooled effects were calculated using the random-effects model.
Seven randomized controlled trials including 227 eyes were included in this meta-analysis. The WMDs of the IOPR comparing the Ologen group with the MMC group were -2.98 (95% Cl: -5.07 to -0.89) at one month, -1.41 (-3.72 to 0.91) at three months, -1.69 (-3.68 to 0.30) at six months, -1.94 (-3.88 to 0.01) at 12 months, and 0.65 (-2.17 to 0.47) at 24 months. There was no statistically significance except at one and 12 months after surgery. No significant difference in the reduction in glaucoma medications or complete and qualified success rates were found. The rates of adverse events also did not differ significantly between Ologen and MMC.
The Ologen implant is comparable with MMC for trabeculectomy in IOP-lowering efficacy, reduction in the number of glaucoma medications, success rates, and tolerability. However, the results should be interpreted cautiously since relevant evidence is still limited, although it is accumulating. Further large-scale, well-designed randomized controlled trials are urgently needed.
评估与丝裂霉素C（MMC）相比，Ologen植入物在小梁切除术中的应用效果，并探讨其风险与获益的平衡。
进行系统的文献检索（PubMed、Embase、Cochrane图书馆和中国生物医学数据库）。选取比较Ologen植入物与MMC在小梁切除术中应用的随机对照试验。疗效指标为眼压降低（IOPR）的加权平均差（WMDs）、青光眼药物使用量的减少以及成功率的相对风险（RRs）。耐受性指标为不良事件的RRs。采用随机效应模型计算合并效应。
本荟萃分析纳入了7项随机对照试验，共227只眼。Ologen组与MMC组相比，1个月时IOPR的WMD为-2.98（95%CI：-5.07至-0.89），3个月时为-1.41（-3.72至0.91），6个月时为-1.69（-3.68至0.30），12个月时为-1.94（-3.88至0.01），24个月时为0.65（-2.17至0.47）。除术后1个月和12个月外，差异无统计学意义。在青光眼药物使用量减少或完全和合格成功率方面未发现显著差异。Ologen组和MMC组不良事件发生率也无显著差异。
在降低眼压疗效、减少青光眼药物使用量、成功率和耐受性方面，Ologen植入物与MMC在小梁切除术中相当。然而，由于相关证据仍然有限，尽管在不断积累，结果仍应谨慎解释。迫切需要进一步开展大规模、设计良好的随机对照试验。
