重组微纤溶酶Ocriplasmin作为玻璃体溶解剂的临床评估

Clinical evaluation of ocriplasmin as a vitreolytic agent

旁中心凹不完全的后玻璃体脱离伴异常的玻璃体黄斑粘连,可引起玻璃体黄斑牵拉和黄斑裂孔等病变,需要行玻璃体切除术治疗.药物玻璃体溶解术,即向玻璃体内注射酶类解除粘连,可以作为替代疗法.Ocriplasmin原称微纤溶酶,是一种重组、截短的纤溶酶,具有针对纤维连接蛋白和层黏连蛋白的水解活性,已获得美国以及欧洲等国家批准用于治疗玻璃体黄斑粘连.多种临床研究结果提示其治疗经过选择的有症状玻璃体黄斑粘连和黄斑裂孔患者是安全和有效的,但与玻璃体切除术比较,其存在成功率低于期待、眼部不良反应（包括玻璃体漂浮物、闪光、视力明显下降）多等缺点,有效性有待进一步证实或提高,安全性值得关注,需要进行更多的临床试验加以评估.

Incomplete perifoveal posterior vitreous detachment （PVD） associated with abnormal vitreomacular adhesion （VMA） can cause vitreomacular traction （VMT） and macular hole（MH） formation,which require vitrectomy treatment.Pharmacologic vitreolysis,which is intravitreal injection with vitreolytic enzymes to resolve VMA,may be used as an alternative therapy.Ocriplasmin,formerly known as microplasmin,is a recombinant truncated form of plasmin with proteolytic activity against fibronectin and laminin.It was recently approved for VMA treatment in the European Union and USA.Phase Ⅲ studies indicated that ocriplasmin injection was a safe and effective treatment for selected cases of symptomatic VMA and MH.VMA release was achieved in 26.5% of ocriplasmin-injected eyes versus 10.1% of the placebo group.MH closure was achieved in 40.6% as compared with 10.6% of the placebo group.In comparison with the outcome after vitrectomy,the success rate of ocriplasmin was still far below expectation.Ocular adverse events included vitreous floaters,photopsia and profound visual decline.Its efficacy and safety need to be further evaluated in more clinical trials.