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[玻璃体内溶解剂奥克纤溶酶的临床评估]

[Clinical evaluation of ocriplasmin as a vitreolytic agent].

作者信息

Li Luxi, Du Hongjun, Li Manhong, Hui Yannian

机构信息

Department of Ophthalmology, Xijing Hospital, The Fourth Military Medical University, The Eye Institute of PLA, Xi'an 710032, China.

Department of Ophthalmology, Xijing Hospital, The Fourth Military Medical University, The Eye Institute of PLA, Xi'an 710032, China. Email:

出版信息

Zhonghua Yan Ke Za Zhi. 2015 Feb;51(2):155-60.

PMID:25908008
Abstract

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.

摘要

不完全性黄斑区后玻璃体脱离(PVD)合并异常玻璃体黄斑粘连(VMA)可导致玻璃体黄斑牵引(VMT)和黄斑裂孔(MH)形成,这需要进行玻璃体切割术治疗。药物性玻璃体溶解术,即玻璃体内注射玻璃体溶解酶以松解VMA,可作为一种替代疗法。奥克纤溶酶,以前称为微纤溶酶,是一种重组截短形式的纤溶酶,对纤连蛋白和层粘连蛋白具有蛋白水解活性。它最近在欧盟和美国被批准用于治疗VMA。III期研究表明,注射奥克纤溶酶对部分有症状的VMA和MH病例是一种安全有效的治疗方法。注射奥克纤溶酶的眼中有26.5%实现了VMA松解,而安慰剂组为10.1%。MH闭合率为40.6%,而安慰剂组为10.6%。与玻璃体切割术后的结果相比,奥克纤溶酶的成功率仍远低于预期。眼部不良事件包括玻璃体混浊、闪光感和严重视力下降。其疗效和安全性需要在更多的临床试验中进一步评估。

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