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初始与延迟光动力疗法联合雷珠单抗治疗息肉样脉络膜血管病变:富士山研究

INITIAL VERSUS DELAYED PHOTODYNAMIC THERAPY IN COMBINATION WITH RANIBIZUMAB FOR TREATMENT OF POLYPOIDAL CHOROIDAL VASCULOPATHY: The Fujisan Study.

作者信息

Gomi Fumi, Oshima Yuji, Mori Ryusaburo, Kano Mariko, Saito Masaaki, Yamashita Ayana, Iwata Eiji, Maruko Ruka

机构信息

*Department of Ophthalmology, Sumitomo Hospital, Osaka, Japan; †Department of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan; ‡Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; §Department of Ophthalmology, Surugadai Nihon University Hospital, Fukuoka, Japan; ¶Department of Ophthalmology, Fukushima Medical University, Fukuoka, Japan; **Department of Ophthalmology, Kagawa University Faculty of Medicine, Kagawa, Japan; and ††Department of Ophthalmology, Nagoya University Graduate School of Medicine, Nagoya, Japan.

出版信息

Retina. 2015 Aug;35(8):1569-76. doi: 10.1097/IAE.0000000000000526.

DOI:10.1097/IAE.0000000000000526
PMID:25830698
Abstract

PURPOSE

To compare the 1-year results of initial or deferred photodynamic therapy (PDT) combined with intravitreal ranibizumab (IVR) for eyes with polypoidal choroidal vasculopathy.

METHODS

Prospectively, 72 men with treatment-naive polypoidal choroidal vasculopathy were randomized to initial or later PDT combined with IVR. In both groups, 2 additional monthly IVR followed. From Month 3, PDT and IVR were administered according to the retreatment criteria. Mean changes in the best-corrected visual acuity between baseline and Month 12 and central retinal thickness, the rate of eyes showing regression of polypoidal lesions, and number of additional treatments were compared.

RESULTS

The best-corrected visual acuity increased by a mean of 8.1 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters in the initial PDT group and 8.8 ETDRS letters in the later PDT group, and there was a no significant difference (P = 0.59). The mean central retinal thickness decreased significantly in both groups but more so with combination therapy within the first 4 months; the difference was not significant at Month 12 (P = 0.30). The rate of eyes showing resolution of polypoidal lesions at 12 months was 62.1% in the initial PDT group and 54.8% in the later PDT group and again, there was no significant difference (P = 0.53). The mean number of additional IVR was 1.5 in initial PDT and 3.8 in later PDT; that of additional PDTs was 0.14 and 0.45, respectively, and they were significantly different (P < 0.001 and P = 0.013, respectively).

CONCLUSION

Both initial and deferred PDT combined with IVR to treat polypoidal choroidal vasculopathy show the similar visual and anatomical improvements at 12 months. Initial PDT combination leads to significantly fewer additional treatments.

摘要

目的

比较初治或延期光动力疗法(PDT)联合玻璃体内注射雷珠单抗(IVR)治疗息肉样脉络膜血管病变(PCV)眼1年的疗效。

方法

前瞻性纳入72例未经治疗的PCV男性患者,随机分为初治PDT联合IVR组或延期PDT联合IVR组。两组均在后续每月额外注射1次IVR。从第3个月起,根据再治疗标准给予PDT和IVR治疗。比较基线至第12个月最佳矫正视力(BCVA)的平均变化、中心视网膜厚度(CRT)、息肉样病变消退的眼数以及额外治疗的次数。

结果

初治PDT组BCVA平均提高8.1个糖尿病视网膜病变早期治疗研究(ETDRS)视力字母,延期PDT组提高8.8个ETDRS视力字母,差异无统计学意义(P = 0.59)。两组CRT均显著降低,但联合治疗组在前4个月降低更明显;第12个月时差异无统计学意义(P = 0.30)。初治PDT组12个月时息肉样病变消退的眼数比例为62.1%,延期PDT组为54.8%,差异无统计学意义(P = 0.53)。初治PDT组额外IVR的平均次数为1.5次,延期PDT组为3.8次;额外PDT的次数分别为0.14次和0.45次,差异有统计学意义(分别为P < 0.001和P = 0.013)。

结论

初治和延期PDT联合IVR治疗PCV在12个月时视力和解剖学改善相似。初治PDT联合治疗所需的额外治疗次数显著更少。

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