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比较雷珠单抗和维替泊芬治疗息肉样脉络膜血管病变的效果:LAPTOP 研究 12 个月结果。

Comparison of the effect of ranibizumab and verteporfin for polypoidal choroidal vasculopathy: 12-month LAPTOP study results.

机构信息

Kobe City Medical Center General Hospital, Kobe, Japan.

出版信息

Am J Ophthalmol. 2013 Oct;156(4):644-51. doi: 10.1016/j.ajo.2013.05.024. Epub 2013 Jul 20.

DOI:10.1016/j.ajo.2013.05.024
PMID:23876867
Abstract

PURPOSE

To compare the effect of photodynamic therapy (PDT) and intravitreal ranibizumab in patients with polypoidal choroidal vasculopathy (PCV).

DESIGN

Randomized clinical trial.

SETTING

Multicenter.

STUDY POPULATION

Total of 93 patients with treatment-naïve PCV.

INTERVENTION

Patients were randomized to 2 arms. Patients in the PDT arm underwent a single session of PDT with verteporfin, and patients in the ranibizumab arm received 3 monthly ranibizumab injections at baseline. Additional treatment was performed as needed in each arm.

MAIN OUTCOME MEASURES

Primary outcome measurement was the proportion of patients gaining or losing more than 0.2 logarithm of minimal angle of resolution (logMAR) units from baseline. Mean change of logMAR and central retinal thickness (CRT) were also evaluated.

RESULTS

In the PDT arm (n = 47), 17.0% achieved visual acuity gain, 55.3% had no change, and 27.7% experienced visual acuity loss. The results were 30.4%, 60.9%, and 8.7%, respectively, in the ranibizumab arm (n = 46), significantly better than the PDT arm (P = .039). In the PDT arm, mean CRT improved (366.8 ± 113.6 μm to 289.1 ± 202.3 μm, P < .001), but logMAR was unchanged (0.57 ± 0.31 to 0.62 ± 0.40). The ranibizumab arm demonstrated improvement in both CRT (418.9 ± 168.6 μm to 311.2 ± 146.9 μm, P < .001) and logMAR (0.48 ± 0.27 to 0.39 ± 0.26, P = .003). Mean change of logMAR was also greater in the ranibizumab arm (P = .011).

CONCLUSION

Intravitreal injection of ranibizumab is more effective than PDT for treatment-naïve PCV.

摘要

目的

比较光动力疗法(PDT)和玻璃体内雷珠单抗治疗息肉状脉络膜血管病变(PCV)的效果。

设计

随机临床试验。

设置

多中心。

研究人群

共 93 例未经治疗的 PCV 患者。

干预

患者随机分为 2 组。PDT 组接受单次维替泊芬 PDT,雷珠单抗组在基线时接受 3 次每月雷珠单抗注射。每个组均按需进行额外治疗。

主要观察指标

主要观察指标为从基线开始视力提高或降低超过 0.2 最小分辨角对数(logMAR)单位的患者比例。还评估了 logMAR 和中央视网膜厚度(CRT)的平均变化。

结果

在 PDT 组(n = 47)中,17.0%的患者视力提高,55.3%的患者视力无变化,27.7%的患者视力下降。雷珠单抗组(n = 46)的结果分别为 30.4%、60.9%和 8.7%,明显优于 PDT 组(P =.039)。在 PDT 组中,平均 CRT 改善(366.8 ± 113.6 μm 至 289.1 ± 202.3 μm,P <.001),但 logMAR 无变化(0.57 ± 0.31 至 0.62 ± 0.40)。雷珠单抗组 CRT(418.9 ± 168.6 μm 至 311.2 ± 146.9 μm,P <.001)和 logMAR(0.48 ± 0.27 至 0.39 ± 0.26,P =.003)均改善。雷珠单抗组 logMAR 的平均变化也更大(P =.011)。

结论

与 PDT 相比,玻璃体内雷珠单抗注射治疗未经治疗的 PCV 更有效。

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