在1+PRN方案下光动力疗法、玻璃体内注射雷珠单抗及联合治疗息肉状脉络膜血管病变的疗效比较
Comparison of the effects of photodynamic therapy, intravitreal ranibizumab and combination for polypoidal choroidal vasculopathy under 1 + PRN regimen.
作者信息
Lai Kunbei, Li Ying, Zhou Lijun, Zhong Xiaojin, Huang Chuangxin, Xu Fabao, Lu Lin, Ge Jian, Jin Chenjin
机构信息
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, 54 South Xianlie Road, Guangzhou, 510060, China.
出版信息
BMC Ophthalmol. 2018 Jun 20;18(1):144. doi: 10.1186/s12886-018-0801-7.
BACKGROUND
The optimal treatment for polypoidal choroidal vasculopathy (PCV) is still under debate. Little knowledge is known about the treatment effect of "1+pro re nata(PRN)" treatment regimen for PCV. The aim of this study was to compare the outcomes of photodynamic therapy (PDT), intravitreal ranibizumab injection (IVR) and combination therapy under the "1 + PRN" treatment regimen for PCV.
METHODS
Fifty-seven eyes of 57 patients completed the 12 months' follow-up in this prospective study. The patients in the PDT arm(n = 23), ranibizumab arm(n = 18), or combination arm(n = 16) underwent a session of PDT, IVR or combination of both at baseline followed by additional IVR as needed. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT) and the regression rate of polyps were evaluated. Cost-benefit analysis was also performed.
RESULTS
At Month 12, the mean logMAR VA improved from 0.90 ± 0.52 to 0.75 ± 0.57 in the PDT group (P < 0.05), from 0.96 ± 0.58 to 0.77 ± 0.41 in the IVR group (P < 0.05), and from 0.94 ± 0.55 to 0.72 ± 0.44 in the combination group (P < 0.05), respectively. The CFT decreased from 478.04 ± 156.70 μm, 527.5 ± 195.90 μm, and 522.63 ± 288.40 μm at the baseline to 366.43 ± 148.28 μm, 373.17 ± 134.88 μm and 328.44 ± 103.25 in the PDT group (P < 0.05), IVR group (P < 0.01), and the combination group (P < 0.05), respectively. However, no statistical difference was found between groups (P > 0.05). PDT treatment (60.87%) was superior to the IVR therapy (22.22%) in achieving complete regression of polyps (P < 0.05). Cost-benefit analysis showed that IVR treatment cost the least money for improving per 0.1logMAR units and the combination therapy demanded the least money for reducing per 100 μm of CFT.
CONCLUSIONS
PDT, IVR and the combination therapy have similar efficacy in the VA improvement as well as the reduction of CFT under the "1 + PRN" treatment regimen.
TRIAL REGISTRATION
Current Controlled Trials NCT03459144 . Registered retrospectively on March 2, 2018.
背景
息肉样脉络膜血管病变（PCV）的最佳治疗方案仍存在争议。对于PCV的“1+按需（PRN）”治疗方案的治疗效果知之甚少。本研究的目的是比较光动力疗法（PDT）、玻璃体内注射雷珠单抗（IVR）以及PCV“1+PRN”治疗方案下联合治疗的效果。
方法
57例患者的57只眼完成了这项前瞻性研究中的12个月随访。PDT组（n=23）、雷珠单抗组（n=18）或联合治疗组（n=16）的患者在基线时接受了一次PDT、IVR或两者联合治疗，随后根据需要进行额外的IVR治疗。评估最小分辨角对数（logMAR）视力（VA）、中心凹厚度（CFT）的平均变化以及息肉的消退率。还进行了成本效益分析。
结果
在第12个月时，PDT组的平均logMAR VA从0.90±0.52提高到0.75±0.57（P<0.05），IVR组从0.96±0.58提高到0.77±0.41（P<0.05），联合治疗组从0.94±0.55提高到0.72±0.44（P<0.05）。CFT在PDT组从基线时的478.04±156.70μm、IVR组的527.5±195.90μm和联合治疗组的522.63±288.40μm分别降至366.43±148.28μm、373.17±134.88μm和328.44±103.25μm（PDT组P<0.05，IVR组P<0.01，联合治疗组P<0.05）。然而，组间未发现统计学差异（P>0.05）。在实现息肉完全消退方面，PDT治疗（60.87%）优于IVR治疗（22.22%）（P<0.05）。成本效益分析表明，IVR治疗改善每0.1logMAR单位花费最少，联合治疗降低每100μm CFT花费最少。
结论
在“1+PRN”治疗方案下，PDT、IVR和联合治疗在改善视力以及降低CFT方面具有相似的疗效。
试验注册
当前受控试验NCT03459144。于2018年3月2日进行回顾性注册。
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