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抗血管内皮生长因子治疗湿性年龄相关性黄斑变性中雷珠单抗负荷剂量后再次治疗适应证的观察者间变异性。

Interobserver variability for retreatment indications after Ranibizumab loading doses in neovascular age-related macular degeneration.

机构信息

University Eye Hospital Regensburg, Germany University Eye Hospital Bern, Switzerland.

出版信息

Acta Ophthalmol. 2012 Feb;90(1):49-55. doi: 10.1111/j.1755-3768.2010.01940.x. Epub 2010 Aug 17.

Abstract

PURPOSE

To assess the interobserver variability (IOV) in indicating retreatment for neovascular Age-related macular degeneration 4 weeks after three Ranibizumab loading doses using spectral domain OCT (SD-OCT) as the primary objective diagnostic tool.

MATERIAL AND METHODS

Four observers decided for or against 4th Ranibizumab injection in 108 patients by six different rating rounds (RR) based on the SD-OCT findings after the loading doses. Postoperative OCT images were supplemented consecutively with information from a chart review as the 'patients subjective estimation of vision (SE)', the course of best-corrected visual acuity (BCVA) and the preoperative OCT as well as all information collectively. Agreement rates (AR) and Kappa statistics were calculated.

RESULTS

Based on post-treatment OCT findings only (RR1), mean reinjection rate of all observers was 37.5%. Adding supplementary information, mean reinjection rate decreased to 20% when all information was available reflecting the 'real' situation (RR 6). Interobserver agreement rates varied from 66.7% to 90.7% depending on rating rounds and interobserver pairs. Mean AR and Kappa values (KV) were as following: AR 81.6%, KV 0.61 (RR1: 'only post-OP OCT'); AR 76.7%, KV 0.33 (RR2: post-OP OCT + SE); AR 80.3%, KV 0.45 (RR3: post-OP OCT + BCVA); AR 80.7%, KV 0.46 (RR4: pre- and post-OP OCT); AR 82.2%, KV 0.49 (RR5: post-OP OCT + SE + BCVA); and finally AR 83.6%, KV 0.47 (RR6: pre- and post-OP OCT + SE + BCVA). The overall mean agreement rate was 80.9% with a Kappa of 0.47.

CONCLUSION

IOV for indicating retreatment after three Ranibizumab loading doses reveals only moderate agreement in Kappa statistics, which seems to be too low considering the high costs for retreatments. More concise guidelines based on the post-treatment OCT scans as the presumably most sensitive and noninvasive objective tool to follow choroidal neovascularization activity by judging the course of sub- and intraretinal fluid are necessary.

摘要

目的

评估使用谱域光相干断层扫描(SD-OCT)作为主要诊断工具,在雷珠单抗负荷剂量后 4 周评估新生血管性年龄相关性黄斑变性(nAMD)患者是否需要再次治疗的观察者间变异性(IOV)。

材料与方法

4 位观察者通过 6 轮不同的评分轮次(RR),根据负荷剂量后 SD-OCT 检查结果,对 108 例患者是否进行第 4 次雷珠单抗注射做出决定。术后 OCT 图像依次补充了图表回顾中的信息,即“患者主观视力评估(SE)”、最佳矫正视力(BCVA)的变化和术前 OCT 以及所有信息的综合结果。计算了一致率(AR)和 Kappa 统计量。

结果

仅根据治疗后 OCT 检查结果(RR1),所有观察者的平均再注射率为 37.5%。当所有信息都可用时,即反映“真实”情况时(RR6),再注射率降低至 20%。观察者间的一致性率从 66.7%到 90.7%不等,具体取决于评分轮次和观察者对。平均 AR 和 Kappa 值(KV)如下:AR81.6%,KV0.61(RR1:“仅术后 OCT”);AR76.7%,KV0.33(RR2:术后 OCT+SE);AR80.3%,KV0.45(RR3:术后 OCT+BCVA);AR80.7%,KV0.46(RR4:术前和术后 OCT);AR82.2%,KV0.49(RR5:术后 OCT+SE+BCVA);最后 AR83.6%,KV0.47(RR6:术前和术后 OCT+SE+BCVA)。总的平均一致性率为 80.9%,Kappa 值为 0.47。

结论

在雷珠单抗负荷剂量治疗后,再次治疗的观察者间变异性仅在 Kappa 统计方面显示出中度一致性,考虑到再次治疗的高成本,这似乎过低。需要制定更简洁的指南,基于治疗后 OCT 扫描作为评估脉络膜新生血管活动的最敏感和非侵入性的客观工具,通过判断脉络膜新生血管活动的亚临床和视网膜内液体的变化来指导治疗。

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