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首页> 外文期刊>Transactions of the American Ophthalmological Society. >RANIBIZUMAB FOR THE PREVENTION OF RADIATION COMPLICATIONS IN PATIENTS TREATED WITH PROTON BEAM IRRADIATION FOR CHOROIDAL MELANOMA (AN AMERICAN OPHTHALMOLOGICAL SOCIETY THESIS)
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RANIBIZUMAB FOR THE PREVENTION OF RADIATION COMPLICATIONS IN PATIENTS TREATED WITH PROTON BEAM IRRADIATION FOR CHOROIDAL MELANOMA (AN AMERICAN OPHTHALMOLOGICAL SOCIETY THESIS)

机译：Ranibizumab用于预防对脉络膜黑色瘤（美国眼科学会）的质子束照射治疗的患者的辐射并发症

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Purpose: To investigate the safety and potential efficacy of ranibizumab for prevention of radiation complications in patients treated with proton irradiation for choroidal melanoma Methods: Forty patients with tumors located within 2 disc diameters of the optic nerve and/or macula were enrolled in this open-label study. Participants received ranibizumab 0.5 mg or 1.0 mg at tumor localization and every 2 months thereafter for the study duration of 24 months. The incidence of adverse events, visual acuity, and other measures of ocular morbidity related to radiation complications were assessed. Historical controls with similar follow-up meeting the eligibility criteria for tumor size, location, and baseline visual acuity were assembled for comparison. Results: Fifteen patients with large tumors and 25 patients with small/medium tumors were enrolled. Thirty-two patients completed the month 24 visit. No serious ocular or systemic adverse events related to ranibizumab were observed. At 24 months, the proportion of patients with visual acuity > 20/200 was 30/31 (97%) in the study group versus 92/205 (45%) in historical controls (P < .001). The proportion of patients with visual acuity >20/40 was 24/31 (77%) in the study group versus 46/205 (22%) in controls at 24 months (P<.001). Clinical evidence of radiation maculopathy at month 24 was seen in 8/24 (33%) patients with small/medium tumors versus 42/62 (68%) of controls (P = .004). Three patients with large tumors developed metastases. Conclusions: In this small pilot study, prophylactic ranibizumab appears generally safe in patients treated with proton irradiation for choroidal melanoma. High rates of visual acuity retention were observed through 2 years.
机译：目的：探讨Ranibizumab预防脉络膜瘤治疗治疗患者的辐射并发症的安全性和潜在疗效：位于视神经和/或黄斑的2个椎间盘直径内的肿瘤内的40例患者入口 - 标签研究。参与者在肿瘤本地化的肿瘤定位和每2个月内接受Ranibizumab 0.5mg或1.0mg，此后每2个月进行24个月的研究持续时间。评估不良事件，视力和其他与放射性并发症的眼镜发病措施的发生率。组装了相似随访的历史控制，满足肿瘤大小，位置和基线视力的资格标准进行比较。结果：15例大型肿瘤患者和25例小/中肿瘤患者。三十二名患者完成了24个月访问。没有观察到与Ranibizumab相关的严重眼或系统不良事件。 24个月，视力> 20/200患者的比例在研究组中为30/31（97％），而历史控制（P <.001）。在24个月的研究组中，视力> 20/40的患者的比例为24/31（77％），在24个月内对照组进行46/205（22％）（p <.001）。在8/24（33％）的小/中肿瘤患者中，42/62（68％）对照（P = .004），在8月24日（33％）患者中观察到辐射小疗病的临床证据（P = .004）。三名大肿瘤患者发育转移。结论：在这个小型试点研究中，预防性Ranibizumab在用质子辐射对脉络膜黑色素瘤治疗的患者中普遍存在。通过2年来观察到高率的视力保留率。

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