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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：雷尼单抗用于预防质子束辐照治疗脉络膜黑色素瘤患者的放射并发症（美国眼科学会论文）

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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：研究兰尼单抗预防以质子辐照治疗脉络膜黑色素瘤患者的放射并发症的安全性和潜在疗效方法：将40例肿瘤位于视神经和/或黄斑直径2个椎间盘直径内的患者纳入研究。标签研究。参与者在肿瘤定位时接受兰尼单抗0.5 mg或1.0 mg，此后每2个月接受24个月的研究。评估了与放射并发症相关的不良事件，视敏度和其他眼病发病率的发生率。收集符合类似肿瘤大小，位置和基线视敏度标准的类似随访的历史对照进行比较。结果：招募了15例大肿瘤患者和25例中小肿瘤患者。 24名患者在24个月内完成了就诊。没有观察到与兰尼单抗相关的严重的眼部或全身不良事件。在24个月时，研究组视力≥20/200的患者比例为30/31（97％），而历史对照组为92/205（45％）（P <.001）。研究组在24个月时视力≥20/ 40的患者比例为24/31（77％），而对照组为46/205（22％）（P <.001）。在有中小肿瘤的8/24（33％）患者中观察到在24个月时发生放射性黄斑病的临床证据，而在对照组中则为42/62（68％）（P = .004）。 3名大肿瘤患者发生转移。结论：在这项小型先导研究中，预防性兰尼单抗在接受质子辐照治疗脉络膜黑色素瘤的患者中通常是安全的。在2年内观察到很高的视力保留率。

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