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碘125近距离放疗与脉络膜黑色素瘤眼球摘除术后的生活质量:协作性眼黑色素瘤研究的5年结果:COMS QOLS报告第3号

Quality of life after iodine 125 brachytherapy vs enucleation for choroidal melanoma: 5-year results from the Collaborative Ocular Melanoma Study: COMS QOLS Report No. 3.

作者信息

Melia Michele, Moy Claudia S, Reynolds Sandra M, Hayman James A, Murray Timothy G, Hovland Kenneth R, Earle John D, Kurinij Natalie, Dong Li Ming, Miskala Päivi H, Fountain Connie, Cella David, Mangione Carol M

机构信息

Wilmer Ophthalmological Institute, Johns Hopkins University, Baltimore, MD, USA.

出版信息

Arch Ophthalmol. 2006 Feb;124(2):226-38. doi: 10.1001/archopht.124.2.226.

Abstract

OBJECTIVE

To describe health- and vision-targeted quality of life following treatment with iodine 125 brachytherapy vs enucleation for choroidal melanoma in a subgroup of patients who were treated and observed prospectively as part of a large randomized clinical trial.

MAIN OUTCOME MEASURES

Difficulty with driving, near vision activities, and activities using stereopsis or binocularity; anxiety; and depression.

PARTICIPANTS

Two hundred nine patients who enrolled in the Collaborative Ocular Melanoma Study trial for medium-sized tumors between March 1995 and July 1998 and gave informed consent prior to randomization to participation in an ancillary study of quality of life.

METHODS

Patients were interviewed by telephone by a trained interviewer from the Collaborative Ocular Melanoma Study Coordinating Center at baseline (prior to randomization), at 6 months, and on annual anniversaries of enrollment. The questionnaire battery included the Medical Outcomes Study Short Form 36, the Activities of Daily Vision Scale, the National Eye Institute Visual Function Questionnaire, and the Hospital Anxiety and Depression Scale. Additional questions concerning satisfaction with posttreatment appearance and concerns about cancer recurrence also were included in posttreatment interviews.

RESULTS

There was a significant increase in both treatment groups in levels of reported difficulty for most vision-oriented activities, and in bodily and ocular pain, 6 months following treatment. Differences in visual function between treatment groups reported during follow-up were relatively small, but significant differences favoring brachytherapy-treated patients were observed for driving during the first year of follow-up and for peripheral vision during the first 2 years of follow-up. Anxiety levels in both groups decreased significantly following treatment, but patients treated with brachytherapy with symptoms of anxiety were less likely to report later resolution of symptoms than patients with symptoms of anxiety who were treated with enucleation. This study was unable to assess impact of treatment on satisfaction with appearance and concern about cancer recurrence during the first year after treatment, but no treatment-related differences were found on these measures at 2 years and later follow-up times.

CONCLUSIONS

Patients treated with brachytherapy reported significantly better visual function than patients treated with enucleation with respect to driving and peripheral vision for up to 2 years following treatment. Differences between treatments in visual function diminished by 3 to 5 years posttreatment, paralleling decline in visual acuity in brachytherapy-treated eyes. Patients treated with brachytherapy were more likely to have symptoms of anxiety during follow-up than patients treated with enucleation.

APPLICATION TO CLINICAL PRACTICE

Given that no significant differences in survival between enucleation and brachytherapy have been found, the differences demonstrated here for driving and anxiety will allow the individual patient and physician to make informed choices regarding treatment based on personal preferences.

摘要

目的

在一项大型随机临床试验的前瞻性治疗和观察的亚组患者中,描述用碘125近距离放射疗法与眼球摘除术治疗脉络膜黑色素瘤后的健康和视力相关生活质量。

主要观察指标

驾驶困难、近视力活动困难以及使用立体视觉或双眼视觉的活动困难;焦虑;抑郁。

参与者

209名患者,他们于1995年3月至1998年7月参加了协作性眼黑色素瘤研究试验中的中型肿瘤试验,并在随机分组参加生活质量辅助研究之前签署了知情同意书。

方法

由协作性眼黑色素瘤研究协调中心训练有素的访员通过电话对患者进行访谈,分别在基线(随机分组前)、6个月以及入组周年纪念日进行。问卷组包括医学结局研究简表36、日常视觉活动量表、国立眼科研究所视觉功能问卷以及医院焦虑抑郁量表。治疗后访谈中还包括了关于对治疗后外观满意度以及对癌症复发担忧的其他问题。

结果

治疗后6个月,两个治疗组中报告的大多数以视力为导向的活动困难程度以及身体和眼部疼痛程度均显著增加。随访期间报告的治疗组之间视觉功能差异相对较小,但在随访的第一年中,近距离放射疗法治疗的患者在驾驶方面以及随访的前两年中在周边视力方面观察到显著优于眼球摘除术治疗患者的差异。两组患者的焦虑水平在治疗后均显著下降,但有焦虑症状的近距离放射疗法治疗患者比有焦虑症状的眼球摘除术治疗患者报告症状后来缓解的可能性更小。本研究无法评估治疗对治疗后第一年外观满意度和癌症复发担忧的影响,但在2年及以后的随访时间,在这些指标上未发现与治疗相关的差异。

结论

在治疗后长达2年的时间里,近距离放射疗法治疗的患者在驾驶和周边视力方面的视觉功能明显优于眼球摘除术治疗的患者。治疗后3至5年,治疗间的视觉功能差异减小,与近距离放射疗法治疗眼的视力下降情况相似。近距离放射疗法治疗的患者在随访期间比眼球摘除术治疗的患者更易出现焦虑症状。

临床实践应用

鉴于眼球摘除术和近距离放射疗法在生存率方面未发现显著差异,此处显示的驾驶和焦虑方面的差异将使个体患者和医生能够根据个人偏好就治疗做出明智选择。

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