他莫昔芬和托瑞米芬治疗乳腺癌患者的眼部副作用：一项随机随访研究。

Ocular side-effects in breast cancer patients treated with tamoxifen and toremifene: a randomized follow-up study.

作者信息

Parkkari M, Paakkala A-M, Salminen L, Holli K

机构信息

Department of Ophthalmology, Tampere University Hospital, PO Box 2000, 33501 Tampere, Finland.

出版信息

Acta Ophthalmol Scand. 2003 Oct;81(5):495-9. doi: 10.1034/j.1600-0420.2003.00116.x.

DOI:10.1034/j.1600-0420.2003.00116.x

PMID:14510798

Abstract

PURPOSE

3Tamoxifen and toremifene are non-steroidal anti-oestrogens widely used in the treatment of advanced breast cancer and as adjuvant therapy following surgery in early stage disease. Tamoxifene has also been approved for use in reducing the incidence of breast cancer amongst high risk women. However, certain well documented adverse effects, mainly involving the reproductive organs, have been reported amongst users of both drugs. The aim of this study was to monitor the ocular side-effects of both of these commonly used anti-oestrogens.

METHODS

Sixty postmenopausal (age range 50-79 years) breast cancer patients were randomized into adjuvant tamoxifen or toremifene therapy groups for 3 years. Prior to commencement of medication, a thorough ocular examination was undertaken. The first follow-up visit took place after 6 months and the remaining three at 12-month intervals thereafter.

RESULTS

Sixteen patients had cataract at the first visit (seven in the tamoxifen group and nine in the toremifene group). Ten patients developed cataract during the study period (five in each group), giving annual cataract rates of 6.8% and 6.2% in the tamoxifen and toremifene groups, respectively. Three patients had macular crystals at the first visit (one in the tamoxifen group and two in the toremifene group). The crystals remained stable throughout the follow-up. Macular drusen were diagnosed in five patients at the first ophthalmological check-up (two in the tamoxifen and three in the toremifene group). Two patients in the toremifene group developed drusen maculopathy during follow-up visits. Yellowish spots in the macular area were found in one tamoxifen-treated patient at the second visit. At the final visit after 3.5 years' follow-up the spots had disappeared. No abnormal corneal findings or keratopathy were documented during the follow-up.

CONCLUSION

We observed no serious ocular side-effects among the 60 breast cancer patients treated with tamoxifen or toremifene over a 3.5-year period.

摘要

目的

他莫昔芬和托瑞米芬是非甾体类抗雌激素药物，广泛用于治疗晚期乳腺癌以及作为早期疾病手术后的辅助治疗。他莫昔芬也已被批准用于降低高危女性患乳腺癌的发生率。然而，在这两种药物的使用者中都报告了一些有充分记录的不良反应，主要涉及生殖器官。本研究的目的是监测这两种常用抗雌激素药物的眼部副作用。

方法

60名绝经后（年龄范围50 - 79岁）乳腺癌患者被随机分为辅助他莫昔芬或托瑞米芬治疗组，为期3年。在开始用药前，进行了全面的眼部检查。第一次随访在6个月后进行，此后每隔12个月进行其余三次随访。

结果

首次就诊时16名患者患有白内障（他莫昔芬组7名，托瑞米芬组9名）。10名患者在研究期间出现白内障（每组5名），他莫昔芬组和托瑞米芬组的年白内障发生率分别为6.8%和6.2%。首次就诊时3名患者有黄斑晶体（他莫昔芬组1名，托瑞米芬组2名）。在整个随访过程中晶体保持稳定。在首次眼科检查时，5名患者被诊断有黄斑玻璃膜疣（他莫昔芬组2名，托瑞米芬组3名）。托瑞米芬组2名患者在随访期间发生黄斑玻璃膜疣病变。在第二次就诊时，1名接受他莫昔芬治疗的患者黄斑区发现淡黄色斑点。在3.5年随访后的最后一次就诊时，斑点已消失。随访期间未记录到异常角膜表现或角膜病变。