Vander J F, Kincaid M C, Hegarty T J, Page M, Averill D, Junck L, Greenberg H S
Department of Ophthalmology, University of Michigan Medical Center, Ann Arbor 48109.
Ophthalmology. 1990 Mar;97(3):352-7. doi: 10.1016/s0161-6420(90)32593-9.
Since July 1985, 23 patients have been entered into a phase I/II clinical trial using intraarterial 5-bromodeoxyuridine (BUdR) (400-600 mg/m2 daily for 8.5 weeks) and focal external beam radiotherapy (59.4 Gy at 1.8 Gy daily in 6.5 weeks) in the treatment of malignant gliomas (Kernohan grades 3 and 4). The side effects in all patients have included varying degrees of anorexia, fatigue, ipsilateral forehead dermatitis, blepharitis, and conjunctivitis. Mucopurulent conjunctivitis and exposure keratitis developed in several patients and spontaneous corneal perforation developed in one. Eyes from two individuals examined at autopsy showed significant changes. Animal studies that predated clinical trials using rhesus monkeys did not predict the ophthalmologic complications seen in human subjects.
自1985年7月起,23例患者进入了一项I/II期临床试验,采用动脉内注射5-溴脱氧尿苷(BUdR)(每日400 - 600 mg/m²,共8.5周)及局部外照射放疗(6.5周内每日1.8 Gy,总量59.4 Gy)治疗恶性胶质瘤(Kernohan 3级和4级)。所有患者的副作用包括不同程度的厌食、疲劳、同侧前额皮炎、睑缘炎和结膜炎。数名患者出现了黏液脓性结膜炎和暴露性角膜炎,1名患者发生了自发性角膜穿孔。尸检时对两名患者的眼睛检查发现了显著变化。在使用恒河猴进行的临床试验之前的动物研究并未预测到人类受试者中出现的眼科并发症。