5-FLUOROURACIL AND GLAUCOMA FILTERING SURGERY

这个由两部分组成的申请的第一个目标是确定长期、 经结膜下注射5-FU的五年安全性和有效性 213例氟尿嘧啶滤过患者的持续随访 外科研究临床试验(FFSS)。FFSS是一种多中心随机 临床试验，于1985年9月开始，以确定术后 结膜下注射5-氟尿嘧啶(5-FU)可增加 预后不良的青光眼滤过手术的成功率。 既往白内障后药物无法控制的青光眼患者 摘除或不成功的滤过手术，或两者兼而有之，随机分为 接受单纯小梁切除术(标准治疗)或联合小梁切除术 辅助性5-FU注射。术后成功率和失败率分别为 再手术率和定义眼压(IOP) 级别。5-FU可能的风险，如角膜、晶状体、视网膜和 监测血液学毒性。安全与数据监控 委员会建议在1988年6月停止招聘时成功 5-FU组一年随访率约为80%，VS 标准治疗组60%(p=.0004)。五年随访 这213名患者将足以确定患者的长期状况 视觉功能，通过视野和视力的稳定性来衡量， 以及随之而来的5-FU治疗风险。重要信息 晚期青光眼眼压控制的远期疗效观察 青光眼也将通过持续的随访而产生。 此两部分应用程序的第二个目标是建立FFSS-Patient 登记以确定标准化低剂量5-羟色胺的有效性和安全性 氟尿嘧啶给药方案：术后第1~7天每日1次，每次5 mg，3次/d 患者在8-14天内的时间与FFSS的时间相当-临床 审判。选择这种剂量是为了最大限度地减少角膜和结膜 上皮性毒性。目前，大多数非FFSS眼科医生都在使用 变量减少的5-FU剂量，尚未在对照试验中进行 时尚。FFSS患者登记处将建立基线疗效 小剂量5-FU的副作用及与新药的未来比较 另一种外科治疗方法。临床进程将由以下因素决定 视力、视野和眼压的标准化测量，以及 使用与#年相同的人员和设备评估副作用 FFSS临床试验。100例FFSS患者的样本量 登记处将提供结果，并与105名患者进行比较 在FFSS临床试验中接受大剂量5-FU产生足够的数据 关于疗效和毒性。

The first goal of this two-part application is to determine the long-term, five year safety and efficacy of subconjunctivally injected 5-FU through the continued follow-up of 213 patients in the Fluorouracil Filtering Surgery Study Clinical Trial (FFSS). The FFSS a multicenter randomized clinical trial, began in September 1985 to determine if postoperative subconjunctival injections of 5-fluorouracil (5-FU) would increase the success rate of glaucoma filtering surgery in eyes with poor prognoses. Patients with medically uncontrolled glaucoma after previous cataract extraction or unsuccessful filtering surgery, or both, were randomized to undergo trabeculectomy alone (standard treatment) or trabeculectomy with adjunctive 5-FU injections. Postoperative success and failure rates were determined by reoperation rates and by defined intraocular pressure (IOP) levels. Possible risks of 5-FU, such as corneal, lenticular, retinal, and hematologic toxicities were monitored. The Safety and Data Monitoring Committee recommended stopping recruitment in June 1988 when the success rate after one year follow-up in the 5-FU group was approximately 80% vs 60% in the standard treatment group (p=.0004). The five year follow-up of these 213 patients will be sufficient to determine the long-term status of visual function, as measured by the stability of visual field and acuity, and the attendant risks of treatment with 5-FU. Important information regarding the long-term effect of IOP control in eyes with advanced glaucoma will also be generated through the continued follow-up. The second goal of this two-part application is to establish a FFSS-Patient Registry to determine the efficacy and safety of a standardized low-dose 5- FU dosage regimen: 5mg once daily on postoperative days 1-7, and 5mg three times during days 8-14 in patients comparable to those in the FFSS-Clinical Trial. This dose has been chosen to minimize corneal and conjunctival epithelial toxicity. Currently most non-FFSS ophthalmologists are using a variably reduced 5-FU dose that has not been tested in a controlled fashion. The FFSS Patient Registry will establish the baseline efficacy and side effects of low dose 5-FU for future comparison with newer alternative surgical therapies. The clinical course will be determined by standardized measurements of visual acuity, perimetry and IOP, and assessment of the side effects using the same personnel and equipment as in the FFSS Clinical Trial. A sample size of 100 patients in the FFSS Patient Registry will provide results to be compared with the 105 patients who received high dose 5-FU in the FFSS Clinical Trial generate sufficient data regarding efficacy and toxicity.