5-FLUOROURACIL & GLAUCOMA FILTERING SURGERY

这个两部分申请的第一个目标是确定长期， 结膜下注射5-FU的5年安全性和有效性 213例氟尿嘧啶滤过治疗患者的随访结果 手术研究临床试验（FFSS）。 FFSS是一项多中心随机 临床试验，开始于1985年9月，以确定是否术后 结膜下注射5-氟尿嘧啶（5-FU）会增加 青光眼滤过手术在视力差眼中的成功率 既往白内障后药物不受控制的青光眼患者 拔牙或不成功的滤过手术，或两者，被随机分配到 仅接受小梁切除术（标准治疗）或小梁切除术联合 连续注射5-FU。 术后成功率和失败率分别为 根据再手术率和定义的眼内压（IOP）确定 程度. 5-FU的可能风险，如角膜、晶状体、视网膜和 监测血液学毒性。 安全性和数据监测 委员会建议在1988年6月停止招募， 5-FU组1年随访后的发生率约为80%， 标准治疗组为60%（p=.0004）。 5年随访 这213名患者将足以确定 视觉功能，通过视野的稳定性和敏锐度来测量， 以及5-FU治疗的伴随风险。 重要信息 关于晚期青光眼患者眼压控制的长期效果， 青光眼也将通过持续随访产生。 这个由两部分组成的应用程序的第二个目标是建立一个FFSS-患者 登记研究，以确定标准化低剂量5- FU给药方案：术后第1-7天5 mg，每日1次，术后第3天5 mg，每日1次。 患者第8-14天的时间与FFSS-临床中的时间相当 审判 选择该剂量是为了尽量减少角膜和结膜炎 上皮细胞毒性 目前，大多数非FFSS眼科医生正在使用 未在对照组中进行过试验的5-FU剂量减少 时尚. FFSS患者登记研究将确定基线疗效 低剂量5-FU的副作用，以便将来与新的 替代手术疗法 临床过程将由以下因素决定： 视力、视野检查和IOP的标准化测量，以及 副作用评估使用相同的人员和设备 FFSS临床试验 FFSS患者中的样本量为100例患者 登记研究将提供与105名患者进行比较的结果， 在FFSS临床试验中接受高剂量5-FU的患者产生了足够的数据 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.