Singh K, Mehta K, Shaikh N M, Tsai J C, Moster M R, Budenz D L, Greenfield D S, Chen P P, Cohen J S, Baerveldt G S, Shaikh S
Stanford University School of Medicine, Stanford, California, USA.
Ophthalmology. 2000 Dec;107(12):2305-9. doi: 10.1016/s0161-6420(00)00391-2.
To evaluate the relative efficacy and safety of 5-fluorouracil (5-FU) and mitomycin C (MMC) when used as adjuncts with primary trabeculectomy in eyes not at high risk for failure.
Prospective multicenter, randomized clinical trial.
One hundred thirteen patients with primary open-angle, pseudoexfoliative, pigmentary, or angle-closure glaucoma undergoing primary trabeculectomy were recruited.
One eye of each patient was randomized to receive either 5-FU (50 mg/ml for 5 minutes) or MMC (0.4 mg/ml for 2 minutes).
Intraocular pressure (IOP), visual acuity, complications, and interventions were documented at fixed intervals after surgery. The study also examined progression of visual field loss, long-term complications, and bleb appearance 3 years after surgery.
Of the 108 patients with complete perioperative information, 54 eyes received 5-FU and 54 received MMC. The proportion of patients reaching different predefined target IOPs after surgery was slightly higher in the MMC group than in the 5-FU group. This difference was less than 25%, which would have been necessary to achieve statistical significance with a power of 0.8 and the sample size used. Likewise, there was no statistically significant difference between the groups with regard to mean preoperative IOP, complications, or interventions. Mean postoperative follow-up was 309 and 330 days in the 5-FU and MMC groups, respectively (P = 0.593).
5-Fluorouracil and MMC were found to be equally safe and effective adjuncts to primary trabeculectomy in the short- and medium-term postoperative periods.
评估5-氟尿嘧啶（5-FU）和丝裂霉素C（MMC）作为辅助药物与原发性小梁切除术联合应用于失败风险不高的眼中的相对疗效和安全性。
前瞻性多中心随机临床试验。
招募了113例接受原发性小梁切除术的原发性开角型、假性剥脱性、色素性或闭角型青光眼患者。
将每位患者的一只眼睛随机分配接受5-FU（50mg/ml，持续5分钟）或MMC（0.4mg/ml，持续2分钟）。
记录术后固定时间间隔的眼压（IOP）、视力、并发症和干预措施。该研究还检查了术后3年视野丧失的进展、长期并发症和滤过泡外观。
在108例有完整围手术期信息的患者中，54只眼接受了5-FU，54只眼接受了MMC。术后达到不同预定义目标眼压的患者比例在MMC组略高于5-FU组。这种差异小于25%，若要有80%的检验效能和所用样本量，该差异需达到统计学显著性才有意义。同样，两组在术前平均眼压、并发症或干预措施方面无统计学显著差异。5-FU组和MMC组术后平均随访时间分别为309天和330天（P = 0.593）。
在术后中短期内，5-氟尿嘧啶和丝裂霉素C被发现作为原发性小梁切除术的辅助药物同样安全有效。
