Cardillo J A, Alves M R, Ambrosio L E, Poterio M B, Jose N K
Department of Ophthalmology, Unicamp Medical School, Campinas-SP, Brazil.
Ophthalmology. 1995 Dec;102(12):1949-52. doi: 10.1016/s0161-6420(95)30770-1.
To determine the minimum effective dosage, most effective route of administration and long-term effects of mitomycin C for prevention of recurrence after pterygium surgery.
In a prospective, masked study, 227 patients undergoing surgery for primary pterygia were assigned randomly to five groups: group 1 received a single intraoperative application of 0.2 mg/ml mitomycin C for 3 minutes; group 2 received a single intraoperative application of 0.4 mg/ml mitomycin C for 3 minutes; group 3 received mitomycin C eye drops 0.2 mg/ml three times daily for 7 days; group 4 received mitomycin C eye drops 0.4 mg/ml three times daily for 14 days; group 5 acted as a control (surgery alone).
After a mean follow-up time of 28 months, recurrence rates of 6.66%, 4.08%, 4.26%, 4.44%, and 29.27%, respectively, were observed. Statistical analysis showed significant differences between groups receiving mitomycin C and the control (P < or = 0.001). There was no statistical difference among treated groups (P > or = 0.0681). No complications of therapy were observed.
These results support the efficacy and relative safety of a single, low-concentration, intraoperative application of mitomycin C in pterygium surgery together with the use of a conjunctival flap, avoiding excessive cauterization of the sclera and leaving bare sclera.
确定丝裂霉素C预防翼状胬肉术后复发的最小有效剂量、最有效的给药途径及长期效果。
在一项前瞻性、盲法研究中,227例行原发性翼状胬肉手术的患者被随机分为五组:第1组术中单次应用0.2mg/ml丝裂霉素C 3分钟;第2组术中单次应用0.4mg/ml丝裂霉素C 3分钟;第3组每日3次应用0.2mg/ml丝裂霉素C眼药水,共7天;第4组每日3次应用0.4mg/ml丝裂霉素C眼药水,共14天;第5组作为对照组(仅手术)。
平均随访28个月后,观察到复发率分别为6.66%、4.08%、4.26%、4.44%和29.27%。统计学分析显示接受丝裂霉素C治疗的组与对照组之间存在显著差异(P≤0.001)。各治疗组之间无统计学差异(P≥0.0681)。未观察到治疗并发症。
这些结果支持在翼状胬肉手术中单次、低浓度术中应用丝裂霉素C联合使用结膜瓣的有效性和相对安全性,避免过度烧灼巩膜并保留裸露的巩膜。