Rubinfeld R S, Stein R M
Department of Ophthalmology/Center for Sight, Georgetown University Medical Center, Washington, DC, USA.
Ophthalmic Surg Lasers. 1997 Aug;28(8):662-9.
Mitomycin-C has been shown to dramatically reduce pterygium recurrence rates; however, its use has been associated with serious complications, especially in higher cumulative doses. The authors investigated the safety and efficacy of progressively reducing dosages of mitomycin-C as an adjunct to pterygium surgery.
Four hundred eighty-one consecutive primary and recurrent pterygia were surgically excised in a prospective nonrandomized trial using five different mitomycin-C dosages. Recurrence was defined as fibrovascular tissue over the corneoscleral limbus onto clear cornea in the area of previous pterygium excision.
Seventy-seven patients in a control group without mitomycin-C had a recurrence rate of 65% with a mean follow-up of 33 months. A group of 77 patients treated with 0.4 mg/ml of mitomycin-C, four times per day for 2 weeks, had a recurrence rate of 2.5% with 6 (10%) serious complications (mean follow-up 34 months). A group of 22 patients treated with 0.2 mg/ml of mitomycin-C, four times per day for 10 days, had a recurrence rate of 55% with 3 (7.3%) non-vision-threatening complications (mean follow-up 32 months). A group of 16 patients treated with 0.2 mg/ml of mitomycin-C intraoperatively for 3 minutes without conjunctival closure had a recurrence rate of 44% with no complications (mean follow-up 35 months). Finally, a group of 289 patients treated with 0.2 mg/ml of mitomycin-C intraoperatively for 3 minutes with conjunctival closure had a recurrence rate of 2.7% and no complications (mean follow-up 26 months).
Although the authors' results with single application are encouraging, the use of mitomycin for pterygia remains controversial. The biologic potency of this agent, the duration of its action, and the dearth of large-scale controlled, randomized trials demand cautious individual judgment by the surgeon when considering the use of this potent drug.
丝裂霉素-C已被证明能显著降低翼状胬肉的复发率;然而,其使用与严重并发症相关,尤其是在累积剂量较高时。作者研究了逐步降低丝裂霉素-C剂量作为翼状胬肉手术辅助治疗的安全性和有效性。
在一项前瞻性非随机试验中,使用五种不同剂量的丝裂霉素-C对481例连续的原发性和复发性翼状胬肉进行手术切除。复发定义为在先前翼状胬肉切除区域的角膜缘纤维血管组织延伸至透明角膜。
77例未使用丝裂霉素-C的对照组患者复发率为65%,平均随访33个月。一组77例患者使用0.4mg/ml丝裂霉素-C,每天4次,持续2周,复发率为2.5%,有6例(10%)出现严重并发症(平均随访34个月)。一组22例患者使用0.2mg/ml丝裂霉素-C,每天4次,持续10天,复发率为55%,有3例(7.3%)出现不威胁视力的并发症(平均随访32个月)。一组16例患者术中使用0.2mg/ml丝裂霉素-C 3分钟,不闭合结膜,复发率为44%,无并发症(平均随访35个月)。最后,一组289例患者术中使用0.2mg/ml丝裂霉素-C 3分钟并闭合结膜,复发率为2.7%,无并发症(平均随访26个月)。
尽管作者单次应用的结果令人鼓舞,但丝裂霉素用于翼状胬肉的治疗仍存在争议。该药物的生物学效力、作用持续时间以及缺乏大规模对照随机试验,要求外科医生在考虑使用这种强效药物时进行谨慎的个人判断。