Turaçli E, Gündüz K, Aktan G, Tamer C
Department of Ophthalmology, Faculty of Medicine, University of Ankara, Turkey.
Eur J Ophthalmol. 1996 Oct-Dec;6(4):398-401. doi: 10.1177/112067219600600410.
This prospective, randomized clinical trial assessed the effects of mitomycin C and cyclosporin A used as antimetabolites in trabeculectomy on the post-operative IOP and success rate. Eighty-six consecutive patients were randomly allocated to three treatment groups. There were 30 patients in the mitomycin C group, 28 in the cyclosporin A group and 28 in the control group. The follow-up periods were different for the three groups and ranged from 6 to 30 months. The treatment groups consisted of primary open-angle glaucoma, closed-angle glaucoma, various secondary glaucomas and prior failed trabeculectomy. There were no significant differences pre-operatively with respect to IOP and number of medications used (p > 0.05). Postoperative IOP was considered to be successfully reduced when it was reduced by more than 25% from baseline or when it was lower than 20 mmHg. According to these criteria, IOP was under control in 90% of the mitomycin C treated eyes, 85.7% of cyclosporin A treated eyes and 71.4% of the control eyes. Postoperatively there was a significant decrease in IOP (p < 0.01) and in the number of medications need to control IOP (p < 0.01) in the mitomycin C and cyclosporin A groups. Post-operative IOP and number of medications in the mitomycin C and cyclosporin A group were similar. Complications encountered in the three groups were similar. There were no serious complications like hypotonus maculopathy. Our study highlights the utility of mitomycin C as an adjunct in glaucoma filtering surgery and indicated that cyclosporin A may also be used as an antimetabolite.
这项前瞻性随机临床试验评估了丝裂霉素C和环孢素A作为抗代谢药物在小梁切除术中对术后眼压和成功率的影响。86例连续患者被随机分为三个治疗组。丝裂霉素C组有30例患者，环孢素A组有28例患者，对照组有28例患者。三组的随访期不同，从6个月到30个月不等。治疗组包括原发性开角型青光眼、闭角型青光眼、各种继发性青光眼以及既往小梁切除术失败的患者。术前眼压和所用药物数量方面无显著差异（p>0.05）。当术后眼压较基线降低超过25%或低于20 mmHg时，认为眼压成功降低。根据这些标准，丝裂霉素C治疗的眼中90%眼压得到控制，环孢素A治疗的眼中85.7%眼压得到控制，对照组眼中71.4%眼压得到控制。术后丝裂霉素C组和环孢素A组的眼压显著降低（p<0.01），控制眼压所需的药物数量也显著减少（p<0.01）。丝裂霉素C组和环孢素A组的术后眼压和药物数量相似。三组遇到的并发症相似。没有像低眼压性黄斑病变这样的严重并发症。我们的研究强调了丝裂霉素C作为青光眼滤过手术辅助药物的效用，并表明环孢素A也可作为抗代谢药物使用。
