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丝裂霉素C对莫尔顿植入物手术的影响:一项为期1年的随机、盲法、前瞻性研究。

The effect of mitomycin C on Molteno implant surgery: a 1-year randomized, masked, prospective study.

作者信息

Cantor L, Burgoyne J, Sanders S, Bhavnani V, Hoop J, Brizendine E

机构信息

Department of Ophthalmology, Indiana University, Indianapolis 46202, USA.

出版信息

J Glaucoma. 1998 Aug;7(4):240-6.

PMID:9713781
Abstract

PURPOSE

The authors assess whether adjunctive mitomycin C improves Molteno tube shunt surgery in terms of intraocular pressure (IOP), visual acuity, and complication rates.

PATIENTS AND METHODS

Twenty-five eyes of twenty-five consecutive patients undergoing double-plate Molteno implant surgery were randomized to receive either mitomycin C (MMC) 0.4 mg/mL for 2 minutes or a control balanced salt solution in a masked, prospective study. Intraocular pressure, visual acuity, and complications were recorded 1 week and 1, 3, 6, and 12 months after surgery. A repeated measures analysis of variance (ANOVA) model was used to test the overall effect of the drug on IOP and percent change from preoperative IOP.

RESULTS

Thirteen eyes received balanced salt solution and 12 eyes received MMC. There was no difference between the groups with respect to age, preoperative IOP, log mean angle of resolution (LogMar) visual acuity, or number of preoperative medications. Except for week 1, there were no differences between the groups at any of the clinic visits with respect to IOP and percent change from baseline IOP. Analysis of the visual acuity (LogMar) showed reduction in vision for both groups. Complications were similar in each group, as were number of postoperative hypotensive agents required.

CONCLUSIONS

Adjunct MMC does not demonstrate a significant difference in outcomes compared with placebo in pressure-ridged Molteno implant surgery. Results of this study are limited by a small number of patients in each group and a fixed dose of MMC.

摘要

目的

作者评估辅助使用丝裂霉素C在眼压、视力和并发症发生率方面是否能改善莫尔顿管分流手术。

患者与方法

在一项前瞻性双盲研究中,连续25例接受双板莫尔顿植入手术的患者的25只眼睛被随机分为两组,一组接受2分钟的0.4mg/mL丝裂霉素C(MMC),另一组接受对照平衡盐溶液。在术后1周以及1、3、6和12个月记录眼压、视力和并发症情况。采用重复测量方差分析(ANOVA)模型来测试药物对眼压的总体影响以及与术前眼压相比的变化百分比。

结果

13只眼睛接受平衡盐溶液,12只眼睛接受MMC。两组在年龄、术前眼压、对数平均分辨角(LogMar)视力或术前用药数量方面无差异。除第1周外,两组在任何一次临床随访时的眼压及与基线眼压相比的变化百分比均无差异。视力(LogMar)分析显示两组视力均下降。每组的并发症情况相似,所需术后降压药物的数量也相似。

结论

在带压力脊的莫尔顿植入手术中,与安慰剂相比,辅助使用MMC在手术结果上未显示出显著差异。本研究结果受每组患者数量少以及MMC固定剂量的限制。

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