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一项比较丝裂霉素C与原发性翼状胬肉切除术后结膜自体移植的随机试验。

A randomized trial comparing mitomycin C and conjunctival autograft after excision of primary pterygium.

作者信息

Chen P P, Ariyasu R G, Kaza V, LaBree L D, McDonnell P J

机构信息

Doheny Eye Institute, University of Southern California School of Medicine, Los Angeles, USA.

出版信息

Am J Ophthalmol. 1995 Aug;120(2):151-60. doi: 10.1016/s0002-9394(14)72602-9.

DOI:10.1016/s0002-9394(14)72602-9
PMID:7639298
Abstract

PURPOSE

To determine the rate of recurrence and complications after bare sclera excision of primary pterygia followed by low-dose mitomycin C (0.2 mg/ml twice daily for five days), placebo (balanced saline solution), or conjunctival autograft.

METHODS

We performed a prospective, double-masked clinical trial of 64 patients (60 Hispanic) randomly assigned to a treatment group. Twenty-four patients received mitomycin C, 23 conjunctival autograft, and 17 placebo. Recurrence was defined as fibrovascular tissue over the corneoscleral limbus onto clear cornea in the area of previous pterygium excision.

RESULTS

The recurrence rate after mitomycin C and conjunctival autograft was 38% and 39% of eyes, respectively, after mean follow-up (in recurrence-free patients) of 12.3 and 13.5 months, respectively. The recurrence rate after placebo treatment was significantly higher (P = .002), 88%, after mean follow-up (in recurrence-free patients) of 9.3 months. Increasing age was associated with significantly fewer recurrences (P = .006) after controlling for pterygium type (atrophic, noninflamed, or inflamed) and treatment group. The mean time to recurrence varied from 3.7 to 4.8 months; only 6% of recurrences were noted after the sixth postoperative month. Major complications included symblepharon (two), loose autograft (one), and pyogenic granuloma (two). No group had significantly more complications.

CONCLUSIONS

Conjunctival autograft and low-dose topical mitomycin C are equally effective as adjunctive treatment after excision of primary pterygia in this young, southern California, predominantly Hispanic population. Both methods have significantly lower rates of recurrence than bare sclera excision alone, and neither is associated with severe complications after one year of follow-up. Increasing patient age is associated with significantly less risk of recurrence.

摘要

目的

确定原发性翼状胬肉单纯巩膜切除术联合低剂量丝裂霉素C(0.2mg/ml,每日两次,共五天)、安慰剂(平衡盐溶液)或结膜自体移植术后的复发率及并发症发生率。

方法

我们对64例患者(60例为西班牙裔)进行了一项前瞻性、双盲临床试验,将其随机分配至各治疗组。24例患者接受丝裂霉素C治疗,23例接受结膜自体移植,17例接受安慰剂治疗。复发定义为在先前翼状胬肉切除区域出现跨越角膜缘至透明角膜的纤维血管组织。

结果

丝裂霉素C组和结膜自体移植组在平均随访(无复发患者)分别为12.3个月和13.5个月后,眼复发率分别为38%和39%。安慰剂治疗组在平均随访(无复发患者)9.3个月后的复发率显著更高(P = 0.002),为88%。在控制翼状胬肉类型(萎缩性、非炎症性或炎症性)和治疗组后,年龄增长与复发显著减少相关(P = 0.006)。复发的平均时间为3.7至4.8个月;仅6%的复发发生在术后第六个月之后。主要并发症包括睑球粘连(2例)、自体移植片松动(1例)和化脓性肉芽肿(2例)。各治疗组并发症无显著差异。

结论

在南加州这个以西班牙裔为主的年轻人群中,结膜自体移植和低剂量局部丝裂霉素C作为原发性翼状胬肉切除术后的辅助治疗同样有效。两种方法复发率均显著低于单纯巩膜切除术,且随访一年后均未出现严重并发症。患者年龄增长与复发风险显著降低相关。

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