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自体耳廓软骨、牛脱细胞真皮基质(Surgimend)和猪脱细胞真皮基质(Enduragen)间隔移植修复下睑退缩的前瞻性随机对照研究。

A Prospective, Randomized Comparison of Lower Eyelid Retraction Repair With Autologous Auricular Cartilage, Bovine Acellular Dermal Matrix (Surgimend), and Porcine Acellular Dermal Matrix (Enduragen) Spacer Grafts.

作者信息

Barmettler Anne, Heo Moonseong

机构信息

Department of Ophthalmology.

Department of Epidemiology and Population Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, U.S.A.

出版信息

Ophthalmic Plast Reconstr Surg. 2018 May/Jun;34(3):266-273. doi: 10.1097/IOP.0000000000000946.

Abstract

PURPOSE

To compare outcomes of lower eyelid retraction repair with 3 types of spacer grafts: autologous auricular cartilage, bovine acellular dermal matrix (Surgimend, Integra, Plainsboro, NJ), porcine acellular dermal matrix (Enduragen, Stryker, Kalamazoo, MI).

METHODS

A prospective, randomized clinical trial was conducted in patients undergoing lower eyelid retraction repair with spacer graft. Subjects received autologous auricular cartilage, bovine acellular dermal matrix, or porcine acellular dermal matrix between June 2015 and July 2016. Patient demographics, margin to reflex distance 2, conjunctival injection, eyelid swelling, tearing, discomfort, itching, and complications were recorded preoperatively and at postoperative week 1, month 1, month 3, and month 6.

RESULTS

Of the 49 randomized lower eyelids (39 patients), 42 eyelids (32 patients) completed the study. The preoperative margin to reflex distance 2, conjunctival injection, eyelid swelling, tearing, discomfort, and itching showed no statistical difference. Postoperative week 1 swelling was statistically significantly higher in auricular cartilage, followed by bovine acellular dermal matrix, then porcine acellular dermal matrix (p = 0.04). The mean postoperative month 6 margin to reflex distance 2 trended toward a better outcome from auricular cartilage over bovine acellular dermal matrix (p = 0.029), but after p was adjusted for multiple pairwise comparisons, this was no longer statistically significant (p = 0.088). All other postoperative 6-month measurements showed no statistical difference.

CONCLUSIONS

Among patients randomized to 3 types of spacer grafts for lower eyelid retraction repair, outcomes were not statistically significant different when the 3 groups were compared.

摘要

目的

比较采用3种不同类型的间隔移植物(自体耳软骨、牛脱细胞真皮基质(Surgimend,Integra公司,新泽西州普林斯顿)、猪脱细胞真皮基质(Enduragen,史赛克公司,密歇根州卡拉马祖))修复下睑退缩的效果。

方法

对接受间隔移植物修复下睑退缩的患者进行一项前瞻性随机临床试验。研究对象在2015年6月至2016年7月期间接受自体耳软骨、牛脱细胞真皮基质或猪脱细胞真皮基质移植。记录患者的人口统计学数据、睑缘至反射距离2、结膜充血、眼睑肿胀、流泪、不适、瘙痒及并发症情况,术前及术后第1周、第1个月、第3个月和第6个月各记录一次。

结果

49例随机分组的下睑(39例患者)中,42例下睑(32例患者)完成研究。术前睑缘至反射距离2、结膜充血、眼睑肿胀、流泪、不适及瘙痒情况无统计学差异。术后第1周,耳软骨组肿胀程度在统计学上显著高于其他两组,其次是牛脱细胞真皮基质组,猪脱细胞真皮基质组最低(p = 0.04)。术后第6个月,耳软骨组的平均睑缘至反射距离2的结果优于牛脱细胞真皮基质组(p = 0.029),但在进行多次两两比较并校正p值后,差异不再具有统计学意义(p = 0.088)。术后6个月的所有其他测量结果均无统计学差异。

结论

在随机接受3种不同类型间隔移植物修复下睑退缩的患者中,3组比较时效果无统计学显著差异。

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