Schellini Silvana, Jorge Eliane, Sousa Roberta, Burroughs John, El-Dib Regina
a Department of Ophthalmology, Faculdade de Medicina de Botucatu/UNESP , Campus Universitario , Botucatu , Brazil.
b Eye and Facial Appearances, Colorado Springs , Colorado , USA.
Orbit. 2016;35(2):78-86. doi: 10.3109/01676830.2016.1139591. Epub 2016 Feb 29.
To assess the efficacy and safety of porous and nonporous implants for management of the anophthalmic socket.
Case series meta-analysis was conducted with no language restriction, including studies from: PUBMED, EMBASE and LILACS. Study eligibility criteria were case series design with more than 20 cases reported, use of porous and/or nonporous orbital implants, anophthalmic socket and, treatment success defined as no implant exposure or extrusion. Complications rates from each included study were quantified. Proportional meta-analysis was performed on both outcomes with a random-effects model and the 95% confidential intervals were calculated.
A total of 35 case series studies with a total of 3,805 patients were included in the meta-analysis. There are no studies comparing porous and nonporous implants in the anophthalmic socket treatment. There was no statistically significant difference between porous polyethylene (PP) and hydroxyapatite (HA) on implant exposure: 0.026 (0.012-0.045) vs 0.054 (0.041-0.070), respectively and, neither on implant extrusion: 0.0042 (0.0008-0.010) vs. 0.018 (0.004-0.042), respectively. However, there was a significant difference supporting the use of PP when compared to bioceramic implant: 0.026 (0.012 -0.045) vs. 0.12 (0.06-0.20), respectively, on implant exposure.
PP implants showed lower chance of exposure than bioceramic implant for anophthalmic socket reconstruction, although we cannot rule out the possibility of heterogeneity bias due to the nature and level of evidence of the included studies. Clinical trials are necessary to expand the knowledge of porous and nonporous orbital implants in the anophthalmic socket management.
评估多孔和无孔植入物用于治疗无眼球眼眶的疗效和安全性。
进行病例系列荟萃分析,无语言限制,纳入来自PUBMED、EMBASE和LILACS的研究。研究纳入标准为病例系列设计且报告病例超过20例、使用多孔和/或无孔眼眶植入物、无眼球眼眶,治疗成功定义为无植入物暴露或脱出。对每项纳入研究的并发症发生率进行量化。采用随机效应模型对两个结果进行成比例荟萃分析,并计算95%置信区间。
荟萃分析共纳入35项病例系列研究,总计3805例患者。没有研究比较无眼球眼眶治疗中多孔和无孔植入物。多孔聚乙烯(PP)和羟基磷灰石(HA)在植入物暴露方面无统计学显著差异:分别为0.026(0.012 - 0.045)和0.054(0.041 - 0.070),在植入物脱出方面也无差异:分别为0.0042(0.0008 - 0.010)和0.018(0.004 - 0.042)。然而,与生物陶瓷植入物相比,PP在植入物暴露方面有显著差异支持其使用:分别为0.026(0.012 - 0.045)和0.12(0.06 - 0.20)。
对于无眼球眼眶重建,PP植入物暴露的可能性低于生物陶瓷植入物,尽管由于纳入研究的性质和证据水平,我们不能排除异质性偏倚的可能性。需要进行临床试验以扩大对无眼球眼眶治疗中多孔和无孔眼眶植入物的认识。