本地制造和进口多孔聚乙烯轨道植入物之间的比较:随机对照等效试验和多中心研究
Sunisa Sintuwong1, Kanjana Leelapatranurak1, Orapan Aryasit2
1Department of Ophthalmology, Mettapracharak (Wat Rai Khing) Hospital, Nakhon Pathom 73210, Thailand.
International journal of ophthalmology
|October 21, 2024
概括
这项研究比较了Medpor和3D打印聚乙烯 (3DP-PE) 轨道植入物在核化后. 虽然两者都显示出相似的成功率和感染率,但由于信任区间较宽,无法统计证实等价性.
科学领域:
- 眼科医生 眼科 眼科
- 生物材料科学 生物材料科学
- 手术创新 在外科创新.
背景情况:
- 轨道植入物对于在核化后恢复美学和功能至关重要.
- 梅德波尔一直是标准,但像3D打印聚乙烯 (3DP-PE) 这样的新材料提供了潜在的优势.
研究的目的:
- 为了比较Medpor和3DP-PE轨道植入物的临床结果.
- 具体评估潜在的随机试验中的暴露率,感染率,增强率和成功率.
主要方法:
- 一项前性,随机化,受控试验,涉及128名接受核切除的患者.
- 参与者接受了Medpor或3DP-PE植入物,并进行了掩盖评估和至少1年的随访.
- 磁共振成像 (MRI) 用于评估纤维血管内生长.
主要成果:
- 在Medpor和3DP-PE之间,暴露率 (6.0%与7.3%) 或成功率 (94%与92.7%) 之间没有统计学上显著的差异.
- 在这两组中都没有报告任何手术后感染.
- 在MRI研究中观察到纤维血管增强,百分比和随访时间各不相同.
结论:
- 在本初步报告中,Medpor和3DP-PE植入物显示了可比的暴露率和成功率.
- 由于置信区间的宽度,无法统计证实这些结果的等价性.
- 这两种植入物类型之间的感染率被认为是相当的.
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