无菌冻干与无菌湿包装人尸体脱细胞真皮基质在即刻组织扩张器乳房重建中的应用：倾向评分分析。
Aseptic Freeze-Dried versus Sterile Wet-Packaged Human Cadaveric Acellular Dermal Matrix in Immediate Tissue Expander Breast Reconstruction: A Propensity Score Analysis.
机构信息
Houston, Texas.
From the Departments of Plastic Surgery and Biostatistics, The University of Texas M. D. Anderson Cancer Center.
出版信息
Plast Reconstr Surg. 2018 May;141(5):624e-632e. doi: 10.1097/PRS.0000000000004323.
BACKGROUND
Although multiple acellular dermal matrix sources exist, it is unclear how its processing impacts complication rates. The authors compared complications between two preparations of human cadaveric acellular dermal matrix (freeze dried and ready-to-use) in immediate tissue expander breast reconstruction to analyze the effect of processing on complications.
METHODS
The authors retrospectively reviewed all alloplastic breast reconstructions with freeze-dried or ready-to-use human acellular dermal matrices between 2006 and 2016. The primary outcome measure was surgical-site occurrence defined as seroma, skin dehiscence, surgical-site infection, or reconstruction failure. The two groups were compared before and after propensity score matching.
RESULTS
The authors included 988 reconstructions (freeze-dried, 53.8 percent; ready-to-use, 46.2 percent). Analysis of 384 propensity score-matched pairs demonstrated a slightly higher rate of surgical-site occurrence (21.4 percent versus 16.7 percent; p = 0.10) and surgical-site infection (9.6 percent versus 7.8 percent; p = 0.13) in the freeze-dried group than in the ready-to-use group, but the difference was not significant. However, failure was significantly higher for the freeze-dried versus ready-to-use group (7.8 percent versus 4.4 percent; p = 0.050).
CONCLUSIONS
This is the largest study comparing the outcomes of alloplastic breast reconstruction using human acellular dermal matrix materials prepared by different methods. The authors demonstrated higher early complications with aseptic, freeze-dried matrix than with sterile ready-to-use matrix; reconstructive failure was the only outcome to achieve statistical significance. The authors conclude that acellular dermal matrix preparation has an independent impact on patient outcomes in their comparison of one company's product.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
背景
尽管存在多种去细胞真皮基质来源，但目前尚不清楚其处理方式对并发症发生率的影响。作者比较了即刻组织扩张器乳房重建中两种人尸体去细胞真皮基质（冻干和即用型）制剂的并发症，以分析处理方式对并发症的影响。
方法
作者回顾性分析了 2006 年至 2016 年间使用冻干或即用型人去细胞真皮基质的所有整形乳房重建病例。主要观察指标为手术部位并发症，定义为血清肿、皮肤裂开、手术部位感染或重建失败。两组在进行倾向评分匹配前后进行比较。
结果
作者纳入 988 例重建病例（冻干组占 53.8%，即用组占 46.2%）。对 384 对倾向评分匹配的病例进行分析显示，冻干组的手术部位并发症（21.4%比 16.7%；p=0.10）和手术部位感染（9.6%比 7.8%；p=0.13）发生率略高，但差异无统计学意义。然而，冻干组的重建失败率明显高于即用组（7.8%比 4.4%；p=0.050）。
结论
这是比较两种不同方法制备的同种异体真皮基质材料在整形乳房重建中应用的最大规模研究。作者发现，冻干、无菌基质的早期并发症高于消毒、即用型基质；重建失败是唯一具有统计学意义的结果。作者得出结论，在比较同一家公司产品时，去细胞真皮基质的制备对患者结局有独立影响。
临床问题/证据水平：治疗性，III 级。
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