Pham Clarabelle, Greenwood John, Cleland Heather, Woodruff Peter, Maddern Guy
ASERNIP-S, Royal Australasian College of Surgeons, and Burns Unit, Royal Adelaide Hospital, South Australia, Australia.
Burns. 2007 Dec;33(8):946-57. doi: 10.1016/j.burns.2007.03.020. Epub 2007 Sep 7.
To assess the safety and efficacy of bioengineered skin substitutes in comparison with biological skin replacements and/or standard dressing methods in the management of burns, through a systematic review of the literature.
Literature databases were searched up to April 2006, identifying randomised controlled trials.
Twenty randomised controlled trials were included in this review. The numerous sub-group analyses and the diversity of skin substitutes limited the ability to draw any conclusions from it. However, the evidence suggested that bioengineered skin substitutes, namely Biobrane, TransCyte, Dermagraft, Apligraf, autologous cultured skin, and allogeneic cultured skin, were at least as safe as biological skin replacements or topical agents/wound dressings. The safety of Integra could not be determined. For the management of partial thickness burns, the evidence suggested that bioengineered skin substitutes, namely Biobrane, TransCyte, Dermagraft, and allogeneic cultured skin, were at least as efficacious as topical agents/wound dressings or allograft. Apligraf combined with autograft was at least as efficacious as autograft alone. For the management of full thickness burns, the efficacy of autologous cultured skin could not be determined based on the available evidence. The efficacy of Integra could not be determined based on the available evidence.
Additional methodologically rigorous randomised controlled trials with long-term follow-up would strengthen the evidence base for the use of bioengineered skin substitutes.
通过对文献的系统综述，评估生物工程皮肤替代物与生物皮肤替代品和/或标准敷料方法相比在烧伤治疗中的安全性和有效性。
检索截至2006年4月的文献数据库，识别随机对照试验。
本综述纳入了20项随机对照试验。众多的亚组分析和皮肤替代物的多样性限制了从中得出任何结论的能力。然而，证据表明，生物工程皮肤替代物，即生物膜、TransCyte、Dermagraft、Apligraf、自体培养皮肤和异体培养皮肤，至少与生物皮肤替代品或局部用药/伤口敷料一样安全。Integra的安全性无法确定。对于浅度烧伤的治疗，证据表明，生物工程皮肤替代物，即生物膜、TransCyte、Dermagraft和异体培养皮肤，至少与局部用药/伤口敷料或同种异体移植一样有效。Apligraf联合自体移植至少与单独自体移植一样有效。对于深度烧伤的治疗，根据现有证据无法确定自体培养皮肤的疗效。根据现有证据无法确定Integra的疗效。
更多方法严谨且有长期随访的随机对照试验将加强使用生物工程皮肤替代物的证据基础。
