脱细胞生物膜修复硬膜缺损的多中心临床试验研究  

Dural repair with acellular biomembrane:multicenter clinical trials

作　　者：穆霄静[1] 侯芳[1] 徐敏宁[1] 吴玉燕[1] 张玉富[1] 王樑[1] 王勇[2] 高国栋[2] 

机构地区：[1]第四军医大学唐都医院神经外科,全军功能神经外科研究所,西安710038 [2]解放军309医院旃坛寺门诊部,北京100034

出　　处：《解放军医学杂志》2011年第1期73-74,共2页Medical Journal of Chinese People's Liberation Army

摘　　要：目的研究新型人工硬脑膜脱细胞生物膜(正海生物膜)在硬脑膜缺损修复中的安全性及有效性。方法选择2007年12月-2008年12月行硬脑膜缺损修复术的患者155例,按多中心随机对照原则分为试验组及对照组,分别采用新型人工硬脑膜脱细胞生物膜及自体筋膜修补硬脑膜。其中试验组74例,男34例,女40例,年龄46.6±14.6岁,修复缺损面积14.28±13.29cm2;对照组81例,男36例,女45例,年龄44.8±12.7岁,修复缺损面积13.44±7.74cm2。分别在术后10d及1、3、6个月时对生命体征、实验室指标、脑CT或MRI检查结果、切口愈合及并发症发生情况进行观察,以评价新型人工硬脑膜脱细胞生物膜的安全性及有效性。结果患者均无脑脊液漏、颅内感染、癫痫发生,实验室检查结果均正常,影像学检查未见异常,无与修补材料相关的不良事件。试验组不良事件发生率为2.7%,而对照组为3.7%,两组间差异无统计学意义。结论新型人工硬脑膜脱细胞生物膜修复硬脑膜缺损的安全性和有效性与自体筋膜相当,可起到及时保护脑组织的作用。Objective To evaluate the safety and efficacy of novel artificial dural acellular biomembrane（Zhenghai biomembrane） in dural repair.Methods A multicenter,randomized control trial was carried out with 155 patients undergone dural repair from Dec.2007 to Dec.2008.The patients were randomly divided into experimental group and control group and received dural repair with novel artificial dural acellular biomembrane and autologous fascia,respectively.There were 74 patients（34 males and 40 females;aged 46.6±14.6 years;reparation area 14.28±13.29cm^2） in experimental group and 81 patients（36 males and 45 females;aged 44.8±12.7 years;reparation area 13.44±7.74cm^2） in control group.Vital signs,laboratory indexes,cerebral CT/MRI scanning,incision healing and occurrence of complications were observed at 10 days and 1,3,6 months after operation,respectively,and the safety and efficacy of the novel artificial dural acellular biomembrane were evaluated.Results No cerebrospinal fluid leakage,intracranial infection or epilepsy was observed in both groups.Laboratory indexes and cerebral CT/MRI scanning were normal,and no repair material-related adverse events were found.The incidence of adverse events was 2.7% in experimental group and 3.7% in control group,and no significant difference was noticed between the two groups.Conclusion The safety and efficacy of dural repair with novel artificial dural acellular biomembrane are similar to that with autologous fascia,and may protect brain tissue timely.

关 键 词：硬脑膜脱细胞生物膜 硬脑膜缺损 神经外科手术 

分 类 号：R651.11[医药卫生—外科学]