摘要目的:探讨人脱细胞同种异体真皮基质材料在硬脑膜缺损修补术中的应用效果。方法:采用随机、平行对照临床研究方法，纳入2015年5月至2018年9月复旦大学附属华山医院神经外科(53例)和上海交通大学附属仁济医院神经外科(35例)收治的需行硬脑膜修复术的患者。将88例受试者随机分配至试验组(45例)和对照组(43例)。试验组采用人脱细胞异体真皮基质进行修补，对照组采用猪来源生物型硬脑膜补片进行修补。术中术者评价材料的韧性、延展性和可缝合性。术后定期住院或门诊随访患者的负压球引流量及不良事件的发生情况。术后10 d、3个月及6个月复查头颅CT或MRI，观察术区硬膜外积液及皮下积液情况，以判断有无脑脊液漏。比较两组患者的基线资料、术中材料的评估结果以及术后不良事件的发生情况等。结果:两组患者的年龄、性别等基线资料的差异均无统计学意义(均 P>0.05)，具有可比性。两组患者比较，术后24 h负压球引流量的差异无统计学意义( P＝0.977)。两组受试者术后伤口均为Ⅰ级愈合，均无皮下积液和脑脊液漏。至术后6个月末次影像学随访，两组患者的影像学检查均提示硬脑膜修补局部无异常信号。试验组与对照组一般不良事件发生率[62.2%(28/45)对比48.8%(21/43)]和严重不良事件发生率[6.7%(3/45)对比4.6%(2/43)]的差异均无统计学意义(均 P>0.05)。两组患者均未发生与人工修补材料相关的不良事件。与对照组比较，术中术者对试验组人工修补材料的韧性、延展性及可缝合性更为满意(均 P<0.05)。 结论:人脱细胞同种异体真皮基质材料在硬脑膜缺损修补术中具有较好的韧性、延展性和可缝合性，修补效果与常规硬脑膜补片相似，且不增加术后不良事件的发生。

abstractsObjective:To investigate the effect of human acellular allogeneic dermal matrix in the repair of dural defects.Methods:A randomized parallel controlled clinical study was conducted. From May 2015 to September 2018, 53 patients in Department of Neurosurgery, Huashan Hospital of Fudan University and 35 patients in Department of Neurosurgery, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine were enrolled into this study. All 88 patients were randomly assigned to the experimental group ( n=45) and the control group ( n=43). The dural defect was repaired with human acellular allogeneic dermal matrix in the experimental group and with porcine biotype dural mesh in the control group. The surgeon evaluated the toughness, ductility, and suturing ability of the material. The negative pressure ball drainage volume and the occurrence of adverse events was followed up regularly in hospital or outpatient department after operation. CT or MRI was performed 10 days, 3 months and 6 months after operation to observe the epidural effusion and subcutaneous effusion in the operation area to determine whether there was cerebrospinal fluid leakage. The baseline data, intraoperative material evaluation results and postoperative adverse events were compared between the two groups. Results:There was no significant difference in the age, gender or other baseline data between the two groups ( P>0.05) which were comparable. There was no significant difference in the volume of negative pressure ball drainage at 24 h after operation between the two groups ( P=0.977). Postoperative wound healing was grade Ⅰ in both groups, and there was no subcutaneous effusion or cerebrospinal fluid leakage. At the end of 6 months after operation, the latest imaging examination of the two groups of patients showed that there was no abnormal signal in the area of dural repair. There were no significant differences in the incidences of general adverse events [62.2% (28/45) vs 48.8% (21/43)] and serious adverse events [6.7% (3/45) vs 4.6% (2/43)] between the experimental group and control group (both P>0.05). There were no adverse events related to artificial repair materials in either group. The surgeons were more satisfied with the toughness, ductility and suturing of the artificial repair material in the experimental group than those in the control group (all P<0.05). Conclusions:Human acellular allogeneic dermal matrix material has good toughness, extensibility and suturing ability in the repair of dural defect. Its repair effect is similar to that of conventional dural mesh, and does not increase the incidence of postoperative adverse events.