三维塑形材料用于颅骨缺损修复的有效性和安全性分析

Analysis of the efficacy and safety of three-dimensional molding materials for the repair of cranial defects

摘要:

目的探究三维塑形材料在颅骨缺损修复中的有效性及安全性。方法回顾性分析采用三维塑形材料进行颅骨修复术的100例患者的临床资料。按照是否发生修复材料出现植入物断裂或外露等并发症，分为无并发症组和并发症组。脑外伤患者预后评价采用格拉斯哥预后评分(GOS)，脑出血患者预后评价采用改良Rankin评分(mRS)。所有患者均在2018年7月6日之前完成手术，入组后进行电话随访，收集患者对颅骨修复后外形和功能恢复的满意度。结果 100例患者中，12例(12.0%)发现并发症，主要发生在颅骨修复术后1年内(75.0%)。单因素分析发现糖尿病、颅骨切除术病因、修复材料种类和术中剥离颞肌与并发症的发生有关(P＜0.05)。颅骨修复术显著改善患者近期和远期预后(P均＜0.01)。患者对修复材料外形满意65.0%，基本满意31.0%，不满意4%；患者对颅骨修复手术后功能恢复非常满意48.0%，基本满意43.0%，不满意9.0%。结论研究发现，三维塑形材料用于颅骨缺损修复手术有效性好，安全性高，但是修复材料相关并发症仍需引起临床重视。

Abstract:

Objective To investigate the effecacy and safety of three-dimensional molding materials in the repair of cranial defects. Methods Clinical data of 100 patients who underwent cranioplasty using three-dimensional molding materials in our hospital were retrospectively analyzed. Material-related complications were defined as implant fracture or exposure. The patients were categorized into none-complication group and complication group according to the occurrence of material-related complication. The prognosis of patients with traumatic brain injury was evaluated using the Glasgow outcome scale (GOS), and the prognosis of patients with cerebral hemorrhage was evaluated using the modified Rankin scale (mRS). All the cases received cranioplasty before July 6, 2018. After enrollment, telephone follow-up was conducted to collect patients’ satisfaction with the restoration of cranial shape and functional recovery after cranioplasty. Results Among the 100 patients, material-related complications were found in 12 cases (12.0%), mainly occurring within 1 year after cranioplasty (75.0%). Univariate analysis revealed that diabetes mellitus, the etiology of craniectomy, the types of material for cranioplasty and intraoperative treatment of temporal muscle were associated with the occurrence of complications (all P<0.05). Cranioplasty significantly improved the short- and long-term prognosis (both P<0.01). Of all the patients, 65.0% were satisfied with the appearance after skull repair, 31.0% were basically satisfied, and 4% were dissatisfied. In addition, 48.0% of the patients were very satisfied with the functional recovery after cranioplasty, 43.0% were mostly satisfied and 9.0% were dissatisfied. Conclusions According to this study, three-dimensional molding materials have good effeacy and high safety in cranial defects repair surgeries. However, complications related to the repair materials still need to be taken seriously by clinical.