基于CT灌注评价早期钛网修补颅骨缺损对脑血流量及神经功能康复的影响:随机对照临床试验

发布时间：2018-04-17 08:40

本文选题：生物相容性材料 + 减压颅骨切除术　；参考：《中国组织工程研究》2017年26期

【摘要】：背景:创伤性脑损伤后去骨瓣减压治疗形成了颅骨缺损,目前公认最合适的颅骨修补人工材料为金属钛网,其生物相容性良好,在临床上获得了广泛应用,但脑损伤后颅骨缺损修复的时机仍存在争议。目的:采用CT灌注技术比较早期、晚期钛网修补颅骨缺损前后患者的脑组织血流灌注变化以及神经功能康复情况。方法:试验为单中心、前瞻性、观察性临床试验,在中国湖北省,湖北医药学院附属太和医院完成。选取2013年1月至2016年1月收治的颅脑损伤后去骨瓣减压患者86例,均采用钛网进行颅骨修复,随机分为2组,试验组40例行早期颅骨修补(去骨瓣减压术后1-3个月),对照组46例行晚期颅骨修补(去骨瓣减压术后6-12个月)。颅骨修补术前3 d和术后第10天,应用CT灌注技术观察脑组织血液灌注量变化;术后30 d评价日常活动能力Barthel指数。试验于2017年7月12日在北美临床试验中心注册(NCT03222297)。试验方案经十堰市太和医院伦理委员会批准,批准号为2012第(08)号。临床试验研究的实施符合《赫尔辛基宣言》和医院对人体研究的相关伦理要求。参与试验的患病个体及其家属为自愿参加,均对试验过程完全知情同意,在充分了解治疗方案的前提下签署"知情同意书"。结果与结论:(1)两组患者颅骨修补后缺损侧顶叶皮质、缺损处皮质的脑血容量和脑血流量均高于颅骨修补前(P0.05),达峰时间则低于颅骨修补前(P0.05);颅骨修补后试验组的缺损侧顶叶皮质、缺损处皮质的脑血容量和脑血流量均高于对照组(P0.05),达峰时间则低于对照组(P0.05);(2)颅骨修补术后30 d试验组的Barthel指数得分高于对照组(P0.05);(3)说明早期行颅骨缺损修补,对改善患侧脑组织灌注情况有利,进而对患侧神经功能的恢复有意义,而CT灌注观测脑血流动力学的变化安全有效。
[Abstract]:Background: cranial defect is caused by decompression of bone flap after traumatic brain injury. At present, the most suitable artificial material for skull repair is titanium metal mesh, which has been widely used in clinic because of its good biocompatibility.However, the timing of skull defect repair after brain injury is still controversial.Objective: to compare the changes of cerebral blood flow perfusion and neurological rehabilitation in patients with cranial defects before and after the late repair of skull defect by CT perfusion technique.Methods: a single-center, prospective, observational clinical trial was conducted in Taihe Hospital, Hubei Medical College, Hubei Province, China.From January 2013 to January 2016, 86 patients with craniocerebral injury underwent craniotomy and decompression, all of whom were treated with titanium mesh for skull repair, and were randomly divided into two groups.Early cranioplasty was performed in 40 patients in the trial group (1-3 months after decompression of bone flap) and late cranioplasty in 46 patients in the control group (6-12 months after decompression of bone flap).Three days before and 10 days after cranioplasty, CT perfusion technique was used to observe the changes of cerebral blood perfusion volume, and the Barthel index of daily activity was evaluated 30 days after operation.The trial was registered at the North American Center for Clinical Trials on July 12, 2017.The test scheme was approved by the Ethics Committee of Taihe Hospital, Shiyan City, approved No. 2012.The implementation of clinical trial research is in line with the Helsinki Declaration and the ethical requirements of human research in hospitals.The patients and their families who participated in the trial were all willing to take part in the experiment and signed the "informed consent" on the premise of full understanding of the treatment plan.Results and conclusion the cerebral blood volume and cerebral blood flow in the defect cortex after cranioplasty were higher than those in the anterior cranioplasty group (P 0.05), the peak time was lower than that in the skull repair group (P 0.05), and the defect parietal cortex in the experimental group after skull repair was lower than that in the control group.The cerebral blood volume and cerebral blood flow in the cortex of the defect were higher than those in the control group (P 0.05), and the peak time was lower than that in the control group (P 0.05). The score of Barthel index in the experimental group 30 days after skull repair was higher than that in the control group (P 0.05).It is beneficial to improve the cerebral perfusion of the affected side and then to recover the nerve function of the affected side, and CT perfusion is safe and effective to observe the changes of cerebral hemodynamics.
【作者单位】：十堰市太和医院(湖北医药学院附属医院)重症医学科;
【基金】：湖北省卫生计生科研项目(WJ2015MB308)~~
【分类号】：R651.1

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