本文選題：生物相容性材料 + 減壓顱骨切除術(shù)�。� 參考：《中國組織工程研究》2017年26期

【摘要】：背景:創(chuàng)傷性腦損傷后去骨瓣減壓治療形成了顱骨缺損,目前公認(rèn)最合適的顱骨修補(bǔ)人工材料為金屬鈦網(wǎng),其生物相容性良好,在臨床上獲得了廣泛應(yīng)用,但腦損傷后顱骨缺損修復(fù)的時(shí)機(jī)仍存在爭(zhēng)議。目的:采用CT灌注技術(shù)比較早期、晚期鈦網(wǎng)修補(bǔ)顱骨缺損前后患者的腦組織血流灌注變化以及神經(jīng)功能康復(fù)情況。方法:試驗(yàn)為單中心、前瞻性、觀察性臨床試驗(yàn),在中國湖北省,湖北醫(yī)藥學(xué)院附屬太和醫(yī)院完成。選取2013年1月至2016年1月收治的顱腦損傷后去骨瓣減壓患者86例,均采用鈦網(wǎng)進(jìn)行顱骨修復(fù),隨機(jī)分為2組,試驗(yàn)組40例行早期顱骨修補(bǔ)(去骨瓣減壓術(shù)后1-3個(gè)月),對(duì)照組46例行晚期顱骨修補(bǔ)(去骨瓣減壓術(shù)后6-12個(gè)月)。顱骨修補(bǔ)術(shù)前3 d和術(shù)后第10天,應(yīng)用CT灌注技術(shù)觀察腦組織血液灌注量變化;術(shù)后30 d評(píng)價(jià)日常活動(dòng)能力Barthel指數(shù)。試驗(yàn)于2017年7月12日在北美臨床試驗(yàn)中心注冊(cè)(NCT03222297)。試驗(yàn)方案經(jīng)十堰市太和醫(yī)院倫理委員會(huì)批準(zhǔn),批準(zhǔn)號(hào)為2012第(08)號(hào)。臨床試驗(yàn)研究的實(shí)施符合《赫爾辛基宣言》和醫(yī)院對(duì)人體研究的相關(guān)倫理要求。參與試驗(yàn)的患病個(gè)體及其家屬為自愿參加,均對(duì)試驗(yàn)過程完全知情同意,在充分了解治療方案的前提下簽署"知情同意書"。結(jié)果與結(jié)論:(1)兩組患者顱骨修補(bǔ)后缺損側(cè)頂葉皮質(zhì)、缺損處皮質(zhì)的腦血容量和腦血流量均高于顱骨修補(bǔ)前(P0.05),達(dá)峰時(shí)間則低于顱骨修補(bǔ)前(P0.05);顱骨修補(bǔ)后試驗(yàn)組的缺損側(cè)頂葉皮質(zhì)、缺損處皮質(zhì)的腦血容量和腦血流量均高于對(duì)照組(P0.05),達(dá)峰時(shí)間則低于對(duì)照組(P0.05);(2)顱骨修補(bǔ)術(shù)后30 d試驗(yàn)組的Barthel指數(shù)得分高于對(duì)照組(P0.05);(3)說明早期行顱骨缺損修補(bǔ),對(duì)改善患側(cè)腦組織灌注情況有利,進(jìn)而對(duì)患側(cè)神經(jīng)功能的恢復(fù)有意義,而CT灌注觀測(cè)腦血流動(dòng)力學(xué)的變化安全有效。
[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.
【作者單位】： 十堰市太和醫(yī)院(湖北醫(yī)藥學(xué)院附屬醫(yī)院)重癥醫(yī)學(xué)科;
【基金】：湖北省衛(wèi)生計(jì)生科研項(xiàng)目(WJ2015MB308)~~
【分類號(hào)】：R651.1

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