CAJ | 학술논문

背景:嗅鞘细胞移植治疗陈旧性脊髓损伤的疗效可受多种影响因素如受伤的时间、节段、性别等的影响,而患者受伤后应在哪个时间段进行嗅鞘细胞移植目前尚无定论.目的:关注嗅鞘细胞移植时间窗的选择对脊髓损伤患者运动和感觉功能恢复的影响.设计:自身前后对照观察.单位:泰安荣军医院神经外科.对象:选择2004-06/2007-06山东省泰安荣军医院脊柱脊髓外科收治的脊髓损伤患者135例,其中男121例,女14例;年龄7～59岁,平均36岁.脊髓损伤时间:0～6个月21例,7个月～2年71例,2年以上43例.纳入患者或其(未成年)父母了解这一临床试验的特殊性和可能结果;患者或其监护人同意接受细胞移植治疗并签自愿接受协议书;实验和治疗方案符合中国卫生部(91-006)文件规定,经山东省泰安荣军医院伦理委员会批准.方法:①将流产胚胎的嗅球消化成单个嗅鞘细胞后培养7～15 d待用.产妇同意提供流产胚胎用于实验,此方案经过医院伦理委员会批准.②患者全身麻醉后,借助显微镜将已培养好的嗅鞘细胞悬液采用多靶点注射的方法分别移植到相应的区域内.靶点的选择据损伤情况而定,一般位于损伤区域的上下两端及左右侧正常脊髓处.据损伤区域的大小决定靶点的多少,每个靶点注射细胞量约100万单位,悬液约50 μL,含量大约2×1010 L-1,一般为2~5个靶点.③于移植前及移植后2～8周按照美国脊髓损伤学会制定的美国脊髓损伤学会标准评估患者运动和感觉功能.主要观察指标:美国脊髓损伤学会标准评分.结果:脊髓损伤患者135例均进入结果分析.不同移植时间窗脊髓损伤患者运动和感觉功能均较移植前有明显提高,差异有非常显著性意义(P < 0.01);不同移植时间窗患者移植后运动和感觉功能分数及分数提高程度比较,差异无显著性意义(P > 0.05).结论:嗅鞘细胞移植可促进脊髓损伤患者的神经功能恢复,且不存在移植时间窗差异. 揹景:嗅鞘細胞移植治療陳舊性脊髓損傷的療效可受多種影響因素如受傷的時間、節段、性彆等的影響,而患者受傷後應在哪箇時間段進行嗅鞘細胞移植目前尚無定論.目的:關註嗅鞘細胞移植時間窗的選擇對脊髓損傷患者運動和感覺功能恢複的影響.設計:自身前後對照觀察.單位:泰安榮軍醫院神經外科.對象:選擇2004-06/2007-06山東省泰安榮軍醫院脊柱脊髓外科收治的脊髓損傷患者135例,其中男121例,女14例;年齡7～59歲,平均36歲.脊髓損傷時間:0～6箇月21例,7箇月～2年71例,2年以上43例.納入患者或其(未成年)父母瞭解這一臨床試驗的特殊性和可能結果;患者或其鑑護人同意接受細胞移植治療併籤自願接受協議書;實驗和治療方案符閤中國衛生部(91-006)文件規定,經山東省泰安榮軍醫院倫理委員會批準.方法:①將流產胚胎的嗅毬消化成單箇嗅鞘細胞後培養7～15 d待用.產婦同意提供流產胚胎用于實驗,此方案經過醫院倫理委員會批準.②患者全身痳醉後,藉助顯微鏡將已培養好的嗅鞘細胞懸液採用多靶點註射的方法分彆移植到相應的區域內.靶點的選擇據損傷情況而定,一般位于損傷區域的上下兩耑及左右側正常脊髓處.據損傷區域的大小決定靶點的多少,每箇靶點註射細胞量約100萬單位,懸液約50 μL,含量大約2×1010 L-1,一般為2~5箇靶點.③于移植前及移植後2～8週按照美國脊髓損傷學會製定的美國脊髓損傷學會標準評估患者運動和感覺功能.主要觀察指標:美國脊髓損傷學會標準評分.結果:脊髓損傷患者135例均進入結果分析.不同移植時間窗脊髓損傷患者運動和感覺功能均較移植前有明顯提高,差異有非常顯著性意義(P < 0.01);不同移植時間窗患者移植後運動和感覺功能分數及分數提高程度比較,差異無顯著性意義(P > 0.05).結論:嗅鞘細胞移植可促進脊髓損傷患者的神經功能恢複,且不存在移植時間窗差異.
배경:후초세포이식치료진구성척수손상적료효가수다충영향인소여수상적시간、절단、성별등적영향,이환자수상후응재나개시간단진행후초세포이식목전상무정론.목적:관주후초세포이식시간창적선택대척수손상환자운동화감각공능회복적영향.설계:자신전후대조관찰.단위:태안영군의원신경외과.대상:선택2004-06/2007-06산동성태안영군의원척주척수외과수치적척수손상환자135례,기중남121례,녀14례;년령7～59세,평균36세.척수손상시간:0～6개월21례,7개월～2년71례,2년이상43례.납입환자혹기(미성년)부모료해저일림상시험적특수성화가능결과;환자혹기감호인동의접수세포이식치료병첨자원접수협의서;실험화치료방안부합중국위생부(91-006)문건규정,경산동성태안영군의원윤리위원회비준.방법:①장유산배태적후구소화성단개후초세포후배양7～15 d대용.산부동의제공유산배태용우실험,차방안경과의원윤리위원회비준.②환자전신마취후,차조현미경장이배양호적후초세포현액채용다파점주사적방법분별이식도상응적구역내.파점적선택거손상정황이정,일반위우손상구역적상하량단급좌우측정상척수처.거손상구역적대소결정파점적다소,매개파점주사세포량약100만단위,현액약50 μL,함량대약2×1010 L-1,일반위2~5개파점.③우이식전급이식후2～8주안조미국척수손상학회제정적미국척수손상학회표준평고환자운동화감각공능.주요관찰지표:미국척수손상학회표준평분.결과:척수손상환자135례균진입결과분석.불동이식시간창척수손상환자운동화감각공능균교이식전유명현제고,차이유비상현저성의의(P < 0.01);불동이식시간창환자이식후운동화감각공능분수급분수제고정도비교,차이무현저성의의(P > 0.05).결론:후초세포이식가촉진척수손상환자적신경공능회복,차불존재이식시간창차이.
BACKGROUND: Many factors affect the outcome of olfactory ensheathing cell transplantation for obsolete spinal cord injury, such as the time of injury, segment and sex. The best time to do olfactory ensheathing cell transplantation is unknown up to now. OBJECTIVE: To investigate the influence of time windows of olfactory ensheathing cell transplantation on the recovery of motion and sensation function in spinal cord injury patients. DESIGN: Self-control observation. SETTING: Department of Neurosurgery, Taian Disabled Soldier's Hospital. PARTICIPANTS: 135 patients with spinal cord injury were enrolled at the Department of Spinal Cord Surgery, Taian Disabled Soldier's Hospital of Shandong Province from June 2004 to June 2007, including 121 males and 14 females, aged 7-59 years, averagely 36 years. Duration of spinal cord injury included 0-6 months in 21 cases, 7 months-2 years in 71 cases and over 2 years in 43 cases. These patients or their guardians signed an informed consent of the cell transplantation. The experimental procedures were accorded with the rules of Ministry of Health of China (No. 91-006) and approved by the Taian Disabled Soldier's Hospital of Shandong Province. METHODS: ①Olfactory bulbs of aborted fetus were digested into single olfactory ensheathing cells, and then cultured for 7-15 days. Parturients signed the informed consent. This study was approved by the Hospital Ethical Committee. ②After general anesthesia, olfactory ensheathing cell suspension was implanted into the corresponding region by the multi-targeted injection with a microscope. According to the injury condition, targets generally located in upper or lower injured region and left or right normal spinal cord. The amount of targets depends on the size of the injured region. About 1 000 000 units of cells were injected into each target, about 50 μL of suspension, at 2×1010 L-1, 2-5 targets. ③American Spinal Injury Association impairment scale was used to assess the motion and sensation function in spinal cord injury patients before transplantation and 2-8 weeks after transplantation. MAIN OUTCOME MEASURES: Scores on American Spinal Injury Association impairment scale. RESULTS: 135 spinal cord injury patients were involved in the result analysis. Motion and sensation function was improved in spinal cord injury patients at different time windows compared with that before transplantation (P < 0.01). There was no significant difference in scores on motion and sensation function and the increased degree of the score at different time windows after transplantation (P > 0.05).CONCLUSION: Olfactory ensheathing cell transplantation can promote the recovery of nerve function in spinal cord injury patients, without the difference in time windows.