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目的探讨人胚胎嗅鞘细胞(olfactory ensheathing cells,OECs)移植治疗肌萎缩侧索硬化症(amyotrophic lateral sclerosis,ALS)患者的近期安全性和有效性。方法回顾性分析2003年2月~2006年4月,采用OECs移植手术治疗的327例ALS患者的临床资料。男241例,女86例。年龄20~84岁(51.6±11.1岁)。病程4.8个月~13年(2.9±2.0年)。根据细胞植入部位分为3组:A组29例,细胞植入脊髓内;B组(6例),细胞分别植入脊髓及双额叶放射冠;C组292例,细胞植入双额叶放射冠。脊髓移植方法,病变处分两点共注入50μlOECs悬液,细胞数约1×106个。脑部移植方法,双侧大脑放射冠处各注射50μlOECs悬液,细胞数约2×106个。结果随访4周,比较术前和随访肌萎缩侧索硬化症功能量表分数变化。A组17.2±8.6增至20.1±9.7(P<0.05),B组24.2±6.8增至25.7±6.6(P>0.05),C组20.3±8.6增至22.0±9.4(P<0.001),3组间改善程度差异无统计学意义(P>0.05)。4周神经功能总改善252例(77.1%)。术后4周行肌电图检查的患者261例(79.8%)显示术后自发电位减少或消失,收缩时肌电波幅较术前明显降低,电位密度明显增加。16例(4.9%)术后出现不良反应,包括头痛、短期发热、癫痫大发作、中枢神经系统感染、肺炎、呼吸衰竭、泌尿系感染、心力衰竭及肺栓塞,其中4例(1.2%)死亡。结论OECs移植术后4周能阻止或逆转ALS的病情恶化。
Objective To investigate the recent safety and efficacy of human embryonic olfactory ensheathing cells (OECs) in the treatment of patients with amyotrophic lateral sclerosis (ALS). Methods The clinical data of 327 ALS patients who underwent OECs transplantation surgery from February 2003 to April 2006 were retrospectively analyzed. 241 males and 86 females. Age 20 to 84 years (51.6 ± 11.1 years). Duration of 4.8 months to 13 years (2.9 ± 2.0 years). The cells were divided into 3 groups according to the site of cell implantation: group A (n = 29), cells were implanted into the spinal cord; group B (n = 6) Leaves radiating crown. Spinal cord transplantation method, the lesion points were injected 50μl OECs suspension, the number of cells about 1 × 106. Brain transplantation method, bilateral cerebrum radiation crown injection of 50μl OECs suspension, the number of cells about 2 × 106. Results The patients were followed up for 4 weeks. The scores of amyotrophic lateral sclerosis (FAS) before and after operation were compared. (P <0.05) in group A from 17.2 ± 8.6 to 20.1 ± 9.7 (P <0.05), in group B from 24.2 ± 6.8 to 25.7 ± 6.6 (P> 0.05), in group C increased from 20.3 ± 8.6 to 22.0 ± 9.4 There was no significant difference between the two groups (P> 0.05). 252 cases (77.1%) improved neurological function at 4 weeks. 261 patients (79.8%) underwent electromyogram 4 weeks after operation showed that the spontaneous potential decreased or disappeared after operation, and the amplitude of EMG decreased significantly and the potential density increased obviously. Twenty-six patients (4.9%) experienced postoperative adverse reactions including headache, short-term fever, epileptic seizures, central nervous system infections, pneumonia, respiratory failure, urinary tract infections, heart failure and pulmonary embolism, of which 4 (1.2%) died . Conclusion OECs 4 weeks after transplantation can prevent or reverse the deterioration of ALS.