Li Lei, Adnan Hafeez, Xu Benchen, Wang Jianmin, Wang Chengke, Li Fang, Tang Kai
First Affliated Hospital of Dalian Medical University, Zhong shan road no. 222, Dalian, 116011, Liaoning, People's Republic of China,
Eur Spine J. 2015 May;24(5):919-30. doi: 10.1007/s00586-014-3416-6. Epub 2014 Jul 8.
The debate on the effects and outcome of olfactory ensheathing cell (OEC) transplantation for the treatment of spinal cord injury (SCI) has remained unresolved for nearly 20 years. This study aimed to evaluate the safety and efficacy of OEC transplantation in chronic SCI patients.
Electronic databases, including PubMed, the Cochrane Library, EMBASE, and MEDLINE, were searched to identify clinical therapeutic trials studying the use of OEC transplantation for SCI in humans. Each trial was analyzed in accordance with the criteria of the Cochrane Handbook 5.1.0 and MOOSE. Data were analyzed with Review Manager 5.2 and Meta-Analyst Beta 3.13 software.
Eleven articles concerning 10 studies of 1,193 patients with chronic SCI treated with OEC transplantation were selected for review. All the articles had low methodological quality. Studies reported their outcomes using the American Spinal Injury Association (ASIA) Impairment Scale; the AISA motor, light touch, pinprick score; the Functional Independence Measure and (or) other measure methods. According to the available relevant data, the incidences of total adverse events and mortality were 7.68% (n = 742) and 0.35% (n = 566), respectively. The most frequently reported adverse events were fever, mild anemia, and syringomyelia; however, the statistical adverse events occurring in different studies were cerebrospinal fluid leakage (7.00%, n = 586, 2 trials), sensory deterioration (0.70%, n = 573, 2 trials), and both motor and sensory deterioration (0.68%, n = 586, 2 trials).
Given the results from our study, we conclude that OEC transplantation appears to be safe, although the evidence for efficacy is modest and requires the support of prospective, randomized trials in larger cohorts of patients. Further randomized controlled trials utilizing strict therapy programs and implanted cell selections are needed to confirm these findings.
关于嗅鞘细胞（OEC）移植治疗脊髓损伤（SCI）的效果和结果的争论近20年来一直没有得到解决。本研究旨在评估OEC移植在慢性SCI患者中的安全性和有效性。
检索电子数据库，包括PubMed、Cochrane图书馆、EMBASE和MEDLINE，以确定研究OEC移植用于人类SCI治疗的临床治疗试验。每项试验均按照Cochrane手册5.1.0和MOOSE的标准进行分析。使用Review Manager 5.2和Meta-Analyst Beta 3.13软件进行数据分析。
选择了11篇文章，涉及10项研究，共1193例接受OEC移植治疗的慢性SCI患者进行综述。所有文章的方法学质量都很低。研究使用美国脊髓损伤协会（ASIA）损伤量表、AISA运动、轻触觉、针刺评分、功能独立性测量和（或）其他测量方法报告其结果。根据现有相关数据，总不良事件发生率和死亡率分别为7.68%（n = 742）和0.35%（n = 566）。最常报告的不良事件是发热、轻度贫血和脊髓空洞症；然而，不同研究中发生的统计不良事件是脑脊液漏（7.00%，n = 586，2项试验）、感觉恶化（0.70%，n = 573，2项试验）以及运动和感觉均恶化（0.68%，n = 586，2项试验）。
根据我们的研究结果，我们得出结论，OEC移植似乎是安全的，尽管疗效证据有限，需要在更大规模的患者队列中进行前瞻性、随机试验的支持。需要进一步的随机对照试验，采用严格的治疗方案和植入细胞选择来证实这些发现。
