嗅鞘细胞治疗晚期脊髓损伤短期与长期疗效的Meta分析

摘要

背景:世界上已开展多项嗅鞘细胞治疗晚期脊髓损伤的临床试验, 但其有效性及安全性仍有争议.目的:综合评价嗅鞘细胞移植治疗晚期脊髓损伤安全性及可行性, 比较其治疗短期疗效与长期疗效.方法:于2018-07-23检索PubMed、Cochrane图书馆、EMBASE、知网、万方数据库, 纳入嗅鞘细胞治疗晚期脊髓损伤的临床研究.安全性研究试验应详细记录不良事件的种类与例数.纳入疗效评价的研究均使用ASIA量表, 评估移植前后脊髓损伤患者的运动、轻触觉及针刺觉功能, 并记录随访时间.运用Review Manager5.3对疗效数据进行系统评价.结果与结论:无论短期评价还是长期随访, 与嗅鞘细胞移植前相比, 患者神经功能均有明显提高 (P <0.05), 且研究结果具有同质性 (Ι2 <50％且P> 0.1) .然而长期疗效不如短期, 这可能与慢性排斥反应及嗅鞘细胞存活率相关.嗅鞘细胞治疗晚期脊髓损伤的总不良事件发生率为8.99％, 未发现与嗅鞘细胞本身相关的并发症.结果表明, 嗅鞘细胞移植治疗晚期脊髓损伤疗效明确, 安全可行, 但仍需要探索更微创的移植方式, 以减少手术并发症.另外, 影响嗅鞘细胞长期疗效的因素需要大量高质量的基础及临床试验予以证实.%BACKGROUND: A number of clinical trials addressing olfactory ensheathing cells for the treatment of chronic spinal cord injury have been conducted in the world, but the efficacy and safety are still controversial. OBJECTIVE: To evaluate the safety and efficacy of olfactory ensheathing cell transplantation for chronic spinal cord injury, and to further compare its short-and long-term efficacy. METHODS: PubMed, Cochrane Library, EMBASE, CNKI and WanFang databases were searched at July 23, 2018 for retrieval of clinical trials addressing olfactory ensheathing cells in the treatment of chronic spinal cord injury. Types and cases of adverse events during the safety trial should be recorded in detail. In the enrolled studies, American Spinal Injury Association scale was used to assess the motor, light touch, and pinprick scores of spinal cord injury patients before and after cell transplantation. The follow-up time was recorded. Systematic evaluation of efficacy data was performed using Review Manager 5.3. RESULTS AND CONCLUSION: Both short-and long-term follow-up data showed that the neurological function of patients was significantly improved after olfactory ensheathing cell transplantation (P < 0.05), and the results were homogeneous (I2 < 50％ and P> 0.1). However, the long-term efficacy was not as good as the short-term efficacy, which may be related to chronic rejection and olfactory ensheathing cell survival. The overall adverse event rate was 8.99％, and no complications associated with olfactory ensheathing cells occurred. These findings show that olfactory ensheathing cell transplantation is effective and safe in the treatment of chronic spinal cord injury, but it is still necessary to explore more minimally invasive approaches to reduce surgical complications. In addition, a large number of high-quality experiments and clinical trials are warranted to confirm factors affecting the long-term efficacy of olfactory ensheathing cell transplantation.