自体骨髓间充质干细胞治疗脊髓损伤有效性和安全性的系统评价

Efficacy and safety of autologous bone marrow mesenchymal stem cells transplantation for spinal cord injury: a systematic review

目的系统评价自体骨髓间充质干细胞(BMSCs)治疗脊髓损伤(SCI)的有效性和安全性。方法计算机检索Pub Med、The Cochrane Library、EMbase、CNKI、CBM、Wan Fang Data和VIP数据库,搜集自体BMSCs移植与康复理疗比较治疗SCI的随机对照试验(RCT)和同期临床对照试验(CCT),检索时限均从建库至2017年6月8日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用Stata 13.1软件进行Meta分析。结果共纳入16个研究,包括954例SCI患者。Meta分析结果显示:与康复理疗相比,自体BMSCs移植能增加患者ASIA运动功能评分[MD=6.91,95%CI(3.95,9.87),P<0.000 01]、ASIA触觉评分[MD=11.79,95%CI(6.66,16.39),P<0.000 01]、ASIA痛觉评分[MD=8.76,95%CI(4.11,13.40),P=0.000 2]、生活能力评分[MD=8.47,95%CI(7.32,9.61),P<0.000 01],改善AIS分级[OR=3.75,95%CI(2.35,5.99),P<0.01],并能降低膀胱残余尿量[MD=–23.32,95%CI(–46.27,–0.37),P=0.05]。BMSCs治疗的不良反应主要包括头痛、低热等,无严重不良反应及异常新生组织形成的报道。结论自体BMSCs移植治疗SCI是一种安全、有效的治疗方法。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objectives To systematically review the safety and efficacy of autologous bone marrow mesenchymal stem cells（BMSCs） transplantation for spinal cord injury（SCI） patients. Methods Pub Med, The Cochrane Library,EMbase, CNKI, CBM, Wan Fang Data and VIP databases were electronically searched to collect randomized controlled trials（RCTs） and clinical controlled trials（CCTs） of autologous BMSCs transplantation for SCI patients from inception to June 8th, 2017. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed using Rev Man 5.3 software. Results A total of 16 studies involving 954 SCI patients were included. The results of meta-analysis showed that： BMSCs could significantly increase the patients＇ ASIA m otor score（MD=6.91, 95%CI 3.95 to 9.87, P〈0.000 01）, ASIA light-tough score（MD=11.79, 95%CI 6.66 to 16.39,P〈0.000 01）, ASIA pain score（MD=8.76, 95%CI 4.11 to 13.40, P=0.000 2）, Barthel index score（MD=8.47, 95%CI 7.32 to9.61, P〈0.000 01）. It could also improve the ASIA grade（OR=3.75, 95%CI 2.35 to 5.99, P〈0.01）, and decrease the bladder urine residue（MD=–23.32, 95%CI –46.27 to –0.37, P=0.05）. The complications mainly included headache, low-grade fever, and so forth. No serious adverse event and abnormal tissue formation occurred. Conclusion Autologous BMSCs transplantation is a safe and effective therapy for SCI. Due to limited quality and quantity of the included studies, more high quality studies are required to verify the above conclusion.