系统评价脐带来源细胞移植治疗脑性瘫痪患者的疗效与安全性  

Systematic review of the efficacy and safety of umbilical cord-derived cell transplantation for patients with cerebral palsy

作　　者：钟李青[1] 钟珊珊 韩伟超 胡润凯 何淑芬 丁少波[1] Zhong Liqing;Zhong Shanshan;Han Weichao;Hu Runkai;He Shufen;Ding Shaobo(Department of Pharmacy,Dongguan People’s Hospital,Dongguan 523000,Guangdong Province,China)

机构地区：[1]东莞市人民医院药学部,广东省东莞市523000

出　　处：《中国组织工程研究》2021年第25期4095-4100,共6页Chinese Journal of Tissue Engineering Research

摘　　要：目的:近年来,脐带来源细胞移植治疗脑瘫被认为是具有前景的策略之一。但是,临床证据仍然有限并且有关干细胞治疗脑瘫的临床疗效存在争议。文章系统评价脐带来源细胞移植治疗脑性瘫痪患者疗效与安全性。方法:系统检索了脐带来源细胞移植治疗脑瘫患者的随机对照试验,检索时间为从建立数据库到2020年8月,数据库包括Cochrane图书馆、PubMed、EMbase、中国知网、万方和中国临床试验注册中心数据库。文章对纳入的研究使用了Cochrane偏倚风险评估工具评估文献质量。由2名评价者对符合纳入的研究进行独立的质量评价、数据提取后采用RevMan 5.0软件对结局指标数据进行Meta分析。结果:①共有6篇符合脐带来源细胞移植治疗脑瘫患者的临床随机对照试验,文献质量中等;②Meta分析的结果表明,与对照组相比,脐带来源细胞治疗可以显着提高粗大运动功能测量评分(SMD=0.83,95%CI:0.36-1.30,P=0.000 6)和粗大运动性能评定量表评分(SMD=0.51,95%CI:0.22-0.80,P=0.000 5);③亚组分析结果表明,脐带来源细胞治疗后,脑瘫患者的6个月的粗大运动功能测量评分显著增加(SMD=0.91,95%CI:0.07-1.74,P=0.03);④两组间的上呼吸道感染、腹泻和便秘等不良事件的比较均无显著性差异。结论:脐带来源细胞移植治疗可显著提高脑瘫患者的运动功能,安全性较好,但是由于纳入文献量较少,未来仍需进行大样本、多中心、高质量临床随机对照试验来进行进一步验证。OBJECTIVE:In recent years,umbilical cord-derived cells transplantation is considered to be one of the promising strategies for the treatment of cerebral palsy.However,clinical evidence is still limited and there is controversy regarding the clinical efficacy of stem cells in the treatment of cerebral palsy.This article systematically evaluated the efficacy and safety of umbilical cord-derived cells transplantation in the treatment of patients with cerebral palsy.METHODS:Randomized controlled trials of umbilical cord-derived cell transplantation in patients with cerebral palsy were systematically searched,from the inception of the database to August 2020,including the Cochrane Library,PubMed,Embase,CNKI,Wanfang Database,and China Clinical Trial Registration Center.We used Cochrane’s risk of bias assessment for the quality of the included studies.Two reviewers conducted independent quality evaluations for the included studies.After data extraction,RevMan 5.0 software was used for meta-analysis of outcome indicators.RESULTS:(1)There are six randomized controlled trials regarding umbilical cord-derived cells transplantation for the treatment of cerebral palsy.Literature quality was medium.(2)The results of meta-analysis showed that umbilical cord-derived cell therapy could significantly improve the gross motor function measurement score(SMD=0.83,95%CI=0.36-1.30,P=0.0006)and the gross motor performance measurement score(SMD=0.51,95%CI=0.22-0.80,P=0.0005).(3)In the subgroup analysis,the results showed that after umbilical cord-derived cell treatment,the gross motor function measurement scores of patients with cerebral palsy increased significantly at 6 months(SMD=0.91,95%CI=0.07-1.74,P=0.03).(4)There was no statistical difference in adverse events such as upper respiratory tract infection,diarrhea and constipation between the two groups.CONCLUSION:Umbilical cord-derived cell transplantation could significantly improve motor function in patients with cerebral palsy,and the safety was good.However,due to the small numb

关 键 词：干细胞 脐带来源细胞 脑性瘫痪 安全性 有效性 Meta分析 随机对照试验 系统评价 

分 类 号：R456[医药卫生—治疗学] R363[医药卫生—临床医学]