干细胞移植治疗扩张型心肌病疗效和安全性的系统评价

目的 系统评价干细胞移植治疗原发性扩张型心肌病的临床疗效和安全性.方法 检索中国生物医学文献光盘数据库、中国知网数据库、维普数据库、万方数据库、Cochrane图书馆临床对照试验数据库、OVID Medline和EMBASE.由2名研究人员独立阅读并交叉核对文献资料.主要疗效指标为病死率和心衰量表;次要疗效指标为左室射血分数(LVEF)、左室舒张末期内径(LVED)和6 min步行距离.安全性指标为不良反应事件发生率.采用RevMan 5.0.2软件进行Meta分析.结果 纳入7个随机对照临床试验(RCT),共263例患者.Meta分析结果显示:干细胞移植联合常规药物治疗的3年病死率与单用常规药物治疗相比无明显差别;于细胞移植联合常规药物治疗在提高术后3个月LVEF方面并不优于单用常规药物治疗;尚未发现与干细胞移植有关的不良反应.结论 干细胞移植联合常规药物治疗并不优于单用常规药物治疗;由于纳入的RCT数量较少且质量较低,结论有待更多大规模高质量的研究进一步论证.

Systematic evaluation of therapeutic effect and safety of stem cell transplantation for dilated cardiomyopathy

Objective To systematically assess the efficacy and safety of stem cell transplantation in the treatment of idiopathic dilated cardiomyopathy.Methods China Biomedical Literature Database on disc,CNKI,VIP,Wanfang Data,Cochrane Controlled Trails Register,OVID Medline and EMBASE were searched.Two researchers independently extracted information,which was then cross-checked by each other.The primary parameters of therapeutic effects were mortality and heart failure questionnaire,the secondary parameters of therapeutic effects were left ventricular ejection fraction(LVEF),left ventricular end-diastolic diameter(LVED) and 6-minute walking distance,and the parameter of safety was prevalence of adverse events.Meta-analysis was performed with RevMan 5.0.2 software.Results Seven randomized clinical trials(RCT) were enrolled,and 263 patients were included.Meat-analysis revealed that there was no significant difference in 3-year mortality between stem cell transplantation combined with standard therapy and single standard drug therapy,stem cell transplantation combined with standard therapy did not performed better than single standard drug therapy in improving LVEF 3 months after operation,and there was no stem cell transplantation-related adverse events.Conclusion The therapeutic effect of stem cell transplantation combined with standard therapy is no better than single standard drug therapy.However,due to the small scale and low quality of included RCT,more studies in large scale and high quality are needed to verify the results.