Chinese Journal of Tissue Engineering Research ›› 2018, Vol. 22 ›› Issue (1): 119-125.doi: 10.3969/j.issn.2095-4344.0421
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Wu Ni-na1, He Jian-yun2, Zhu Lei3, Li Xiao-mei3
Revised:
2017-08-16
Online:
2018-01-08
Published:
2018-01-08
Contact:
Li Xiao-mei, Master, Associate chief physician, Room for Cardiac Intervertions, Xiangyang Hospital, Hubei University of Medicine, Xiangyang 441000, Hubei Province, China
About author:
Wu Ni-na, Nurse in charge, Department of Cardiovascular Medicine, Xiangyang Hospital, Hubei University of Medicine, Xiangyang 441000, Hubei Province, China
CLC Number:
Wu Ni-na, He Jian-yun, Zhu Lei, Li Xiao-mei. The safety and efficacy of bone marrow stem cell transplantation for ischemic heart failure: a Meta-analysis[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(1): 119-125.
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2.1 文献检索结果 各数据库共检出文献1 012篇,运用NoteExpress3.1软件排重后获文献927篇,经标题、摘要初筛获得可能纳入的文献119篇,再通过阅读全文复筛,最终8个随机对照试验符合纳入标准被纳入[19-26]。其中,中文文献2篇[19-20],英文文献6篇[21-26]。 2.2 纳入文献基本特征 8个随机对照试验,共涉及缺血性心力衰竭患者350例,其中干细胞治疗组191例,常规治疗组159例。研究发表年份介于2007至2016年。4个研究地点位于中国[19-21,25],其余4个研究地点位于国外[22-24,26]。纳入研究对象均为中老年患者(平均年龄>55岁),心功能分级多为NYHA Ⅱ级以上,2个研究未报告缺血性心肌病病程[20,26]。常规治疗主要包括经皮冠状动脉介入治疗、冠状动脉搭桥术及抗心力衰竭药物治疗,4个研究运用骨髓间充质干细胞治疗[19-20,24,26],4个研究运用骨髓单个核细胞治疗[21-23,25],5个研究给干细胞途径为冠脉内注射[19-21,24-25],3个研究为心肌内注射[22-23,26]。干细胞数量级均为107。随访时间最短为3个月[19],最长为14个月[20]。结局指标包括:左心室射血分数、左心室收缩末期容积、左心室舒张末期容积及不良事件发生率。纳入研究基本特征见表1。Cochrane随机对照试验偏倚风险评估工具评价结果见图1。改良Jadad量表评价结果见表1。2个研究得分为2分[19-20],评价为“低质量”研究,其余研究得分均≥4分,为“高质量”研究。"
2.3 Meta分析结果 2.3.1 左心室射血分数 8个研究比较了骨髓干细胞移植与常规疗法对缺血性心力衰竭患者左心室射血分数的影响[19-26]。干细胞治疗组191例,常规治疗组159例。异质性检验结果显示研究间存在异质性(P < 0.01,I2=92%)。运用随机效应模型进行统计分析(图2),结果显示两种治疗方式对增加患者左心室射血分数疗效差异有显著性意义[MD=4.68,95%CI(1.79,7.56),P < 0.01],说明骨髓干细胞移植在增加患者左心室射血分数方面优于常规治疗。排除2个低质量研究[19-20],合并结果仍显示骨髓干细胞移植在增加患者左心室射血分数方面优于常规治疗[I2=94%,MD=4.68,95%CI(1.11,8.39),P < 0.01]。 2.3.2 左心室舒张末期容积 6个研究比较了骨髓干细胞移植与常规疗法对缺血性心力衰竭患者左心室舒张末期容积疗效的差异[19-20,22-24,26]。总样本量258例,其中,干细胞治疗组142例,常规治疗组116例。异质性检验结果显示研究间存在异质性(P=0.01,I2=69%)。运用随机效应模型进行Meta分析,合并结果显示骨髓干细胞移植与常规疗法在降低缺血性心力衰竭患者左心室舒张末期容积方面差异无显著性意义[MD=-3.86,95%CI(-9.90,2.17),P=0.21](图3)。排除2个低质量研究[19-20],Meta分析结果仍显示两种治疗方法在降低患者左心室舒张末期容积方面差异无显著性意义[I2=0%,MD=0.28,95%CI(-2.44,2.99),P=0.84]。"
2.3.3 左心室收缩末期容积 5个研究比较了骨髓干细胞移植与常规疗法对缺血性心力衰竭患者左心室收缩末期容积疗效的差异[19-20,22-24]。总样本量238例,其中,干细胞治疗组132例,常规治疗组106例。异质性检验结果显示研究间存在异质性(P < 0.01,I2=78%)。运用随机效应模型进行Meta分析,合并结果显示骨髓干细胞移植与常规疗法在降低缺血性心力衰竭患者左心室收缩末期容积方面差异无显著性意义[MD=-3.20,95%CI(-9.21,2.80),P =0.30](图4)。排除2个低质量研究[19-20],Meta分析结果仍显示两种治疗方法在降低患者左心室收缩末期容积方面差异无显著性意义[I2=49%,MD=-0.80,95%CI(-10.91,9.31),P=0.88]。 2.3.4 不良事件发生率 5个研究报道了治疗过程中不良事件发生率[20,22-24,26],合计样本量202例,干细胞治疗组116例,常规治疗组86例。其中2个研究在治疗过程中均无不良事件发生[20,26],3个研究数据纳入该结局指标统计分析[22-24]。Meta分析结果显示干细胞治疗组与常规疗法相比,在不良反应发生率方面差异无显著性意义[I2=13%,RR=0.85,95%CI(0.25,2.89),P=0.79] (图5)。"
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