Chinese Journal of Tissue Engineering Research ›› 2017, Vol. 21 ›› Issue (5): 780-788.doi: 10.3969/j.issn.2095-4344.2017.05.021
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Ai Jin-wei1, 2, 3, Liu Ying1, Liu Chu-fan1, Pei Bin1, 2, 3
Online:
2017-02-18
Published:
2017-03-20
Contact:
Pei Bin, Master’s supervisor, Chief physician, Professor, Evidence-Based Medicine Center, Xiangyang Hospital, Hubei University of Medicine, Xiangyang 442000, Hubei Province, China
About author:
Ai Jin-wei, Master, Attending physician, Evidence-Based Medicine Center, Xiangyang Hospital, Hubei University of Medicine, Xiangyang 442000, Hubei Province, China
Liu Ying, Master, Associate chief nurse, Evidence-Based Medicine Center, Xiangyang Hospital, Hubei University of Medicine, Xiangyang 442000, Hubei Province, China
Ai Jin-wei and Liu Ying contributed equally to this work.
Supported by:
the General Project for Western Medicine of Hubei Province in 2015-2016, No. WJ2015MB187; the Key Teaching and Research Project of Hubei University of Medicine, No. 2015025
CLC Number:
Ai Jin-wei, Liu Ying, Liu Chu-fan, Pei Bin. Safety and efficacy of autologous bone marrow mesenchymal stem cells for dilated cardiomyopathy: a Meta-analysis[J]. Chinese Journal of Tissue Engineering Research, 2017, 21(5): 780-788.
2.1 文献检索结果 各数据库初检出文献1 375篇,Note Express3.1软件排重后获文献1 217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7个RCT符合纳入标准被纳入[26-32]。其中,中文文献5篇[26-30],英文文献2篇[31-32]。 2.2 纳入文献基本特征 7个RCT共涉及扩张性心肌病患者341例,其中BMSCs治疗组169例,常规药物治疗组172例。扩张性心肌病均以症状、体征及影像学检查确诊,并符合1995年世界卫生组织/国际心脏病学协会诊断标准。各项研究均描述为两组间基线均衡,具有可比性。BMSCs治疗组干预措施为BMSCs移植加常规抗心力衰竭药物治疗,BMSCs移植均为经皮冠状动脉内注射,给细胞量介于107-108个;对照组均运用常规药物抗心力衰竭治疗,具体药物包括利尿剂、血管紧张素转化酶抑制剂、血管紧张素受体拮抗剂、β-受体拮抗剂、地高辛等,3个研究对照组设计为“假手术”——冠脉内注射生理盐水[26,29-30]。随访时间介于3-60个月。结局指标主要包括:左心室射血分数、左室舒张末期内径、6 min步行距离、心肌灌注缺损面积百分比、恶性心律失常及心脏移植率、死亡率。3个研究改良Jadad量表评分≥4分,评价为“高质量研究”[30-32],其余研究均评价为“低质量研究”,总体研究方法学质量较低。纳入研究基本特征见表1。"
2.3 Meta分析结果 Meta分析结果汇总,见表2。 2.3.1 左心室射血分数 6个研究报告了左心室射血分数结局指标[26,28-32],合计样本量317例,BMSCs治疗组158例,常规药物治疗组159例。Meta分析结果显示:与常规药物治疗组比较,BMSCs治疗组可增加左心室射血分数[治疗后1个月:I2=0,MD=3.02,95%CI(1.55,4.49),P < 0.01;3个月:I2=0,MD=4.38,95%CI(3.50,5.25),P < 0.01;6个月:I2=0,MD=6.47,95%CI(4.78,8.15),P < 0.01;12个月:I2=0,MD=8.23,95%CI(7.27,9.19),P < 0.01],见图1。"
2.3.2 左室舒张末期内径 6个研究报告了左室舒张末期内径结局指标[26,28-32],合计样本量316例,BMSCs治疗组157例,常规药物治疗组159例。Meta分析结果显示:对于减小左室舒张末期内径,BMSCs与常规药物在治疗后1个月时疗效比较差异无统计学意义,但在3个月后比较差异均有显著性意义[治疗后1个月:I2=0,MD=-0.91, 95%CI(-2.60,0.78),P=0.29;3个月:I2=49.0%,MD=-0.65,95%CI(-0.72,-0.59),P < 0.01;6个月:I2=0,MD=-0.12,95%CI(-0.21,-0.03),P=0.01;12个月:I2=39.8%,MD=-0.19,95%CI(-0.24,-0.13),P < 0.01],见图2。 2.3.3 6 min步行距离 5个研究报告了两种治疗措施治疗前后6 min步行距离差异[26-28,31-32],合计样本量265例,BMSCs治疗组134例,常规药物治疗组131例。Meta分析结果显示:两组治疗1个月和3个月6 min步行距离比较差异无显著性意义,治疗6,12个月后比较差异有显著性意义[治疗后1个月:I2=0,MD=2.11,95%CI(-25.87,30.09),P=0.88;3个月:I2=90.1%,MD=46.74,95%CI(-14.81,108.30),P < 0.14;6个月:I2=74.8%,MD=87.70,95%CI(51.55,123.85),P < 0.01;12个月:I2=0, MD,95%CI(122.73,164.93),P < 0.01],见图3。=143.83 在治疗后3,6个月各研究结果异质性较大,3个月时Vrtovec等[32]和常快乐等[28]对异质性影响较明显,分别予以排除进行敏感性分析。发现排除后异质性明显降低且结果性质未发生变化[治疗后3个月:I2=20.2%,MD=15.17,95%CI(-9.62,39.97),P=0.14;6个月:I2=29.8%,MD=108.60,95%CI(93.46,123.74),P < 0.01]。"
2.3.4 心肌灌注缺损面积百分比 2个研究报告了治疗前后心肌灌注缺损面积百分比变化情况[26,30],合计样本量75例,BMSCs治疗组35例,常规药物治疗组40例。Meta分析结果显示:两组治疗后1个月心肌灌注缺损面积百分比比较差异无显著性意义[I2=0,MD=-0.23,95%CI(-2.15,1.69),P=0.82],治疗3个月比较差异有显著性意义[I2=0,MD=-3.56,95%CI(-5.57,-1.55),P < 0.01],见图4。 2.3.5 死亡率 4个研究报随访过程中两组死亡率情况[27,29-31],合计样本量220例,BMSCs治疗组107例,常规药物治疗组123例。Meta分析结果显示:与常规药物治疗相比,自体BMSCs移植能降低患者死亡率[I2=0,RR=0.46,95%CI(0.24,0.89),P=0.02],见图5。 2.3.6 恶性心律失常、心脏移植发生率 4个研究报告了治疗及随访过程中恶性心律失常及心脏移植发生率[27,29,31-32],合计样本量238例,BMSCs治疗组118例,常规药物治疗组120例。Meta分析结果显示:两种治疗措施降低恶心心律失常及心脏移植发生率比较差异无显著性意义[I2=13.3%,RR=0.66,95%CI(0.33,1.31),P=0.23],见图6。"
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