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目的系统评价骨髓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。方法计算机检索Pub Med、CENTRAL、EMbase、Web of Knowledge、VIP、CNKI、CBM和Wan Fang Data数据库,查找所有骨髓干细胞移植治疗扩张性心肌病的随机对照试验(RCT),检索时限均为建库至2014年3月31日。由2位研究者按照纳入与排除标准筛选文献、提取资料和评价纳入研究的方法学质量,而后采用Rev Man 5.2.0软件进行Meta分析。结果共纳入10个RCT,包括374例患者。Meta分析结果显示:1安全性:与常规治疗相比,骨髓干细胞移植3个月后患者恶性心律失常事件发生率差异无统计学意义[RR=0.81,95%CI(0.38,1.72),P=0.58]。2疗效:与对照组相比,骨髓干细胞移植3个月后患者左室射血分数增加[WMD=3.86,95%CI(2.53,5.20),P<0.000 01]、6个月后左室射血分数增加[WMD=5.54,95%CI(3.02,8.06),P<0.000 1],3个月后6 min步行距离增加[WMD=22.12,95%CI(7.78,36.46),P=0.003],6个月后6 min步行距离增加[WMD=102.79,95%CI(50.16,155.41),P=0.000 1],3个月的心肌灌注缺损面积百分比减小[WMD=–4.00,95%CI(–5.87,–2.13),P<0.000 1];但在3个月后左室舒张末期内径[WMD=–0.37,95%CI(–1.67,0.93),P=0.57]和6个月后左室舒张末期内径[WMD=–0.70,95%CI(–2.76,1.36),P=0.51]方面,差异无统计学意义。结论骨髓干细胞移植治疗扩张性心肌病可明显改善患者心功能且安全性较好。受纳入研究数量和质量的限制,上述结果仍需要更多高质量、大样本的RCT予以验证。
Objective To evaluate the clinical efficacy and safety of bone marrow stem cell transplantation in the treatment of primary dilated cardiomyopathy. Methods Randomized controlled trials (RCTs) of all bone marrow stem cell transplantation for dilated cardiomyopathy were searched by searching databases of Pub Med, CENTRAL, EMbase, Web of Knowledge, VIP, CNKI, CBM and Wan Fang Data. March 31, 2014. Two investigators screened the literature for inclusion and exclusion criteria, extracted data and evaluated the methodological quality of the included studies, then performed a meta-analysis using Rev Man 5.2.0 software. Results A total of 10 RCTs were included, including 374 patients. Meta-analysis showed that: 1 Safety: There was no significant difference in the incidence of malignant arrhythmic events after 3 months of bone marrow stem cell transplantation compared with conventional treatment [RR = 0.81, 95% CI (0.38, 1.72), P = 0.58]. 2 Efficacy: Compared with the control group, the left ventricular ejection fraction increased 3 months after transplantation of bone marrow stem cells [WMD = 3.86,95% CI (2.53, 5.20), P <0.000 01]. After 6 months, The increase in blood fraction [WMD = 5.54, 95% CI 3.02, 8.06, P 0.0001] increased the walking distance 6 min after 3 months [WMD = 22.12,95% CI 7.78, 36.46, P 0.003] , 6 min after 6 min walking distance increased [WMD = 102.79,95% CI (50.16,155.41), P = 0.0001], 3 months reduced myocardial perfusion defect area percentage [WMD = -4.00,95% CI (-5.87, -2.13), P <.0001]; but after 3 months the LV end-diastolic diameter [WMD = -0.37,95% CI (-1.67,0.93), P = 0.57] and after 6 months The left ventricular end-diastolic diameter [WMD = -0.70,95% CI (-2.76,1.36), P = 0.51], the difference was not statistically significant. Conclusion Bone marrow stem cell transplantation for the treatment of dilated cardiomyopathy can significantly improve the patient’s cardiac function and safety. Due to the limited number and quality of studies included, the above results still require more high-quality, large sample RCTs to be validated.