Chinese Journal of Tissue Engineering Research ›› 2021, Vol. 25 ›› Issue (19): 3110-3116.doi: 10.3969/j.issn.2095-4344.3524
Stem cell transplantation for diabetic patients with lower-extremity arterial disease: a meta-analysis
Xia Wenshen1, 2, He Renjiao2, Ai Jinwei2, 3, Wang Jun4, Li Desheng2, Pei Bin1, 3
- 1Postgraduate Training Basement of Jinzhou Medical University, Hubei University of Medicine, Xiangyang 441000, Hubei Province, China; 2Third Department of Orthopedics, 3Evidence-Based Medicine Center, 4Department of Cardiology, Xiangyang No.1 People’s Hospital, Hubei University of Medicine, Xiangyang 441000, Hubei Province, China
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Received:2020-03-23Revised:2020-03-27Accepted:2020-05-30Online:2021-07-09Published:2021-01-14 -
Contact:Pei Bin, Master, Chief physician, Professor, Postgraduate Training Basement of Jinzhou Medical University, Hubei University of Medicine, Xiangyang 441000, Hubei Province, China; Evidence-Based Medicine Center, Xiangyang No.1 People’s Hospital, Hubei University of Medicine, Xiangyang 441000, Hubei Province, China -
About author:Xia Wenshen, Master candidate, Physician, Postgraduate Training Basement of Jinzhou Medical University, Hubei University of Medicine, Xiangyang 441000, Hubei Province, China; Third Department of Orthopedics, Xiangyang No.1 People’s Hospital, Hubei University of Medicine, Xiangyang 441000, Hubei Province, China He Renjiao, Senior nurse, Third Department of Orthopedics, Xiangyang No.1 People’s Hospital, Hubei University of Medicine, Xiangyang 441000, Hubei Province, China Xia Wenshen and He Renjiao contributed equally to this article. -
Supported by:the General Items of Health and Family Planning Western Medicine in Hubei Province from 2015 to 2016, No. WJ2015MB187 (to PB); the Key Teaching and Research Project of Hubei Medical University, No. 2015025 (to PB); the Science and Technology Project in Xiangyang, No. 2010GG3A21 (to PB)
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Cite this article
Xia Wenshen, He Renjiao, Ai Jinwei, Wang Jun, Li Desheng, Pei Bin. Stem cell transplantation for diabetic patients with lower-extremity arterial disease: a meta-analysis[J]. Chinese Journal of Tissue Engineering Research, 2021, 25(19): 3110-3116.
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2.1 文献筛选流程及结果 各数据库初检出文献773篇，经逐层筛选最终纳入13个随机对照试验[16-28]，文献筛选流程及结果见图2。"
2.2 纳入研究的基本特征与偏倚风险评价结果 纳入13个随机对照试验[16-28]。干细胞组给细胞途径均为沿下肢动脉血管走行肌肉内注射；对照组治疗措施主要包括药物治疗、血管成形术及介入治疗。纳入研究的基本特征见表1。偏倚风险评价结果见表2，文献总体为中等质量研究。"
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2.3 Meta分析结果 2.3.1 各组截肢率差异 共纳入3个研究[24，26，28]，共132例患者，干细胞移植组65例，常规治疗组67例。固定效应模型Meta分析结果显示，与常规治疗比较，干细胞移植能降低截肢率(RR=0.29，95%CI：0.10-0.84，P=0.02)，见图3。"
2.3.2 各组侧支血管新生情况差异 共纳入4个研究[20，24，26，28]，共166例患者，干细胞移植组84例，常规治疗组82例。固定效应模型Meta分析结果显示，与常规治疗比较，干细胞移植能促进侧支血管新生(RR=3.16，95%CI：2.12-4.70， P < 0.000 01)，见图4。"
2.3.3 各组踝肱指数差异 共纳入13个研究[16-28]，共580例患者，干细胞移植组300例，常规治疗组280例。与常规治疗比较，治疗12周时干细胞移植能增加踝肱指数(MD=0.17，95%CI：0.10-0.24，P < 0.000 01)，见图5。治疗4，24周时干细胞移植能增加踝肱指数，但差异无显著性意义(4周：MD=0.07，95%CI：-0.08-0.21，P=0.36；24周：MD=0.12，95%CI：-0.05-0.30，P=0.17)。"
2.3.4 各组经皮氧分压差异 共纳入5个研究[16-17，19，23，28]，共292例患者，干细胞移植组156例，常规治疗组136例。随机效应模型结果显示与常规治疗比较，干细胞移植能增加经皮氧分压(MD=7.71，95%CI：3.99-11.43，P < 0.000 01)，见图6。根据随访时间进行亚组分析，结果显示与常规治疗比较，治疗4，12周时干细胞移植能增加经皮氧分压，但差异无显著性意义(4周：MD=0.09，95%CI：-4.69-6.48，P=0.75；12周：MD=1.39，95%CI： -1.29-4.06，P=0.31)。而治疗24周时干细胞移植能增加经皮氧分压，且差异有显著性意义(MD=9.71，95%CI：5.89-13.54，P < 0.000 01)。 "
2.3.5 各组皮肤温度差异 共纳入6个研究[16-17，20-21，23，25]，共275例患者，干细胞移植组149例，常规治疗组126例。随机效应模型结果显示，与常规治疗比较，干细胞移植能增加下肢皮肤温度(MD=1.90，95%CI：1.28-2.53，P < 0.000 01)，见图7。根据随访时间进行亚组分析，结果显示与常规治疗比较，治疗4周干细胞移植能增加皮肤温度，但差异无显著性意义(MD= -0.39，95%CI：-0.11-0.34，P=0.30)，治疗12，24周时差异有显著性意义(12周：MD=1.58，95%CI：0.86-2.30，P < 0.000 01；24周：MD=2.17，95%CI：0.72-3.63，P=0.003)。 "
2.3.6 各组跛行距离差异 共纳入6个研究[16，19，24-26，28]，共321例患者，干细胞移植组170例，常规治疗组151例。随机效应模型结果显示与常规治疗比较，干细胞移植能增加跛行距离(MD=150.61，95%CI：43.49-257.74，P=0.006)，见图8。根据随访时间进行亚组分析，结果显示与常规治疗比较，治疗4周干细胞移植能增加跛行距离，但差异无显著性意义(MD=9.22，95%CI：-10.16-28.60，P=0.35)，治疗 12周及24周时差异有显著性意义(12周：MD=110.67，95%CI：32.85-188.48，P=0.005；24周：MD=205.42，95%CI：57.54-353.03，P=0.006)。 "
2.3.7 各组静息痛评分差异 共纳入8个研究[16-18，20-21，24，26，28]，共334例患者，干细胞移植组179例，常规治疗组155例。随机效应模型结果显示与常规治疗比较，干细胞移植能降低静息痛评分(MD=-1.61，95%CI：-1.92至-1.30， P < 0.000 01)，见图9。根据随访时间进行亚组分析，结果显示与常规治疗比较，治疗4，12，24周，干细胞移植均能降低静息痛评分(4周：MD=-2.04，95%CI：-2.04至-1.72，P < 0.000 01； 12周：MD=-1.36，95%CI：-1.56至 -1.16，P < 0.000 01；24周：MD= -2.41，95%CI：-3.13至-1.69，P < 0.000 01)。 "
2.3.8 各组冷感评分差异 共纳入5个研究[16-18，20-21]，共221例患者，干细胞移植组123例，常规治疗组98例。随机效应模型结果显示与常规治疗比较，干细胞移植能降低冷感评分(MD= -2.00，95%CI：-2.49至-1.50，P < 0.000 01)，见图10。根据随访时间进行亚组分析，结果显示与常规治疗比较，治疗4，12，24周，干细胞移植均能降低冷感评分(4周：MD=-1.44，95%CI：-2.81至-0.06，P < 0.000 01；12周：MD=-2.09，95%CI：-2.39至-1.79，P < 0.000 01；24周：MD=-2.86，95%CI： -3.59至-2.13，P < 0.000 01)。 "
2.3.9 各组并发症发生率差异 共11个研究观察了治疗及随访过程中并发症发生率[16-18，20-22，24-28]，各研究均显示治疗过程中无死亡、肿瘤及肝肾功能损害等严重并发症发生。另外2个研究未观察干细胞移植治疗糖尿病下肢血管病变安全性指标[19，23]。 2.4 发表偏倚分析 所有研究均报告了干细胞移植与常规治疗对治疗糖尿病下肢血管病变踝肱指数的影响，以踝肢指数为例绘制“漏斗图”识别发表偏倚，见图11，漏斗图基本对称，说明存在发表偏倚的可能性小。"
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