中国组织工程研究

中国组织工程研究 ›› 2021, Vol. 25 ›› Issue (19): 3110-3116.doi: 10.3969/j.issn.2095-4344.3524

• 干细胞循证医学 evidence-based medicine of stem cells • 上一篇    

干细胞移植治疗糖尿病下肢血管病变的Meta分析

夏稳伸1，2，何仁姣2，艾金伟2，3，王  君4，李德胜2，裴  斌1，3   

  1. 1锦州医科大学湖北医药学院研究生培养基地，湖北省襄阳市  441000；湖北医药学院附属襄阳市第一人民医院，2骨三科，3循证医学中心，4心血管内科，湖北省襄阳市  441000
  • 收稿日期:2020-03-23 修回日期:2020-03-27 接受日期:2020-05-30 出版日期:2021-07-09 发布日期:2021-01-14
  • 通讯作者: 裴斌，硕士，主任医师，教授，锦州医科大学湖北医药学院研究生培养基地，湖北省襄阳市 441000；湖北医药学院附属襄阳市第一人民医院循证医学中心 441000
  • 作者简介:夏稳伸，男，1995年生，湖北省武汉市人，汉族，锦州医科大学在读硕士，医师。 何仁姣，女，1995年生，湖北省襄阳市人，汉族，襄阳职业技术学院毕业，护师。
  • 基金资助:
    湖北省卫生计生西医类2015-2016年度一般项目(WJ2015MB187)，项目负责人：裴斌；湖北医药学院教研重点项目(2015025)，项目负责人：裴斌；襄阳市科技计划项目(2010GG3A21)，项目负责人：裴斌

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   

  1. 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
  • Received:2020-03-23 Revised:2020-03-27 Accepted:2020-05-30 Online:2021-07-09 Published: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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摘要：

文题释义：
干细胞分类：根据干细胞所处的发育阶段分为胚胎干细胞和成体干细胞；根据干细胞的发育潜能分为全能干细胞、多能干细胞和单能干细胞。
糖尿病下肢血管病变：是下肢血管，尤其是中小动脉慢性、进行性发生狭窄和闭塞，同时多伴有肢体感觉神经受损，早期症状主要表现为肢体发冷、乏力，随即出现间歇性跛行、静息痛，随病情的发展，最终可导致肢/趾体坏死，是糖尿病严重并发症之一。

目的：干细胞移植已用于糖尿病下肢血管病变的临床治疗，因各研究样本量小，研究结论不一致。文章系统评价干细胞移植治疗糖尿病下肢血管病变的有效性和安全性。
方法：计算机检索PubMed、The Cochrane Library(2019年第11期)、EMbase、中国知网、CBM、维普、万方数据库中干细胞移植治疗糖尿病下肢血管病变的随机对照试验，检索时间均为建库至2019年12月10日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后，采用RevMan 5.3软件进行统计分析。
结果：纳入13个随机对照试验，包括糖尿病下肢血管病变患者546例，其中干细胞移植组287例，常规治疗组259例。Meta分析结果显示：与常规治疗相比，干细胞移植能降低截肢率(RR=0.29，95%CI：0.10-0.84，P=0.02)，促进侧支血管新生(RR=3.16，95%CI：2.12-4.70，P < 0.000 01)，增加踝肱指数(MD=0.17，95%CI：0.10-0.24，P < 0.000 01)、经皮氧分压(MD=7.71，95%CI：3.99-11.43，P < 0.000 01)、皮肤温度(MD=1.90，95%CI：1.28-2.53，P < 0.000 01)和跛行距离(MD=150.61，95%CI：43.49-257.74，P=0.006)，还可降低静息痛评分(MD= -1.16，95%CI：-1.92至-1.30，P < 0.000 01)和肢体冷感评分(MD= -2.00，95%CI：-2.49至-1.50，P < 0.000 01)。各研究均无死亡、肿瘤及肝肾功能损害等严重并发症发生。
结论：干细胞移植治疗糖尿病下肢血管病变是一种安全、有效的治疗方法，但由于受纳入研究数量和质量限制，未来文章结论尚需大样本、高质量、长期随访的随机对照试验予以证实。  

关键词: 干细胞, 糖尿病, 血管, 下肢, 细胞, 截肢, 随机对照试验, Meta分析

Abstract: OBJECTIVE: Stem cell transplantation has been used in the clinical treatment of diabetic lower limb vascular diseases. The conclusions were inconsistent due to the small sample size of each study. This article systematically reviewed the safety and efficacy of stem cells transplantation for diabetic patients with lower-extremity arterial disease. 
METHODS: PubMed, The Cochrane Library (Issue 11, 2019), EMbase, CNKI, CBM, VIP and Wanfang databases were electronically searched to collect randomized controlled trials of stem cell transplantation for diabetic patients with lower-extremity arterial disease from inception to December 10, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software. 
RESULTS:  A total of 13 randomized controlled trials involving 546 patients, with 287 patients in stem cell transplantation group and 259 patients in conventional treatment group were included. The meta-analysis results showed that compared with the conventional treatment group, stem cell transplantation could significantly decrease the rate of lower limb amputation (RR=0.29, 95%CI: 0.10-0.84, P=0.02], improve the collateral angiogenesis (RR=3.16, 95%CI: 2.12-4.70, P < 0.000 01), increase ankle brachial pressure index (MD=0.17, 95%CI: 0.10-0.24, P < 0.000 01), transcutaneous oxygen pressure (MD=7.71, 95%CI: 3.99-11.43, P < 0.000 01), skin temperature (MD=1.90, 95%CI: 1.28-2.53, P < 0.000 01) and intermittent limp distance (MD=150.61, 95%CI: 43.49-257.74, P=0.006), reduce the scores of rest pain (MD=-1.16, 95%CI: -1.92 to -1.30, P < 0.000 01), and cold feeling (MD=-2.00, 95%CI: -2.49 to -1.50, P < 0.000 01). No severe complications such as death, neoplasm, or hepatorenal function impairment were observed in all of our included studies. 
CONCLUSION: Stem cell transplantation maybe an effective and safe therapeutic method for diabetic patients with lower-extremity arterial disease. However, due to the limited quantity and quality of included studies, more high-quality, long-term follow-up and large sample size randomized controlled trials are needed to confirm the above conclusions.


Key words: stem cell, diabetes mellitus, blood vessel, lower extremity, cell, amputation, randomized controlled trial, meta-analysis

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