自体干细胞移植联合血管成形术治疗糖尿病足或 肢体缺血性疾病的系统评价
| 作者: |
1谢保城,
1王清辉,
1许周媚,
2周晨慧,
1,3徐道华
1 广东医科大学药理学教研室，广东 东莞 523808 2 广东医科大学护理学院，广东 东莞 523808 3 广东医科大学 中药与新药研究所，广东 东莞 523808 |
| 通讯: |
徐道华
Email: daohuax108@163.com |
| DOI: | 10.3978/.2017.12.013 |
| 基金: | 广东省自然科学基金资助项目（2014A030313534），广东省东莞市社会发展基金资助项目（2014108101052）； 广东省中医药局建设中医药强省立项基金资助项目（20151263）。 |
摘要
目的：系统评价自体干细胞移植联合血管成形术（PTA）治疗糖尿病足或肢体缺血性疾病的疗效和安全性。
方法：计算机检索多个国内外数据库，搜集自体干细胞移植联合PTA治疗糖尿病足或肢体缺血性疾病患者的临床对照试验。检索时限均为从建库至2017年11月。由2位评价员按照文献质量评价方法、纳入与排除标准，筛选文献、提取资料和评价纳入研究的偏倚风险后，采用Revman 5.3软件进行Meta分析。
结果：最终纳入12个临床对照试验，共630例糖尿病足或肢体缺血患者。Meta分析结果显示，与单纯PTA治疗组患者比较，自体干细胞移植联合PTA治疗组患者踝肱指数（MD=0.07，95% CI=0.02~0.13，P=0.01）、经皮血氧分压（MD=4.03，95% CI=2.94~5.12，P<0.00001）、患肢冷感（RR=1.29，95% CI=1.14~1.45，P<0.0001）、跛行距离（MD=372.89，95% CI=108.97~636.81，P=0.006）、疗效评定（RR=1.18，95% CI=1.08~1.29，P=0.0004）均明显改善。
结论：自体干细胞移植联合PTA治疗糖尿病足或肢体缺血病变的疗效优于单纯PTA、安全性好，但该结论仍需大型多中心临床随机试验支持。
关键词：
缺血；下肢；干细胞移植；血管成形术；临床对照试验；Meta分析
方法：计算机检索多个国内外数据库，搜集自体干细胞移植联合PTA治疗糖尿病足或肢体缺血性疾病患者的临床对照试验。检索时限均为从建库至2017年11月。由2位评价员按照文献质量评价方法、纳入与排除标准，筛选文献、提取资料和评价纳入研究的偏倚风险后，采用Revman 5.3软件进行Meta分析。
结果：最终纳入12个临床对照试验，共630例糖尿病足或肢体缺血患者。Meta分析结果显示，与单纯PTA治疗组患者比较，自体干细胞移植联合PTA治疗组患者踝肱指数（MD=0.07，95% CI=0.02~0.13，P=0.01）、经皮血氧分压（MD=4.03，95% CI=2.94~5.12，P<0.00001）、患肢冷感（RR=1.29，95% CI=1.14~1.45，P<0.0001）、跛行距离（MD=372.89，95% CI=108.97~636.81，P=0.006）、疗效评定（RR=1.18，95% CI=1.08~1.29，P=0.0004）均明显改善。
结论：自体干细胞移植联合PTA治疗糖尿病足或肢体缺血病变的疗效优于单纯PTA、安全性好，但该结论仍需大型多中心临床随机试验支持。
Systematical evaluation of autologous stem cell transplantation combined with angioplasty therapy in treatment of diabetic foot or limb ischemia
CorrespondingAuthor:XU Daohua Email: daohuax108@163.com
Abstract
Objective: To systematically evaluate the efficacy and safety of autologous stem cell transplantation combined with percutaneous transluminal angioplasty (PTA) in treatment of diabetic foot or limb ischemia.
Methods: The literature of clinical controlled trials (CCTs) concerning autologous stem cell transplantation combined with PTA in treatment of diabetic foot or limb ischemia was collected by searching several national and international databases. The search included all articles from the inception of the databases until November 2017. After literature screening by two reviewers according to the quality assessment methods and inclusion/exclusion criteria, and then data extraction and assessment of risk of the included studies, Meta-analysis was performed by using Revman 5.3 software.
Results: Twelve CCTs were finally included involving 630 patients with diabetic foot or limb ischemia. Meta-analysis showed that in patients undergoing autologous stem cell transplantation combined with PTA compared with those undergoing PTA alone, the ankle brachial index (MD=0.07, 95% CI=0.02–0.13, P=0.01), transcutaneous oxygen tension (MD=4.03, 95% CI=2.94–5.12, P<0.00001), cold sensation of the diseased limb (RR=1.29, 95% CI=1.14–1.45, P<0.0001), claudication distance (MD=372.89, 95% CI=108.97–636.81, P=0.006) and effectiveness evaluation (RR=1.18, 95% CI=1.08–1.29, P=0.0004) were all significantly improved.
Conclusion: Autologous stem cell transplantation combined with PTA is superior in efficacy to PTA alone in treatment of diabetic foot or limb ischemia, with better safety. However, the conclusions still need to be supported by large multicenter randomized clinical trials.
Keywords：
Ischemia; Lower Extremity; Stem Cell Transplantation; Angioplasty; Controlled Clinical Trial; Meta-Analysis
Methods: The literature of clinical controlled trials (CCTs) concerning autologous stem cell transplantation combined with PTA in treatment of diabetic foot or limb ischemia was collected by searching several national and international databases. The search included all articles from the inception of the databases until November 2017. After literature screening by two reviewers according to the quality assessment methods and inclusion/exclusion criteria, and then data extraction and assessment of risk of the included studies, Meta-analysis was performed by using Revman 5.3 software.
Results: Twelve CCTs were finally included involving 630 patients with diabetic foot or limb ischemia. Meta-analysis showed that in patients undergoing autologous stem cell transplantation combined with PTA compared with those undergoing PTA alone, the ankle brachial index (MD=0.07, 95% CI=0.02–0.13, P=0.01), transcutaneous oxygen tension (MD=4.03, 95% CI=2.94–5.12, P<0.00001), cold sensation of the diseased limb (RR=1.29, 95% CI=1.14–1.45, P<0.0001), claudication distance (MD=372.89, 95% CI=108.97–636.81, P=0.006) and effectiveness evaluation (RR=1.18, 95% CI=1.08–1.29, P=0.0004) were all significantly improved.
Conclusion: Autologous stem cell transplantation combined with PTA is superior in efficacy to PTA alone in treatment of diabetic foot or limb ischemia, with better safety. However, the conclusions still need to be supported by large multicenter randomized clinical trials.