摘要
目的系统评价自体骨髓细胞移植治疗糖尿病足的有效性和安全性,并采用GRADE系统对结局指标的证据质量进行评价。方法计算机检索PubMed、EMbase、The Cochrane Library、CBM、WanFang Data和CNKI,搜集有关自体骨髓细胞移植治疗糖尿病的随机对照试验(RCT),检索时限均从建库至2017年2月28日。由2名评价员独立筛选文献、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Meta分析。通过GRADE profiler 3.6软件评价合并后结局指标的证据等级。结果最终纳入4个研究。Meta分析结果显示,与对照组相比,自体骨髓细胞移植治疗组可降低截肢率[RR=0.08,95%CI(0.00,1.32),P=0.08]和静息痛症状评分[MD=–1.89,95%CI(–2.24,–1.55),P<0.000 01],增加溃疡愈合率[RR=2.01,95%CI(1.45,2.79),P<0.000 1],促进侧支新生血管[MD=1.33,95%CI(0.60,2.05),P=0.000 3],改善踝肱指数[MD=0.16,95%CI(0.10,0.22),P<0.000 01]和经皮氧分压[MD=18.81,95%CI(16.06,21.57),P<0.000 01]。纳入研究均无不良事件发生。但GRADE结局指标评价显示所有结局指标的证据质量为低或极低。结论现有证据提示,自体骨髓干细胞移植治疗糖尿病足有一定的效果,且安全性较高。但受纳入研究数量和质量的限制,上述结论尚需更多大样本多中心临床试验予以验证。
Objectives To systematically review the efficacy and safety of autologous bone marrow cells therapy for patients with diabetic foot. GRADE system was used to evaluate the evidence quality of outcomes. Methods We searched databases including PubMed, EMbase, The Cochrane Library, CBM, WanFang Data and CNKI for randomized controlled trials （RCTs） about bone marrow cell transplantation in patients with diabetic foot from inception to February 28th 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was performed using RevMan 5.3 software. The evidence quality was evaluated by using GRADE profiler 3.6 software. Results Four RGTs were included. Meta-analysis showed that the bone marrow cell transplantation could decrease the rate of amputation （RR--0.08, 95%CI 0.00 to 1.32, P^0.08） and rest pain score （MD=-l.89, 95%CI -2.24 to -1.55, P〈0.000 01）, increase the rate of ameliorate ulcer healing （RR=2.01, 95%CI 1.45 to 2.79, P〈0.000 1） and the quantity of new collateral vessels （MD=1.33, 95%CI 0.60 to 2.05, P〈0.000 3）. Besides, bone marrow cell transplantation could improve anlde-brachial index （MD=0.16, 95%CI 0.10 to 0.22, P〈O.O00 01） and transcutaneous arterial oxygen tension （MD=18.81, 95%CI 16.06 to 21.57, P〈0.000 01）. No adverse event was reported for all included studies. The qualities of evidence for all outcomes were rated as ＂low＂ to ＂very low＂. Conclusion Based on the current evidence, autologous bonemarrow cells transplantation therapy has a certain effect and it is safe for patients with diabetic foot. However, due to the limited quantity and quality of included studies, the above conclusions are still needed more multicenter clinical trials with large sample size to confirm.
出处
《中国循证医学杂志》
CSCD
北大核心
2018年第2期185-191,共7页
Chinese Journal of Evidence-based Medicine
基金
国家自然科学基金项目(编号:81471043
81400811)
国家重大新药创制专项资金项目(编号:2017ZX09304023)
关键词
糖尿病足
自体骨髓细胞移植
随机对照试验
META分析
系统评价
Diabetic foot
Autologous bone marrow mononuclear cell transplantation
Randomized controlledtrial
Meta-analysis
Systematic review
