中国循证医学杂志

中国循证医学杂志

自体骨髓细胞移植治疗糖尿病足的系统评价

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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 RCTs 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=–1.89, 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 ankle-brachial index (MD=0.16, 95%CI 0.10 to 0.22,P<0.000 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 bone marrow 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.

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

Key words: Diabetic foot; Autologous bone marrow mononuclear cell transplantation; Randomized controlled trial; Meta-analysis; Systematic review

引用本文: 高海慧, 吕霞飞, 李舍予, 田浩明, 冉兴无. 自体骨髓细胞移植治疗糖尿病足的系统评价. 中国循证医学杂志, 2018, 18(2): 185-191. doi: 10.7507/1672-2531.201708010 复制

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