Gao Wei, Wang Fang, Liu Guanjian, Ran Xingwu
Diabetic Foot Care Center, Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, PR China.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2011 May;25(5):610-7.
To evaluate the effectiveness and safety of autologous hemopoietic stem cell implantation for peripheral arterial disease (PAD).
Randomized controlled trials (RCTs) were identified from CBM (1978 to September 2010), CNKI (1979 to September 2010), MEDLINE (1950 to September 2010), Pubmed (1950 to September 2010), Embase (1970 to September 2010), and Cochrane library (issue 4, 2010). The papers of the RCTs of clinical therapeutic studies on PAD treated by autologous hemopoietic stem cell implantation were included and analyzed according to the criteria of the Cochrane handbook.
Eight RCTs involving 280 patients and 322 extremities were included, with majority of trials of low methodological quality. Meta-analysis indicated that autologous hemopoietic stem cell transplantation had an increased ulcer cure rate [RD = 0.38, 95% CI = (0.25, 0.50)], a significant improvement in the ankle brachial index [MD = 0.11, 95% CI = (0.04, 0.18)], transcutaneous oxygen tension [MD = 7.33, 95% CI = (3.14, 11.51)], and pain-free walking distance [SMD = 1.35, 95% CI = (0.90, 1.79)], a significant reduction in rest pain scores [MD = 1.70, 95% CI= (2.15, 1.25)], and a significant benefit in terms of limb salvage [RD = 0.19, 95% CI = (-0.31, 0.07)]. Only 2 trials reported the side effects of autologous hemopoietic stem cell transplantation, such as limbs swelling and concentrations of serum creatine phosphokinase increasing, and the long-term safety was not reported.
Based on the review, autologous hemopoietic stem cell transplantation may have positive effect on "no-option" patients with PAD. However, the evidence is not strong enough due to the general low methodological quality, so we can not draw a reliable conclusion about the effects of autologous stem cell transplantation for PAD at the moment. Further larger, randomized, double blind, placebo-controlled, and multicenter trials are needed.
评估自体造血干细胞移植治疗外周动脉疾病（PAD）的有效性和安全性。
从中国生物医学文献数据库（CBM，1978年至2010年9月）、中国知网（CNKI，1979年至2010年9月）、医学文献数据库（MEDLINE，1950年至2010年9月）、PubMed（1950年至2010年9月）、荷兰医学文摘数据库（Embase，1970年至2010年9月）和考克兰图书馆（2010年第4期）中检索随机对照试验（RCT）。纳入自体造血干细胞移植治疗PAD的临床治疗研究的RCT论文，并根据考克兰手册的标准进行分析。
纳入8项RCT，涉及280例患者和322个肢体，大多数试验的方法学质量较低。Meta分析表明，自体造血干细胞移植的溃疡治愈率提高[风险差（RD）=0.38，95%置信区间（CI）=(0.25, 0.50)]，踝肱指数显著改善[平均差（MD）=0.11，95%CI=(0.04, 0.18)]，经皮氧分压[MD = 7.33，95%CI=(3.14, 11.51)]，无痛步行距离[标准化均数差（SMD）=1.35，95%CI=(0.90, 1.79)]，静息痛评分显著降低[MD = 1.70，95%CI=(2.15, 1.25)]，在保肢方面有显著益处[RD = 0.19，95%CI = (-0.31, 0.07)]。仅有2项试验报告了自体造血干细胞移植的副作用，如肢体肿胀和血清肌酸磷酸激酶浓度升高，且未报告长期安全性。
基于该综述，自体造血干细胞移植可能对“别无选择”的PAD患者有积极作用。然而，由于总体方法学质量较低，证据不够充分，因此目前我们无法就自体干细胞移植治疗PAD的效果得出可靠结论。需要进一步开展更大规模、随机、双盲、安慰剂对照的多中心试验。
