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目的评价自体造血干细胞移植治疗周围动脉疾病(peripheral arterial disease,PAD)的疗效和安全性。方法计算机检索中国生物医学文献数据库(CBM,1978年-2010年9月)、中国期刊全文数据库(CNKI,1979年-2010年9月)、MEDLINE(1950年-2010年9月)、Pubmed(1950年-2010年9月)、Embase(1970年-2010年9月)和Cochrane图书馆(2010年第4期),收集以自体造血干细胞移植为干预措施治疗PAD的随机对照试验(randomized controlled trials,RCTs),按照Cochrane系统评价方法,由2位研究者独立地对符合纳入标准的试验进行资料提取,并对纳入文献进行质量评估和对提取的有效数据进行Meta分析。结果有8个RCTs,共280例PAD患者322条肢体符合纳入标准,但大多数研究的方法学质量较差。Meta分析结果显示,自体造血干细胞移植治疗PAD较常规治疗能提高溃疡治愈率[RD=0.38,95%CI=(0.25,0.50)]、踝肱指数[MD=0.11,95%CI=(0.04,0.18)]、经皮氧分压[MD=7.33,95%CI=(3.14,11.51)]和无痛性行走距离[SMD=1.35,95%CI=(0.90,1.79)],可降低截肢率[RD=–0.19,95%CI=(—0.31,—0.07)]和静息痛评分[MD=—1.70,95%CI=(—2.15,—1.25)]。仅2个试验报道了自体造血干细胞移植治疗的不良反应,如肢体肿胀和血清磷酸激酶升高等。结论自体造血干细胞移植治疗PAD可能有一定疗效,但由于尚缺乏高质量的RCTs证据支持,其疗效尚不能作出最后结论,还需进行更多高质量RCTs才能得出肯定性结论。
Objective To evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation in the treatment of peripheral arterial disease (PAD). Methods We searched the Chinese Biomedical Literature Database (CBM, 1978 - September 2010), Chinese Journal Full-text Database (CNKI, 1979 - September 2010), MEDLINE (1950 - September 2010), Pubmed Year-September 2010), Embase (1970-September 2010) and the Cochrane Library (Issue 4, 2010) randomized controlled trials of autologous hematopoietic stem cell transplantation for the treatment of PAD, RCTs). According to the Cochrane systematic review method, two investigators independently extracted data from eligible trials and conducted meta-analyzes on the quality of the included literature and the valid data extracted. Results There were 8 RCTs and a total of 322 limbs in 280 PAD patients met the inclusion criteria, but most of the studies performed poor methodological quality. Meta-analysis showed that the autologous hematopoietic stem cell transplantation treatment of PAD compared with conventional treatment can improve the cure rate of ulcer [RD = 0.38,95% CI = (0.25,0.50)], ankle-brachial index [MD = 0.11,95% CI = 0.18), percutaneous oxygen pressure [MD = 7.33, 95% CI = (3.14, 11.51)] and painless walking distance [SMD = 1.35,95% CI = (0.90, 1.79) [RD = -0.19, 95% CI = (-0.31, -0.07)] and rest pain score [MD = -1.70, 95% CI = (-2.15, -1.25)]. Only two trials reported adverse effects of autologous hematopoietic stem cell transplantation, such as swollen limbs and elevated serum levels of phosphokinase. Conclusion Autologous hematopoietic stem cell transplantation may be effective in treating PAD. However, due to the lack of high quality RCT evidence, the curative effect can not be concluded yet. Therefore, more high quality RCTs are needed to reach a certain conclusion.