Pu Hongji, Huang Qun, Zhang Xing, Wu Zhaoyu, Qiu Peng, Jiang Yihong, Wang Ruihan, Zhao Zhen, Xu Zhijue, Qin Jinbao, Lu Xinwu, Li Weimin
Department of Vascular Surgery, Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.
Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
J Vasc Surg. 2022 Apr;75(4):1440-1449.e5. doi: 10.1016/j.jvs.2021.10.051. Epub 2021 Nov 14.
Atherosclerosis obliterans (ASO) is a chronic occlusive arterial disease and the most common type of peripheral arterial disease. Current treatment options like medication and vascularization have limited effects for "no-option" patients, and stem cell therapy is considered a viable option, although its application and efficacy have not been standardized. The objective of this review was to assess the safety and efficacy of autologous stem cell therapy in patients with ASO.
We performed a literature search of published randomized controlled trials (RCTs) for patients with ASO receiving stem cell therapy without a revascularization option. PubMed, Embase, and the Cochrane Library were searched. This study was conducted by a pair of authors independently and audited by a third author. Data were synthesized with a random-effects model.
A total of 630 patients in 12 RCTs were included. The results showed that cell therapy significantly improved total amputation (relative risk [RR], 0.64; 95% confidence interval [CI], 0.47-0.87; P = .004), major amputation (RR, 0.69; 95% CI, 0.50-0.94; P = .02), ankle-brachial index (mean difference [MD], 0.08; 95% CI, 0.02-0.13; P = .004), transcutaneous oxygen tension (MD, 11.52; 95% CI, 3.60-19.43; P = .004), and rest pain score (MD, -0.64; 95% CI, -1.10 to -0.17; P = .007) compared with placebo or standard care. However, current studies showed cell therapy was not superior to placebo or standard care in all-cause death (RR, 0.75; 95% CI, 0.41-1.36; P = .34) and ulcer size (MD, -8.85; 95% CI, -29.05 to 11.36; P = .39). The number of trials included was limited. Moreover, most trials were designed for "no-option" patients, and thus the results should be applied with caution to other patients with peripheral arterial disease.
Patients with ASO can benefit from autologous cell therapy in limb salvage, limb blood perfusion, and rest pain alleviation.
闭塞性动脉硬化症（ASO）是一种慢性闭塞性动脉疾病，也是最常见的外周动脉疾病类型。目前的治疗方法，如药物治疗和血管重建，对“无其他选择”的患者效果有限，干细胞疗法被认为是一种可行的选择，尽管其应用和疗效尚未标准化。本综述的目的是评估自体干细胞疗法治疗ASO患者的安全性和疗效。
我们对已发表的关于接受无血管重建选择的干细胞疗法的ASO患者的随机对照试验（RCT）进行了文献检索。检索了PubMed、Embase和Cochrane图书馆。本研究由两位作者独立进行，并由第三位作者审核。数据采用随机效应模型进行综合分析。
12项RCT共纳入630例患者。结果显示，与安慰剂或标准治疗相比，细胞疗法显著改善了总截肢率（相对危险度[RR]，0.64；95%置信区间[CI]，0.47 - 0.87；P = .004）、大截肢率（RR，0.69；95% CI，0.50 - 0.94；P = .02）、踝肱指数（平均差[MD]，0.08；95% CI，0.02 - 0.13；P = .004）、经皮氧分压（MD，11.52；95% CI，3.60 - 19.43；P = .004）和静息痛评分（MD， - 0.64；95% CI， - 1.10至 - 0.17；P = .007）。然而，目前的研究表明，在全因死亡（RR，0.75；95% CI，0.41 - 1.36；P = .34）和溃疡大小（MD， - 8.85；95% CI， - 29.05至11.36；P = .39）方面，细胞疗法并不优于安慰剂或标准治疗。纳入的试验数量有限。此外，大多数试验是针对“无其他选择”的患者设计的，因此这些结果应用于其他外周动脉疾病患者时应谨慎。
ASO患者可从自体细胞疗法中受益，在保肢、肢体血液灌注和缓解静息痛方面。
