Three-year outcomes of peripheral blood mononuclear cells vs purified CD34(+) cells in the treatment of angiitis-induced no-option critical limb ischemia and a cost-effectiveness assessment: A randomized single-blinded noninferiority trial.
Three-year outcomes of peripheral blood mononuclear cells vs purified CD34(+) cells in the treatment of angiitis-induced no-option critical limb ischemia and a cost-effectiveness assessment: A randomized single-blinded noninferiority trial.
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DOI：
10.1002/sctm.20-0033
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发表时间：
2021-05
影响因子：
6
通讯作者：
Dong Z
中科院分区：
文献类型：
--
作者：
Liu H;Pan T;Fang Y;Fang G;Liu Y;Jiang X;Chen B;Wei Z;Gu S;Liu P;Fu W;Dong Z
对于血管炎性重症肢体缺血(AICLI)患者，细胞移植，如纯化的CD34+细胞(PCCs)和外周血单个核细胞(PBMNCs)，正逐渐成为一种有前途的治疗方法。这是第一个随机、单盲、非劣势试验(编号：nct 02089828)，专门设计用来评估PCCs移植与PBMNCs移植治疗急性脑梗塞的疗效。我们的目的是比较两组的中期安全性和有效性，并确定它们各自的优势。从2014年4月至2019年9月，50例AICLI患者被平均分配到两组，除1名走失患者、1名截肢者和1名患者死于心脏病外。其余47例患者完成了36个月的随访。术后6个月大鼠无截肢存活率和全无截肢存活率分别为96.0%和84.0%，PCCs组分别为96.0%和72.0%。这些比率在12个月、24个月和36个 月保持稳定。PCCs组的休息疼痛缓解概率显著高于PBMNCs组，而PBMNCs组在Rutherford分级中观察到更早的显著改善。因此，对于有明显疼痛的患者，PCCs可能是首选，而对于有两个或更多严重缺血肢体的患者，PBMNCs可能是一个很好的选择。关于成本效益，多氯联苯并不比多国跨国公司更具成本效益。这些结果需要从涉及更多患者的长期试验中进行验证。这两种疗法显示出相似的中期安全性和有效性，但每种细胞疗法都有其独特的优势，建议在某些情况下使用：例如，对有两条或更多严重缺血肢体的患者使用外周血单核细胞，对有严重疼痛的患者使用纯化的CD34+细胞。
For patients with angiitis‐induced critical limb ischemia (AICLI), cell transplantation, such as purified CD34+ cells (PCCs) and peripheral blood mononuclear cells (PBMNCs), is gradually being used as a promising treatment. This was the first randomized single‐blinded noninferiority trial (number: NCT 02089828) specifically designed to evaluate the therapeutic efficacies of the transplantation of PCCs vs those of PBMNCs for the treatment of AICLI. We aimed to compare the mid‐term safety and efficacy between the two groups and determine their respective advantages. From April 2014 to September 2019, 50 patients with AICLI were equally allocated to the two groups, except for 1 lost patient, 1 amputee, and 1 patient who died of heart disease. The other 47 patients completed the 36‐month follow‐up. The endpoints were as follows: major amputation‐free survival and total amputation‐free survival at 6 months, which were 96.0% and 84.0% in the PBMNCs group and 96.0% and 72.0% in the PCCs group, respectively. These rates remained stable at 12, 24, and 36 months. The PCCs group had a significant higher probability of rest pain relief than the PBMNCs group, whereas earlier significant improvements in the Rutherford classification were observed in the PBMNCs group. Accordingly, PCCs would be preferred for patients with significant pain, whereas PBMNCs may be a good option for patients with two or more critically ischemic limbs. Concerning cost‐effectiveness, PCCs are not more cost‐effective than PBMNCs. These outcomes require verification from long‐term trials involving larger numbers of patients. The two therapies demonstrated similar mid‐term safety and efficacy, while each cell therapy had its unique advantages and is recommended for certain conditions: for example, peripheral blood mononuclear cells for patients with two or more critical ischemic limbs and purified CD34+ cells for patients with significant pain.
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影响因子：
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作者：
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通讯作者：
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影响因子：
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