Neurosurgery Division, Department of Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Department of Anesthesiology and Operating Room, Phramongkutklao Hospital, Bangkok, Thailand.
Biomed Eng Online. 2020 Sep 29;19(1):74. doi: 10.1186/s12938-020-00819-7.
There is a need to promote recovery after stroke with novel therapeutic interventions. Of them, bone-marrow mononuclear cell (BM-MNC) therapy offers promising outcomes in preclinical and clinical models.
To investigate the efficacy and safety of BM-MNCs versus traditional medical care of stroke patients. A meta-analysis was conducted involving controlled prospective studies and randomized clinical trials (RCTs) which investigated the changes in the scores of neurological functions (the National Institutes of Health Stroke Scale [NIHSS]), the indices of functional recovery (the Barthel Index [BI] and the modified Rankin scale [mRS]) at 3 and 6 month post-transplantation. A total of nine studies (five RCTs) recruited 469 stroke patients (65.5% males, 49.25% received the intervention). There were no significant differences in NIHSS, BI, or mRS scores after 3 months of follow-up. However, the BI indices of BM-MNCs-receiving patients improved significantly after 6 months (standardized mean difference = 1.17, 95% confidence interval, 0.23 to 2.10, P = 0.01) as compared to traditional treatment. The risk of mortality and adverse events and the proportion of patients with favorable outcomes (mRS ≤ 3) were similar in both groups.
Both the BM-MNCs and medical stroke treatment have similar outcomes in terms of safety and short-term efficacy, while the effect of therapy is significant only after 6 months. More well-designed, large sized RCTs are needed to confirm the efficacy of stem cell therapy over long periods of follow-up.
需要通过新的治疗干预措施来促进中风后的康复。其中,骨髓单个核细胞(BM-MNC)治疗在临床前和临床模型中显示出有前景的结果。
调查 BM-MNC 与传统的中风患者医疗相比的疗效和安全性。进行了一项荟萃分析,其中包括了调查神经功能评分(国立卫生研究院中风量表 [NIHSS])、功能恢复指标(巴氏指数 [BI] 和改良 Rankin 量表 [mRS])在移植后 3 个月和 6 个月变化的对照前瞻性研究和随机临床试验(RCT)。共有 9 项研究(5 项 RCT)纳入了 469 名中风患者(65.5%男性,49.25%接受了干预)。在 3 个月的随访后,NIHSS、BI 或 mRS 评分没有显著差异。然而,与传统治疗相比,接受 BM-MNC 治疗的患者在 6 个月后 BI 指数显著改善(标准化均数差=1.17,95%置信区间,0.23 至 2.10,P=0.01)。两组的死亡率和不良事件风险以及预后良好(mRS≤3)的患者比例相似。
BM-MNC 和医学中风治疗在安全性和短期疗效方面具有相似的结果,而治疗效果仅在 6 个月后才明显。需要更多设计良好、规模较大的 RCT 来确认干细胞治疗在长期随访中的疗效。