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自体骨髓单核干细胞治疗脑卒中患者的疗效:一项荟萃分析的比较研究。

Autologous bone-marrow mononuclear stem cell therapy in patients with stroke: a meta-analysis of comparative studies.

机构信息

Neurosurgery Division, Department of Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

Department of Anesthesiology and Operating Room, Phramongkutklao Hospital, Bangkok, Thailand.

出版信息

Biomed Eng Online. 2020 Sep 29;19(1):74. doi: 10.1186/s12938-020-00819-7.

Abstract

BACKGROUND

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.

AIMS

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.

CONCLUSION

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.

摘要

背景

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。

目的

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。

结论

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3227/7526242/c4159ed6bf00/12938_2020_819_Fig1_HTML.jpg

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