Chinese Journal of Tissue Engineering Research ›› 2022, Vol. 26 ›› Issue (7): 1085-1092.doi: 10.12307/2022.149
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Fang Xiaolei¹, Leng Jun², Zhang Chen¹, Liu Huimin¹, Guo Wen¹
Received:
2021-04-26
Revised:
2021-04-27
Accepted:
2021-05-26
Online:
2022-03-08
Published:
2021-10-29
Contact:
Leng Jun, Associate chief physician, Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250001, Shandong Province, China
About author:
Fang Xiaolei, Master candidate, Shandong University of Traditional Chinese Medicine, Jinan 250355, Shandong Province, China
Supported by:
CLC Number:
Fang Xiaolei, Leng Jun, Zhang Chen, Liu Huimin, Guo Wen. Systematic evaluation of different therapeutic effects of mesenchymal stem cell transplantation in the treatment of ischemic stroke[J]. Chinese Journal of Tissue Engineering Research, 2022, 26(7): 1085-1092.
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2.4 Meta分析结果 2.4.1 各组NIHSS评分差异 有11篇文献报道NIHSS作为结局指标[15-17,20-26,31],其中8项研究使用自体骨髓间充质干细胞[16-17,20-21,23,25-26,31],2项研究使用脐血间充质干细胞[22,24],1项研究使用外周血干细胞[15],Meta分析异质性检验结果显示:I2=87%,P < 0.00 001,提示有异质性,故采用随机效应模型,结果显示间充质干细胞组在降低NIHSS评分方面明显优于对照组(MD=-2.10,95%Cl:-3.30至-0.90,P < 0.000 01)。亚组分析显示,脐血间充质干细胞组和外周血干细胞移植组NIHSS评分均优于对照组(P < 0.000 01),见图3。"
2.4.6 安全性评价结果 有4篇文献报告了死亡病例[16-19],为严重不良结局。异质性检验结果显示:I2=39%,P=0.18,提示异质性较小,Meta分析表明干细胞移植与死亡事件的发生之间差异无显著性意义(P=0.31),两者之间无直接联系。 刘定华等[25]报告术后3例患者出现发热,1例患者出现头痛;冯龚等[24]报告1例发热病例;宋承伟等[22]报告4例发热患者;赵新利等[23]报告1例发热;以上症状出现后均得到及时治疗,治疗后以上症状痊愈。JAILLARD等[31]报告1例患者出现溺水,与干细胞移植无关;BANG等[20]报告1例蜂窝织炎,但是由足癣引起,与干细胞移植无直接联系。 2.5 文献异质性分析结果 2.5.1 亚组分析结果 NIHSS评分的亚组分析显示,根据不同注射方式分组,静脉注射I2=0%,非静脉注射I2=61%,提示使用不同移植途径可能为异质性的来源。FMA评分的亚组分析显示,根据不同间充质干细胞分组,自体骨髓间充质干细胞I2=50%,脐血间充质干细胞I2=0%,可见使用不同间充质干细胞可能为异质性的来源。BI亚组分析显示,根据不同注射方式分组,静脉注射I2=67%,P=0.05;非静脉注射:I2=92%,P < 0.000 01,提示非静脉注射可能是异质性来源,但不能完全降低异质性,见表3。"
2.5.2 敏感性分析结果 针对FIM评分,尝试去除陈文斗等[27]的研究,异质性降到I2=0%,P=0.46,通过对该文献的认真剖析,发现异质性的来源可能与该文献质量较低有关。在剔除该研究后重新合并效应量,剔除前后合并结果未发生大的变化,剔除前合并效应量(MD=14.83,95%CI:6.39-23.27,P=0.000 6);剔除后合并效应量(MD=10.90,95%CI:5.82-15.99,P < 0.000 19) 。说明敏感性低,此meta分析结果稳健可信。 2.6 网状Meta分析结果 2.6.1 网状证据关系 纳入研究中有11项研究报道了NIHSS评分作为结局指标,网状Meta分析中有5种移植方式,分别是立体定向植入、静脉注射、颈动脉注射、经蛛网膜下腔注射、经蛛网膜下腔注射结合静脉注射和常规治疗(未移植)。此5种不同的移植方式和常规治疗未形成闭环,见图8。"
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