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关节内注射培养扩增间充质干细胞联合非手术治疗膝骨关节炎:系统评价和荟萃分析。

Intra-articular Injection of Culture-Expanded Mesenchymal Stem Cells Without Adjuvant Surgery in Knee Osteoarthritis: A Systematic Review and Meta-analysis.

机构信息

Department of Orthopedic Surgery, Hyundae General Hospital, Chung-Ang University, Namyangju-Si, Kyunggi-Do, Republic of Korea.

Department of Orthopedic and Traumatology, Fatmawati General Hospital, South Jakarta, Indonesia.

出版信息

Am J Sports Med. 2020 Sep;48(11):2839-2849. doi: 10.1177/0363546519892278. Epub 2019 Dec 24.

DOI:10.1177/0363546519892278
PMID:31874044
Abstract

BACKGROUND

Although many clinical studies have assessed the efficacy of mesenchymal stem cells (MSCs) in knee osteoarthritis, evidence on their efficacy remains unclear owing to heterogeneity of cell entity and concomitant procedures.

PURPOSE

To determine the efficacy of culture-expanded MSCs in knee osteoarthritis in terms of clinical outcome and cartilage repair via meta-analysis of randomized controlled trials (RCTs) without adjuvant surgery.

STUDY DESIGN

Meta-analysis.

METHODS

PubMed, Embase, the Cochrane Library, CINAHL, and Scopus were searched from inception to December 31, 2018. RCTs with culture-expanded MSCs for treating knee osteoarthritis were included. Studies with adjuvant surgery or cell concentrate were excluded. Quality was assessed by the Cochrane Collaboration risk-of-bias tool. For meta-analysis, data on clinical outcomes were measured using a visual analog scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and data on cartilage repair were measured using the Whole-Organ Magnetic Resonance Imaging Score (WORMS); categorization related to improvement was extracted.

RESULTS

Six RCTs (203 patients) were included. Two studies were deemed to have a low risk of bias. In pooled analysis, the only significant difference was in the VAS score (mean difference, -13.55; 95% CI, -22.19 to -4.9). In cumulative pain analysis with VAS and WOMAC pain scores, there was significant improvement after treatment (standardized mean difference, -0.54; 95% CI, -0.85 to -0.23). There was no significant difference in cartilage repair assessed by magnetic resonance imaging (standardized mean difference, 0.11; 95% CI, -0.51 to 0.73), WORMS (standardized mean difference, 1.68; 95% CI -14.84 to 18.21), or categorical results (odds ratio, 1.56; 95% CI, 0.32-7.59).

CONCLUSION

Intra-articular injection of culture-expanded MSCs without adjuvant surgery can improve pain for patients experiencing knee osteoarthritis at short-term follow-up (6-12 months). However, evidence regarding function and cartilage repair remains limited.

摘要

背景

尽管许多临床研究评估了间充质干细胞(MSCs)在膝骨关节炎中的疗效,但由于细胞实体和伴随手术的异质性,其疗效证据仍不明确。

目的

通过对无辅助手术的随机对照试验(RCT)进行荟萃分析,确定培养的 MSCs 在膝骨关节炎的临床疗效和软骨修复方面的效果。

研究设计

荟萃分析。

方法

从建库到 2018 年 12 月 31 日,检索 PubMed、Embase、Cochrane 图书馆、CINAHL 和 Scopus。纳入使用培养的 MSCs 治疗膝骨关节炎的 RCT。排除辅助手术或细胞浓缩的研究。使用 Cochrane 协作风险偏倚工具评估质量。对于荟萃分析,使用视觉模拟量表(VAS)和西安大略和麦克马斯特大学骨关节炎指数(WOMAC)测量临床结果数据,使用全器官磁共振成像评分(WORMS)测量软骨修复数据;提取与改善相关的分类数据。

结果

纳入 6 项 RCT(203 例患者)。其中两项研究被认为具有低偏倚风险。在汇总分析中,唯一显著的差异在于 VAS 评分(平均差值,-13.55;95%CI,-22.19 至-4.9)。在 VAS 和 WOMAC 疼痛评分的累积疼痛分析中,治疗后疼痛明显改善(标准化平均差值,-0.54;95%CI,-0.85 至-0.23)。磁共振成像评估的软骨修复无显著差异(标准化平均差值,0.11;95%CI,-0.51 至 0.73)、WORMS(标准化平均差值,1.68;95%CI,-14.84 至 18.21)或分类结果(比值比,1.56;95%CI,0.32-7.59)。

结论

在短期随访(6-12 个月)中,关节内注射无辅助手术的培养的 MSCs 可改善膝骨关节炎患者的疼痛。然而,关于功能和软骨修复的证据仍然有限。

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