Is there a role for autologous conditioned serum injections in osteoarthritis? A systematic review and meta-analysis of randomised controlled trials

IF 7.2 2区 医学 Q1 ORTHOPEDICS Osteoarthritis and Cartilage Pub Date : 2024-06-13 DOI:10.1016/j.joca.2024.06.004
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Abstract

Objective

To assess whether patient reported outcome measures (PROMs) improve after autologous conditioned serum (ACS) administration in patients with osteoarthritis.

Methods

Databases and clinical trial registers were searched to March 2024 for randomised controlled trial (RCTs) comparing ACS vs comparators/controls. Primary outcomes were pain, function and stiffness measured with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and visual analogue scale (VAS). Secondary outcome was complications. Risk of bias (RoB) and certainty of evidence were assessed using RoB 2 and the Grades of Recommendation, Assessment, Development and Evaluation Working Group (GRADE) respectively. Meta-analysis was undertaken using RevMan v5.4. Results are presented as standardised mean differences (SMD) or mean differences (MD) with 95% confidence intervals (CI). Sensitivity analysis compared all comparators and saline control.

Results

Five RCTs were identified (n = 741 participants); two (n = 529 participants) compared ACS against saline (placebo). Three studies were “some concern” and two studies “high risk” for bias. Analysis comparing ACS with all comparators significantly favoured ACS at 6 months for WOMAC: SMD −0.61 (95% CI −1.01 to −0.21; p = 0.003); and VAS: SMD −1.24 (95% CI −2.11 to −0.38; p = 0.005); with high heterogeneity. Comparing ACS with saline, there was no significant difference in WOMAC or VAS at 6 months: SMD −0.40 (95% CI −0.93 to 0.12; p = 0.13) and MD −9.87 (95% CI −27.73 to 7.98, p = 0.28). Complications were similar: ACS (24.8%) vs saline (24.4%), with serious complications rare.

Conclusion

There is currently insufficient data to support the use of ACS in osteoarthritis with conflicting results when compared to alternative therapies and saline control, with high heterogeneity. Before consideration as a potential treatment, a high-quality multicentre RCT is required to assess the efficacy of ACS.

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自体条件性血清注射对骨关节炎有作用吗?随机对照试验的系统回顾和荟萃分析》。
目的评估骨关节炎患者服用自体有条件血清(ACS)后,患者报告的疗效(PROMs)是否有所改善:方法:检索截至 2024 年 3 月的数据库和临床试验登记册,以寻找比较 ACS 与对比药/对照药的 RCT。主要结果是疼痛、功能和僵硬度,用WOMAC和VAS测量。次要结果为并发症。分别采用RoB2和GRADE对偏倚风险和证据确定性进行评估。使用 RevManv5.4 进行了 Meta 分析。结果以标准化平均差异 (SMD) 或平均差异 (MD) 及 95% 置信区间表示。敏感性分析比较了所有比较药和生理盐水对照:共确定了五项 RCT(n=741 名参与者);其中两项(n=529 名参与者)将 ACS 与生理盐水(安慰剂)进行了比较。三项研究存在 "一定程度的偏倚",两项研究存在 "高风险"。将 ACS 与所有比较者进行比较分析后发现,ACS 在六个月后对 WOMAC 的治疗效果明显更佳:SMD为-0.61(95% CI为-1.01至-0.21;p=0.003);VAS:SMD为-1.24(95% CI为-2.11至-0.38;p=0.005);异质性较高。将 ACS 与生理盐水进行比较,六个月后的 WOMAC 或 VAS 没有显著差异:SMD -0.40 (95% CI -0.93 to 0.12; p=0.13) 和 MD -9.87 (95% CI -27.73 to 7.98, p=0.28)。并发症情况相似:ACS(24.8%)与生理盐水(24.4%)的并发症相似,严重并发症罕见:目前没有足够的数据支持在 OA 中使用 ACS,与替代疗法和生理盐水对照组相比,结果相互矛盾,异质性很高。在考虑将 ACS 作为一种潜在的治疗方法之前,需要进行高质量的多中心 RCT 研究,以评估 ACS 的疗效。
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来源期刊
Osteoarthritis and Cartilage
Osteoarthritis and Cartilage 医学-风湿病学
CiteScore
11.70
自引率
7.10%
发文量
802
审稿时长
52 days
期刊介绍: Osteoarthritis and Cartilage is the official journal of the Osteoarthritis Research Society International. It is an international, multidisciplinary journal that disseminates information for the many kinds of specialists and practitioners concerned with osteoarthritis.
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