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在韩国健康保险审查与评估服务数据库(HIRA)中,基于原发性膝关节骨关节炎,对关节内透明质酸注射与全膝关节置换术延迟的相关性及其安全性进行评估分析。

Association between intra-articular hyaluronic acid injections in delaying total knee arthroplasty and safety evaluation in primary knee osteoarthritis: analysis based on Health Insurance Review and Assessment Service (HIRA) claim database in Republic of Korea.

机构信息

Department of Orthopaedic Surgery, College of Medicine, Anam Hospital, Korea University, 73, Goryeodae-ro, Seongbuk-gu, Seoul, South Korea.

Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, South Korea.

出版信息

BMC Musculoskelet Disord. 2024 Sep 4;25(1):706. doi: 10.1186/s12891-024-07698-2.

DOI:10.1186/s12891-024-07698-2
PMID:39232733
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11373335/
Abstract

BACKGROUND

The prevalence of knee osteoarthritis (KOA), a progressive degenerative disease, is gradually increasing, and it is a progressive degenerative disease. In patients with mild-to-moderate KOA, intra-articular hyaluronic acid (IA-HA) has been shown to be an effective non-operative treatment option that can provide significant pain relief and symptom improvement by increasing intra-articular viscoelasticity. This study aimed to evaluate the efficacy of IA-HA injections in delaying total knee arthroplasty (TKA) and the safety of IA-HA according to IA-HA type and combination with intra-articular corticosteroid (IA-CS) using a large health insurance claim database.

METHODS

For this retrospective cohort study, the study population included patients aged ≥ 50 years with a first diagnosis of KOA between 2009 and 2014, who underwent TKA by 2020, using the Health Insurance Review and Assessment Service claim database in Republic of Korea. IA-HA injections were categorized as single or multiple injection regimen agents. Cox proportional hazard models estimated hazard ratios (HR) for TKA risk, adjusted for covariates. Logistic regression assessed the occurrence of adverse events after IA-HA administration.

RESULTS

In all, 36,983 patients were included. Patients who received IA-HA injections had a significantly longer time to TKA compared to those who did not (mean delay of approximately 1 year). The IA-HA group had a significantly lower risk of TKA (HR: 0.61, 95% CI: 0.60-0.62) than non-IA-HA group after adjusting for covariates, which included age, sex, medical history, number of hospital beds, and CS injection. Single injection IA-HA regimen agents showed the longest time to TKA and lowest risk (HR: 0.56, 95% CI: 0.53-0.59). TKA risk decreased with the number of IA-HA cycles. Adverse events occurred in 6.7% of IA-HA cases without CS, with very low incidence of infection. Multiple injection regimen agents (multiple injection regimen 7.0% vs. single injection regimen 3.6%) and concurrent IA-CS use (concurrent IA-CS use 13.9% vs. IA-HA only 6.7%) were associated with higher infection risk.

CONCLUSION

IA-HA injections were associated with a significant delay in TKA among patients with KOA. Single-injection regimen agents had the lowest TKA risk. Infection risk increased with multiple injections and concurrent IA-CS use. These findings could suggest the use of IA-HA as an effective non-operative intervention option for managing KOA and delaying TKA. Careful selection of IA-HA type and consideration of concurrent IA-CS use could play a role in delaying the time to TKA and reducing complications.

摘要

背景

膝骨关节炎(KOA)是一种进行性退行性疾病,其患病率逐渐上升,且为进行性退行性疾病。在轻中度 KOA 患者中,关节内透明质酸(IA-HA)已被证明是一种有效的非手术治疗选择,通过增加关节内粘弹性,可显著缓解疼痛并改善症状。本研究旨在使用大型医疗保险理赔数据库,根据 IA-HA 类型和与关节内皮质类固醇(IA-CS)联合使用情况,评估 IA-HA 注射对延迟全膝关节置换术(TKA)的疗效和 IA-HA 的安全性。

方法

本回顾性队列研究的研究人群包括 2009 年至 2014 年间年龄≥50 岁、初次诊断为 KOA 且于 2020 年前接受 TKA 的患者,使用韩国健康保险审查与评估服务理赔数据库。IA-HA 注射分为单次或多次注射方案药物。Cox 比例风险模型估计 TKA 风险的风险比(HR),并调整了协变量。逻辑回归评估了 IA-HA 给药后的不良事件发生情况。

结果

共纳入 36983 例患者。与未接受 IA-HA 注射的患者相比,接受 IA-HA 注射的患者 TKA 时间明显延长(平均延迟约 1 年)。IA-HA 组在调整年龄、性别、病史、医院床位数和 CS 注射等协变量后,TKA 风险显著低于非 IA-HA 组(HR:0.61,95%CI:0.60-0.62)。单次注射 IA-HA 方案药物显示 TKA 时间最长,风险最低(HR:0.56,95%CI:0.53-0.59)。随着 IA-HA 周期数的增加,TKA 风险降低。IA-HA 组不良事件发生率为 6.7%,无 CS 组感染发生率极低。多次注射方案药物(多次注射方案 7.0%比单次注射方案 3.6%)和同时使用 IA-CS(同时使用 IA-CS 13.9%比仅使用 IA-HA 6.7%)与更高的感染风险相关。

结论

IA-HA 注射可显著延迟 KOA 患者的 TKA。单次注射方案药物的 TKA 风险最低。感染风险随着多次注射和同时使用 IA-CS 而增加。这些发现可能表明,IA-HA 可作为管理 KOA 和延迟 TKA 的有效非手术干预选择。IA-HA 类型的选择和同时使用 IA-CS 的考虑可能会影响 TKA 的时间和并发症的发生。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/371b/11373335/2c22523baa9b/12891_2024_7698_Figd_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/371b/11373335/f15b3521bfb9/12891_2024_7698_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/371b/11373335/bb98afc0badc/12891_2024_7698_Figb_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/371b/11373335/459074a5c8e8/12891_2024_7698_Figc_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/371b/11373335/2c22523baa9b/12891_2024_7698_Figd_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/371b/11373335/f15b3521bfb9/12891_2024_7698_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/371b/11373335/bb98afc0badc/12891_2024_7698_Figb_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/371b/11373335/459074a5c8e8/12891_2024_7698_Figc_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/371b/11373335/2c22523baa9b/12891_2024_7698_Figd_HTML.jpg

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