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膝关节骨关节炎关节腔内注射透明质酸重复小剂量与单次大剂量给药的疗效及成本的一年随访

One-year follow-up of efficacy and cost of repeated doses versus single larger dose of intra-articular hyaluronic acid for knee osteoarthritis.

作者信息

Suppan Vijaya Kumar L, Tew Mei Mei, Wong Bor Chern, Chan Huan Keat, Chew Yu Wei, Tan Chin Siong, Nanta Kumar Vijay Kumar, Shafie Asrul Akmal, Sadashiva Rao Ashutosh

机构信息

Department of Orthopaedics, Hospital Sultan Abdul Halim, Sungai Petani, Kedah, Malaysia.

Clinical Research Centre, Hospital Sultan Abdul Halim, Sungai Petani, Kedah, Malaysia.

出版信息

J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(1):2309499019895029. doi: 10.1177/2309499019895029.

Abstract

PURPOSE

A recent 3-month randomized, open-label controlled trial found that the intra-articular hyaluronic acid injection (GO-ON) given as a single dose of 5 mL is as effective and safe as three repeated doses of 2.5 mL in patients with knee osteoarthritis. However, the information on the long-term efficacy and economic implications of the single-dose regimen is still limited. Hence, this follow-up study was designed to compare the effectiveness and costs of the two regimens 12 months following the treatment.

METHODS

All the 127 patients, who received either three repeated doses ( = 64) or a single dose ( = 63) of GO-ON in the previous trial, were followed up in month 12 following the treatment. The effectiveness of both the regimens was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the mean WOMAC scores were compared with those recorded at the baseline and in month 3. Additionally, the total treatment costs of the two regimens, taking account of both direct and indirect costs, were computed and compared.

RESULTS

A total of 125 patients (98.4%) completed the assessment. Despite the reduction of the overall mean WOMAC score from 39.24 to 19.93 ( < 0.001) in the first 3 months following the treatment with GO-ON, no further changes were observed up to month 12 ( > 0.95). In the meantime, the two regimens did not differ in the mean WOMAC scores ( = 0.749) and in the subscale scores for pain ( = 0.970), stiffness ( = 0.526), and physical functioning ( = 0.667) in month 12. The cost for single-dose injection was found to be approximately 30% lower compared to the repeated doses.

CONCLUSION

These findings indicate that the single larger dose of GO-ON is as effective as the repeated doses over 12 months, and yet the total treatment cost is lowered.

摘要

目的

最近一项为期3个月的随机、开放标签对照试验发现,对于膝关节骨关节炎患者,单剂量5 mL的关节腔内注射透明质酸(GO-ON)与三次重复剂量2.5 mL的效果和安全性相当。然而,关于单剂量方案的长期疗效和经济影响的信息仍然有限。因此,本随访研究旨在比较治疗12个月后两种方案的有效性和成本。

方法

在前一项试验中接受三次重复剂量(n = 64)或单剂量(n = 63)GO-ON治疗的127例患者,在治疗后的第12个月进行随访。使用西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评估两种方案的有效性,并将WOMAC平均得分与基线和第3个月记录的得分进行比较。此外,计算并比较了两种方案的总治疗成本,同时考虑了直接成本和间接成本。

结果

共有125例患者(98.4%)完成了评估。尽管在接受GO-ON治疗后的前3个月,总体WOMAC平均得分从39.24降至19.93(P < 0.001),但直到第12个月均未观察到进一步变化(P > 0.95)。同时,两种方案在第12个月的WOMAC平均得分(P = 0.749)以及疼痛(P = 0.97)、僵硬(P = 0.526)和身体功能(P = 0.667)子量表得分方面没有差异。发现单剂量注射的成本比重复剂量低约30%。

结论

这些结果表明,单次较大剂量的GO-ON在12个月内与重复剂量一样有效,且总治疗成本降低。

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