比较传统与新型单次大剂量关节腔内注射补充透明质酸治疗膝骨关节炎疗效的随机对照试验

Randomized controlled trial comparing efficacy of conventional and new single larger dose of intra-articular viscosupplementation in management of knee osteoarthritis.

作者信息

Suppan Vijaya Kumar L, Wei Chew Yu, Siong Tan Chin, Mei Tew Mei, Chern Wong Bor, Nanta Kumar Vijay Kumar, Sheng Kee Rong, Sadashiva Rao Ashutosh

机构信息

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

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

出版信息

J Orthop Surg (Hong Kong). 2017 Sep-Dec;25(3):2309499017731627. doi: 10.1177/2309499017731627.

Abstract

BACKGROUND

Intra-articular hyaluronic acid (HA) injection is used in management of knee, hand and hip osteoarthritis. While HA injection is included in the list of evaluated therapies, its efficacy and optimum dosing still have no consensus. This study was conducted to explore the possibility of using single injection HA to increase patient convenience while maintaining the therapeutic efficacy.

METHODS

We present a prospective, open label, non-blinded, randomized controlled trial performed in accordance with guidelines in principles of good clinical practice. Block randomization was done for patients to receive either single 5 ml GO-ON injection or the conventional three injections of 2.5 ml GO-ON at weekly interval. Baseline Western Ontario McMaster University Osteoarthritis (WOMAC) scores were evaluated and recorded. All subjects were re-evaluated at 3 months and the WOMAC score recorded again as primary end points. Data analyses were performed with IBM SPSS Statistics for Windows software (version 21.0, IBM Corp, Armonk, New York, USA).

RESULTS

In the cohort of 127 patients, 33 were males and 94 females. The mean age was 59.1 years (standard deviation (SD) = 7.25) in single injection arm and 60.1 years (SD = 7.72) in triple injection arm. The two groups were recorded to have no significant difference in age ( p = 0.46) and Kellgren-Lawrence radiological grade ( p = 0.694). There was significant increase in the WOMAC scores from the baseline (pre-injection) to that recorded 3 months after injection ( p < 0.001) in patients of both groups. However, there was no statistically significant difference noticed in this clinical improvement between the two arms ( p = 0.889).

CONCLUSION

The study shows single 5 ml dose regime comparing well with conventional three doses of 2.5 ml of intra-articular GO-ON HA injected at weekly intervals and confirms good efficacy, tolerability and safety of single larger dose of GO-ON knee intra-articular injection.

摘要

背景

关节内注射透明质酸(HA)用于治疗膝关节、手部和髋关节骨关节炎。虽然HA注射已被列入评估治疗方法清单,但其疗效和最佳剂量仍未达成共识。本研究旨在探讨单次注射HA在提高患者便利性的同时维持治疗效果的可能性。

方法

我们开展了一项前瞻性、开放标签、非盲法、随机对照试验,该试验按照良好临床实践原则的指南进行。对患者进行区组随机分组,使其接受单次5毫升的GO-ON注射或每周一次、每次2.5毫升的常规三次GO-ON注射。评估并记录基线期西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分。所有受试者在3个月时进行重新评估,并再次记录WOMAC评分作为主要终点。使用IBM SPSS Statistics for Windows软件(版本21.0,IBM公司,美国纽约州阿蒙克)进行数据分析。

结果

在127例患者队列中,男性33例,女性94例。单次注射组的平均年龄为59.1岁(标准差(SD)=7.25),三次注射组为60.1岁(SD = 7.72)。记录显示两组在年龄(p = 0.46)和凯尔格伦-劳伦斯放射学分级(p = 0.694)方面无显著差异。两组患者从基线期(注射前)到注射后3个月记录的WOMAC评分均有显著增加(p < 0.001)。然而,两组之间在这一临床改善方面未观察到统计学上的显著差异(p = 0.889)。

结论

该研究表明,单次5毫升剂量方案与每周一次、每次2.5毫升的常规三次关节内注射GO-ON HA效果相当,并证实了单次较大剂量的GO-ON膝关节内注射具有良好的疗效、耐受性和安全性。

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