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多核苷酸、透明质酸钠和交联透明质酸钠治疗膝骨关节炎疼痛的比较:一项多中心、随机、双盲、平行组研究

Comparison of Polynucleotide, Sodium Hyaluronate, and Crosslinked Sodium Hyaluronate for the Management of Painful Knee Osteoarthritis: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study.

作者信息

Moon Jee Youn, Kim Jeongsoo, Lee Jin Young, Ko Youngkwon, Park Hue Jung, Jeon Young Hoon

机构信息

Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.

Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, Republic of Korea.

出版信息

Pain Med. 2023 May 2;24(5):496-506. doi: 10.1093/pm/pnac155.

DOI:10.1093/pm/pnac155
PMID:36255262
Abstract

OBJECTIVE

To compare the clinical effectiveness of sodium polynucleotide, classic hyaluronic acid, and crosslinked hyaluronic acid for the management of painful knee osteoarthritis.

DESIGN

Randomized, double-blind, parallel-group clinical trial.

SETTING

Multicenter study.

SUBJECTS

Patients with chronic painful knee osteoarthritis.

METHODS

Ninety patients were selected and randomized into polynucleotide, classic hyaluronic acid, and crosslinked hyaluronic acid groups (30 per group). Intra-articular injections of the viscosupplement for each group were administered to the patients three times at one-week intervals. The primary outcome was differences in changes of weight-bearing pain scores at 16 weeks between the groups. The secondary outcomes were changes in the intensity of knee pain during weight-bearing, walking, and rest, and functional disability, quality of life, and adverse events during the 16-week follow-up period.

RESULTS

At 16 weeks, the polynucleotide group showed a higher reduction in pain score using a Visual Analog Scale score (0-100) than the classic hyaluronic acid (-17.6 [95% CI = -35.1 to -0.1]; P = .048) and crosslinked hyaluronic acid (-22.4 [95% CI = -41.5 to -3.3]; P = .016) groups. The polynucleotide and crosslinked hyaluronic acid groups showed an early-onset reduction in knee pain during weight-bearing, walking, and rest. All three groups showed reductions in functional disability and improved quality of life at 16 weeks without inter-group differences. No severe adverse events were reported throughout the study period.

CONCLUSION

Polynucleotide significantly relieves pain more and relieves pain faster in patients with knee osteoarthritis than classic and crosslinked hyaluronic acid, with improved health-related quality of life.

摘要

目的

比较多聚核苷酸、经典透明质酸和交联透明质酸治疗膝关节疼痛性骨关节炎的临床疗效。

设计

随机、双盲、平行组临床试验。

地点

多中心研究。

受试者

慢性膝关节疼痛性骨关节炎患者。

方法

选取90例患者,随机分为多聚核苷酸组、经典透明质酸组和交联透明质酸组(每组30例)。每组患者每隔一周接受3次关节内注射粘性补充剂。主要结局是16周时各组间负重疼痛评分的变化差异。次要结局是16周随访期内负重、行走和休息时膝关节疼痛强度的变化、功能障碍、生活质量和不良事件。

结果

16周时,多聚核苷酸组使用视觉模拟评分量表(0-100)的疼痛评分降低幅度高于经典透明质酸组(-17.6[95%CI=-35.1至-0.1];P=0.048)和交联透明质酸组(-22.4[95%CI=-41.5至-3.3];P=0.016)。多聚核苷酸组和交联透明质酸组在负重、行走和休息时膝关节疼痛出现早期减轻。所有三组在16周时功能障碍均减轻,生活质量均改善,组间无差异。整个研究期间未报告严重不良事件。

结论

与经典透明质酸和交联透明质酸相比,多聚核苷酸能更显著地减轻膝关节骨关节炎患者的疼痛,且止痛速度更快,同时改善了与健康相关的生活质量。

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