交联透明质酸治疗膝骨关节炎——一项前瞻性随机试验的结果

[Cross-linked hyaluronic acid in the treatment of osteoarthritis of the knee--results of a prospective randomized trial].

作者信息

Auerbach Babett, Melzer C

机构信息

Waldkrankenhaus Bad Düben, Fachkrankenhaus für Orthopädie, Germany.

出版信息

Zentralbl Chir. 2002 Oct;127(10):895-9. doi: 10.1055/s-2002-35137.

DOI:10.1055/s-2002-35137

PMID:12410458

Abstract

PURPOSE

The objective of this trial was to compare the effectiveness of intraarticular injection of highly cross-linked hyaluronic acid (HA) with intraarticular injection of gaseous oxygen (O 2 ) in patients with clinical symptoms of cartilage damage in the knee.

METHODS

Based on arthroscopically verified diagnosis, 111 patients were randomised and treated prospectively either with HA or O 2. The treatment was completed with an exercise program. The follow up was one year. 109 patients (56 x HA, 53 x O 2 ) were statistically calculated with the Wilcoxon-test according to the results of the Lysholm-score, the Tegner-activity-index, the Womac-score for pain, stiffness, function and the VAS for pain in rest and under strain.

RESULTS

Both treatments were able to attain a statistically significant reduction of pain (VAS in rest and under strain, Womac part A), a reduction of joint stiffness (Womac part B) and improvement of joint function (Womac part C, Lysholm-score) during the follow up of one year. The Tegner-activity-index showed no significant change under both treatments. The comparison of both treatments showed differences in VAS under strain (p = 0.001), the Lysholm-score (p = 0.003), Womac part A (p = 0.003) and part C (p = 0.001). As a result HA showed significant better improvements with the VAS and Lysholm-score and oxygen showed significant better changes in the Womac-score part A and C. The results with cartilage damage 2 degrees were the same as in the total (VAS strain: p = 0.029 for O 2, Lysholm-score: p = 0.003 for HA, WOMAC part A: p = 0.009 for HA, Womac part C: p = 0.006 for O 2 ). The results with cartilage damage 3 degrees showed significant differences in reduction of joint stiffness (Womac part B: p = 0.012) for O 2. For cartilage damage 4 degrees HA showed significant reduction of pain (VAS rest: p = 0.001, VAS strain: p = 0.003) and O 2 significant reduction of pain and function (Womac part A: p = 0.004, part C: p = 0.002).

CONCLUSION

Both methods are suitable to improve significantly the discomfort due one year to osteoarthritis. The pain relief by HA and the improvement of joint function by O 2 treatment have been shown for higher degrees of cartilage damage.

摘要

目的

本试验的目的是比较关节内注射高交联透明质酸（HA）与关节内注射气态氧（O₂）对膝关节软骨损伤临床症状患者的疗效。

方法

基于关节镜检查确诊，111例患者被随机分组并前瞻性地接受HA或O₂治疗。治疗通过一个锻炼计划完成。随访为期一年。根据Lysholm评分、Tegner活动指数、Womac疼痛、僵硬、功能评分以及静息和负重时的视觉模拟评分（VAS）结果，对109例患者（56例HA组，53例O₂组）进行Wilcoxon检验统计分析。

结果

在一年的随访期间，两种治疗方法均能使疼痛（静息和负重时的VAS、Womac A部分）在统计学上显著降低，关节僵硬（Womac B部分）减轻，关节功能（Womac C部分、Lysholm评分）改善。两种治疗方法下Tegner活动指数均无显著变化。两种治疗方法的比较显示，负重时VAS（p = 0.001）、Lysholm评分（p = 0.003）、Womac A部分（p = 0.003）和C部分（p = 0.001）存在差异。结果显示，HA在VAS和Lysholm评分方面改善显著更好，而氧气在Womac评分A部分和C部分变化显著更好。软骨损伤2度的结果与总体结果相同（负重时VAS：O₂组p = 0.029，Lysholm评分：HA组p = 0.003，WOMAC A部分：HA组p = 0.009，Womac C部分：O₂组p = 0.006）。软骨损伤3度的结果显示，O₂在减轻关节僵硬方面（Womac B部分：p = 0.012）存在显著差异。对于软骨损伤4度，HA在减轻疼痛方面显著（静息时VAS：p = 0.001，负重时VAS：p = 0.003），而O₂在减轻疼痛和功能方面显著（Womac A部分：p = 0.004，C部分：p = 0.002）。