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关节内高渗葡萄糖(增生疗法)治疗膝骨关节炎的疗效:一项随机对照试验。

Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial.

机构信息

Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong

Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.

出版信息

Ann Fam Med. 2020 May;18(3):235-242. doi: 10.1370/afm.2520.

Abstract

PURPOSE

To test the efficacy of intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection for knee osteoarthritis (KOA).

METHODS

A single-center, parallel-group, blinded, randomized controlled trial was conducted at a university primary care clinic in Hong Kong. Patients with KOA (n = 76) were randomly allocated (1:1) to DPT or NS groups for injections at weeks 0, 4, 8, and 16. The primary outcome was the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score. The secondary outcomes were the WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score. All outcomes were evaluated at baseline and at 16, 26, and 52 weeks using linear mixed model.

RESULTS

Randomization produced similar groups. The WOMAC pain score at 52 weeks showed a difference-in-difference estimate of -10.34 (95% CI, -19.20 to -1.49, = 0.022) points. A similar favorable effect was shown on the difference-in-difference estimate on WOMAC function score of -9.55 (95% CI, -17.72 to -1.39, = 0.022), WOMAC composite score of -9.65 (95% CI, -17.77 to -1.53, = 0.020), VAS pain intensity score of -10.98 (95% CI, -21.36 to -0.61, = 0.038), and EuroQol-5D VAS score of 8.64 (95% CI, 1.36 to 5.92, = 0.020). No adverse events were reported.

CONCLUSION

Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high.

摘要

目的

测试关节内高渗葡萄糖普鲁卡因(prolotherapy, DPT)治疗膝骨关节炎(knee osteoarthritis, KOA)与生理盐水(normal saline, NS)注射的疗效。

方法

在香港一所大学的基层医疗诊所进行了一项单中心、平行组、盲法、随机对照试验。将 76 名 KOA 患者(1:1)随机分配到 DPT 或 NS 组,分别在第 0、4、8 和 16 周进行注射。主要结局是 Western Ontario McMaster University Osteoarthritis Index(WOMAC;0-100 分)疼痛评分。次要结局包括 WOMAC 综合评分、功能和僵硬评分、客观评估的身体功能测试结果、膝关节疼痛视觉模拟量表(visual analogue scale, VAS)评分和 EuroQol-5D 评分。所有结局均在基线时以及 16、26 和 52 周时使用线性混合模型进行评估。

结果

随机分组产生了相似的组。52 周时 WOMAC 疼痛评分的差值估计为-10.34 分(95%置信区间,-19.20 至-1.49, = 0.022)。在 WOMAC 功能评分的差值估计上也显示出类似的有利效果,差值为-9.55 分(95%置信区间,-17.72 至-1.39, = 0.022)、WOMAC 综合评分的差值为-9.65 分(95%置信区间,-17.77 至-1.53, = 0.020)、VAS 疼痛强度评分的差值为-10.98 分(95%置信区间,-21.36 至-0.61, = 0.038)和 EuroQol-5D VAS 评分的差值为 8.64 分(95%置信区间,1.36 至 5.92, = 0.020)。未报告不良事件。

结论

与盲法 NS 注射相比,关节内葡萄糖普鲁卡因注射可减轻 KOA 患者的疼痛,改善其功能和生活质量。该操作简单安全,患者的依从性和满意度均较高。

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