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透明质酸注射治疗足底筋膜炎的短期疗效和安全性。

Short-term efficacy and safety of hyaluronic acid injection for plantar fasciopathy.

机构信息

Department of Orthopaedic Surgery, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8521, Japan.

Agatsuma Higashi Orthopaedic Clinic, 756-1, Isemachi, Nakanojo-machi Agatsuma-gun, Gumma, 377-0423, Japan.

出版信息

Knee Surg Sports Traumatol Arthrosc. 2018 Mar;26(3):903-911. doi: 10.1007/s00167-017-4467-0. Epub 2017 Mar 2.

Abstract

PURPOSE

Plantar fasciopathy is the most common cause of plantar heel pain and is considered to be a type of enthesopathy. The short-term efficacy, safety, and dose-response relationship of high-molecular-weight hyaluronic acid (HA) was investigated in patients with plantar fasciopathy.

METHODS

In this multicenter, prospective, randomized, double-blind, placebo-controlled trial, 168 patients with persistent pain from plantar fasciopathy for more than 12 weeks were randomly assigned to receive 2.5 mL of 1% HA (H-HA), 0.8 mL of 1% HA (L-HA), or 2.5 mL of 0.01% HA (control group) once a week for 5 weeks. The primary endpoint was improvement in visual analogue scale (VAS) score for pain from baseline to week 5.

RESULTS

The VAS scores (least squares mean ± standard error) in each group decreased gradually after the start of treatment, a change of -3.3 ± 0.3 cm for the H-HA group, -2.6 ± 0.3 cm for the L-HA group, and -2.4 ± 0.3 cm for the control group, with the H-HA group improving significantly more than the control group (P = 0.029). No serious adverse events were reported. There was no difference between the groups in the incidence rates of adverse drug reactions.

CONCLUSION

The administration of five injections of high-molecular-weight HA is an effective treatment with no serious adverse drug reactions and is a conservative treatment option for plantar fasciopathy. This treatment contributed to alleviation of pain in patients with plantar fasciopathy and improvement in their activities of daily living.

LEVEL OF EVIDENCE

I.

摘要

目的

足底筋膜炎是足底足跟疼痛最常见的原因,被认为是一种附着病。本研究旨在探讨高分子量透明质酸(HA)治疗足底筋膜炎的短期疗效、安全性和剂量反应关系。

方法

本多中心、前瞻性、随机、双盲、安慰剂对照试验纳入了 168 例患有持续足底筋膜炎超过 12 周的患者,随机分为 3 组,分别接受 2.5ml 浓度为 1%的高分子量 HA(H-HA)、0.8ml 浓度为 1%的低分子量 HA(L-HA)或 2.5ml 浓度为 0.01%的 HA(对照组),每周 1 次,共 5 周。主要终点为治疗 5 周后疼痛视觉模拟评分(VAS)较基线的变化。

结果

治疗开始后,每组的 VAS 评分(最小二乘均数±标准误)逐渐下降,H-HA 组下降 3.3±0.3cm,L-HA 组下降 2.6±0.3cm,对照组下降 2.4±0.3cm,H-HA 组的改善明显优于对照组(P=0.029)。未报告严重不良事件。各组不良反应发生率无差异。

结论

给予 5 次注射高分子量 HA 是一种有效且安全的治疗方法,无严重药物不良反应,是治疗足底筋膜炎的一种保守选择。该治疗有助于缓解足底筋膜炎患者的疼痛,提高其日常生活活动能力。

证据水平

I。

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