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关节内透明质酸(Hyalubrix)注射与局部麻醉药治疗髋关节骨关节炎的对比、双盲、对照研究。

Comparative, double-blind, controlled study of intra-articular hyaluronic acid (Hyalubrix) injections versus local anesthetic in osteoarthritis of the hip.

机构信息

Operative Unit of Rheumatology, San Pietro Fatebenefratelli Hospital, via Cassia 600, 00189 Rome, Italy.

出版信息

Arthritis Res Ther. 2009;11(6):R183. doi: 10.1186/ar2875. Epub 2009 Dec 9.

Abstract

INTRODUCTION

Comparison of intra-articular bacterial-derived hyaluronic acid (Hyalubrix) (HA) with local analgesia (mepivacaine) for osteoarthritis (OA) of the hip.

METHODS

A pilot prospective, double-blind, 6-month randomized trial of 42 patients with hip OA. HA or mepivacaine was administered twice (once a month) under ultrasound guidance. Efficacy measurements included the Lequesne's algofunctional index, a visual analog scale for pain, concomitant use of analgesia, patient and physician global measurement, and safety.

RESULTS

Patients in the HA group exhibited a significantly reduced Lequesne's algofunctional index 3 and 6 months after treatment (P < 0.001) and significantly reduced visual analog scale pain scores 3 and 6 months after treatment (P < 0.05) compared with the local anesthetic group. All primary and secondary measures were significantly improved versus baseline, but other than the above were not different from each other at 3 or 6 months. Adverse effects were minimal.

CONCLUSIONS

This comparative study suggests a beneficial effect and safety of intra-articular HA in the management of hip OA.

TRIAL REGISTRATION NUMBER

ISRCTN39397064.

摘要

简介

比较关节内细菌源性透明质酸(Hyalubrix)(HA)与局部麻醉药(甲哌卡因)治疗髋关节骨关节炎(OA)。

方法

42 例髋关节 OA 患者进行了一项前瞻性、双盲、6 个月随机试验。在超声引导下,HA 或甲哌卡因每两个月(每月一次)给药两次。疗效测量包括 Lequesne 的algofunctional 指数、疼痛视觉模拟评分、同时使用的镇痛药、患者和医生的整体测量以及安全性。

结果

与局部麻醉药组相比,HA 组患者在治疗后 3 个月和 6 个月时 Lequesne 的algofunctional 指数显著降低(P < 0.001),疼痛视觉模拟评分也显著降低(P < 0.05)。与基线相比,所有主要和次要措施均显著改善,但在 3 个月或 6 个月时彼此之间没有差异。不良反应最小。

结论

这项比较研究表明关节内 HA 对髋关节 OA 的治疗具有有益的效果和安全性。

试验注册号

ISRCTN39397064。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f45/3003515/c7c0851560e5/ar2875-1.jpg

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