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关节腔内注射新研发的富含生长因子血浆(PRGF)与透明质酸对膝骨关节炎患者疼痛和功能的疗效:一项单盲随机临床试验

Efficacy of Intra-articular Injection of a Newly Developed Plasma Rich in Growth Factor (PRGF) Versus Hyaluronic Acid on Pain and Function of Patients with Knee Osteoarthritis: A Single-Blinded Randomized Clinical Trial.

作者信息

Raeissadat Seyed Ahmad, Rayegani Seyed Mansoor, Ahangar Azadeh Gharooee, Abadi Porya Hassan, Mojgani Parviz, Ahangar Omid Gharooi

机构信息

Physical Medicine and Rehabilitation Research Center, Clinical Research Development Center of Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

College of Medical and Dental Sciences, Birmingham medical school, Birmingham, UK.

出版信息

Clin Med Insights Arthritis Musculoskelet Disord. 2017 Oct 10;10:1179544117733452. doi: 10.1177/1179544117733452. eCollection 2017.

Abstract

BACKGROUND AND OBJECTIVES

Knee osteoarthritis is the most common joint disease. We aimed to compare the efficacy and safety of intra-articular injection of a newly developed plasma rich in growth factor (PRGF) versus hyaluronic acid (HA) on pain and function of patients with knee osteoarthritis.

METHODS

In this single-blinded randomized clinical trial, patients with symptomatic osteoarthritis of knee were assigned to receive 2 intra-articular injections of our newly developed PRGF in 3 weeks or 3 weekly injections of HA. Our primary outcome was the mean change from baseline until 2 and 6 months post intervention in scores of visual analog scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index. We used analysis of variance for repeated-measures statistical test.

RESULTS

A total of 69 patients entered final analysis. The mean age of patients was 58.2 ± 7.41 years and 81.2% were women. In particular, total WOMAC index decreased from 42.9 ± 13.51 to 26.8 ± 13.45 and 24.4 ± 16.54 at 2 and 6 months in the newly developed PRGF group (within subjects  = .001), and from 38.8 ± 12.62 to 27.8 ± 11.01 and 27.4 ± 11.38 at 2 and 6 months in the HA group (within subjects  = .001), respectively (between subjects  = .631). There was no significant difference between PRGF and HA groups in patients' satisfaction and minor complications of injection, whereas patients in HA group reported significantly lower injection-induced pain.

CONCLUSIONS

In 6 months follow up, our newly developed PRGF and HA, both are effective options to decrease pain and improvement of function in patients with symptomatic mild to moderate knee osteoarthritis.

摘要

背景与目的

膝关节骨关节炎是最常见的关节疾病。我们旨在比较关节内注射新研发的富含生长因子血浆(PRGF)与透明质酸(HA)对膝关节骨关节炎患者疼痛和功能的疗效及安全性。

方法

在这项单盲随机临床试验中,有症状的膝关节骨关节炎患者被分配接受在3周内进行2次关节内注射新研发的PRGF,或每周注射1次HA,共3次。我们的主要结局是从基线到干预后2个月和6个月时视觉模拟量表、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)以及勒凯斯内指数评分的平均变化。我们使用重复测量方差分析进行统计检验。

结果

共有69例患者进入最终分析。患者的平均年龄为58.2±7.41岁,81.2%为女性。特别是,新研发的PRGF组在2个月和6个月时WOMAC总指数分别从42.9±13.51降至26.8±13.45和24.4±16.54(组内P = 0.001),HA组在2个月和6个月时分别从38.8±12.62降至27.8±11.01和27.4±11.38(组内P = 0.001)(组间P = 0.631)。PRGF组和HA组在患者满意度和注射轻微并发症方面无显著差异,而HA组患者报告注射引起的疼痛明显较低。

结论

在6个月的随访中,我们新研发的PRGF和HA都是减轻有症状的轻至中度膝关节骨关节炎患者疼痛和改善功能的有效选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f93c/5638152/1c2471c70ab8/10.1177_1179544117733452-fig1.jpg

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