富血小板血浆（PRP）、富含生长因子的血浆（PRGF）、透明质酸（HA）和臭氧关节内注射治疗膝骨关节炎的比较效果：一项为期一年的随机临床试验。

The comparison effects of intra-articular injection of Platelet Rich Plasma (PRP), Plasma Rich in Growth Factor (PRGF), Hyaluronic Acid (HA), and ozone in knee osteoarthritis; a one year randomized clinical trial.

机构信息

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

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

出版信息

BMC Musculoskelet Disord. 2021 Feb 3;22(1):134. doi: 10.1186/s12891-021-04017-x.

BACKGROUND

Our study compare the short and long-term efficacy of the intra articular injections (IAIs) of hyaluronic acid (HA), platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), and ozone in patients with knee osteoarthritis (OA).

METHODS

In this randomized clinical trial, 238 patients with mild to moderate knee OA were randomized into 4 groups of IAIs: HA (3 doses weekly), PRP (2 doses with 3 weeks interval), PRGF (2 doses with 3 weeks interval), and Ozone (3 doses weekly). Our outcome measures were the mean changes from baseline (immediately from the first injections) until 2,6, and 12 months post intervention in scores of visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index.

RESULTS

A total of 200 patients enrolled in the final analysis. The mean age of patients was 56.9 ± 6.3 years, and 69.5% were women. In 2 months follow up, significant improvement of pain, stiffness, and function were seen in all groups compared to the baseline, but the ozone group had the best results (P < 0.05). In 6 month follow up HA, PRP, and PRGF groups demonstrated better therapeutic effects in all scores in comparison with ozone (P < 0.05). At the end of the 12th month, only PRGF and PRP groups had better results versus HA and ozone groups in all scores (P < 0.05). Despite the fact that ozone showed better early results, its effects begin to wear off earlier than other products and ultimately disappear in 12 months.

CONCLUSIONS

Ozone injection had rapid effects and better short-term results after 2 months, but its therapeutic effects did not persist after 6 months and at the 6-month follow up, PRP,PRGF and HA were superior to ozone. Only patients in PRP and PRGF groups improved symptoms persisted for 12 months. Therefore, these products could be the preferable choices for long-term management.

TRIAL REGISTRATION

Registered in the Iranian Center of Clinical Trials ( www.irct.ir ) in 11/11/2017 with the following code: IRCT2017082013442N17.

背景

本研究比较了关节内注射透明质酸（HA）、富血小板血浆（PRP）、富含生长因子的血浆（PRGF）和臭氧治疗膝关节骨关节炎（OA）的短期和长期疗效。

方法

在这项随机临床试验中，238 例轻中度膝 OA 患者随机分为 4 组关节内注射：HA（每周 3 次）、PRP（2 次，间隔 3 周）、PRGF（2 次，间隔 3 周）和臭氧（每周 3 次）。我们的疗效评估指标为视觉模拟评分（VAS）、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）和 Lequesne 指数从基线（第一次注射后立即）到干预后 2、6 和 12 个月的平均变化。

结果

共有 200 例患者纳入最终分析。患者的平均年龄为 56.9±6.3 岁，69.5%为女性。在 2 个月的随访中，与基线相比，所有组的疼痛、僵硬和功能均有显著改善，但臭氧组的效果最好（P<0.05）。在 6 个月的随访中，HA、PRP 和 PRGF 组在所有评分中均优于臭氧组（P<0.05）。在第 12 个月结束时，只有 PRGF 和 PRP 组在所有评分中均优于 HA 和臭氧组（P<0.05）。尽管臭氧早期疗效较好，但 6 个月后疗效开始减弱，12 个月后消失。