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常规剂量与超大剂量富血小板血浆治疗膝骨关节炎的比较:一项前瞻性、三盲、随机临床试验

Comparison of Conventional Dose Versus Superdose Platelet-Rich Plasma for Knee Osteoarthritis: A Prospective, Triple-Blind, Randomized Clinical Trial.

作者信息

Patel Sandeep, Gahlaut Shivam, Thami Tarkik, Chouhan Devendra Kumar, Jain Ashish, Dhillon Mandeep Singh

机构信息

Department of Orthopedic Surgery, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.

Department of Transfusion Medicine, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.

出版信息

Orthop J Sports Med. 2024 Feb 26;12(2):23259671241227863. doi: 10.1177/23259671241227863. eCollection 2024 Feb.

Abstract

BACKGROUND

Confusion persists regarding the ideal dosage of platelet-rich plasma (PRP) injection for knee osteoarthritis (OA).

PURPOSE/HYPOTHESIS: The purpose of the study was to compare the efficacy of 2 different single-injection PRP dosages in patients with early knee OA-a conventional 4 mL dose and a superdose of 8 mL. It was hypothesized that 8 mL of PRP would be superior to 4 mL of PRP in this patient population.

STUDY DESIGN

Randomized clinical trial; Level of evidence, 1.

METHODS

Patients with early knee OA (Kellgren-Lawrence grades 1 and 2) who met the inclusion criteria were randomly divided into 2 groups: Group A (n = 50 knees) received a 4-mL PRP injection, and group B (n = 49 knees) received an 8-mL PRP injection, both prepared using the same procedure. Patients were evaluated at the baseline, 6 weeks, 3 months, and 6 months using the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the WOMAC-Pain subscale, the visual analog scale for pain, the Knee injury and Osteoarthritis Outcome Score, and patient satisfaction, and results were compared between the groups.

RESULTS

The baseline characteristics of the 2 groups were comparable (group A: mean age, 51.96 ± 6.93 years; group B: mean age, 49.12 ± 9.8 3 years). Leucocyte-depleted PRP with 3.5 times concentration (final product platelet concentration, 706.74 × 10-μL) was injected. The mean absolute platelet count injected was 2.82 ± 0.0012 billion in group A and 5.65 ± 0.0022 billion in group B. All patient-reported outcome scores improved significantly in both groups from the baseline to the final follow-up ( < .001), with overall trends and results significantly better in group B than in group A ( < .001). Patient satisfaction at the 6-month follow-up was also better in group B (96%) compared with group A (68%). Short (2 to 7 days) self-limiting complications, such as pain and stiffness, occurred more often in group B ( < .001).

CONCLUSION

Patients with early knee OA had significantly better improvement in pain and function when treated with an 8-mL injection of PRP compared with a 4-mL injection of PRP. The larger dose of PRP had approximately twice the number of platelets.

REGISTRATION

CTRI/2020/02/023403 (Clinical Trials Registry-India identifier).

摘要

背景

对于膝骨关节炎(OA)患者,富血小板血浆(PRP)注射的理想剂量仍存在争议。

目的/假设:本研究旨在比较两种不同单次注射PRP剂量对早期膝OA患者的疗效,即传统的4 mL剂量和8 mL超大剂量。假设在该患者群体中,8 mL PRP的疗效优于4 mL PRP。

研究设计

随机临床试验;证据等级为1级。

方法

符合纳入标准的早期膝OA(Kellgren-Lawrence分级为1级和2级)患者被随机分为两组:A组(n = 50膝)接受4 mL PRP注射,B组(n = 49膝)接受8 mL PRP注射,两组均采用相同方法制备。在基线、6周、3个月和6个月时,使用西安大略和麦克马斯特大学骨关节炎指数(WOMAC)、WOMAC疼痛子量表、视觉模拟疼痛量表、膝关节损伤和骨关节炎疗效评分以及患者满意度对患者进行评估,并比较两组结果。

结果

两组的基线特征具有可比性(A组:平均年龄51.96±6.93岁;B组:平均年龄49.12±9.83岁)。注射了浓度为3.5倍的去白细胞PRP(最终产品血小板浓度为706.74×10⁶/μL)。A组注射的平均绝对血小板计数为28.2±0.0012亿,B组为56.5±0.0022亿。从基线到最终随访,两组所有患者报告的结局评分均显著改善(P <.001),B组的总体趋势和结果显著优于A组(P <.001)。B组在6个月随访时的患者满意度(96%)也高于A组(68%)。B组更常出现短期(2至7天)自限性并发症,如疼痛和僵硬(P <.001)。

结论

与4 mL PRP注射相比,8 mL PRP注射治疗早期膝OA患者时,疼痛和功能改善明显更好。较大剂量的PRP所含血小板数量约为前者的两倍。

注册信息

CTRI/2020/02/023403(印度临床试验注册标识符)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1d2/10896053/2041a7d353cf/10.1177_23259671241227863-fig1.jpg

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