Akeda Koji, Ohishi Kohshi, Masuda Koichi, Bae Won C, Takegami Norihiko, Yamada Junichi, Nakamura Tomoki, Sakakibara Toshihiko, Kasai Yuichi, Sudo Akihiro
Department of Orthopaedic Surgery, Mie University Graduate School of Medicine, Tsu, Japan.
Blood Transfusion Service, Mie University Hospital, Tsu, Japan.
Asian Spine J. 2017 Jun;11(3):380-389. doi: 10.4184/asj.2017.11.3.380. Epub 2017 Jun 15.
Preliminary clinical trial.
To determine the safety and initial efficacy of intradiscal injection of autologous platelet-rich plasma (PRP) releasate in patients with discogenic low back pain.
PRP, which is comprised of autologous growth factors and cytokines, has been widely used in the clinical setting for tissue regeneration and repair. PRP has been shown and to potentially stimulate intervertebral disc matrix metabolism.
Inclusion criteria for this study included chronic low back pain without leg pain for more than 3 months; one or more lumbar discs (L3/L4 to L5/S1) with evidence of degeneration, as indicated via magnetic resonance imaging (MRI); and at least one symptomatic disc, confirmed using standardized provocative discography. PRP releasate, isolated from clotted PRP, was injected into the center of the nucleus pulposus. Outcome measures included the use of a visual analog scale (VAS) and the Roland-Morris Disability Questionnaire (RDQ), as well as X-ray and MRI (T2-quantification).
Data were analyzed from 14 patients (8 men and 6 women; mean age, 33.8 years). The average follow-up period was 10 months. Following treatment, no patient experienced adverse events or significant narrowing of disc height. The mean pain scores before treatment (VAS, 7.5±1.3; RDQ, 12.6±4.1) were significantly decreased at one month, and this was generally sustained throughout the observation period (6 months after treatment: VAS, 3.2±2.4, RDQ; 3.6±4.5 and 12 months: VAS, 2.9±2.8; RDQ, 2.8±3.9; <0.01, respectively). The mean T2 values did not significantly change after treatment.
We demonstrated that intradiscal injection of autologous PRP releasate in patients with low back pain was safe, with no adverse events observed during follow-up. Future randomized controlled clinical studies should be performed to systematically evaluate the effects of this therapy.
初步临床试验。
确定椎间盘内注射自体富血小板血浆（PRP）释放物治疗椎间盘源性下腰痛患者的安全性和初始疗效。
PRP由自体生长因子和细胞因子组成，已在临床中广泛用于组织再生和修复。PRP已被证明可能刺激椎间盘基质代谢。
本研究的纳入标准包括慢性下腰痛且无腿痛超过3个月；通过磁共振成像（MRI）显示一个或多个腰椎间盘（L3/L4至L5/S1）有退变迹象；以及至少一个经标准化激发性椎间盘造影证实的有症状椎间盘。从凝结的PRP中分离出的PRP释放物被注射到髓核中心。观察指标包括使用视觉模拟量表（VAS）和罗兰-莫里斯残疾问卷（RDQ），以及X线和MRI（T2定量）。
对14例患者（8例男性和6例女性；平均年龄33.8岁）的数据进行了分析。平均随访期为10个月。治疗后，没有患者出现不良事件或椎间盘高度明显变窄。治疗前的平均疼痛评分（VAS，7.5±1.3；RDQ，12.6±4.1）在1个月时显著降低，并且在整个观察期内基本保持（治疗后6个月：VAS，3.2±2.4，RDQ；3.6±4.5；12个月：VAS，2.9±2.8；RDQ，2.8±3.9；P均<0.01）。治疗后平均T2值没有显著变化。
我们证明，椎间盘内注射自体PRP释放物治疗下腰痛患者是安全的，随访期间未观察到不良事件。未来应进行随机对照临床研究，以系统评估该疗法的效果。
