Schneider Byron J, Hunt Christine, Conger Aaron, Qu Wenchun, Maus Timothy P, Vorobeychik Yakov, Cheng Jianguo, Duszynski Belinda, McCormick Zachary L
Department of Physical Medicine and Rehabilitation, Vanderbilt University, Nashville, TN, USA.
Department of Anesthesiology & Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA.
Spine J. 2022 Feb;22(2):226-237. doi: 10.1016/j.spinee.2021.07.015. Epub 2021 Aug 2.
There are limited treatments for discogenic low back pain. Intradiscal injections of biologic agents such as platelet-rich plasma (PRP) or stem cells (SC) are theorized to have regenerative properties and have gained increasing interest as a possible treatment, but the evidence supporting their use in clinical practice is not yet well-defined.
Determine the effectiveness of intradiscal biologics for treating discogenic low back pain.
PRISMA-compliant systematic review.
Patients with discogenic low back pain confirmed by provocation discography or clinical and imaging findings consistent with discogenic pain.
The primary outcome was the proportion of individuals with ≥50% pain relief after intradiscal biologic injection at 6 months. Secondary outcomes included ≥2-point pain score reduction on NRS; patient satisfaction; functional improvement; decreased use of other health care, including analgesics and surgery; and structural disc changes on MRI.
Comprehensive literature search performed in 2018 and updated in 2020. Interventions included were biologic therapies including mesenchymal stem cells, platelet rich plasma, microfragmented fat, amniotic membrane-based injectates, and autologous conditioned serum. Any other treatment (sham or active) was considered for comparative studies. Studies were independently reviewed.
The literature search yielded 3,063 results, 37 studies were identified for full-text review, and 12 met established inclusion criteria for review. The quality of evidence on effectiveness of intradiscal biologics was very low. A single randomized controlled trial evaluating platelet-rich plasma reported positive outcomes but had significant methodological flaws. A single trial that evaluated mesenchymal stem cells was negative. Success rates for platelet-rich plasma injectate in aggregate were 54.8% (95% Confidence Interval: 40%-70%). For mesenchymal stem cells, the aggregate success rate at six months was 53.5% (95% Confidence Interval: 38.6%-68.4%), though using worst-case analysis this decreased to 40.7% (95% Confidence Interval: 28.1%-53.2%). Similarly, ≥30% functional improvement was achieved in 74.3% (95% Confidence Interval: 59.8%-88.7%) at six months but using worst-case analysis, this decreased to 44.1% (95% Confidence Interval: 28.1%-53.2%).
Limited observational data support the use of intradiscal biologic agents for the treatment of discogenic low back pain. According to the Grades of Recommendation, Assessment, Development and Evaluation System, the evidence supporting use of intradiscal mesenchymal stem cells and platelet-rich plasma is very low quality.
椎间盘源性下腰痛的治疗方法有限。理论上，向椎间盘内注射生物制剂，如富血小板血浆（PRP）或干细胞（SC），具有再生特性，作为一种可能的治疗方法越来越受到关注，但支持其在临床实践中应用的证据尚不明确。
确定椎间盘内生物制剂治疗椎间盘源性下腰痛的有效性。
符合PRISMA标准的系统评价。
经激发性椎间盘造影确诊或临床及影像学表现符合椎间盘源性疼痛的椎间盘源性下腰痛患者。
主要观察指标为椎间盘内生物制剂注射6个月后疼痛缓解≥50%的个体比例。次要观察指标包括数字评分法（NRS）疼痛评分降低≥2分；患者满意度；功能改善；减少包括镇痛药和手术在内的其他医疗保健的使用；以及MRI上椎间盘的结构变化。
2018年进行了全面的文献检索，并于2020年更新。纳入的干预措施包括生物治疗，如间充质干细胞、富血小板血浆、微片段脂肪、基于羊膜的注射剂和自体条件血清。比较研究考虑任何其他治疗（假手术或积极治疗）。对研究进行独立审查。
文献检索共获得3063条结果，确定37项研究进行全文审查，12项符合既定的纳入标准进行审查。椎间盘内生物制剂有效性的证据质量非常低。一项评估富血小板血浆的随机对照试验报告了阳性结果，但存在重大方法学缺陷。一项评估间充质干细胞的试验结果为阴性。富血小板血浆注射剂的总体成功率为54.8%（95%置信区间：40%-70%）。对于间充质干细胞，6个月时的总体成功率为53.5%（95%置信区间：38.6%-68.4%），但采用最坏情况分析时，该成功率降至40.7%（95%置信区间：28.1%-53.2%）。同样，6个月时74.3%（95%置信区间：59.8%-88.7%）的患者功能改善≥30%，但采用最坏情况分析时，该比例降至44.1%（95%置信区间：28.1%-53.2%）。
有限的观察数据支持使用椎间盘内生物制剂治疗椎间盘源性下腰痛。根据推荐分级、评估、制定和评价系统，支持使用椎间盘内间充质干细胞和富血小板血浆的证据质量非常低。
