Department of Spinal Surgery, General Hospital of Armed Police Force, Beijing 100039, China Department of Orthopaedics, 304th Hospital, Beijing, China Department of Orthopaedics, Sanhe People Hospital, Hebei, China Department of Orthopaedics, Shengli Hospital, Shandong, China.
Pain. 2010 Apr;149(1):124-129. doi: 10.1016/j.pain.2010.01.021. Epub 2010 Feb 18.
A preliminary report of clinical study revealed that chronic discogenic low back pain could be treated by intradiscal methylene blue (MB) injection. We investigated the effect of intradiscal MB injection for the treatment of chronic discogenic low back pain in a randomized placebo-controlled trial. We recruited 136 patients who were found potentially eligible after clinical examination and 72 became eligible after discography. All the patients had discogenic low back pain lasting longer than 6 months, with no comorbidity. Thirty-six were allocated to intradiscal MB injection and 36 to placebo treatment. The principal criteria to judge the effectiveness included alleviation of pain, assessed by a 101-point numerical rating scale (NRS-101), and improvement in disability, as assessed with the Oswestry Disability Index (ODI) for functional recovery. At the 24-month follow-up, both the groups differed substantially with respect to the primary outcomes. The patients in MB injection group showed a mean reduction in pain measured by NRS of 52.50, a mean reduction in Oswestry disability scores of 35.58, and satisfaction rates of 91.6%, compared with 0.70%, 1.68%, and 14.3%, respectively, in placebo treatment group (p<0.001, p<0.001, and p<0.001, respectively). No adverse effects or complications were found in the group of patients treated with intradiscal MB injection. The current clinical trial indicates that the injection of methylene blue into the painful disc is a safe, effective and minimally invasive method for the treatment of intractable and incapacitating discogenic low back pain.
一项临床研究的初步报告显示，椎间盘内注射亚甲蓝可治疗慢性椎间盘源性下腰痛。我们在一项随机安慰剂对照试验中研究了椎间盘内注射亚甲蓝治疗慢性椎间盘源性下腰痛的效果。我们招募了 136 名经临床检查后认为可能符合条件的患者，其中 72 名在椎间盘造影后符合条件。所有患者均患有持续时间超过 6 个月的椎间盘源性下腰痛，且无合并症。36 名患者被分配到椎间盘内注射亚甲蓝组，36 名患者被分配到安慰剂治疗组。判断疗效的主要标准包括疼痛缓解，采用 101 点数字评分量表（NRS-101）评估；以及功能恢复的 Oswestry 残疾指数（ODI）评估的残疾改善。在 24 个月的随访中，两组在主要结局方面存在显著差异。与安慰剂治疗组的 0.70%、1.68%和 14.3%相比，亚甲蓝注射组的患者在 NRS 测量的疼痛平均减轻 52.50，ODI 残疾评分平均减轻 35.58，满意率为 91.6%（p<0.001、p<0.001 和 p<0.001）。在接受椎间盘内注射亚甲蓝治疗的患者中，未发现不良反应或并发症。本临床试验表明，向疼痛椎间盘内注射亚甲蓝是治疗难治性和致残性椎间盘源性下腰痛的一种安全、有效、微创的方法。
