Schnitzer Thomas J, Torbey Souraya, Herrmann Kristi, Kaushal Gagan, Yeasted Renita, Vania Apkarian A
Department of Physical Medicine and Rehabilitation and Division of Rheumatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
Department of Psychiatry, University of Virginia School of Medicine, VA, USA.
Mol Pain. 2016 Nov 15;12. doi: 10.1177/1744806916678627. Print 2016.
Few effective pharmacological treatment options exist for chronic back pain, the leading cause of disability in the US, and all are associated with significant adverse effects.
To determine the efficacy and safety of D-cycloserine, a partial agonist to the N-methyl-D-aspartate receptor, in the treatment of chronic low back pain.
A total of 41 participants with chronic back pain who met all inclusion and exclusion criteria were enrolled in a double-blind, placebo-controlled randomized pilot trial of D-cycloserine. Treatment was administered orally for six weeks at escalating daily doses of 100 mg, 200 mg, and 400 mg, each for two weeks. The primary outcome measure was back pain intensity using the Numeric Rating Scale (0-10). Secondary measures were back pain-related questionnaires: McGill Pain Questionnaire short form, painDETECT, PANAS, and BDI. The pre-specified analysis was a two-way repeated measures analysis of variance.
A treatment difference was observed between groups treated with D-cycloserine and placebo at six weeks of 1.05 ± 3.1 units on the Numeric Rating Scale, with an effect size of 0.4 and p = 0.14. This trend of better chronic back pain relief with D-cycloserine was also observed in the secondary measures. No safety issues were seen.
The difference in mean pain between the D-cycloserine and placebo groups did not reach statistical significance. However, a clinically meaningful effect size in the magnitude of pain relief was observed with a consistent pattern across multiple outcome measures with good safety, supporting further research into the effectiveness of D-cycloserine for chronic back pain.
慢性背痛是美国导致残疾的主要原因，有效的药物治疗选择很少，而且所有治疗都伴有显著的不良反应。
确定N-甲基-D-天冬氨酸受体部分激动剂D-环丝氨酸治疗慢性下背痛的疗效和安全性。
共有41名符合所有纳入和排除标准的慢性背痛患者参加了一项关于D-环丝氨酸的双盲、安慰剂对照随机试点试验。治疗采用口服方式，为期六周，每日剂量递增，分别为100毫克、200毫克和400毫克，各服用两周。主要结局指标是使用数字评分量表（0-10）评估的背痛强度。次要指标是与背痛相关的问卷：麦吉尔疼痛问卷简表、疼痛检测问卷、正性和负性情绪量表以及贝克抑郁量表。预先指定的分析是双向重复测量方差分析。
在六周时，D-环丝氨酸治疗组和安慰剂组在数字评分量表上的治疗差异为1.05±3.1个单位，效应大小为0.4，p=0.14。在次要指标中也观察到D-环丝氨酸缓解慢性背痛效果更佳的这一趋势。未发现安全问题。
D-环丝氨酸组和安慰剂组之间的平均疼痛差异未达到统计学意义。然而，在疼痛缓解程度上观察到了具有临床意义的效应大小，且在多个结局指标上呈现一致模式，安全性良好，这支持对D-环丝氨酸治疗慢性背痛的有效性进行进一步研究。
