【目的】 探究归原疏筋合剂治疗腰椎间盘突出症（LDH）患者的临床疗效及其可能的作用机制。【方法】 将68例气滞血瘀 证LDH患者随机分为试验组和对照组，每组各34例。对照组给予塞来昔布及甲钴胺片内服治疗，试验组在对照组的基础上 加用归原疏筋合剂内服治疗，疗程为 4周。观察 2组患者治疗前后腰痛和下肢痛视觉模拟量表（VAS）评分、Oswestry功能障 碍指数（ODI）评分、改良日本骨科协会（JOA）评分以及血清炎症因子[肿瘤坏死因子α（TNF-α）、白细胞介素6（IL-6）、白细胞 介素 1β（IL-1β）]和血清核因子 κB p65（NF-κB p65）水平的变化情况，并评价 2 组患者的临床疗效和用药安全性。【结果】 （1）脱落情况方面，研究过程中，试验组脱落1例，对照组脱落3例，最终试验组33例、对照组31例纳入疗效统计。（2）疗效 方面，治疗4周后，试验组的总有效率为96.97%（32/33），对照组为87.10%（27/31）；组间比较（秩和检验），试验组的疗效明 显优于对照组（P＜0.05）。（3）量表评分方面，治疗后，2组患者的腰痛及下肢痛VAS评分、ODI评分均较治疗前降低（P＜0.05 或 P＜0.01），改良 JOA评分均较治疗前升高（P＜0.01），且试验组对腰痛及下肢痛 VAS评分、ODI评分的降低幅度及对改良 JOA 评分的升高幅度均明显优于对照组（P＜0.05 或 P＜0.01）。（4）血清炎症相关指标方面，治疗后，2 组患者血清 TNF-α、 IL-6、IL-1β、NF-κB p65水平均较治疗前降低（P＜0.01），且试验组的降低幅度均明显优于对照组（P＜0.01）。（5）安全性方 面，治疗过程中，试验组的不良事件发生率为 2.94%（1/34），对照组为 8.82%（3/34），组间比较，差异无统计学意义（P＞ 0.05）。【结论】 归原疏筋合剂治疗气滞血瘀证LDH患者疗效确切，可有效缓解患者疼痛症状，改善患者腰椎功能，降低血清 炎症因子及NF-κB p65表达水平，其作用机制可能与降低炎症因子水平，抑制NF-κB信号通路的活化有关。

Objective To investigate the clinical efficacy of Guiyuan Shujin Mixture in the treatment of patients with lumbar disc herniation （LDH） and to explore its possible therapeutic mechanism. Methods Sixty-eight patients with LDH of qi stagnation and blood stasis syndrome were randomly divided into trial group and control group，with 34 cases in each group. The control group was treated with Celecoxib Tablets and Mecobalamin Tablets orally，and the trial group was treated with Guiyuan Shujin Mixture on the basis of treatment for the control group.The course of treatment lasted for 4 weeks. Before and after treatment，the two groups were observed in the changes of the Visual Analogue Scale（VAS）score of low back pain and lower limb pain，Oswestry Disability Index（ODI） score， modified Japanese Orthopedic Association（JOA）score， serum levels of inflammatory factors of tumor necrosis factor α（TNF-α），interleukin 6（IL-6）and interleukin 1β（IL-1β），and serum nuclear factor-κB p65 （NF-κB p65）level. After treatment，the clinical efficacy and safety of the two groups were evaluated. Results （1）During the trial， one case fell off in the trial group and 3 cases fell off in the control group. Eventually， 33 cases in the trial group and 31 cases in the control group were included for the efficacy statistics.（2）After 4 weeks of treatment，the total effective rate of the trial group was 96.97%（32/33），and that of the control group was 87.10%（27/31）. The intergroup comparison（tested by rank sum test）showed that the curative effect of the trial group was significantly superior to that of the control group（P＜0.05）.（3）After treatment，the VAS score and ODI score of low back pain and lower limb pain in the two groups were lower than those before treatment（P＜ 0.05 or P＜0.01），and the modified JOA score was higher than that before treatment（P＜0.01）. The decrease of VAS score and ODI score of low back pain and lower limb pain and the increase of modified JOA score in the trial group were significantly superior to those in the control group（P＜0.05 or P＜0.01）.（4）After treatment，the serum levels of inflammation-related indicators of TNF-α，IL-6，IL-1β and NF-κB p65 in the two groups were lower than those before treatment（P＜0.01），and the decrease in the trial group was significantly superior to that in the control group（P＜0.01）.（5）During the treatment，the incidence of adverse events in the trial group was 2.94%（1/34）and that in the control group was 8.82%（3/34），and the difference between the two groups was not significant（P＞0.05）. Conclusion Guiyuan Shujin Mixture exerts certain effect in the treatment of LDH patients with qi stagnation and blood stasis syndrome. It can effectively relieve the pain symptoms of patients，improve the lumbar function of patients，and reduce the expression levels of serum inflammatory factors and NF-κB p65. The mechanism may be related with the decrease of the level of inflammatory factors and with the inhibition of the activation of NF-κB signaling pathway.

R274.9

国家自然科学基金面上项目（编号：81771323）；广东省自然科学基金项目（编号：2021A1515010722）；深圳市自然科学基金项目 （编号：JCYJ20190813112401660）