麻黄附子细辛汤加味治疗风寒痹阻型颈椎病的随机对照研究及其对血清炎症因子的调节作用

A Randomised Controlled Trial of Modified Mahuang Fuzi Xixin Decoction in the Treatment of Cervical Spondylosis with Wind-Cold Obstruction, and Its Regulatory Effects on Serum Inflammatory Factors

摘要: 目的：基于六经辨证理论，观察麻黄附子细辛汤加味治疗风寒痹阻型颈椎病的临床疗效及对血清炎症因子TNF-α、IL-6、IL-1β的影响。方法：将64例风寒痹阻型颈椎病患者随机分为治疗组(麻黄附子细辛汤加味，每日1剂)和对照组(塞来昔布胶囊，0.2 g/d)，每组32例，疗程2周，观察VAS疼痛评分、ODI功能障碍指数、临床总有效率及血清炎症因子水平。结果：治疗2周后，治疗组总有效率为90.6% (29/32)，明显高于对照组的62.5% (20/32)，组间比较差异有统计学意义(P < 0.05)。两组VAS评分均较治疗前下降，治疗组从治疗前的(6.85 ± 1.12)分降至(2.03 ± 0.85)分，对照组从(6.79 ± 1.08)分降至(3.64 ± 1.03)分，治疗组下降幅度大于对照组(P < 0.01)。ODI指数治疗组由(42.36 ± 8.57)%降至(16.24 ± 5.63)%，对照组由(41.92 ± 8.43)%降至(28.57 ± 6.82)%，组间差异有统计学意义(P < 0.01)。炎症因子方面，治疗组治疗后血清TNF-α、IL-6、IL-1β水平分别为(28.46 ± 6.23) pg/mL、(17.34 ± 4.15) pg/mL、(12.67 ± 3.48) pg/mL，显著低于对照组的(41.58 ± 7.69) pg/mL、(28.92 ± 5.73) pg/mL、(21.43 ± 4.56) pg/mL (均P < 0.01)。两组均未发生严重不良反应。结论：基于六经辨证理论运用麻黄附子细辛汤加味治疗风寒痹阻型颈椎病疗效确切，可显著缓解疼痛、改善功能障碍，其机制可能与降低血清TNF-α、IL-6、IL-1β水平相关。

Abstract: Objective: Based on the theory of the Six Meridians, this study investigated the clinical efficacy of Modified Ephedra-Aconite-Asarum Decoction in treating cervical spondylosis of the wind-cold obstruction pattern, as well as its effects on the serum inflammatory factors TNF-α, IL-6 and IL-1β. Methods: Sixty-four patients with cervical spondylosis of the wind-cold obstruction type were randomly divided into a treatment group (modified Mahuang Fuzi Xixin Decoction, one dose daily) and a control group (celecoxib capsules, 0.2 g/day), with 32 patients in each group. The treatment course lasted two weeks, during which the Visual Analogue Scale (VAS) pain score, the Oswestry Disability Index (ODI), the overall clinical response rate, and serum inflammatory factor levels were assessed. Results: After 2 weeks of treatment, the overall response rate in the treatment group was 90.6% (29/32), significantly higher than the 62.5% (20/32) in the control group; the difference between the groups was statistically significant (P < 0.05). VAS scores in both groups decreased compared to pre-treatment levels: the treatment group decreased from (6.85 ± 1.12) points to (2.03 ± 0.85) points, whilst the control group decreased from (6.79 ± 1.08) points to (3.64 ± 1.03) points; the reduction in the treatment group was greater than that in the control group (P < 0.01). The ODI score in the treatment group decreased from (42.36 ± 8.57)% to (16.24 ± 5.63)%, whilst in the control group it decreased from (41.92 ± 8.43)% to (28.57 ± 6.82)%; the difference between the groups was statistically significant (P < 0.01). Regarding inflammatory factors, post-treatment serum levels of TNF-α, IL-6 and IL-1β in the treatment group were (28.46 ± 6.23) pg/mL, (17.34 ± 4.15) pg/mL and (12.67 ± 3.48) pg/mL, which were significantly lower than those in the control group (41.58 ± 7.69) pg/mL, (28.92 ± 5.73) pg/mL, and (21.43 ± 4.56) pg/mL (all P < 0.01). No serious adverse reactions occurred in either group. Conclusion: Based on the theory of the Six Meridians, the use of modified Mahuang Fuzi Xixin Decoction for the treatment of cervical spondylosis of the wind-cold obstruction pattern is effective, significantly alleviating pain and improving functional impairment. The mechanism of action may be related to the reduction in serum levels of TNF-α, IL-6 and IL-1β.