甘草泻心汤加减治疗灼口综合征的临床疗效及对血清IL-6、TNF-α的影响

Clinical Efficacy of Modified Gancao Xiexin Decoction for Burning Mouth Syndrome and Its Effects on Serum IL-6 and TNF-α

摘要: 目的：探讨甘草泻心汤加减治疗灼口综合征的临床疗效及其对血清白细胞介素-6 (IL-6)、肿瘤坏死因子-α (TNF-α)水平的影响。方法：选取2023年3月至2025年2月遂宁市中心医院收治的灼口综合征患者100例，采用随机数字表法分为观察组和对照组，各50例。观察组给予甘草泻心汤加减口服，对照组给予维生素B1联合甲钴胺治疗，疗程均为4周。比较两组治疗前后中医证候积分、视觉模拟评分法(VAS)评分、血清IL-6及TNF-α水平变化，并评价临床疗效及安全性。结果：两组治疗4周后中医证候积分及VAS评分均较治疗前降低(均P < 0.001)。治疗后观察组中医证候积分低于对照组[(1.90 ± 1.33)分比(2.46 ± 1.30)分，P < 0.05]，但两组减分值比较差异未达统计学意义(P ≈ 0.061)。观察组总有效率为86.0% (43/50)，对照组为78.0% (39/50)，差异无统计学意义(P > 0.05)。两组治疗后血清IL-6及TNF-α水平均较治疗前下降(P < 0.05)；观察组治疗后IL-6水平低于对照组[(36.29 ± 6.92) pg/mL比(54.36 ± 11.40) pg/mL，P < 0.001]，且IL-6下降幅度大于对照组[(−47.21 ± 15.87) pg/mL比(−23.36 ± 5.81) pg/mL，P < 0.001]。两组治疗后TNF-α水平及其下降幅度比较差异均无统计学意义(P > 0.05)。治疗期间两组均未见严重不良反应。结论：甘草泻心汤加减可有效改善灼口综合征患者的临床症状，并在降低血清IL-6水平方面显示出优势；其整体疗效与维生素B1联合甲钴胺方案相当，具有较好的安全性。

Abstract: Objective: To investigate the clinical efficacy of modified Gancao Xiexin Decoction in patients with burning mouth syndrome (BMS) and its effects on serum interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Methods: A total of 100 patients with BMS treated at Suining Central Hospital from March 2023 to February 2025 were randomly assigned to an observation group and a control group, with 50 cases in each group. The observation group received modified Gancao Xiexin Decoction, while the control group received vitamin B1 plus mecobalamin for 4 weeks. Traditional Chinese medicine (TCM) syndrome score, visual analogue scale (VAS) score, serum IL-6, serum TNF-α, clinical efficacy, and adverse reactions were compared between the two groups before and after treatment. Results: After 4 weeks of treatment, both groups showed significant reductions in TCM syndrome score and VAS score (all P < 0.001). The post-treatment TCM syndrome score in the observation group was lower than that in the control group [(1.90 ± 1.33) vs. (2.46 ± 1.30), P < 0.05], whereas the between-group difference in change score did not reach statistical significance (P ≈ 0.061). The total effective rate was 86.0% (43/50) in the observation group and 78.0% (39/50) in the control group, with no significant difference (P > 0.05). Serum IL-6 and TNF-α levels decreased significantly in both groups after treatment (P < 0.05). After treatment, IL-6 levels in the observation group were lower than those in the control group [(36.29 ± 6.92) pg/mL vs. (54.36 ± 11.40) pg/mL, P < 0.001], and the magnitude of the decrease in IL-6 was greater than that in the control group [(−47.21 ± 15.87) pg/mL vs. (−23.36 ± 5.81) pg/mL, P < 0.001]. There were no statistically significant differences between the two groups regarding post-treatment TNF-α levels or the magnitude of their decrease (P > 0.05). No serious adverse reactions were observed in either group during the treatment period. Conclusion: Modified Gancao Xiexin Decoction can effectively alleviate clinical symptoms in patients with burning mouth syndrome and demonstrates an advantage in reducing serum IL-6 levels; its overall therapeutic efficacy is comparable to that of the Vitamin B1 plus mecobalamin regimen, and it exhibits a favorable safety profile.