自拟消炎止痛含漱液对牙髓炎患者牙痛症状及炎症因子的临床试验研究

Clinical Trial Study on the Effect of a Self-Formulated Anti-Inflammatory and Analgesic Mouthwash on Toothache Symptoms and Inflammatory Markers in Patients with Pulpitis

摘要: 目的：探讨自拟消炎止痛含漱液对牙髓炎患者牙痛症状及血清炎症因子的影响，评估其临床疗效与安全性。方法：将120例牙髓炎患者随机分为实验组和对照组各60例。实验组采用自拟消炎止痛含漱液含漱，对照组采用生理盐水含漱，每日3次，连续7天。比较两组治疗前后疼痛VAS评分、血清IL-6及TNF-α水平、牙龈红肿及牙周袋深度等指标，并记录不良反应。结果：最终纳入统计分析114例，实验组与对照组各57例。两组患者基线资料具有可比性(P > 0.05)。治疗后第3天及第7天，实验组VAS评分均显著低于对照组(P < 0.01)；实验组治疗后第7天血清IL-6、TNF-α水平较治疗前显著下降(P < 0.01)，且显著低于对照组(P < 0.01)；实验组牙龈红肿评分及牙周袋深度改善程度均优于对照组(P < 0.01)；实验组解救药物使用率为8.8%，显著低于对照组的21.1% (P < 0.05)。两组不良反应发生率低，未见严重不良事件。结论：自拟消炎止痛含漱液能有效缓解牙髓炎患者的牙痛症状，降低血清炎症因子水平，改善局部炎症体征，且安全性良好，可作为牙髓炎辅助治疗的有效手段。

Abstract: Objective: To investigate the effects of a proprietary anti-inflammatory and analgesic mouthwash on dental pain symptoms and serum inflammatory factors in patients with pulpitis, and to evaluate its clinical efficacy and safety. Methods: One hundred and twenty patients with pulpitis were randomly assigned to an experimental group and a control group, comprising 60 patients each. The experimental group used the self-formulated anti-inflammatory and analgesic mouthwash, while the control group used physiological saline solution, both for gargling three times daily for seven consecutive days. Pre- and post-treatment comparisons were made between the two groups for pain VAS scores, serum IL-6 and TNF-α levels, gingival redness and swelling, and periodontal pocket depth, with adverse reactions also recorded. Results: A total of 114 patients (57 in each group) were ultimately included in statistical analysis. Baseline characteristics were comparable between groups (P > 0.05). On days 3 and 7 post-treatment, the experimental group exhibited significantly lower VAS scores than the control group (P < 0.01). Serum IL-6 and TNF-α levels in the experimental group decreased significantly from baseline by day 7 (P < 0.01) and remained significantly lower than those of the control group (P < 0.01). The experimental group demonstrated superior improvement in gingival erythema and swelling scores and periodontal pocket depth compared to the control group (P < 0.01). The rescue medication usage rate in the experimental group was 8.8%, significantly lower than the control group’s 21.1% (P < 0.05). Adverse reaction rates were low in both groups, with no serious adverse events observed. Conclusion: The proprietary anti-inflammatory and analgesic mouthwash effectively alleviates dental pain symptoms in patients with pulpitis, reduces serum inflammatory factor levels, and improves local inflammatory signs. Demonstrating good safety, it may serve as an effective adjunctive treatment for pulpitis.