散风通窍滴丸治疗变应性鼻炎肺经伏热证的临床研究

目的 探讨散风通窍滴丸治疗变应性鼻炎肺经伏热证的临床疗效。方法 选取2020年3月-2021年6月北京中西医结合医院收治的91例变应性鼻炎肺经伏热证患者,按照随机分组法将患者分为鼻渊通窍颗粒组（30例）、氯雷他定组（30例）和散风通窍滴丸组（31例）。鼻渊通窍颗粒组口服鼻渊通窍颗粒,1袋/次,3次/d。氯雷他定组口服氯雷他定片,10 mg/次,1次/d。散风通窍滴丸组口服散风通窍滴丸,20丸/次,3次/d。3组均连续治疗1个月。观察3组临床疗效,比较3组中医证候积分、鼻结膜炎生活质量量表（RQLQ）评分、血清细胞因子的变化。结果 治疗后,散风通窍滴丸组综合疗效总有效率是90.32%,显著高于鼻渊通窍颗粒的76.67%和氯雷他定组的83.33%（P<0.05）;散风通窍滴丸组单项症状、体征疗效的总有效率是93.55%,显著高于鼻渊通窍颗粒的83.33%和氯雷他定组的86.67%（P<0.05）。治疗后,3组治疗前后中医证候评分均较同组治疗前显著降低（P<0.05）;散风通窍滴丸组鼻塞、鼻黏膜肿胀评分显著低于鼻渊通窍颗粒组和氯雷他定组;散风通窍滴丸组流清/黏稠涕评分、口干评分、舌红苔薄白/黄评分、脉数评分显著低于氯雷他定组（P<0.05）。治疗后,3组RQLQ评分均较治疗前显著降低（P<0.05）;且治疗后,散风通窍滴丸组RQLQ评分显著低于氯雷他定（P<0.05）。治疗后,3组患者血清白细胞介素-4（IL-4）、白细胞介素-13（IL-13）水平均较治疗前显著降低（P<0.05）;治疗后3组患者血清炎性因子水平比较差异无统计学意义。治疗期间,鼻渊通窍颗粒组不良反应发生率是6.67%,氯雷他定组是13.33%,散风通窍滴丸组是3.23%,氯雷他定组不良反应发生率显著高于散风通窍滴丸组（P<0.05）。结论 散风通窍滴丸是一种安全有效的治疗变应性鼻炎肺经伏热证的药物,可明显改善各项中医证候指标,显著改善变应性鼻炎鼻塞和鼻黏膜肿胀症状,能降低血清IL-4和IL-13水平。

Clinical study of Sanfeng Tongqiao Dropping Pills in treatment of allergic rhinitis lung meridian latent heat syndrome

Objective To explore the clinical effect of Sanfeng Tongqiao Dropping Pills in treatment of allergic rhinitis lung meridian latent heat syndrome. Methods A total of 91 patients with allergic rhinitis lung meridian latent heat syndrome admitted to Beijing Hospital of Integrated Traditional Chinese and Western Medicine from March 2020 to June 2021 were selected and divided into Biyuan Tongqiao Granules group (30 cases), loratadine group (30 cases), and Sanfeng Tongqiao Dropping Pills group (31 cases) according to randomization method. Patients in Biyuan Tongqiao Granule group were po administered with Biyuan Tongqiao Granules, 1 bag/time, three times daily. Patients in loratadine group were po administered with Loratadine Tablets, 10 mg/time, once daily. Patients in Sanfeng Tongqiao Dropping Pill group were po administered with Sanfeng Tongqiao Dropping Pills, 20/time, three times daily. Patients in three groups were treated for 1 month. After treatment, the clinical efficacy was evaluated, and the changes of TCM syndrome score, RQLQ score and serum cytokines in three groups were compared. Results After treatment, the total effective rate of Sanfeng Tongqiao Dropping Pill group was 90.32%, which was significantly higher than that of Biyuan Tongqiao Granules (76.67%) and loratadine group (83.33%) (P < 0.05). The total effective rate of single symptom and sign in Sanfeng Tongqiao Dropping Pills group was 93.55%, which was significantly higher than that of Biyuan Tongqiao Granules (83.33%) and loratadine group (86.67%) (P < 0.05). After treatment, the TCM syndrome scores of 3 groups before and after treatment were significantly lower than those before treatment (P < 0.05); Nasal congestion and mucosal swelling scores of Sanfeng Tongqiao Dropping Pill group were significantly lower than those of Biyuan Tongqiao Granule group and loratadine group. The scores of run-clear/sticky nose, dry mouth, red tongue and thin white/yellow tongue and pulse number in Sanfeng Tongqiao Dropping Pill group were significantly lower than those in loratadine group (P < 0.05). After treatment, RQLQ score in 3 groups was significantly lower than before treatment (P < 0.05). After treatment, RQLQ score of Sanfeng Tongqiao Dropping Pill group was significantly lower than that of loratadine group (P < 0.05). After treatment, serum IL-4 and IL-13 levels in 3 groups were significantly decreased compared with before treatment (P < 0.05). After treatment, there was no significant difference in serum inflammatory factors among 3 groups. During treatment, the incidence of adverse reactions was 6.67% in the Biyuan Tongqiao Granule group, 13.33% in the loratadine group and 3.23% in the Sanfeng Tongqiao Dropping Pill group. The incidence of adverse reactions in the loratadine group was significantly higher than that in the Sanfeng Tongqiao Dropping Pills group (P< 0.05). Conclusion Sanfeng Tongqiao Dropping Pills is a safe and effective drug for the treatment of allergic rhinitis lung meridian heat syndrome, and can significantly improve various TCM syndrome indicators, significantly improve the symptoms of allergic rhinitis nasal congestion and nasal mucosal swelling, and can reduce serum IL-4 and IL-13 levels.