温肺益气方治疗肺气虚寒型变应性鼻炎的临床疗效及对Th1/Th2和Th17/Treg平衡影响随机双盲对照研究

Clinical Effects of Wenfei Yiqi Decoction in Treating Allergic Rhinitis of Fei-qi Deficiency and Cold Syndrome and Its Impact on Th1/Th2 and Th17/Treg Balance:A Randomized Double-Blind Controlled Study

目的观察温肺益气方治疗肺气虚寒型变应性鼻炎的临床疗效及对Th1/Th2和Th17/Treg平衡影响。方法采用随机双盲对照设计,将肺气虚寒型变应性鼻炎患者100例随机分为对照组(10%温肺益气方剂量)和观察组(100%温肺益气方剂量),每组50例。比较两组治疗前后的症状及体征评分并进行临床疗效评定;采用视觉模拟量表(VAS)及鼻眼结膜相关生活质量问卷调查量表(RQLQ)评价AR患者生活质量改善情况;检测治疗前后两组外周血中嗜酸性粒细胞(EOS)计数、特异性免疫球蛋白E(Ig E)水平以及血清炎性因子IL-2、γ-干扰素(IFN-γ)、IL-4、IL-5、IL-10、IL-17的水平。结果对照组43例、观察组46例完成研究,并纳入统计分析。与本组治疗前比较,两组治疗后鼻痒、喷嚏积分、VAS、RQLQ评分降低;观察组治疗后流涕、鼻塞、下鼻甲肿胀积分、外周血EOS计数及Ig E水平、血清IL-4、IL-5及IL-17水平降低(P<0.05),血清IL-10水平升高(P<0.05)。与对照组同期比较,观察组治疗后鼻痒、流涕、喷嚏、鼻塞、下鼻甲肿胀积分、VAS、RQLQ评分、外周血EOS计数、Ig E水平以及血清IL-4、IL-5、IL-17水平降低(P<0.05),血清IL-10水平升高(P<0.05)。观察组有效率91.3%(42/46)高于对照组的23.3%(10/43,P<0.05)。结论温肺益气方可能通过调节Th1/Th2和Th17/Treg细胞平衡改善鼻过敏症状和促进鼻功能的恢复,从而提高了变应性鼻炎患者的生活质量。国家全民保障信息平台-医学研究登记备案信息系统(备案号:MR-31-21-010699)。

Objective To observe the clinical effects of Wenfei Yiqi Decoction in treating allergic rhinitis of Fei-qi deficiency and cold syndrome and its impact on Th1/Th2 and Th17/Treg balance.Methods Adopting a randomized controlled double blind research method,totally 100 patients with allergic rhinitis of Fei-qi deficiency and cold syndrome were randomly assigned to control group(containing 10%active ingredients of Wenfei Yiqi Decoction)and observation group(containing 100%active ingredients of Wenfei Yiqi Decoction),with 50 cases in each group.The clinical symptoms and signs were scored before and after treatment to evaluate the clinical efficacy.The Visual Analog Scale(VAS)and Rhinocoujunctivitis Quality of Life Questionaire(RQLQ)were used to evaluate the improvement of quality of life in AR patients.The number of eosinophil(EOS)and the specific immunoglobulin E(IgE)level in peripheral blood were detected,and the following levels of inflammatory factors in serum were determined:IL-2,interferon-γ(IFN-γ),IL-4,IL-5,IL-10,and IL-17 before and after treatment in two groups.Results Finally,43 patients in the control group and 46 patients in the observation group completed this study,and the research data was included in statistical analysis.Compared with the same group before treatment,the scores of nasal itching and sneezing,VAS,and RQLQ decreased in both groups after treatment;the scores of rhinorrhea,nasal obstruction,and inferior nasal mucosa edema,the number of EOS and the level of specific IgE in blood,and the levels of IL-4,IL-5 and IL-17 in serum decreased(P<0.05),while the IL-10 level increased(P<0.05)in the observation group after treatment.Compared with the control group at the same time,the scores of nasal itching,rhinorrhea,sneezing,nasal obstruction,inferior nasal mucosa edema,VAS,RQLQ,the number of EOS and the level of specific IgE in blood,and the levels of IL-4,IL-5 and IL-17 in serum decreased(P<0.05),while the IL-10 level increased(P<0.05)in the observation group after treatment.The total effective rate was 91.3%(42/46)in the observation group,which was better than 23.3%(10/43)in the control group(P<0.05).Conclusions Wenfei Yiqi Decoction may improve nasal allergy symptoms and promote the recovery of nasal function by regulating the balance of Th1/Th2 and Th17/Treg cells,thereby improving the quality of life of patients with allergic rhinitis.National Public Security Information Platform-Medical Research Registration and Filing Information System(Filing Number:MR-31-21-010699)