基于“伏气学说”的清透法治疗变应性鼻炎的随机对照临床研究

摘要

目的 评价基于“伏气学说”的清透法治疗变应性鼻炎患者的临床疗效和安全性.方法 120例患者随机分为3组,中药组、西药组及中西药组各40例,中药组给予清透法中药(200mL/次,2次/d),西药组给予枸地氯雷他定片(8.8mg/次,1次/d),中西药组给予清透法中药和枸地氯雷他定片,各组1个疗程连续1周治疗,共治疗3个疗程,每次间隔2d.比较3组患者治疗前、疗程结束后、随访1年患者症状评分、生活质量评分,并观察各组复发率及安全性.结果 治疗结束后,3组症状评分及生活质量评分均较治疗前明显降低(p＜0.01).随访结束,西药组症状评分和生活质量评分较治疗前无统计学差异(P＞0.05),明显高于中药组、中西药组(P＜0.01);中药组、中西药组较治疗前均明显降低(P＜0.01),组间相比较无统计学差异(P＞0.05).3月内各组患者复发率无统计学差异(P＞0.05),3月后中药组、中西药组明显低于西药组(P＜0.01),中药组与中西药组相比较无统计学差异(P＞0.05).3组患者均未发生明显试验相关不良反应.结论 基于“伏气学说”的清透法中药和枸地氯雷他定片均能有效改善患者症状评分和生活质量评分,远期疗效及改善复发率方面,清透法中药优于枸地氯雷他定片,且临床安全性良好.%Objective Evaluation on clinical efficacy and safety of heatclearing and pathogenicexpelling method based on theory of latent pathogen in the treatment of patients with allergic rhinitis.Methods A total of 120 patients with allergic rhinitis were randomly divided into three groups:traditional Chinese medicine (TCM) group treated with heatclearing and pathogenicexpelling method (200mL/ times,2 times/D),western medicine group with Desioratadine Citrate Disodium Tablets (8.8mg/times,1 times/D),and integrated Chinese and western medicine group with heatclearing and pathogenicexpelling method combined with Desloratadine Citrate Disodium Tablets,Each treatment group was treated with continuous 1W for 1 courses,a total of 3 courses of treatment,each interval of 2D.40 cases in each group.Allergic rhinitis symptom score (ARSS) and quality of life score (QOLS) before,immediately after treatment,and after 1-year follow-up were compared among the three groups;and the recurrence rates and clinical safety were observed in all groups.Results After treatment,ARSS and QOLS decreased notably in all groups compared with those before treatment(P＜0.01).After the end of follow-up,the ARSS and QOLS in western medicine group showed insignificant differences compared with those before treatment(P＞ 0.05),but were evidently higher than those in TCM group and integrated Chinese and western medicine group (P＜0.01).The scores also decreased prominendy in TCM group and integrated Chinese and western medicine group (P＜0.01),but the difference was not significant between these two groups (P＞0.05).There was insignificant difference among the three groups in the recurrence rate within 3 months(P＞0.05).The recurrence rate was notably lower in both TCM group and integrated Chinese and western medicine group than in western medicine group (P＜0.01) 3 months later;however there was insignificant difference between TCM group and integrated Chinese and western medicine group (P＞0.05).No obvious trial related adverse reactions were observed in the three groups.Conclusion Both TCM of heatclearing and pathogenicexpelling method based on latent pathogen theory and Desloratadine Citrate Disodium Tablets can effectively improve the ARSS and QOLS.In terms of long-term clinical efficacy and recurrence rate improvement,TCM of heatclearing and pathogenicexpelling method is superior to Desloratadine Citrate Disodium Tablets,with greater clinical safety.