中医体质综合干预变应性鼻炎的实效性随机对照试验

Identification and intervention of traditional Chinese medicine constitution for allergic rhinitis:A pragmatic randomized controlled trial

目的:探讨变应性鼻炎(A R)中医体质调护的临床疗效。方法:采用实效性随机对照试验(PRCT),选取278例AR患者随机分为试验(A)组、对照(B)组。两组均行阶梯化西药治疗4~8周,A组同时行中医体质辨识并予中医体质调护。治疗前及治疗后4、8、24周比较两组患者AR症状VAS评分、药物积分变化。结果:自身前后纵向对照,两组VAS评分及药物积分均较干预前改善(P<0.05);组间横向比较,前3个时间点两组变化大致相同,治疗后24周A组改善优于B组,重复测量方差分析提示“时间*分组”交互作用:FVAS=6.55,PVAS<0.001;F药物积分=5.04,P药物积分=0.002,说明A组VAS评分及药物积分的长期疗效优于B组。结论:单纯西药治疗AR短期疗效明显,中医体质调护能持续促进和维持AR症状改善、减少药物使用。

Objective:To investigate the clinical effect of identification of intervention of TCM constitution treatment for allergic rhinitis(AR).Methods:This was a pragmatic randomized controlled trial.A total of 278 patients with AR were randomized into the TCM constitution and conventional medicine group(Group A)or conventional group(Group B).Two groups received stepped pharmacotherapy according the severity of allergic rhinitis for 4 to 8 weeks.Besides the pharmacotherapy,comprehensive treatments based on TCM constitution identification were also given to Group A.The symptoms of AR based on visual analogue scale(VAS)and medication scores(MS)in two groups were campared before the treatment and 4,8,24 weeks after the treatment.Results:Vertical comparision:the VAS and medication scores of the two groups were increased after the treatment(P<0.05).Horizontal comparision:Similar variation tendency could be observed in the two groups on the first 3 time points.24 weeks after treatment,group A was better than group B,repeated measurement analysis of variance pointed out that‘time*group’were interaction,FVAS=6.55,PVAS<0.001;FMS=5.04,PMS=0.002,which indicated a superior long term effect of VAS and medication scores in Group A than Group B.Conclusion:It shows a significant short term effect of pharma cotreatment for AR.The identification and intervention of TCM constitution takes a longer effect and could help to maintain the stable period of AR and to reduce the use of medicines due to the recurrent symptoms.