丹栀逍遥片治疗灼口综合征的临床研究

Efficacy of traditional Chinese medicine Danzhixiaoyao pills in the treatment of burning mouth syndrome

目的:采用随机对照的方法,探讨中成药丹栀逍遥片精准施治肝郁化火夹虚型灼口综合征的有效性和安全性。方法:收集2020年10月~2022年10月本院口腔黏膜科符合纳入标准的灼口综合征受试者78例。随机分为实验组和对照组,实验组给予丹栀逍遥片及甲钴胺片,对照组给予甲钴胺片。所有受试者在入组时、2周、4周及6周分别记录视觉模拟疼痛记分、焦虑抑郁量表积分、口腔健康影响程度表积分、中医证候积分和不良反应发生情况。结果:治疗后,实验组视觉模拟疼痛记分、抑郁量表、口腔健康影响程度表、中医证候积分下降更为明显(P<0.05)。而丹栀逍遥片对实验组焦虑症状的改善与对照组相似(P>0.05)。采用中、西医疗效评价体系评价结果一致,两组均有统计学差异(Z=-1.729,P<0.05;Z=-2.688,P<0.05)。两组患者均未发生不良反应。结论:采用丹栀逍遥片能有效治疗肝郁化火夹虚型灼口综合征,同时建立两个可相互印证、相互补充的中西医结合疗效评价体系以供参考。

Objective:This randomized control trail aims to evaluate the efficacy and safety of Chinese patent drug Danzhixiaoyao pills in accurately treating burning mouth syndrome.Methods:Collect a total of 78 patients from the oral mucosa department who were considered eligible from October 2020 to October 2022.The patients were randomized and divided into trial group and control group.The trail group received Danzhixiaoyao pills and mecobalamine tablets while the control group was given mecobalamine tablets.The visual analogue scale(VAS),Beck anxiety inventory(BAI),Beck depression inventory(BDI),oral health impact profile(OHIP-14),traditional Chinese medicine(TCM)syndrome integral and adverse reactions were performed at baseline and after 2,4,and 6 weeks of treatment.Results:The experimental group of patients showed a more significant decrease in visual analogue pain scores,depression inventory scores,oral health impact profile scores,and traditional Chinese medicine syndrome scores after treatment(P<0.05).However,Danzhixiaoyao pills showed similar improvement in anxiety symptoms compared to the control group(P>0.05).The evaluation results of both the traditional Chinese medicine and Western medicine efficacy assessment systems were consistent,and there were statistically significant differences between the two groups(Z=-1.729,P<0.05;Z=-2.688,P<0.05).No adverse reactions occurred in either group of patients.Conclusion:Danzhixiaoyao pills has demonstrated to have a positive effect in relieving BMS symptoms and in improving a patient’s overall quality of life.Additionally,this study establishes two integrated Chinese and Western medicine evaluation systems that can mutually corroborate and complement each other for therapeutic effects,providing a reference.