| ObjectiveThis study investigated the clinical efficacy,TCM syndrome efficacy,long-term efficacy and safety of Qingyang decoction in the treatment of recurrent oral ulcer(Cold-heat Complicated Syndrome),providing reference for TCM treatment of recurrent oral ulcer.Methods64 patients who met the inclusion criteria were randomly divided into treatment group and control group by "random number table".All patients stopped taking other drugs 2 weeks before the trial.The treatment group was given Qingyang decoction orally,which increased and decreased according to the disease.Swallow it with gargle in oral cavity for 30 seconds,one dose daily,divided into two times.The control group was given Jinhoujian spray,3 times a day,each time appropriate amount,sprayed on the affected area.Both groups were treated for 2 courses(14 days)with 7 days as a course.Baseline,clinical efficacy,TCM syndrome efficacy,quantitative index of local lesions,ulcer pain index,degree of oral ulcer affecting quality of life,TCM syndrome score,ulcer period,anxiety level,oral ulcer recurrence,drug irritation and drug safety were observed and recorded in the two groups.SPSS26.0 was used for statistical analysis of the recorded data after the observation.Results1.Compared the two groups before treatment of gender,age,ROU total duration,average ulcer ulcer days,before the doctor always period,number of previous 3 months ulcer recurrence,disease classification quantitative table score,pain score,oral ulcer,the degree of quality of life,before treatment of TCM syndrome integral,Hamilton anxiety rating scale,had no statistical difference(P > 0.05).2.Comparison of clinical efficacy on the fifth day of treatment: the total effective rate of the treatment group was 96.8%,and the total effective rate of the control group was 80.6%.The treatment group was superior to the control group,with significant difference(P<0.01).3.Comparison of quantified scores of disease lesions on the fifth day of treatment: there were significant differences in the quantified total scores of disease lesions and individual scores of various local lesions between the two groups before and on the fifth day of treatment(P<0.01).There were statistically significant differences in total score,ulcer area,ulcer number,hyperemia degree,edema degree and burning sensation between the two groups(P<0.05),and the treatment group was superior to the control group.There was no statistical difference in the degree of exudation and ulcer pain(P>0.05).4.Comparison of scores of oral ulcer affecting quality of life: there were significant differences in the four dimensions of pain,physical dysfunction,psychological dysfunction and social dysfunction as well as the total scores of oral ulcer affecting quality of life before and on the fifth day of treatment between the two groups(P<0.01).On day 5 of treatment,there were no significant differences in pain and social disability between the two groups(P>0.05).There were significant differences in the mental dysfunction dimension and the total score of oral ulcer affecting quality of life(P<0.01),and the treatment group was better than the control group.There was statistical difference in physiological dysfunction dimension(P<0.05),and the treatment group was superior to the control group.5.Comparison of VAS pain index scores: VAS pain index scores of the two groups at1/3/5/7/9 days of treatment were compared.On the 1st and 3rd days of treatment,VAS scores of the treatment group and the control group were significantly different(P<0.01),and the treatment group was lower than the control group.The VAS scores of the treatment group and the control group showed no significant difference on the 5th and 7th day of treatment,and the VAS scores of all patients in the two groups were 0 on the 9th day of treatment.There was statistical difference in the duration of ulcer pain between the two groups after treatment(P<0.05),and the duration of ulcer pain in the treatment group was shorter.6.Comparison of ulcer period: there was significant difference between the average ulcer period in the past and the current ulcer period in the two groups(P<0.01),indicating that both the treatment group and the control group could promote ulcer healing and effectively shorten the ulcer period.There was a significant difference between the two groups in ulcer period(P<0.01),and the ulcer healing time in the treatment group was shorter than that in the control group.7.Evaluation and comparison of curative effect of TCM syndromes after treatment: the curative effect of TCM syndromes after treatment was compared between the two groups,and the treatment group was superior to the control group,with significant difference(P<0.01).8.Comparison of TCM syndrome scores: TCM syndrome scores before and after treatment were compared between the two groups.There were significant differences in the total TCM syndrome scores and single TCM symptom scores before and after treatment in the treatment group(P<0.01).In the control group,there were significant differences in the total score of TCM syndromes and single score of dry mouth and bitter mouth before and after treatment(P<0.01),statistical differences in epigastric discomfort,upset and insomnia(P<0.05),and no statistical differences in stool situation,chills and cold limbs,fatigue and fatigue(P>0.05).There were significant differences in TCM syndrome score,total TCM syndrome score and single TCM sub-syndrome score after treatment between the two groups(P<0.01),and the improvement effect of the treatment group was better than the control group.9.Comparison of anxiety level: The anxiety level of the two groups was compared after treatment,and the treatment group was lower than the control group,with significant difference(P<0.01).There was no significant difference in anxiety level before and after treatment in the control group(P>0.05).10.Comparison of long-term efficacy: the recurrence rate of the two groups within 3months after treatment was compared,the recurrence rate of the treatment group was 61.3%,and the recurrence rate of the control group was 100%.There was significant difference in the recurrence rate of the two groups within 3 months after treatment(P<0.01).The recurrence times of 3 months before and after treatment were compared between the two groups.The recurrence times of 3 months before and after treatment in the treatment group were significantly different(P<0.01),and the recurrence times of 3 months after treatment were significantly reduced in the control group,while there was no statistical difference in the recurrence times of 3 months before and after treatment in the control group(P>0.05).11.Comparison of the irritation of ulcer mucosa: there were significant differences in the irritation of ulcer mucosa between the two groups(P<0.01),and the irritation of drugs in the control group was stronger.12.Safety of clinical study: No adverse events occurred in the treatment group and the control group.It is suggested that the two groups are safe for clinical use.Conclusion1.Qingyang decoction has clinical efficacy,TCM syndrome efficacy and long-term efficacy in the treatment of recurrent oral ulcer(Cold-heat Complicated Syndrome).2.Both Qingyang decoction and Jinhoujian can effectively shorten the ulcer period of recurrent oral ulcer,relieve the symptoms of local lesions and relieve pain,and the effect of Qingyang decoction is better than That of Jinhoujian.Qingyang decoction can effectively improve the systemic symptoms of patients with cold and heat syndrome,and its effect is better than That of Jinhoujian spray.Qingyang decoction can improve patients’ anxiety state and reduce the frequency of recurrent oral ulcer.3.The stimulation of Qingyang decoction for oral ulcer is lower than that of Jinhoujian. |
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