| Objective:To observe the clinical efficacy of Qinghuo-Jieyu Anshen decoction in the treatment of paroxysmal atrial fibrillation,and to provide new treatment ideas and effective prescription for clinical treatment of paroxysmal atrial fibrillation(PAF).Methods:A randomized controlled clinical trial was conducted.Thirty-six patients who met the diagnostic criteria of PAF of western medicine and TCM liver-depression and fire syndrome were randomly divided into treatment group and control group according to the random number table method,18 cases in each group.The control group was given propafenone 150mg,3 times a day;Rivaroxaban 15mg,once a day,without traditional Chinese medicine;The treatment group was treated with Qinghuojieyu Anshen Decoction(No.2)granules twice a day,one bag once on the basis of the control group.The observation period was 28 days.The changes of the frequency and time record of atrial fibrillation,AFEQT score,TCM syndrome score,TCM single symptom score and Hamilton Anxiety Scale were observed and compared between the two groups before and after treatment.Hamilton Depression Scale(HAMD),Hamilton Depression Scale(HAMA),and adverse events were recorded.Results:1 General information and baseline conditionsThere were no statistically significant differences in gender,age,and course of disease between the two groups(P>0.05).Before treatment,there were no significant differences in the number of episodes of atrial fibrillation,the time of atrial fibrillation,the quality of life score of atrial fibrillation,the TCM syndrome score,the Hamilton anxiety score and the Hamilton depression score between the two groups(P>0.05),which were comparable.2 Comparison of the number and duration of atrial fibrillation episodesAfter treatment,the number and time of atrial fibrillation attacks in the two groups were significantly lower than those before treatment,and the difference was statistically significant(P<0.05).From the point of view of the ability to reduce the number of atrial fibrillation attacks,the treatment group had better ability to reduce the number of atrial fibrillation attacks,and the difference was statistically significant(P<0.05).In terms of reducing the onset time of atrial fibrillation,the reduction degree of atrial fibrillation in the treatment group was better than that in the control group after treatment,and there was a significant statistical difference(P<0.05).The treatment group was better than the control group in reducing the number of episodes of atrial fibrillation and reducing the onset time of atrial fibrillation.3 Comparison of atrial fibrillation quality of life(AFEQT)scoresAfter treatment,the total score of AFEQT and the scores of four dimensions in the two groups were higher than those before treatment,and the differences were statistically significant(P<0.05).The total score of AFEQT,symptom score,daily activity score and the score of treatment satisfaction dimension in the treatment group were higher than those in the control group,and the differences were statistically significant(P<0.05).In the dimension of treatment focus,there was no significant statistical difference between the treatment group and the control group in the ability to improve the score of this dimension(P>0.05).The treatment group was better than the control group in improving the quality of life of atrial fibrillation,and the treatment group was better than the control group in improving the scores of symptoms,daily activities and treatment satisfaction.4 TCM syndrome score and therapeutic effect comparisonThe effective rate of TCM syndrome was 83.33%in the treatment group and 50.00%in the control group.The effective rate of the treatment group was higher than that of the control group,and the difference was statistically significant(P<0.05).The TCM syndrome scores of the two groups after treatment were significantly lower than those before treatment,and the difference between the two groups was statistically significant(P<0.05),and the degree of decline in the treatment group was more obvious,and the difference was statistically significant(P<0.05).The treatment group was better than the control group in TCM syndrome efficacy and improving TCM syndrome score.5 TCM single symptom score and therapeutic effect comparisonThe curative effect of the treatment group was higher than that of the control group in the aspects of irritability,chest tightness,shortness of breath,dry mouth and bitter mouth,insomnia,with significant statistical differences(P<0.05).In the treatment group,except for the ability to startle and easy to fear,the scores of single TCM symptom after treatment were lower than those before treatment,with statistically significant differences(P<0.05).In the control group,the single symptom score of TCM after treatment was lower than that before treatment,except for the ability to panic and fear,dry mouth,bitter mouth,constipation and yellow urine,the difference was statistically significant(P<0.05).There were significant differences in the scores of irritability,flank pain and insomnia between the treatment group and the control group(P<0.05).The results showed that both treatment methods could improve palpitation,irritability,chest tightness and shortness of breath,flank pain,fatigue and insomnia,and the treatment group was better than the control group in the improvement of irritability,flank pain and insomnia.6.Hamilton Anxiety Scale(HAMA)score and efficacy comparisonThe effective rate of HAMA score was 88.89%in the treatment group and 50.00%in the control group,and the difference was statistically significant(P<0.05).After treatment,the HAMA score of the two groups decreased significantly compared with that before treatment,with statistically significant differences(P<0.05),and the HAMA score of the treatment group decreased more significantly than that of the treatment group.The difference was statistically significant(P<0.05).This indicated that the treatment group was better than the control group in terms of HAMA score efficacy and improvement.7 Hamilton Depression scale(HAMD)score and efficacy comparisonThe HAMD score was 83.33%in the treatment group and 50.00%in the control group,and the difference was statistically significant(P<0.05).After treatment,the HAMD score of the two groups decreased significantly compared with that before treatment,and the difference was statistically significant(P<0.05),and the HAMD score of the treatment group decreased more significantly.The difference was statistically significant(P<0.05).The results showed that the treatment group was superior to the control group in the improvement of HAMD score.8 Adverse reactions were recordedThe adverse reaction time did not appear in the two groups during the experiment,indicating that the clinical application of Qinghuojieyu Anshen decoction(No.2)is safe.Conclusions:The results showed that Qinghuo-Jieyu Anshen decoction(No.2)was safe and effective in the treatment of paroxysmal atrial fibrillation with liver depression and heat disturbing the mind.Qinghuo-jieyu Anshen decoction(No.2)combined with western medication was superior to western medication alone in reducing the frequency and time of atrial fibrillation attack,improving the quality of life of atrial fibrillation,improving TCM syndromes,reducing Hamilton anxiety score and Hamilton depression score.Small sample confirmed that soothing liver and relieving depression and clearing heart and relieving restfulness were effective for the treatment of paroxysmal atrial fibrillation.Qinghuo-jieyu Anshen Decoction(No.2)was an effective prescription for the treatment of paroxysmal atrial fibrillation,which could be further promoted in clinical application. |
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