| Background:Atrial fibrillation(AF)is one of the most common arrhythmia diseases worldwide,and paroxysmal atrial fibrillation(PAF)is a common type of atrial fibrillation,with a prevalence rate of 1-2%in the general population,seriously endangering people’s lives and health.Although anti-arrhythmic drugs(AADs)and surgical treatment can effectively treat atrial fibrillation attacks,there is still room for development in alleviating other related symptoms,improving daily life quality,and long-term recurrence of atrial fibrillation in patients.Traditional Chinese medicine has a long history of treating atrial fibrillation and has significant effects,making it one of the effective solutions to such problems.Paroxysmal atrial fibrillation belongs to the category of "palpitations" in traditional Chinese medicine according to its clinical manifestations.It has the characteristics of occasional onset and cessation,susceptibility to external environmental influences,and a variety of comorbidities,which is in line with the pathogenic factors of "wind" in traditional Chinese medicine.Based on Professor Wang Xian’s theory of "internal movement of collateral wind" and combined with the clinical manifestations of paroxysmal atrial fibrillation,our team has concluded that"internal movement of collateral wind" is an important factor in the pathogenesis of paroxysmal atrial fibrillation,while "phlegm and blood stasis are intertwined and qi yin deficiency" is the pathological basis for the occurrence of paroxysmal atrial fibrillation.Based on the above,a new treatment principle and method for relieving paroxysmal atrial fibrillation is proposed,which includes "dispelling wind and clearing collaterals,resolving phlegm and blood stasis,supplementing qi and nourishing yin".Therefore,the " Shen Long Ding Ji Formula." is established to treat patients with paroxysmal atrial fibrillation of qi yin deficiency and phlegm stasis obstructing collaterals.Objective:This study focuses on patients with paroxysmal atrial fibrillation of qi yin deficiency and phlegm stasis obstruction syndrome,and explores the effectiveness and safety of Shen Long Ding Ji Formula in treating paroxysmal atrial fibrillation.At the same time,it provides a preliminary research basis for further clinical and basic experiments on the treatment of atrial fibrillation with Shen Long Ding Ji Formula.Method:This study is a pathological controlled study that included patients with paroxysmal atrial fibrillation of qi yin deficiency and phlegm stasis obstruction type who visited or were hospitalized in the cardiology department of Dongzhimen Hospital from September 2021 to December 2022.They were randomly divided into an experimental group and a control group in a 1:1 ratio.The control group was treated with basic drugs,while the experimental group was treated with Shenlong Dingzhe Formula on the basis of the control group,for a total of 4 weeks.Collect clinical baseline data and relevant information for the start of the trial,2 weeks,4 weeks,and 1 month follow-up of two groups of patients.The main outcome measure was the score of the atrial fibrillation effect on quality of life(AFEQT)scale for patients with atrial fibrillation.The secondary outcome measure was the frequency and time of symptomatic atrial fibrillation attacks,and the score of traditional Chinese medicine symptoms.Safety indicators before and after treatment were collected.Compare the relevant evaluation indicators and safety differences within and between two groups of patients,and explore the efficacy and safety of Shen Long Ding Ji Formula.Result:During the period from September 2021 to December 2022,a total of 60 eligible subjects and 4 dropouts were collected.Finally,56 patients were included in the data statistical study,including 28 in the control group and 28 in the experimental group.1.There was no statistically significant difference(P>0.05)in baseline information between the two groups of patients,including gender,age,vital signs,duration of atrial fibrillation,smoking and drinking history,comorbidities,and basic drug treatment,indicating comparability.2.AFEQT score:Both groups of patients showed improvement in their quality of life after the whole experiment,with the improvement in the experimental group being better than that in the control group(P<0.05).In terms of total points,the experimental group was superior to the control group(72.16 ± 6.68 vs 44.05 ± 9.76,P<0.05).In terms of atrial fibrillation symptoms,the experimental group was superior to the control group(83.78 ± 9.31 vs 55.65±11.01,P<0.05).In terms of treatment anxiety,the experimental group was superior to the control group(63.89 ± 11.64 vs 41.17 ± 14.39,P<0.05).In terms of daily life,the experimental group was superior to the control group(72.54± 9.84 vs 40.40±11.65,P<0.05).In terms of treatment satisfaction,the experimental group was superior to the control group(63.12±7.67 vs 36.60±13.10,P<0.05);3.Frequency and duration of symptomatic atrial fibrillation attacks:After the whole treatment,the frequency and duration of attacks in both groups of patients decreased,and the experimental group was better than the control group(P<0.05);Traditional Chinese Medicine Syndrome Score:Both groups of patients showed improvement in traditional Chinese medicine syndrome after the experiment,but the improvement in the experimental group was better than that in the control group(P>0.05).In terms of total points of traditional Chinese medicine syndromes,the experimental group was superior to the control group(7.39±0.567 vs 20.46±0.725,P<0.05).4.Traditional Chinese Medicine Syndrome Score:Both groups of patients showed improvement in traditional Chinese medicine syndrome after the experiment,but the improvement in the experimental group was better than that in the control group(P<0.05).In terms of total points of traditional Chinese medicine syndromes,the experimental group was superior to the control group(7.39 ± 0.567 vs 20.46 ± 0.725,P<0.05).In terms of various traditional Chinese medicine syndromes,the experimental group showed better results than the control group in terms of palpitations,chest tightness,fatigue,shortness of breath,lazy speech,tingling,spontaneous sweating,insomnia,and tongue symptoms after the experiment(P<0.05).However,there was no significant difference in pulse score between the two groups after treatment(P>0.05);5.Safety evaluation indicators:There were no adverse events before and after treatment in the two groups of patients,and there was no statistical difference in blood,urine,stool routine,liver and kidney function,and ion before and after treatment(P>0.05).Conclusion:The treatment of patients with paroxysmal atrial fibrillation caused by deficiency of both qi and yin and obstruction of phlegm and blood stasis with Shen Long Ding Ji Formula can significantly improve their quality of life and traditional Chinese medicine syndrome,and to a certain extent,reduce the occurrence of paroxysmal atrial fibrillation. |
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