疏肝定悸颗粒治疗阵发性房颤肝郁气滞证的临床研究OA

Objective To observe the clinical efficacy and safety of Shugan Dingji Granules for treating paroxysmal atrial fibrillation(AF)with liver qi stagnation syndrome.Methods A randomized controlled trial was conducted.Patients with paroxysmal AF with liver qi stagnation syndrome admitted to the outpatient department or ward of the Cardiology Department of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from March 2023 to November 2023 were randomly divided into experimental and control groups.Each group included 40 patients after screening using the inclusion and exclusion criteria.A total of 80 patients(including seven excluded cases)were enrolled.The experimental group was treated with Shugan Dingji Granules,and the control group was treated with Western medicine.Both groups were treated for 4 weeks.The frequency and duration of AF,24-hour Holter electrocardiogram,traditional Chinese medicine(TCM)syndrome score,AF Effect on Quality-of-life(AFEQT)score,safety indicators,and TCM/Western medicine efficacy outcomes were evaluated before and after medication.Results Before treatment,no significant differences were observed in the baseline data of the two groups,making them comparable.The frequency and duration of AF in the experimental group decreased after treatment compared with before treatment(P＜0.01),and also decreased compared with the control group after treatment(P＜0.05).In a 24-hour ambulatory electrocardiogram,the average heart rate in the experimental group decreased after treatment compared with the control group after treatment(P＜0.05);the fastest heart rate showed no significant differences within and between groups after treatment.The slowest heart rate in the experimental group increased after treatment compared with before treatment(P＜0.01);however,no significant difference was observed between groups;the heart rate fluctuation range in the experimental group decreased after treatment compared with before treatment(P＜0.01).Although the reduction was greater than that in the control group,no significant difference was observed between groups;the sinus rhythm maintenance rate in the experimental group increased after treatment compared with before treatment(P＜0.01);however,no significant difference was noted compared with the control group after treatment.The total score of TCM syndrome in both groups decreased after treatment compared with before treatment(P＜0.01),and the score in the experimental group decreased more than that in the control group after treatment(P＜0.01).The AFEQT score in the experimental group decreased after treatment compared with before treatment(P＜0.01),and also decreased compared with the control group after treatment(P＜0.05).No significant differences were observed in safety indicators within and between groups before and after treatment.The total effective rates of TCM and Western medicine were 62.2%and 30.6%in the experimental and control groups,respectively,for Western medicine,and 86.5%and 47.2%,respectively,for TCM.The experimental group was superior to the control group regarding both(P＜0.05).Conclusion Shugan Dingji Granules reduce the frequency and duration of AF,and improve the quality of life of patients by improving depression and anxiety.