参龙定悸方对阵发性房颤气阴两虚、痰瘀阻络型患者生活质量的影响  

Effect of Shenlong Dingji Formula(参龙定悸方)on the Quality of Life in Patients with Paroxysmal Atrial Fibrillation of Qi-Yin Deficiency and Phlegm-Stasis Obstructing Collaterals Syndrome

作　　者：马梁 王保福 丁宇坤 王显[1,2] MA Liang;WANG Baofu;DING Yukun;WANG Xian(Beijing University of Chinese Medicine,Beijing,100029;Dongzhimen Hospital,Beijing University of Chinese Medicine;China-Japan Friendship Hospital;Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine)

机构地区：[1]北京中医药大学,北京100029 [2]北京中医药大学东直门医院 [3]中日友好医院 [4]北京市丰台中西医结合医院

出　　处：《中医杂志》2025年第1期42-49,共8页Journal of Traditional Chinese Medicine

基　　金：国家中医药管理局高水平中医药重点学科建设项目(zyyzdx-2023259)。

摘　　要：目的观察参龙定悸方对阵发性房颤(PAF)气阴两虚、痰瘀阻络型患者生活质量的影响与安全性。方法收集PAF气阴两虚、痰瘀阻络型患者60例,随机分为治疗组与对照组各30例。对照组予以西医基础治疗,治疗组在对照组基础上口服参龙定悸方,每日1剂。两组均治疗4周。主要结局指标为房颤特异性生活质量(AFEQT)量表积分,包括房颤相关症状、治疗担心、日常生活及治疗满意度4个维度积分;次要结局指标包括有症状性房颤发作频率及持续时间、中医证候积分(包括心悸、胸闷、疲乏、气短、懒言、自汗、刺痛、失眠评分)。以上指标分别于治疗前、治疗2周后、治疗4周后、给药结束后4周(随访时)各评价1次,并记录治疗前后安全性指标及试验过程中不良事件的发生情况以评价安全性。结果共有56例患者完成试验,两组各28例。主要结局指标:1)治疗组治疗2周后、治疗4周后及随访时AFEQT量表积分较前一时间点均明显升高,且治疗2周后、治疗4周后及随访时均高于治疗前(P<0.05)。对照组仅治疗4周后与治疗前比较明显升高(P<0.05)。治疗组治疗2周后、治疗4周后、随访时AFEQT量表积分均高于对照组同时间(P<0.01)。2)治疗组随访时AFEQT量表治疗满意度维度积分较治疗4周后差异无统计学意义(P>0.05),其余各维度积分每个时间点均高于前一时间点(P<0.05)。对照组治疗2周后、治疗4周后房颤相关症状维度积分均高于前一时间点(P<0.05),治疗满意度维度中仅在治疗2周后、治疗4周后较治疗前有明显升高(P<0.05)。次要结局指标:1)治疗组除持续时间在随访时较治疗4周后无明显降低(P>0.05),其余各时间点治疗组有症状性房颤发作频率和持续时间均较前一时间点明显降低(P<0.05)。对照组发作频率在各时间点均较治疗前有明显降低(P<0.05),持续时间则在随访时较治疗2周后明显降低(P<0.05)。2)治疗组Objective To explore the effectiveness and safety of Shenlong Dingji Formula(参龙定悸方)on the quality of life in patients with paroxysmal atrial fibrillation(PAF)of qi-yin deficiency and phlegm-stasis obstructing collaterals syndrome.Methods A total of 60 patients with PAF of qi-yin deficiency and phlegm-stasis obstructing collaterals syndrome were recruited and randomly divided into a treatment group and a control group,with 30 patients in each group.The control group received standard western medicine treatment,while the treatment group was additionally given Shenlong Dingji Formula orally,one dose per day.Both groups were treated for 4 weeks.The primary outcome measure is the Atrial Fibrillation Effect on Quality of Life(AFEQT)score including scores of four dimensions,i.e.atrial fibrillation-related symptoms,treatment concerns,daily activities,and treatment satisfaction.The secondary outcome measures included the frequency and duration of symptomatic atrial fibrillation episodes and traditional Chinese medicine(TCM)syndrome scores covering symptoms such as palpitations,chest tightness,fatigue,shortness of breath,reluctance to speak,spontaneous sweating,stabbing pain,and insomnia.These indicators were assessed at baseline(before treatment),after 2-week of treatment,after 4-week of treatment,and 4 weeks after the end of treatment(follow-up).Additionally,safety indicators before and after treatment and adverse events occurring during the trial were recorded to evaluate safety.Results A total of 56 patients completed the study,with 28 in each group.Primary outcome indicators:1)the treatment group showed significant improvement in the total score of the AFEQT scale,with significantly higher total scores after 2-week treatment,4-week treatment,and follow-up compared to the previous time point(P<0.05).In the control group,the AFEQT score significantly increased only after 4-week treatment compared to baseline(P<0.05).In the treatment group,the AFEQT scores after 2-week,4-week treatment,and during follow-up were

关 键 词：阵发性房颤 生活质量 络风内动 气阴两虚 痰瘀阻络 参龙定悸方 

分 类 号：R259[医药卫生—中西医结合]