摘要
目的 评价炙甘草汤加味颗粒预防心房颤动(简称房颤)气阴两虚型患者射频消融术后早期复发的临床疗效及安全性。方法 采用多中心、随机、双盲、安慰剂对照试验研究设计,纳入3个中心首次行射频消融术的房颤气阴两虚型患者116例,随机分为治疗组59例和对照组57例。两组患者术后均给予西医基础治疗,治疗组再同时给予炙甘草汤加味颗粒口服,对照组同时给予炙甘草汤加味安慰剂颗粒口服,均每次20 g,每日2次,连续治疗12周。记录两组患者术后24 h、术后4周、术后8周、术后12周时复发情况,治疗前及治疗12周后检测两组患者血清B型利钠肽(BNP)、白细胞介素6(IL-6)、超敏C反应蛋白(hs-CRP)、肿瘤坏死因子α(TNF-α)水平,治疗前及治疗4周、8周、12周后比较房颤对生活质量影响(AFEQT)量表评分(包括日常生活维度积分、症状维度积分、治疗担心维度积分、治疗满意度维度积分及总积分)和中医证候积分。治疗前后进行血常规、尿常规、肝功能、肾功能等安全性指标的检测。结果 治疗组脱落9例,对照组脱落7例,最终治疗组与对照组各50例纳入统计分析。术后24h、术后4周、术后8周、术后12周时,治疗组复发率分别为2.0%(1/50)、2.0%(1/50)、4.0%(2/50)、10.0%(5/50),对照组分别复发2.0%(1/50)、26.0%(13/50)、28.0%(14/50)、34.0%(17/50)。与对照组同时间比较,治疗组术后4周、8周和12周时房颤早期复发率均明显降低(P<0.01)。与本组治疗前比较,治疗组治疗12周后血清BNP、hs-CRP、IL-6、TNF-α水平均降低(P<0.05);治疗组hs-CRP治疗前后差值高于对照组(P<0.01)。与本组治疗前比较,两组患者在治疗4周、8周、12周后AFEQT总积分、日常生活维度积分、治疗担心维度积分、症状维度积分及中医证候积分均降低,治疗满意度维度积分均升高(P<0.01),且治疗组各积分在各时间点改善优于对照组(P<0.05或P<0.01)。两组患者治疗前后各安全性指标均处于正常值范围内,未出现不良反应和不良事件。结论 炙甘草汤加味颗粒可以降低房颤气阴两虚型患者射频消融术后的早期复发率,改善临床症状及生活质量,抑制炎症反应,且安全性良好。
Objective To evaluate the clinical effectiveness and safety of Modified Zhigancao Granules(炙甘草汤加味颗粒)for preventing the early recurrence following radiofrequency ablation in patients with atrial fibrillation(AF)of qi-yin deficiency syndrome.Methods A multi-center,randomized,double-blind,placebo-controlled trial was designed.A total of 116 patients with atrial fibrillation of qi-yin deficiency syndrome who underwent radiofrequency ablation for the first time were enrolled from 3 centers,and they were randomly divided into a treatment group(59 cases)and a control group(57 cases).Both groups received basic western medicine treatment after surgery.In addition,the treatment group was given oral Modified Zhigancao Granules,while the control group was given oral placebo granules.The dosage for both groups was 20 g each time,twice a day,with continuous treatment for 12 weeks.The recurrence of atrial fibrillation in both groups was recorded at 24 hours,4 weeks,8 weeks,and 12 weeks after surgery.The serum levels of B-type natriuretic peptide(BNP),interleukin-6(IL-6),high-sensitivity C-reactive protein(hs-CRP),and tumor necrosis factor-α(TNF-α)were detected before treatment and 12 weeks after treatment in both groups.The scores of Atrial Fibrillation Effect on QualiTy-of-life(AFEQT)Questionnaire(including scores of the daily life dimension,symptom dimension,treatment worry dimension,treatment satisfaction dimension,and total score)and traditional Chinese medicine(TCM)syndrome scores were compared before treatment and at 4 weeks,8 weeks,and 12 weeks between groups.Safety indicators such as blood routine,urine routine,liver function,and renal function were monitored before and after treatment.Results Nine of the treatment group and seven of the control group dropped out.Finally,50 patients in each group were included in the statistical analysis.At 24 hours,4 weeks,8 weeks,and 12 weeks after surgery,the recurrence rates of AF in the treatment group were 2.0%(1/50),2.0%(1/50),4.0%(2/50),and 10.0%(5/50),respectively;while those in the control group were 2.0%(1/50),26.0%(13/50),28.0%(14/50),and 34.0%(17/50),respectively.Compared with the control group at the same time points,the early recurrence rates of AF in the treatment group were significantly lower at 4 weeks,8 weeks,and 12 weeks after surgery(P<0.01).Compared with the baseline within group,BNP,hs-CRP,IL-6,and TNF-αin the treatment group all decreased after 12 weeks of treatment(P<0.05);the difference in hs-CRP levels(before vs.after treatment)in the treatment group was higher than that in the control group(P<0.01).Compared with the baseline within group,both groups showed decreases in the total score of AFEQT Questionnaire,scores of the daily life dimension,treatment worry dimension,symptom dimension,and TCM syndrome scores at 4 weeks,8 weeks,and 12 weeks after treatment.Meanwhile,the score of the treatment satisfaction dimension of AFEQT increased in both groups(P<0.01),and the improvements in all the above scores in the treatment group were superior to those in the control group at all time points(P<0.05 or P<0.01).All safety indicators of patients in both groups were within the normal range before treatment and at 12 weeks after treatment,and no adverse reactions or adverse events occurred in either group.Conclusion Modified Zhigancao Granules can reduce the early recurrence rate following radiofrequency ablation in AF patients with qi-yin deficiency syndrome,improve clinical symptoms and quality of life,suppress inflammatory response,and show good safety.
作者
胡宇才
邱伯雍
卫靖靖
李彬
邢作英
彭慧霞
朱明军
王永霞
ZHONG Shuai;JIANG Ping;ZHAO Xiaohu;LIU Yuan;TIAN Xuanhe(First Clinical Medical College,Shandong University of Traditional Chinese Medicine,Jinan,250014;Affiliated Hospital of Shandong University of Traditional Chinese Medicine)
出处
《中医杂志》
北大核心
2025年第23期2460-2466,共7页
Journal of Traditional Chinese Medicine
基金
2023年度河南省国家中医药传承创新中心科研专项(2023ZXZX1028)
河南省中医学“双一流”创建学科中医学科学研究专项(HSRP-DFCTCM-2023-3-10)
河南省二〇二五年科技发展计划(252102311252)。
关键词
心房颤动
射频消融术
早期复发
气阴两虚
炙甘草汤
生活质量
炎症反应
atrial fibrillation
radiofrequency ablation
early recurrence
deficiency of both qi and yin
Zhigancao Decoction(炙甘草汤)
quality of life
inflammatory response
