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Article(id=1239174987861512327, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239174986137661844, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2024.04.06, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1682611200000, receivedDateStr=2023-04-28, revisedDate=null, revisedDateStr=null, acceptedDate=1699977600000, acceptedDateStr=2023-11-15, onlineDate=1773371939863, onlineDateStr=2026-03-13, pubDate=1713974400000, pubDateStr=2024-04-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773371939863, onlineIssueDateStr=2026-03-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773371939863, creator=13701087609, updateTime=1773371939863, updator=13701087609, issue=Issue{id=1239174986137661844, tenantId=1146029695717560320, journalId=1205117082300743687, year='2024', volume='43', issue='4', pageStart='241', pageEnd='320', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773371939453, creator=13701087609, updateTime=1773372128807, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1239175780396233704, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239174986137661844, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1239175780396233705, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239174986137661844, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=268, endPage=272, ext={EN=ArticleExt(id=1239174988079616140, articleId=1239174987861512327, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=Safety and efficacy of dronedarone in blanking period in patients underwent atrial fibrillation catheter ablation, columnId=1207314218647392369, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Original Article, runingTitle=null, highlight=null, articleAbstract=
AIM

To evaluate the safety and efficacy of dronedarone in the blanking period in patients underwent atrial fibrillation catheter ablation in the real-world.

METHODS

A total of 150 patients with atrial fibrillation who underwent catheter ablation at co-operative centers between May 1st, 2021 and December 31st, 2021 were included. During the blanking period, the patients were given oral dronedarone（400 mg, morning and evening）for 3 months. At 3 months ± 14 days after surgery, the patients were followed up, and 24-hour Holter, transthoracic echocardiography, liver function and renal function were reviewed. The adverse events occurred during the follow-up were recorded.

RESULTS

Compared with before surgery,there were no significant differences in heart rate, PR interval, and left ventricular ejection fraction were observed at 3 months after surgery, while QTc interval increased（（434.0±29.2）ms vs.（443.5±31.8）ms, P=0.017））. Left atrial diameter（（40.6±6.5）mm vs.（38.4±6.0）mm, P=0.007））and lower left ventricular end-diastolic diameter（（47.9±4.3）mm vs.（46.4±5.1）mm, P=0.012））decreased. Six patients discontinued in the blanking period（included high atrioventricular block in 1 patient, significant bradycardia in 2 patients, significant prolongation of the QTc interval in 1 patient, and digestive system symptoms in 2 patients）. There were no composite endpoints of cardiovascular death, heart failure or rehospitalization associated with antiarrhythmic drugs. At follow-up of 3 months, the rate of sinus rhythm maintenance was 85.3%（128/150）.

CONCLUSION

Dronedarone is safe and effective in the blanking period for patients underwent atrial fibrillation catheter ablation. Moreover, it’s good in adherence.

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目的

评估决奈达隆在心房颤动导管消融空白期应用的真实世界安全性和有效性。

方法

纳入2021年5月1日至2021年12月31日间在各合作中心接受导管消融治疗的心房颤动患者150例，空白期予口服决奈达隆片，每次400 mg，早晚各1次，持续3个月。术后3个月±14 d至门诊随访，复查24 h动态心电图、经胸心脏彩超、肝功能、肾功能等，记录随访期间发生的不良事件。

结果

与手术前相比，术后用药3个月时患者的心率、PR间期及左室射血分数无显著变化，QTc间期延长[（434.0±29.2）ms vs.（443.5±31.8）ms，P=0.017]，左房内径[（40.6±6.5）mm vs.（38.4±6.0）mm，P=0.007]及左室舒张末内径[（47.9±4.3）mm vs.（46.4±5.1）mm，P=0.012]减小。6例患者空白期内停药，包括高度房室传导阻滞1例、显著心动过缓2例、QTc间期显著延长1例及消化系统症状2例。未出现与抗心律失常药物相关的心血管死亡、心力衰竭、再住院的复合终点。术后随访3个月时，患者窦性心律维持率85.3%（128/150）。

结论

决奈达隆在心房颤动导管消融空白期应用安全、有效，依从性好。

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储慧民
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方任远，男，主治医师，硕士，主要从事心电生理与起搏的研究，E-mail: ；

储慧民，男，主任医师，硕士，主要从事心电生理与起搏的研究，E-mail:

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项目术前术后3个月差值
心率/次·min-179.5±18.778.8±17.4-0.7±0.2a
PR间期/ms157.9±27.8163.7±27.35.6±1.5a
QTc间期/ms434.0±29.2443.5±31.810.4±2.3b
左房内径/mm40.6±6.538.4±6.0-2.4±0.5b
左室舒张末内径/mm47.9±4.346.4±5.1-1.6±0.3b
左室射血分数/%63.5±6.262.7±6.4-0.9±0.2a
), ArticleFig(id=1239213769256137535, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239174987861512327, language=CN, label=表1, caption=

术前和术后3个月随访时心电图和心超指标比较

, figureFileSmall=null, figureFileBig=null, tableContent=
项目术前术后3个月差值
心率/次·min-179.5±18.778.8±17.4-0.7±0.2a
PR间期/ms157.9±27.8163.7±27.35.6±1.5a
QTc间期/ms434.0±29.2443.5±31.810.4±2.3b
左房内径/mm40.6±6.538.4±6.0-2.4±0.5b
左室舒张末内径/mm47.9±4.346.4±5.1-1.6±0.3b
左室射血分数/%63.5±6.262.7±6.4-0.9±0.2a
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决奈达隆在心房颤动导管消融空白期应用的安全性和有效性
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方任远 1 , 杜先锋 1 , 何斌 1 , 丰明俊 1 , 边昶 2 , 冷冰 3 , 王彬浩 1 , 卓伟东 1 , 周忠 1 , 李恒栋 4 , 孙汉泽 5 , 沈文均 6 , 赵乾磊 7 , 谢达奇 8 , 吴斌 9 , 储慧民 1
中国新药与临床杂志 | 论著 2024,43(4): 268-272
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中国新药与临床杂志 | 论著 2024, 43(4): 268-272
决奈达隆在心房颤动导管消融空白期应用的安全性和有效性
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方任远1 , 杜先锋1, 何斌1, 丰明俊1, 边昶2, 冷冰3, 王彬浩1, 卓伟东1, 周忠1, 李恒栋4, 孙汉泽5, 沈文均6, 赵乾磊7, 谢达奇8, 吴斌9, 储慧民1
作者信息
  • 1.宁波大学附属第一医院，浙江 宁波　315000
  • 2.浙江大学医学院附属第二医院，浙江 杭州　310003
  • 3.浙江大学明州医院，浙江 宁波　315800
  • 4.中国科学院大学宁波华美医院，浙江 宁波　315099
  • 5.慈溪市人民医院，浙江 宁波　315399
  • 6.宁波市医疗中心李惠利医院，浙江 宁波　315040
  • 7.宁波大学附属人民医院，浙江 宁波　315020
  • 8.宁波市第九医院，浙江 宁波　315032
  • 9.宁波市海曙区第二医院，浙江 宁波　315099

    • 方任远，男，主治医师，硕士，主要从事心电生理与起搏的研究，E-mail: ；

    储慧民，男，主任医师，硕士，主要从事心电生理与起搏的研究，E-mail:

通讯作者:

储慧民
Safety and efficacy of dronedarone in blanking period in patients underwent atrial fibrillation catheter ablation
Ren-yuan FANG1 , Xian-feng DU1, Bin HE1, Ming-jun FENG1, Chang BIAN2, Bing LENG3, Bin-hao WANG1, Wei-dong ZHUO1, Zhong ZHOU1, Heng-dong LI4, Han-ze SUN5, Wen-jun SHEN6, Qian-lei ZHAO7, Da-qi XIE8, Bin WU9, Hui-min CHU1
Affiliations
  • 1.The First Affiliated Hospital of Ningbo University, Ningbo ZHEJIANG 315000, China
  • 2.The Second Affiliated Hospital,Zhejiang University School of Medicine, Hangzhou ZHEJIANG 310003, China
  • 3.Zhejiang University Mingzhou Hospital,Ningbo ZHEJIANG 315800, China
  • 4.Huamei Hospital, University of Chinese Academy of Sciences, Ningbo ZHEJIANG 315099, China
  • 5.Cixi People’s Hospital, Ningbo ZHEJIANG 315399, China
  • 6.Ningbo Medical Center Lihuili Hospital,Ningbo ZHEJIANG 315040, China
  • 7.The Affiliated People’s Hospital of Ningbo University, Ningbo ZHEJIANG 315020, China
  • 8.Ningbo Ninth Hospital, Ningbo ZHEJIANG 315032, China
  • 9.The Second Hospital of Haishu District of Ningbo,Ningbo ZHEJIANG 315099, China
出版时间: 2024-04-25 doi: 10.14109/j.cnki.xyylc.2024.04.06
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摘要
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目的

评估决奈达隆在心房颤动导管消融空白期应用的真实世界安全性和有效性。

方法

纳入2021年5月1日至2021年12月31日间在各合作中心接受导管消融治疗的心房颤动患者150例，空白期予口服决奈达隆片，每次400 mg，早晚各1次，持续3个月。术后3个月±14 d至门诊随访，复查24 h动态心电图、经胸心脏彩超、肝功能、肾功能等，记录随访期间发生的不良事件。

结果

与手术前相比，术后用药3个月时患者的心率、PR间期及左室射血分数无显著变化，QTc间期延长[（434.0±29.2）ms vs.（443.5±31.8）ms，P=0.017]，左房内径[（40.6±6.5）mm vs.（38.4±6.0）mm，P=0.007]及左室舒张末内径[（47.9±4.3）mm vs.（46.4±5.1）mm，P=0.012]减小。6例患者空白期内停药，包括高度房室传导阻滞1例、显著心动过缓2例、QTc间期显著延长1例及消化系统症状2例。未出现与抗心律失常药物相关的心血管死亡、心力衰竭、再住院的复合终点。术后随访3个月时，患者窦性心律维持率85.3%（128/150）。

结论

决奈达隆在心房颤动导管消融空白期应用安全、有效，依从性好。

决奈达隆  /  心房颤动  /  射频消融术  /  抗心律失常药  /  空白期
AIM

To evaluate the safety and efficacy of dronedarone in the blanking period in patients underwent atrial fibrillation catheter ablation in the real-world.

METHODS

A total of 150 patients with atrial fibrillation who underwent catheter ablation at co-operative centers between May 1st, 2021 and December 31st, 2021 were included. During the blanking period, the patients were given oral dronedarone（400 mg, morning and evening）for 3 months. At 3 months ± 14 days after surgery, the patients were followed up, and 24-hour Holter, transthoracic echocardiography, liver function and renal function were reviewed. The adverse events occurred during the follow-up were recorded.

RESULTS

Compared with before surgery,there were no significant differences in heart rate, PR interval, and left ventricular ejection fraction were observed at 3 months after surgery, while QTc interval increased（（434.0±29.2）ms vs.（443.5±31.8）ms, P=0.017））. Left atrial diameter（（40.6±6.5）mm vs.（38.4±6.0）mm, P=0.007））and lower left ventricular end-diastolic diameter（（47.9±4.3）mm vs.（46.4±5.1）mm, P=0.012））decreased. Six patients discontinued in the blanking period（included high atrioventricular block in 1 patient, significant bradycardia in 2 patients, significant prolongation of the QTc interval in 1 patient, and digestive system symptoms in 2 patients）. There were no composite endpoints of cardiovascular death, heart failure or rehospitalization associated with antiarrhythmic drugs. At follow-up of 3 months, the rate of sinus rhythm maintenance was 85.3%（128/150）.

CONCLUSION

Dronedarone is safe and effective in the blanking period for patients underwent atrial fibrillation catheter ablation. Moreover, it’s good in adherence.

dronedarone  /  atrial fibrillation  /  radiofrequency ablation  /  anti-arrhythmia agents  /  blanking period
方任远, 杜先锋, 何斌, 丰明俊, 边昶, 冷冰, 王彬浩, 卓伟东, 周忠, 李恒栋, 孙汉泽, 沈文均, 赵乾磊, 谢达奇, 吴斌, 储慧民. 决奈达隆在心房颤动导管消融空白期应用的安全性和有效性. 中国新药与临床杂志, 2024 , 43 (4) : 268 -272 . DOI: 10.14109/j.cnki.xyylc.2024.04.06
Ren-yuan FANG, Xian-feng DU, Bin HE, Ming-jun FENG, Chang BIAN, Bing LENG, Bin-hao WANG, Wei-dong ZHUO, Zhong ZHOU, Heng-dong LI, Han-ze SUN, Wen-jun SHEN, Qian-lei ZHAO, Da-qi XIE, Bin WU, Hui-min CHU. Safety and efficacy of dronedarone in blanking period in patients underwent atrial fibrillation catheter ablation[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (4) : 268 -272 . DOI: 10.14109/j.cnki.xyylc.2024.04.06
正文
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心房颤动（atrial fibrillation，AF）是临床上最常见的心律失常，导管消融已成为当前AF的有效治疗方式。但AF消融术后3个月内可能出现心房节律及频率不稳定的情况，这段时间定义为AF消融的空白期。空白期内持续30 s以上的AF及房性心动过速发作，定义为早期复发（early recurrence）。循证医学证据表明，空白期内早期复发的发生可能与远期复发独立相关，甚至可能是AF远期复发唯一的独立预测因素[1，2]。因此，几乎所有AF指南均推荐术后空白期内使用抗心律失常药物（anti-arrhythmic drug，AAD）来控制或减少早期复发[3-5]，但往往消融术后的患者会因为各种AAD的不良反应或疗效欠佳而停药[6]，因此术后AAD的选择非常重要。其中，Ⅲ类AAD如胺碘酮因其具有广谱抗心律失常作用，而得到较为普遍的应用，但其心脏外毒性也较明显，包括导致甲状腺功能异常及肺纤维化等。
决奈达隆是新一代Ⅲ类AAD，保留了胺碘酮的药物基本结构骨架，去除了碘原子，增加了甲磺氨基，从而实现既保留胺碘酮的抗心律失常作用，又避免或减少了胺碘酮的一些不良反应。然而，目前罕有关于决奈达隆在AF消融空白期内用药安全性、有效性的研究经验，尤其真实世界数据更少。本研究是一项前瞻性、多中心、真实世界研究，观察决奈达隆在AF消融空白期应用的安全性和有效性，为广大临床医生提供借鉴。
资料与方法
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研究对象
入选2021年5月1日至2021年12月31日在宁波市第一医院、浙江大学医学院附属第二医院、宁波市李惠利医院、中国科学院大学宁波华美医院、宁波大学医学院附属人民医院、慈溪市人民医院、浙江大学明州医院住院接受导管消融治疗并在空白期服用决奈达隆的150例AF患者。入选标准：（1）年龄≥18岁；（2）符合《2020年ESC心房颤动诊断及管理指南》中对症状性、非瓣膜性AF的诊断标准[4]；（3）拟行AF导管消融（包括射频消融及球囊冷冻消融）且术后选择决奈达隆作为空白期内抗心律失常治疗药物者。排除标准：（1）先天性心脏病、瓣膜性心脏病、心绞痛、心肌梗死、心肌炎、心肌病、肺源性心脏病、严重感染、自身免疫疾病、血液系统疾病、恶性肿瘤；（2）同时合并其他缓慢性心律失常，如房室传导阻滞、病态窦房结综合征等，并出现相应临床症状，未植入心脏起搏器且无法耐受术后AAD治疗者；（3）曾行AF导管射频或球囊冷冻消融术者；（4）NYHA纽约心功能分级Ⅲ级或以上，或心脏彩超示左室射血分数≤35%者；（5）存在AF导管消融手术禁忌者，如左心房或左心耳血栓；（6）存在严重的神经系统疾病（神经系统感染等）、精神疾病（包括药物滥用、慢性酗酒等）；（7）合并严重肝功能异常（丙氨酸转氨酶或天冬氨酸转氨酶大于正常上限3倍）或肾功能异常（血清肌酐> 3.5 mg·dL-1或肌酐清除率<30 mL·min-1）。
术前准备
患者入院后采集详细病史，收集基线资料，并完善心电图、超声心动图检查，记录心率、PR间期、QTc间期、左室射血分数、左房内径及左室舒张末内径。术前48h完善经食管超声心动图，除外左心房血栓。若患者术前使用华法林抗凝，空白期不间断使用，维持国际标准化比值于2.0~3.0；若患者术前使用非维生素K拮抗剂口服抗凝药，则于术前12~24 h停药。术前禁食禁水至少8 h。
手术过程
患者深度镇静下取仰卧位，常规消毒铺巾，2%利多卡因进行局部麻醉，穿刺患者双侧股静脉，经左侧股静脉放置冠状窦电极（美国巴德公司），经右侧股静脉放置SWARTS鞘管（美国圣犹达公司），送入房间隔穿刺针行房间隔穿刺。完成房间隔穿刺后，立即静脉推注剂量100 U·kg-1的普通肝素进行肝素化，之后每1 h推注普通肝素1 000 U，使患者的活化凝血时间维持在250~300 s之间。射频消融手术在X线及三维电解剖标测系统（Carto，美国强生公司或Ensite NavX，美国雅培公司）指导下进行，完成左心房建模、肺静脉建模及双侧环肺静脉电隔离。阵发性AF患者的消融策略为肺静脉隔离，非阵发性AF患者则在此基础上加行额外线性消融。术中通过消融或同步直流电复律转复窦性心律。消融终点：左心房-肺静脉传导双向阻滞且心房程序刺激不能诱发≥30 s的快速性房性心律失常。
空白期用药方案
患者于术后第2日口服决奈达隆［石药集团欧意药业有限公司，规格为每片400 mg（按C31H44N2O5S计），国药准字H20193291］，每次400 mg，早晚各1次，持续3个月。
随访
术后3个月±14 d至门诊随访，复查12导心电图或24 h动态心电图、经胸心脏彩超、肝功能、肾功能等，记录不良事件。
终点事件
主要终点事件为AF导管消融术后空白期内应用决奈达隆期间，与AAD相关的心血管死亡、心力衰竭、再住院的复合终点；用药期间与AAD相关的不良反应。
次要终点事件包括决奈达隆首次给药至空白期内首次出现早期复发（持续30 s以上的AF或房性心动过速）的时间；术后空白期内决奈达隆的停药率，出现以下情况需要停药：心动过缓（窦性心动过缓<55次·min-1、窦性停搏、窦房阻滞）；PR间期显著延长≥280 ms；Ⅱ度或Ⅲ度房室传导阻滞；QTc间期显著延长≥500 ms；尖端扭转型室速；NYHA心功能分级≥Ⅲ级；血压低于90/60 mmHg；肝功能异常，丙氨酸转氨酶/天冬氨酸转氨酶≥120 U·L-1；肾功能异常，肌酐较使用前上升≥30%；出现胃肠道不适、皮疹等其他不良反应，患者无法耐受；药物相关不良反应需确认与决奈达隆相关。
统计学分析
运用SPSS 25.0软件建立数据库并进行统计分析，计量资料以均数±标准差表示，计数资料以率或构成比表示，决奈达隆服用前后相关指标的比较采用配对t检验，所有时间-事件变量结果以中位生存时间表示，以P < 0.05为有显著差异。
结果
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基线资料
150例患者中持续性AF 13例（8.7%）、阵发性AF 137例（91.3%），年龄为（63.9±10.3）岁，男性83例（55.3%）。AF病程为24（4，75）个月，体重指数（24.4±3.1）kg·m-2。吸烟史36例（24.0%）、饮酒史33例（22.0%），合并高血压76例（50.7%）、糖尿病22例（14.7%）、外周血管病28例（18.7%），出血病史1例（0.7%），有短暂性脑缺血发作/缺血性脑卒中病史16例（10.7%）。
服药前后患者心电图及心超指标对比
与术前相比，空白期用药后，术后3个月随访时患者的心率、PR间期及左室射血分数无显著变化，QTc间期延长［（434.0±29.2）ms vs.（443.5±31.8）ms，P = 0.017］，左房内径［（40.6±6.5）mm vs.（38.4±6.0）mm，P = 0.007］及左室舒张末内径［（47.9±4.3）mm vs.（46.4±5.1）mm，P = 0.012］减小。见表1。
随访资料
150例患者均完成术后3个月门诊随访，患者窦性心律维持率85.3%（128/150），见图1。在随访过程中未出现与AAD相关的心血管死亡、心力衰竭、再住院的复合终点；用药期间与AAD相关的心血管不良反应有心动过缓2例（1.3%）、高度房室传导阻滞1例（0.7%）、QTc间期显著延长1例（0.7%）；心外不良事件有皮肤症状3例（2.0%）、睡眠障碍2例（1.3%）、消化道症状2例（1.3%）；术后空白期内停药患者6例（停药率4%），原因包括高度房室传导阻滞1例、显著心动过缓（<50次·min-1）2例、QTc间期显著延长1例及消化系统症状2例。4例心血管不良反应病例停用决奈达隆后，相关症状缓解，后续未用其他AAD；2例出现消化系统症状的患者停用决奈达隆后症状缓解，后续改用索他洛尔稳定心律。其他出现心外不良事件患者，均以观察为主，未停药或调整用药剂量。
讨论
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胺碘酮具有“广谱”抗心律失常作用，但其心脏外毒性较明显。尽管理论上术后短期服用，绝大部分患者的耐受性良好，但多数患者往往术前就已开始服用，因此空白期内继续服用，可能会加剧药物在甲状腺的蓄积，从而引起甲状腺功能不稳定，而这本身也是其致心律失常，尤其是导致包括AF、房速在内的房性心律失常发作的重要诱因之一[7]。真实世界研究发现，在没有慢性心力衰竭病史的AF患者中，胺碘酮与包括决奈达隆、索他洛尔、普罗帕酮等AAD相比，其导致心血管事件、卒中、慢性心力衰竭的风险更高[8]。
决奈达隆为多离子通道阻滞剂，且不含碘基团，可在不影响甲状腺的同时，有效延长心房肌细胞的动作电位时程、减慢房室结传导，发挥维持窦性心律及减慢心室率的作用。EURIDIS/ADONIS研究[9]是一项多中心、安慰剂对照、随机双盲临床试验，结果发现，决奈达隆400 mg bid可使首次AF复发时间延长至116 d，基本涵盖了AF术后空白期，理论上可有效抑制早期复发，同时可使AF复发率降低25%。而在事后分析中，根据肾功能对患者进行分层后，发现在肾功能受损的患者中决奈达隆仍具有可接受的安全性[10]。而ATHENA研究[11]更证实，与安慰剂相比，决奈达隆可降低AF/房扑患者25.9%的心血管风险、29%的急性冠状动脉综合征住院风险，31%的心血管因素死亡风险及45%的心律失常致死风险。研究的事后分析显示，在包括射血分数保留的心力衰竭（HFpEF）和射血分数轻度降低的心力衰竭（HFmrEF）患者中，决奈达隆与阵发性或持续性AF/房扑和心力衰竭患者心血管事件减少相关[12]。另外，专家们还根据患者年龄和性别分层评估了决奈达隆的疗效和安全性，结果支持使用决奈达隆改善年龄≥ 65岁患者的临床预后，而不考虑男女性别[13]。一项纳入1 795例AF患者的研究显示，无论决奈达隆浓度高于或低于中位数，接受决奈达隆治疗的患者AF/房扑复发率均显著降低[14]。在德国、西班牙、意大利和美国进行的国际观察性队列研究显示，决奈达隆在预防首次AF复发方面的疗效与其他AAD的疗效相当[15]。近期基础研究发现，决奈达隆可较胺碘酮更为有效地抑制小电导钙激活型钾通道，从而更为有效地抑制慢性AF的进程[16]。
Meta分析间接对比发现，虽然胺碘酮预防AF复发的作用优于决奈达隆，但其全因死亡及需要停药的不良反应事件发生率也显著高于决奈达隆[17]。来自我国台湾省的回顾性研究显示，不管抗血栓策略如何，更长的决奈达隆服用时间与更少的心血管不良事件相关[18]。一项来自美国的回顾性队列研究显示，决奈达隆和任何新型口服抗凝药物联合使用并未增加胃肠道出血、颅内出血或其他部位出血的风险[19]。而在美国国防部军事卫生系统数据库和HealthCore综合研究数据库中进行的平行回顾性队列研究发现，决奈达隆组患者的间质性肺病风险与胺碘酮组相当或更低，与索他洛尔组相似[20]。另外，决奈达隆还可作为胺碘酮诱发甲状腺疾病AF患者的有效治疗选择[7]。
综上，决奈达隆在AF消融空白期应用安全、有效。但本研究存在部分局限性：（1）样本量较小；（2）缺乏与胺碘酮、索他洛尔或其他AAD的对比。今后，还需要更多前瞻性、大样本量的对照研究，进一步分析真实世界中决奈达隆的有效性、安全性数据，为AF患者术后制定更优化的治疗方案。
基金
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  • 浙江省医药卫生科技计划项目(2020KY821)
  • 浙江省医药卫生科技计划项目(2022KY302)
  • 宁波市科技计划项目(2022Z149)
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参考文献 引证文献
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2024年第43卷第4期
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doi: 10.14109/j.cnki.xyylc.2024.04.06
  • 接收时间：2023-04-28
  • 首发时间：2026-03-13
  • 出版时间：2024-04-25
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  • 收稿日期：2023-04-28
  • 录用日期：2023-11-15
基金
浙江省医药卫生科技计划项目(2020KY821)
浙江省医药卫生科技计划项目(2022KY302)
宁波市科技计划项目(2022Z149)
作者信息
    1.宁波大学附属第一医院，浙江 宁波　315000
    2.浙江大学医学院附属第二医院，浙江 杭州　310003
    3.浙江大学明州医院，浙江 宁波　315800
    4.中国科学院大学宁波华美医院，浙江 宁波　315099
    5.慈溪市人民医院，浙江 宁波　315399
    6.宁波市医疗中心李惠利医院，浙江 宁波　315040
    7.宁波大学附属人民医院，浙江 宁波　315020
    8.宁波市第九医院，浙江 宁波　315032
    9.宁波市海曙区第二医院，浙江 宁波　315099

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储慧民
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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