新加丹参饮联合华法林治疗血瘀证心房颤动随机对照研究  

Efficacy and Safety of Xinjia Danshen Decoction Combined with Warfarin in the Treatment of Atrial Fibrillation with Blood Stasis Syndrome:A Randomized Controlled Trial

作　　者：赵静如 鲁成[1,2] 刘永明[1] 王慧颖[1] ZHAO Jing-ru;LU Cheng;LIU Yong-ming;WANG Hui-ying(Department of Cardiology,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,201203;Department of Cardiology,Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,200137)

机构地区：[1]上海中医药大学附属曙光医院心内科,上海201203 [2]上海中医药大学附属第七人民医院心内科,上海200137

出　　处：《中国中西医结合杂志》2023年第2期156-161,共6页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：国家自然科学基金资助项目(No.81973611,No.81102671);上海市青年科技英才扬帆计划资助(No.20YF1436800);上海市第七人民医院人才培养(No.XX2018-03,No.XX2020-04)。

摘　　要：目的探讨新加丹参饮联合华法林治疗血瘀证心房颤动的疗效和安全性。方法符合抗凝治疗适应症的持续性心房颤动且为血瘀证的患者64例,随机分为治疗组和对照组,每组各32例。治疗组予以新加丹参饮联合华法林抗凝治疗,对照组予以华法林治疗。两组疗程均为3个月,观察两组治疗前后的血瘀证候积分、血瘀证证候疗效和血栓事件的发生率,以及安全性指标(血常规、凝血功能、肝肾功能和出血事件的发生率)。结果治疗前两组血瘀证候积分比较,差异无统计学意义(P>0.05);治疗后治疗组血瘀证候积分较治疗前降低(P<0.05),且低于对照组(P<0.05)。治疗组治疗总有效率[84.38%(27/32)],高于对照组[37.50%(12/32),P<0.05]。治疗后,两组红细胞、血红蛋白、血小板、丙氨酸转氨酶、谷草转氨酶、血清肌酐值、血尿酸、凝血酶原时间、活化部分促凝血酶原激酶时间、国际标准化比值水平比较,差异无统计学意义(P>0.05);两组出血事件、血栓栓塞事件及卒中发生情况比较,差异无统计学意义(P>0.05)。结论新加丹参饮联合华法林治疗血瘀证持续性心房颤动时对患者肝肾功能、血液系统指标、总体出血事件均无明显影响,不增加肝肾负荷前提下显著改善患者中医证候。Objective To explore the efficacy and safety of Xinjia Danshen Decoction combined with warfarin in treating atrial fibrillation with blood stasis syndrome. Methods Totally 64 patients with persistent atrial fibrillation with blood stasis syndrome who met the indications of anticoagulant therapy were randomly assigned into 2 groups,the treatment group and the control group,with 32 cases in each group. The treatment group was treated with Xinjia Danshen Decoction combined with warfarin,while the control group was treated with warfarin. The course of treatment was 3 months in both groups. The scores of blood stasis syndrome,curative effect of blood stasis syndrome,incidence of thrombotic events and incidence of safety indicators(blood routine,coagulation function,liver and kidney function and bleeding events)were observed before and after treatment.Results Before treatment,there was no statistically difference in the scores of blood stasis syndrome between the 2 groups(P>0.05). After treatment,the scores of blood stasis syndrome in the treatment group was lower than that before treatment(P<0.05),and was lower than that in the control group(P<0.05). Meanwhile,the overall response rate of the treatment group [84.38%(27/32)] was higher than that of the control group [37.50%(12/32)]. Furthermore,there was no statistically significant difference between the 2 groups in the levels of red blood cells,hemoglobin,platelet,alanine aminotransferase,alanine aminotransferase,serum creatinine value,serum uric acid,prothrombin time,activated partial thromboplastin time and international normalized ratio after treatment(P>0.05). In addition,no statistically difference was found in the comparison of the occurrence of bleeding events,thromboembolic events and stroke between the 2 groups(P>0.05). Conclusion For the treatment of persistent atrial fibrillation patients with blood stasis syndrome,the modified therapeutic regimen of Xinjia Danshen Decoction combined with warfarin has no significant impact on the liver and renal functions,

关 键 词：心房颤动 新加丹参饮 血瘀证 中西医结合 

分 类 号：R541.75[医药卫生—心血管疾病]