摘要
目的 基于真实世界评价芪参益气滴丸治疗缺血性心力衰竭(IHF)的临床疗效和安全性。方法采用多中心、前瞻性队列研究设计,纳入全国84家医院的IHF患者1228例,根据患者意愿分为治疗组644例和对照组584例。两组患者均参照相关规范接受西药治疗方案,治疗组在西药治疗基础上加服芪参益气滴丸(每次0.5 g,每日3次)。两组疗程均为90天,访视点为治疗后30天、60天、90天,以美国纽约心脏病协会(NYHA)心功能分级、明尼苏达心力衰竭生存质量量表(MLHFQ)评分为主要疗效指标,以中医四诊信息积分、左室射血分数(LVEF)及复合终点事件为次要疗效指标,并采用安全性数据集分析两组患者治疗期间不良事件的发生情况。结果 治疗组最终纳入分析641例,对照组584例。治疗后30天治疗组与对照组NYHA心功能分级总有效率分别为50.55%(324例/641例)与35.10%(205例/584例),治疗后60天分别为58.66%(376例/641例)与40.07%(234例/584例),治疗后90天分别为71.45%(458例/641例)与48.63%(284例/584例),治疗组NYHA心功能分级总有效率均高于对照组(P<0.01);采用Logistic回归分析校正基线中潜在混杂因素后,结果显示加载芪参益气滴丸可明显提高患者NYHA心功能分级疗效(P<0.01)。治疗后30、90天时两组MLHFQ评分均较本组治疗前降低(P<0.01),且治疗后90天治疗组MLHFQ评分明显低于对照组(P<0.01);经多重线性回归分析校正基线中潜在混杂因素后,结果显示加载芪参益气滴丸可明显改善患者MLHFQ评分(P<0.01)。治疗前治疗组患者中医四诊信息积分高于对照组、LVEF低于对照组(P<0.05);治疗后两组中医四诊信息积分均降低、LVEF均提高(P<0.01),且治疗组中医四诊信息积分明显低于对照组(P<0.01)。治疗组发生复合终点事件患者20例(3.12%),对照组27例(4.62%),两组复合终点事件发生率比较差异无统计学意义(P>0.05);研究过程中治疗组发生不良事件36例、�
Objective To evaluate the clinical effectiveness and safety of Qishen Yiqi Dripping Pill(芪参益气滴丸,QYDP)in the treatment of ischemic heart failure(IHF)based on a real-world study.Methods In this prospective cohort study,1,228 IHF patients from 84 hospitals across the country were enrolled,and they were divided into treatment group(644 cases)and control group(584 cases)according to patients’preference.Both groups received western medicine as required by the guidelines,and the treatment group was additionally administered with QYDP,0.5 g each time,three times per day.The course of treatment for both groups was 90 days.The follow-up time was 30days,60 days,and 90 days after enrollment.The primary outcomes were New York Heart Association(NYHA)functional class and Minnesota Living with Heart Failure Questionnaire(MLHFQ)score.The secondary outcomes were the scores of the four examinations information in traditional Chinese medicine(TCM),left ventricular ejection fraction(LVEF),and composite endpoint events.The safety data set was used to analyze the occurrence of adverse events in the two groups during treatment.Results A total of 641 cases in the treatment group and 584 cases in the control group were included in the analysis.When measured 30 days,60 days and 90 days after enrollment,the total effective rates regarding NYHA functional class in the treatment group and control group were 50.55%(324/641)versus35.10%(205/584)(P<0.01),58.66%(376/641)versus 40.07%(234/584)(P<0.01),and 71.45%(458/641)versus 48.63%(284/584)(P<0.01),respectively.Logistic regression analysis was used to correct for potential confounding factors at baseline,and the results showed that the addition of QYDP significantly improved the total effective rate regarding NYHA functional class(P<0.01).At 30 days and 90 days after enrollment,the MLHFQ scores of both groups significantly decreased as compared with those before treatment(P<0.01),and lower score was found in the treatment group than in the control group after 90 days treatment(P<0.
作者
王帅
赵志强
王贤良
阎小妍
钟成梁
尚美霞
王聪
林姗姗
胡思源
毛静远
张伯礼
WANG Shuai;ZHAO Zhiqiang;WANG Xianliang;YAN Xiaoyan;ZHONG Chengliang;SHANG Meixia;WANG Cong;LIN Shanshan;HU Siyuan;MAO Jingyuan;ZHANG Boli(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin,300381;Peking University Clinical Research Institute;Peking University First Hospital;Tianjin University of Traditional Chinese Medicine)
出处
《中医杂志》
CSCD
北大核心
2022年第7期635-643,共9页
Journal of Traditional Chinese Medicine
基金
国家中医药管理局中医药循证能力建设项目(2019XZZX-XXG007)
国家中医药管理局中医药行业科研专项(201007001-02)
教育部创新团队发展计划(IRT_16R54)。
关键词
缺血性心力衰竭
芪参益气滴丸
心功能
生存质量
队列研究
ischemic heart failure
Qishen Yiqi Dripping Pill(芪参益气滴丸)
cardiac function
quality oflife
cohort study