注射用益气复脉(冻干)治疗457例心力衰竭患者的临床特征分析——一项多中心真实世界研究  

Analysis of clinical characteristics of 457 patients with heart failure treated with lyophilized Yiqifumai injection:a multicenter real-world study

作　　者：刘学政[1] 史国花 王丽婕 王睿[1] 吕仕超[1] Liu Xuezheng;Shi Guohua;Wang Lijie;Wang Rui;Lyu Shichao(Department of Geriatric,the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,National Clinical Research Center for Acupuncture and Moxibustion,Tianjin 300381,China)

机构地区：[1]天津中医药大学第一附属医院老年病科,国家中医针灸临床医学研究中心,天津300381

出　　处：《中国中西医结合急救杂志》2024年第4期433-437,共5页Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care

基　　金：天津市中医药重点领域科研项目(2024002)。

摘　　要：目的基于真实世界探讨注射用益气复脉(冻干)治疗心力衰竭(心衰)患者的临床特征,为合理、规范使用注射用益气复脉(冻干)提供依据.方法选择2023年4月至11月全国81家医院收治的使用注射用益气复脉(冻干)治疗的心衰住院患者作为研究对象,收集患者的一般资料[性别、年龄、纽约心脏病学会(NYHA)心功能分级]、住院时间、用药时间,以及N末端脑钠肽前体(NT-proBNP)、左室射血分数(LVEF)和左室舒张期末内径(LVEDD)等资料,分析注射用益气复脉(冻干)治疗心衰患者的临床表现,比较不同分型心衰患者临床资料的差异.结果共收集457例心衰患者的资料,其中射血分数(EF)降低型心衰(HFrEF)96例、EF中间型心衰(HFmrEF)70例、EF保留型心衰(HFpEF)291例.HFpEF型和HFrEF型患者的NYHA以Ⅲ级为主[分别占48.1%(140/291)和54.2%(52/96)],HFmrEF型患者的NYHA以Ⅳ级为主[(41.4%(29/70)];HFmrEF型患者的平均住院时间最长,为(9.30±3.02)d,HFrEF型患者的平均住院时间最短,为(8.77±3.11)d;HFrEF型患者的平均用药时间最短,为(8.54±2.95)d,HFpEF型患者的平均用药时间最长,为(8.82±2.82)d.与治疗前比较,3种类型心衰患者治疗后血清NT-proBNP水平均明显降低[ng/L:HFrEF型为2435.00(1169.25,5607.75)比5334.00(2077.33,9108.88),HFmrEF型为2313.25(598.09,6224.67)比4559.21(1325.75,8922.75),HFpEF型为824.00(169.46,2298.75)比1265.00(215.00,3458.80),均P<0.05],其中HFrEF型治疗后NT-proBNP降低的程度最为明显;HFrEF型治疗后LVEF明显升高[0.340(0.290,0.378)比0.336(0.280,0.360),P<0.05],HFmrEF型和HFpEF型治疗前后LVEF无明显变化,差异均无统计学意义(均P>0.05);3种类型患者治疗前后LVEDD比较差异均无统计学意义(均P>0.05).结论真实世界中注射用益气复脉(冻干)治疗HFrEF型的优势更为明显,对于其他类型心衰尚需进一步的循证医学证据支撑.Objective To explore the clinical characteristics of patients with heart failure(HF)treated with lyophilized Yiqifumai injection based on real-world data,providing evidence for the rational and standardized use of Yiqifumai injection.Methods Hospitalized HF patients from 81 hospitals across China were included in this study between April and November 2023.We collected demographics information[sex,age,New York Heart Association(NYHA)functional classification],length of hospital stay,duration of medication use,and biomarkers such as N-terminal pro-brain natriuretic peptide(NT-proBNP),left ventricular ejection fraction(LVEF),and left ventricular end-diastolic diameter(LVEDD).Clinical features of HF patients treated with Yiqifumai injection were analyzed,and comparisons were made among different HF subtypes.Results A total of 457 HF patients were included:96 with heart failure with reduced ejection fraction(HFrEF),70 with HF with mildly reduced ejection fraction(HFmrEF),and 291 with HF with preserved ejection fraction(HFpEF).The majority of HFpEF type and HFrEF type patients were classified as NYHA classⅢ[48.1%(140/291)and 54.2%(52/96),respectively],while most HFmrEF type patients were classified as classⅣ[41.4%(29/70)].The longest average hospital stay was recorded in HFmrEF type patients[(9.30±3.02)days],while the shortest was recorded in HFrEF type patients[(8.77±3.11)days].The shortest average medication duration was found in the HFrEF type[(8.54±2.95)days],while the longest was observed in HFpEF type patients[(8.82±2.82)days].Serum NT-proBNP levels were significantly decreased post-treatment in all three types[ng/L:HFrEF was 2435.00(1169.25,5607.75)vs.5334.00(2077.33,9108.88),HFmrEF type was 2313.25(598.09,6224.67)vs.4559.21(1325.75,8922.75),HFpEF type was 824.00(169.46,2298.75)vs.1265.00(215.00,3458.80),all P<0.05],with the most pronounced decrease observed in the HFrEF type.LVEF was significantly improved in the HFrEF type[0.340(0.290,0.378)vs.0.336(0.280,0.360),P<0.05],while no significant changes wer

关 键 词：注射用益气复脉 心力衰竭 真实世界 

分 类 号：R541.6[医药卫生—心血管疾病]