超滤治疗急性失代偿性心力衰竭伴水钠潴留的有效性和安全性评价:一项中国注册登记研究的中期分析报告

Evaluation of the efficacy and safety of ultrafiltration in patients hospitalized with acute decompensated heart failure with water and sodium retention:An interm analysis report of the China registry study

目的利用我国的全国注册登记研究数据评价超滤治疗急性失代偿性心力衰竭(ADHF)伴水钠潴留患者的有效性和安全性。方法纳入2017年4月至2021年5月期间于全国20家医院因ADHF伴水钠潴留住院接受超滤治疗的患者,以超滤治疗后呼吸困难评分提高、体质量下降及血浆N末端B型利钠肽原(NT-proBNP)水平下降为主要有效性评价指标,以超滤治疗前后血压、心率等生命体征,血红蛋白、血钾、血钠、血肌酐等实验室指标变化为主要安全性指标,以院内病死及出院后90天内全因死亡为主要终点事件来评价超滤治疗的有效性和安全性。结果中期分析共纳入380例患者,超滤前呼吸困难评分的中位值(四分位数)为3(2,11),体质量为(71.2±17.0)kg,血浆NT-proBNP水平的中位值(四分位数)为7880(2392,21021)pg/mL。与超滤治疗前比较,超滤治疗结束时有276例患者(84.7%)呼吸困难评分提高,其中,呼吸困难评分绝对值提高>5分的有173例(53.1%);有244例(87.1%)患者的体质量下降,体质量绝对值下降>3 kg的有144例(51.4%);有141例(65.9%)患者的血浆NT-proBNP水平下降,NT-proBNP相对下降>30%有97例(45.3%)。与超滤治疗前比较,超滤治疗结束时低血压(收缩压<90 mmHg)(1 mmHg=0.133 kPa)、中重度贫血(血红蛋白<90 g/L)、高钾血症(血钾>5.0 mmol/L)、低钠血症(血钠<135 mmol/L)及中重度肾功能不全(血肌酐≥265.2μmol/L)的发生率均无显著变化(P均>0.05)。纳入分析患者的院内病死率为7.1%,存活出院患者随访90天内全因死亡率为14.2%。呼吸困难评分提高>5分及血浆NT-proBNP下降>30%患者院内病死率低于评分提高≤5分及NT-proBNP下降≤30%患者(P均<0.05),体质量下降>3 kg患者出院后随访90天全因死亡率低于体质量下降≤3 kg患者(P<0.01)。结论超滤治疗ADHF伴水钠潴留住院患者可以有效、安全地减轻体质量,改善呼吸困难评分,降低血浆NT-proBNP水平,不同有效性评价指标与终点事件的关系不同。

Objective To evaluate the efficacy and safety of ultrafiltration in patients hospitalized with acute decompenssated heart failure(ADHF)with water and sodium retention by using of data from the national registry study.Methods Patients hospitalized for ADHF with water and sodium retention in 20 hospitals in China from April 2017 to May 2021 were enrolled.The primary efficacy parameters included improvement in dyspnea score,decrease in body weight,and decrease in plasma level of N terminal-pro B-type natriuretic peptide(NT-proBNP)after ultrafiltration.The main safety indexes included the changes of vital signs such as blood pressure and heart rate,and laboratory parameters such as hemoglobin,serum level of potassium,sodium and creatinine before and after ultrafiltration.The in-hospital mortality(IHM)and all-cause death(ACD)within 90 days after discharge was regarded as the primary endpoint events.Results A total of 380 patients were included in this interim analysis.Before ultrafiltration,the median(interquartile,IQR)value of dyspnea score was 3(2,11),the body weight was(71.2±17.0)kg,and the NT-proBNP was 7880(2392,21021)pg/mL.After ultrafiltration,276(84.7%)patients showed an improvement in dyspnea score,244(87.1%)with a decrease in body weight and 141(65.9%)with a decrease in NT-proBNP,of which 173(53.1%)cases showed an absolute increase in dyspnea score of>5 points,144(51.4%)with an absolute decrease in body weight of>3 kg and 97(45.3%)with a relative decrease in NT-proBNP of>30%,respectively.There were no significant differences in the occurrence of hypotension(systolic blood pressure<90 mmHg)(1 mmHg=0.133 kPa),moderate to severe anemia(hemoglobin<90 g/L),hyperkalemia(serum potassium>5.0 mmol/L),hyponatremia(serum sodium<135 mmol/L)and moderate to severe renal insufficiency(serum creatinine≥265.2μmol/L)(all P values>0.05).The overall IHM rate of the study population was 7.1%and the rate of ACD after discharge was 14.2%during 90-day follow-up.There were significantly lower rate of IHM among patients with an absolute increase in dyspnea score of>5 points and a relative decrease in NT-proBNP of>30%than those without(both P values<0.05),while there was significantly lower rate of post-discharge ACD within 90d follow-up among patients with an absolute decrease in body weight of>3 kg than those without(P<0.01).Conclusion For hospitalized ADHF patients with water and sodium retention,ultrafiltration can effectively and safely reduce body weight,improve dyspnea score,and reduce plasma level of NT-proBNP.Moreover,there was varied relationships between different efficacy parameters and primary endpoint events.