竹林汤治疗心力衰竭利尿剂抵抗的疗效：一项随机对照试验。
Effectiveness of Zhuling decoction on diuretic resistance in patients with heart failure: a randomized, controlled trial.
机构信息
Department of Cardiovascular, Taicang Hospital affiliated with Nanjing University of Traditional Chinese Medicine, Suzhou 215400, China.
Department of Cardiovascular, Changzhou Hospital affiliated with Nanjing University of Traditional Chinese Medicine, Changzhou 213003, China.
出版信息
J Tradit Chin Med. 2022 Jun;42(3):439-445. doi: 10.19852/j.cnki.jtcm.20220311.003.
OBJECTIVE
To test the effects of Zhuling decoction on patients with diuretic resistance in heart failure compared with a group of patients undergoing conventional treatment alone.
METHODS
This research was a prospective, randomized, controlled study. From July 2018 to August 2020, 96 diuretic resistance patients from the Cardiovascular Research Center of Taicang Hospital affiliated with Nanjing University of Traditional Chinese Medicine (Grade III Hospital of Traditional Chinese Medicine) were enrolled in the study. The subjects were randomly divided into an observation group (48 cases) and a control group (48 cases). Patients in both groups received conventional treatment. In addition, observation group patients received Traditional Chinese Medicine Zhuling decoction. The primary endpoint was the urine output mean difference between Day 1 and Day 7 after treatment. Secondary endpoints were the changes over time in the N-terminal pro-B type natriuretic peptide (NT-proBNP), New York Heart Association (NYHA) functional classification, and Minnesota Living with Heart Failure Questionnaire (MLHFQ). The safety and tolerability of the drug were comprehensively evaluated based on adverse drug reactions, as well as laboratory-assisted tests for liver and kidney function and electrolytes.
RESULTS
Significant improvements were demonstrated for urine output in the two groups at Day 7, with a 1325 1045 mL difference in favor of the observation group ( = 0.018). The observation group also had greater improvements in NT-proBNP and NYHA functional classification changes than the control group. At the 30th day of follow-up, a significant reduction in negative findings on the MLHFQ from baseline was observed in both groups, but the observation group demonstrated a significantly greater reduction than the control group ( <0.001).
CONCLUSIONS
Zhuling decoction could be used in combination therapy for patients with diuretic resistance in heart failure in addition to standard treatment.
目的
与单独接受常规治疗的心力衰竭患者相比，检测猪苓汤对利尿剂抵抗患者的影响。
方法
这是一项前瞻性、随机、对照研究。2018 年 7 月至 2020 年 8 月，共纳入 96 例来自南京中医药大学附属太仓医院心血管病研究中心（三级甲等中医院）的利尿剂抵抗患者。将患者随机分为观察组（48 例）和对照组（48 例）。两组患者均接受常规治疗。此外，观察组患者还服用中药猪苓汤。主要终点是治疗第 1 天和第 7 天之间的平均尿量差异。次要终点是 N 末端脑钠肽前体（NT-proBNP）、纽约心脏协会（NYHA）功能分级和明尼苏达州心力衰竭生活质量问卷（MLHFQ）的时间变化。根据不良反应以及肝肾功能和电解质的实验室辅助检查，综合评估药物的安全性和耐受性。
结果
两组患者在第 7 天的尿量均有显著改善，观察组的尿量差异为 1325 1045 mL（ = 0.018）。观察组在 NT-proBNP 和 NYHA 功能分级变化方面的改善也优于对照组。在 30 天的随访中，两组患者的 MLHFQ 评分均较基线时呈显著下降，但观察组的下降幅度明显大于对照组（ <0.001）。
结论
猪苓汤可与心力衰竭利尿剂抵抗患者的标准治疗联合使用。
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