主 办:北 京 中 医 药 大 学
ISSN 1006-2157 CN 11-3574/R

北京中医药大学学报 ›› 2021, Vol. 44 ›› Issue (3): 272-279.doi: 10.3969/j.issn.1006-2157.2021.03.013

• 临床研究 • 上一篇    下一篇

络风宁2号方对慢性心衰利尿剂抵抗患者临床疗效及安全性观察*

杨雪卿1, 王显2#   

  1. 1 北京中医医院顺义医院心血管内科 101300;
    2 北京中医药大学东直门医院
  • 收稿日期:2020-10-08 出版日期:2021-03-30 发布日期:2021-03-30
  • 通讯作者: #王显,男,博士,教授,主任医师,博士生导师,主要研究方向:介入心脏病学与中医药,E-mail:wx0515@hotmail.com
  • 作者简介:杨雪卿,女,博士,主治医师
  • 基金资助:
    *国家自然科学基金面上项目(No.82074263),北京市属医院科研培育计划项目(No.PZ2019025)

Clinical efficacy and safety observation of Luofengning Formula II Granules in the treatment of patients with chronic heart failure and diuretic resistance*

Yang Xueqing1, Wang Xian2#   

  1. 1 Department of Cardiovascular Medicine, Beijing Hospital of Traditional Chinese Medicine in Shunyi, Beijing 101300, China;
    2 Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
  • Received:2020-10-08 Online:2021-03-30 Published:2021-03-30
  • Contact: Prof. Wang Xian, Ph.D., Chief Physician, Doctoral Supervisor. Dongzhimen Hospital, Beijing University of Chinese Medicine. No.5 Haiyuncang Street, Dongcheng District, Beijing 100700. E-mail: wx0515@hotmail.com
  • Supported by:
    National Natural Science Foundation of China (No. 82074263), Research Cultivation Program of Beijing Municipal Hospitals (No.PZ2019025) Ethical review: Medical Ethics Committee of Beijing Hospital of Traditional Chinese Medicine in Shunyi (No.2019SYKY12-01)

摘要: 目的 观察络风宁2号方对慢性心衰利尿剂抵抗患者的临床疗效及安全性。方法 将70例慢性心衰合并利尿剂抵抗患者随机分为治疗组35例,对照组35例。应用24 h尿量、体质量、血浆N-端脑的肽前体(NT-proBNP)、典型心衰症状量化评分、托拉塞米用量以及心衰患者的疗效评价标准以及电解质、肝肾功能等安全性指标作为评价指标,分别于治疗前、治疗2周后进行评估。治疗前两组患者24 h尿量、体质量、血浆NT-proBNP比较,差异无统计学意义(P>0.05)。结果 治疗2周后,与治疗前比较,2组患者24 h尿量、体质量、血浆NT-proBNP均有所改善,差异有统计学意义(P<0.01 或P<0.05);组间比较,治疗后治疗组24 h尿量明显高于对照组(P<0.05),NT-proBNP水平、体质量均较对照组下降(P<0.05)。2组总有效率比较,差异无统计学意义(P>0.05),但体现出了一定的有效性。2组患者在用药后,除了治疗组患者浮肿、少尿症状较对照组有所改善外(P<0.05),其余自觉症状改善均不明显,差异均无统计学意义(P>0.05)。2组患者托拉塞米用量均较治疗前明显减少(P<0.01),治疗后治疗组患者托拉塞米用量明显低于对照组(P<0.05)。安全性指标比较,治疗后治疗组患者Cr、Na+较对照组有所改善,差异具有统计学意义(P<0.05)。结论 络风宁2号方能够改善患者的利尿剂抵抗情况,使心功能得到改善,并且治疗期间未发现毒副作用,安全性良好。

关键词: 络风宁2号方, 慢性心力衰竭, 利尿剂抵抗

Abstract: Objective To investigate clinical efficacy and safety of Luofengning (Collateral-Wind-Calming) Formula II Granules (LFNFIIG) in the treatment of patients with chronic heart failure with diuretic resistance. Methods 70 patients with chronic heart failure and diuretic resistance were randomly divided into the treatment group (n=35) and the control group (n=35). Parameters such as 24-hour urine volume, body weight, plasma levels of NT-proBNP, typical heart failure symptom quantitative score, Torasemide dosage, efficacy evaluation standard of patients with heart failure, and electrolyte, liver and kidney function and other safety parameters were used to appraise the clinical efficacy and safety before and after 2 weeks of treatment respectively. There was no significant difference in the 24-hour urine volume, body weight and plasma NT proBNP levels between the two groups before treatment (P> 0.05). Results After 2 weeks of treatment, the 24-hour urine volume, body weight, plasma levels of NT-proBNP of two groups were improved with statistical significance (P<0.01 or P<0.05) compared with before treatment. After treatment, the 24-hour urine volume of treatment group was higher than that of the control group and the plasma level of NT-proBNP and weight of the treatment group were significantly lower than those of the control group (P<0.05). There was no significant difference in the total effective rate between the two groups (P> 0.05), but the treatment group demonstrated better efficacy. After treatment, edema and oliguria of the treatment group were reduced obviously (P<0.05) compared with the control group. However, the other self-reported symptoms of the treat group were not significantly improved, and the differences between the two groups were not statistically significant (P> 0.05). After treatment, the dosage of torasemide used by the two groups was significantly lower than that before treatment (P<0.01) and torasemide dosage of the treatment group was significantly lower than that of the control group (P<0.05). After treatment, safety parameters such as Cr and Na+ of the treatment group were better than those of the control group and the difference was statistically significant (P<0.05). Conclusion LFNFIIG can improve the diuretic resistance and heart function of patients without side effects and with a good safety profile during the treatment.

Key words: Luofengning Formula II Granules, chronic heart failure, diuretic resistance

中图分类号: 

  • R256.2