Clinical trial of tolvaptan tablets in the treatment of heart failure with systolic dysfunction
10.13699/j.cnki.1001-6821.2019.07.005
- VernacularTitle:托伐普坦片治疗心力衰竭伴收缩功能障碍的临床研究
- Author:
Wu-Ming HU
1
;
Zhen-Hua SHI
;
Shi-Yong YE
;
Yi-Jia XIANG
;
Chun-Lai ZENG
Author Information
1. 丽水市中心医院 心内科
- Keywords:
tolvaptan tablet;
furosemide injection;
heart failure;
systolic dysfunction;
safety assessment
- From:
The Chinese Journal of Clinical Pharmacology
2019;35(7):617-619
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the clinical efficacy and safety of tolvaptan tablets and furosemide injection in the treatment of heart failure with systolic dysfunction. Methods One hundred and four patients of heart failure with systolic dysfunction were randomly divided into control group (n = 49 cases) and treatment group (n = 55 cases) . Control group received furosemide 40 mg per time, qd, intravenous bolus. Treatment group received tolvaptan 15 mg per time, qd, orally. The clinical efficacy, heart rate, pulmonary artery pressure, pulmonary capillary pressure and cardiac output, and adverse drug reactions were compared between two groups. Results After treatment, the total effective rates of treatment and control groups were 89. 09% (49 cases/55 cases) and71. 43% (35 cases/49 cases) with significant difference (P < 0. 05) .After treatment, the main indexes of treatment and control groups were compared: heart rates were (80. 15 ± 10. 04) and (84. 71 ± 9. 66) beat·min-1, pulmonary artery pressure were (21. 85 ± 4. 49) and (28. 47 ± 4. 46) mm Hg, pulmonary capillary pressure were (11. 24 ± 1. 61) and (15. 18 ± 2. 76) mm Hg, cardiac output were (1. 94 ± 0. 30) and (2. 16 ± 0. 25) L · min-1· m-2, the differences were statistically significant (all P < 0. 05) . The adverse drug reactions of treatment group were increased blood sodium, urinary frequency and dry mouth, which in control group were fatigue, thirst and muscle soreness. The total incidences of adverse drug reactions in the treatment and control groups were 12. 73% and 12. 24% without significant difference (P> 0. 05) . Conclusion Tolvaptan tablets have a definitive clinical efficacy in the treatment of heart failure with systolic dysfunction, which can effectively improve the heart rate, pulmonary artery pressure, pulmonary capillary pressure and cardiac output, without increasing the incidence of adverse drug reactions.