Xiao-Ying Luo1, Feng-Ru Zhang, Ru-Min He. 1. Department of Cardiology, Ruijin Hospital, Shanghai Jiaotong University, Shanghai. luoxiaoying@yahoo.com
Abstract
OBJECTIVE: To evaluate the clinical efficacy of Shenfu Injection (SFI), as a adjuvant therapy, in treating patients of ischemic cardiomyopathy with heart insufficiency (ICP-HI). METHODS:One hundred patients of ICP-HF were equally randomized into two groups, the SFI group and the control group. All received the conventional treatment, but to patients in the SFI group SFI was given additionally via intravenous injection, 60 mL once a day, 10 days each month, the treatment course was 6 months. Changes of cardial functional grading, 6-min walking distance, echocardiographic indices, plasma N terminal pro-brain natriuretic peptide (pro-BNP) level were observed before and after treatment, and the occurrence of major adverse cardiovascular events (MACE) and mortality in patients were observed as well. RESULTS: As compared with the conventional treatment alone, additional application of SFI showed a more significant efficacy in improving NYHA functional grade and 6-min walking distance, reducing the diameters of left ventricular at end diastole and systole, increasing left ventricular ejection fraction, and decreasing plasma N terminal pro-BNP level (P <0.05). The occurrence of MACE and the mortality in the SFI group were significantly lower than those in the control group respectively (P <0.05). CONCLUSIONS: Based on the conventional treatment, the adjuvant therapy of SFI could improve the cardiac function, improve the quality of life, ameliorate ventricular reconstruction, and decrease the occurrence of cardiovascular events in patients of ICP-HI.
RCT Entities:
OBJECTIVE: To evaluate the clinical efficacy of Shenfu Injection (SFI), as a adjuvant therapy, in treating patients of ischemic cardiomyopathy with heart insufficiency (ICP-HI). METHODS: One hundred patients of ICP-HF were equally randomized into two groups, the SFI group and the control group. All received the conventional treatment, but to patients in the SFI group SFI was given additionally via intravenous injection, 60 mL once a day, 10 days each month, the treatment course was 6 months. Changes of cardial functional grading, 6-min walking distance, echocardiographic indices, plasma N terminal pro-brain natriuretic peptide (pro-BNP) level were observed before and after treatment, and the occurrence of major adverse cardiovascular events (MACE) and mortality in patients were observed as well. RESULTS: As compared with the conventional treatment alone, additional application of SFI showed a more significant efficacy in improving NYHA functional grade and 6-min walking distance, reducing the diameters of left ventricular at end diastole and systole, increasing left ventricular ejection fraction, and decreasing plasma N terminal pro-BNP level (P <0.05). The occurrence of MACE and the mortality in the SFI group were significantly lower than those in the control group respectively (P <0.05). CONCLUSIONS: Based on the conventional treatment, the adjuvant therapy of SFI could improve the cardiac function, improve the quality of life, ameliorate ventricular reconstruction, and decrease the occurrence of cardiovascular events in patients of ICP-HI.
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