Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome).
机构：[1]First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM), Tianjin, 300193, China [2]The First Affiliated Hospital of Henan University of T.C.M., Henan, 450000, China [3]The First Affiliated Hospital of Guangxi University of Chinese Medicine, Guangxi, 530000, China [4] Xiyuan Hospital, China Academy of Chinese Medical Sciences (CACMS), Beijing, 100091, China [5]The First Affiliated Hospital of Guangzhou University of T.C.M, Guangzhou, 510450, China [6]Department of Cardiovascular, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China [7]Affiliated Hospital of Jiangxi University of T.C.M., Jiangxi, 330000, China [8]Teaching Hospital of Chengdu University of T.C.M., Chengdu, 610000, China [9]Second Affiliated Hospital of Tianjin University of T.C.M., Tianjin, 300143, China [10]West China Hospital of Sichuan University, Sichuan, 610000, China 四川大学华西医院[11]Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Guangxi, 530000, China [12]Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
Shenfu injection (SFI) has shown a remarkable therapeutic effect in patients with chronic heart failure (CHF) during the acute phase of symptom aggravation since it became commercially available in 1987. However, the therapeutic effect of SFI has not been validated in a standard clinical study. As a pilot clinical trial, this study aimed to evaluate the safety and efficacy of SFI for treatment of CHF patients during the acute phase.
A total of 160 patients experiencing acute phase CHF were enrolled in this study and randomly assigned to receive the placebo (placebo group, 150 ml glucose (GS)) or SFI (SFI group, 50 ml SFI + 100 ml GS) in addition to their standard medications for CHF treatment. The treatment lasted for 7 ± 1 days, and the follow-up continued for 28 ± 3 days after treatment. The primary endpoints were New York Heart Association (NYHA) classification and Traditional Chinese Medicine (TCM) syndrome scores.
After 7±1 days of treatment, the efficacy of SFI according to improvements in NYHA and TCM syndrome scores in the SFI group (78.38% and 89.19%, respectively) was significantly higher than that in the placebo group (61.43% and 60.00%, respectively; P<0.05). The SFI group had a longer increase in amplitude than the placebo group (113.00 m versus 82.99 m, P<0.05). The incidence of adverse events and other safety indices showed no significant differences between the two groups.
SFI combined with conventional therapy for treatment of CHF during acute symptom aggravation ameliorated the cardiac dysfunction and clinical symptoms and improved the patients' quality of life without any significant AEs compared with the conventional therapy alone.
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外文
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出版当年[2018]版：
大类|4 区医学
小类|3 区全科医学与补充医学
最新[2025]版：
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第一作者：
第一作者机构：[1]First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM), Tianjin, 300193, China
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推荐引用方式(GB/T 7714)：
Wang Xianliang,Zhao Zhiqiang,Mao Jingyuan,et al.Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome).[J].Evidence-based complementary and alternative medicine : eCAM.2019,2019:9297163.doi:10.1155/2019/9297163.
APA：
Wang Xianliang,Zhao Zhiqiang,Mao Jingyuan,Du Tinghai,Chen Yuanping...&Liu Chunxiang.(2019).Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome)..Evidence-based complementary and alternative medicine : eCAM,2019,
MLA：
Wang Xianliang,et al."Randomized, Double-Blinded, Multicenter, Placebo-Controlled Trial of Shenfu Injection for Treatment of Patients with Chronic Heart Failure during the Acute Phase of Symptom Aggravation (Yang and Qi Deficiency Syndrome).".Evidence-based complementary and alternative medicine : eCAM 2019.(2019):9297163
