重组人心房利钠肽1小时输注治疗急性失代偿性心力衰竭患者的疗效与安全性：一项III期、随机、双盲、安慰剂对照、多中心试验
Efficacy and Safety of 1-Hour Infusion of Recombinant Human Atrial Natriuretic Peptide in Patients With Acute Decompensated Heart Failure: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.
作者信息
Wang Guogan, Wang Pengbo, Li Yishi, Liu Wenxian, Bai Shugong, Zhen Yang, Li Dongye, Yang Ping, Chen Yu, Hong Lang, Sun Jianhui, Chen Junzhu, Wang Xian, Zhu Jihong, Hu Dayi, Li Huimin, Wu Tongguo, Huang Jie, Tan Huiqiong, Zhang Jian, Liao Zhongkai, Yu Litian, Mao Yi, Ye Shaodong, Feng Lei, Hua Yihong, Ni Xinhai, Zhang Yuhui, Wang Yang, Li Wei, Luan Xiaojun, Sun Xiaolu, Wang Sijia
机构信息
From the Department of Cardiology (G. Wang, P. Wang, J. Huang, H. Tan, J. Zhang, Z. Liao, L. Yu, Y. Mao, S. Ye, L. Feng, Y. Hua, X. Ni, Y. Zhang, X. Luan, X. Sun, S. Wang), Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College; Heart Center (P. Wang), First Hospital of Tsinghua University; Key Laboratory of Cardiovascular Drugs of Ministry of Health (Y. Li), Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Department of Cardiology (W. Liu, S. Bai), Beijing Anzhen Hospital, The Capital University Medical Sciences, Beijing; Department of Cardiology (Y. Zhen), The First Hospital of Jilin University, Changchun; Department of Cardiology (D. Li), The Affiliated Hospital of Xuzhou Medical College, Xuzhou; Department of Cardiology (P. Yang, Y. Chen), China-Japan Friendship Hospital, Jilin University, Changchun; Department of Cardiology (LH), Jiangxi Provincial People's Hospital, Nanchang; Department of Cardiology (J. Sun), The First People's Hospital of Changzhou, Changzhou; Department of Cardiology (J. Chen), First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou; Department of Cardiology (X. Wang), Beijing Military General Hospital; Department of Cardiology (J. Zhu, D. Hu), Peking University People's Hospital, Beijing; Department of Cardiology (H. Li), The 254 Hospital of People's Liberation Army, Tianjin; Department of Cardiology (T. Wu), Guangzhou Red Cross Hospital, Guangzhou; and Medical Research & Biometrics Center (Y. Wang, W. Li), National Center for Cardiovascular Diseases, Beijing, China.
出版信息
Medicine (Baltimore). 2016 Mar;95(9):e2947. doi: 10.1097/MD.0000000000002947.
The aim of the study was to evaluate the efficacy and safety of 1-h infusion of recombinant human atrial natriuretic peptide (rhANP) in combination with standard therapy in patients with acute decompensated heart failure (ADHF). This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Eligible patients with ADHF were randomized to receive a 1-h infusion of either rhANP or placebo at a ratio of 3:1 in combination with standard therapy. The primary endpoint was dyspnea improvement (a decrease of at least 2 grades of dyspnea severity at 12 h from baseline). Reduction in pulmonary capillary wedge pressure (PCWP) 1 h after infusion was the co-primary endpoint for catheterized patients. Overall, 477 patients were randomized: 358 (93 catheterized) patients received rhANP and 118 (28 catheterized) received placebo. The percentage of patients with dyspnea improvement at 12 h was higher, although not statistically significant, in the rhANP group than in the placebo group (32.0% vs 25.4%, odds ratio=1.382, 95% confidence interval [CI]: 0.863-2.212, P = 0.17). Reduction in PCWP at 1 h was significantly greater in patients treated with rhANP than in patients treated with placebo (-7.74 ± 5.95 vs -1.82 ± 4.47 mm Hg, P < 0.001). The frequencies of adverse events and renal impairment within 3 days of treatment were similar between the 2 groups. Mortality at 1 month was 3.1% in the rhANP group vs 2.5% in the placebo group (hazard ratio = 1.21, 95% CI: 0.34-4.26; P > 0.99). 1-h rhANP infusion appears to result in prompt, transient hemodynamic improvement with a small, nonsignificant, effect on dyspnea in ADHF patients receiving standard therapy. The safety of 1-h infusion of rhANP seems to be acceptable. (WHO International Clinical Trials Registry Platform [ICTRP] number, ChiCTR-IPR-14005719.).
本研究旨在评估重组人心房利钠肽（rhANP）1小时静脉输注联合标准治疗对急性失代偿性心力衰竭（ADHF）患者的疗效和安全性。这是一项III期、随机、双盲、安慰剂对照、多中心试验。符合条件的ADHF患者按3:1的比例随机接受rhANP或安慰剂1小时静脉输注，并联合标准治疗。主要终点为呼吸困难改善情况（自基线起12小时时呼吸困难严重程度至少降低2级）。对于行导管插入术的患者，输注后1小时肺毛细血管楔压（PCWP）降低是共同主要终点。总体而言，477例患者被随机分组：358例（93例行导管插入术）患者接受rhANP治疗，118例（28例行导管插入术）患者接受安慰剂治疗。rhANP组12小时时呼吸困难改善患者的百分比高于安慰剂组，尽管无统计学意义（32.0%对25.4%，优势比=1.382，95%置信区间[CI]：0.863 - 2.212，P = 0.17）。rhANP治疗患者输注后1小时PCWP的降低幅度显著大于安慰剂治疗患者（-7.74±5.95对-1.82±4.47 mmHg，P < 0.001）。两组治疗3天内不良事件和肾功能损害的发生频率相似。rhANP组1个月时的死亡率为3.1%，安慰剂组为2.5%（风险比 = 1.21，95% CI：0.34 - 4.26；P > 0.99）。对于接受标准治疗的ADHF患者，rhANP 1小时静脉输注似乎能迅速、短暂地改善血流动力学，对呼吸困难有轻微但无显著意义的影响。rhANP 1小时静脉输注的安全性似乎是可以接受的。（世界卫生组织国际临床试验注册平台[ICTRP]编号，ChiCTR - IPR - 14005719。）
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