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Efficacy and safety of short-term administration of recombinant human atrial natriuretic peptide (rhANP) for congestive heart failure: a phase II, multicentre randomized controlled dose-finding study

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机构: [1]Chinese Acad Med Sci, State Key Lab Cardiovasc Dis, Fu Wai Hosp, Natl Ctr Cardiovasc Dis, Beijing 100730, Peoples R China; [2]Peking Union Med Coll, Beijing 100021, Peoples R China; [3]Capital Univ Med Sci, Dept Cardiol, Beijing Anzhen Hosp, Beijing, Peoples R China; [4]Natl Ctr Cardiovasc Dis, Med Res & Biometr Ctr, Beijing, Peoples R China; [5]CAMS, Dept Cardiol, Cardiovasc Inst, 167 Beilishi Rd, Beijing 100037, Peoples R China
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关键词: congestive heart failure controlled clinical trial dose-finding study

摘要:
What is known and objective Although the long-term infusion of ANP has proved effective to treat heart failure, no published randomized controlled study has been reported to confirm the efficacy of the short-term ANP infusion in congestive heart failure (CHF) patients. This study was designed to assess the efficacy and safety of short-term infusion of recombinant human atrial natriuretic peptide (rhANP) in CHF patients. Methods A total of 48 patients with CHF were enrolled and randomized into four groups, treated with standard therapy or rhANP (0.05, 0.1 or 0.2 mu g/kg/min) for 1-hour infusion in addition to standard therapy. The hemodynamics were assessed for 12h by Swan-Ganz catheter. Results and discussion The effect of the 0.05 mu g/kg/min rhANP dose group on CO was modest and transient. The 0.2 mu g/kg/min rhANP dose group tended to be associated with better effect on SV, CO and dyspnoea improvement, but modest effect on PCWP and more adverse events probably attributed to the study drug. However, the 0.1 mu g/kg/min rhANP infusion was well tolerated and effective both on PCWP decrease (maximum:-9.46 +/- 5.81mmHg compared with baseline (P=0.0002) and -6.75mmHg compared with standard therapy, the 95% confidential interval [-13.43, -0.06mmHg] at 1h) and CO increase (maximum: 1.02 +/- 1.43L/min [P=0.0308] at 1h). What is new and conclusion In this small-sample study, 1-hour infusion of rhANP produced beneficial hemodynamic effects in CHF patients compared with standard therapy, and it was well tolerated. 0.1 mu g/kg/min may be the optimum dose for short-term rhANP infusion to treat CHF for the further large sample trial before clinical application.

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出版当年[2012]版:
大类 | 4 区 医学
小类 | 4 区 药学
最新[2023]版:
大类 | 4 区 医学
小类 | 4 区 药学
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出版当年[2011]版:
Q3 PHARMACOLOGY & PHARMACY
最新[2023]版:
Q3 PHARMACOLOGY & PHARMACY

影响因子: 最新[2023版] 最新五年平均 出版当年[2011版] 出版当年五年平均 出版前一年[2010版] 出版后一年[2012版]

第一作者:
第一作者机构: [1]Chinese Acad Med Sci, State Key Lab Cardiovasc Dis, Fu Wai Hosp, Natl Ctr Cardiovasc Dis, Beijing 100730, Peoples R China; [2]Peking Union Med Coll, Beijing 100021, Peoples R China;
通讯作者:
通讯机构: [1]Chinese Acad Med Sci, State Key Lab Cardiovasc Dis, Fu Wai Hosp, Natl Ctr Cardiovasc Dis, Beijing 100730, Peoples R China; [2]Peking Union Med Coll, Beijing 100021, Peoples R China; [5]CAMS, Dept Cardiol, Cardiovasc Inst, 167 Beilishi Rd, Beijing 100037, Peoples R China
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