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Randomized, Double Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Tolvaptan in Chinese Patients with Hyponatremia Caused by SIADH
Chen, Shi1,2; Zhao, Jia-Jun3; Tong, Nan-Wei4; Guo, Xiao-Hui5; Qiu, Ming-Cai6; Yang, Gang-Yi7; Liu, Zhi-Min8; Ma, Jian-Hua9; Zhang, Zhen-Wen10; Gu, Feng1,2
关键词Syndrome Of Inappropriate Antidiuretic Hormone Hyponatremia Tolvaptan
刊名JOURNAL OF CLINICAL PHARMACOLOGY
2014-12-01
DOI10.1002/jcph.342
54期:12页:1362-1367
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Pharmacology & Pharmacy
研究领域[WOS]Pharmacology & Pharmacy
关键词[WOS]VASOPRESSIN V-2-RECEPTOR ANTAGONIST ; ANTI-DIURETIC HORMONE ; INAPPROPRIATE SECRETION ; ORAL TOLVAPTAN ; WATER ; DEMECLOCYCLINE ; ANTIDIURESIS ; PHARMACOLOGY ; RESTRICTION ; OPTIONS
英文摘要

To study the effect of tolvaptan on non-acute, non-hypovolemic hyponatremia in inappropriate secretion of antidiuretic hormone (SIADH) syndrome in Chinese patients. Hyponatremic SIADH patients received placebo (N=18) or tolvaptan (N=19) at an initial dose of 15mg/day with further titration to 30mg/day and 60mg/day based on serum sodium concentrations. Randomized, double-blind, placebo-controlled trial. Primary endpoint was the change of the serum sodium from baseline to days 4 and 7. Analysis of covariance (ANCOVA) was used for statistical analysis. At day 4, average daily changes in serum sodium levels from baseline was 1.9 +/- 2.9mmol/L (1.9 +/- 2.9 mEq/L) in the placebo group and 8.1 +/- 3.6mmol/L (8.1 +/- 3.6 mEq/L) in the tolvaptan group; at day 7, the values were 2.5 +/- 3.9mmol/L (2.5 +/- 3.9 mEq/L) and 8.6 +/- 3.9mmol/L (8.6 +/- 3.9 mmEq/L) for the placebo and tolvaptan groups (ANCOVA, P<0.001). At days 4 and 7, daily urine output and proportions of patients with normalized serum sodium were significantly superior in the tolvaptan group. The most common adverse events occurring in the tolvaptan group were dry mouth and thirst. Tolvaptan demonstrated superiority to placebo in the treatment of Chinese SIADH patients with hyponatremia by elevating serum sodium concentration with acceptable safety profile.

语种英语
WOS记录号WOS:000344786900006
资助机构Otsuka Pharmaceutical
引用统计
被引频次:5[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/56265
专题北京大学第一临床医学院_内分泌内科
作者单位1.Chinese Acad Med Sci, Dept Endocrinol, Key Lab Endocrinol, Minist Hlth,Peking Union Med Coll Hosp, Beijing 100730, Peoples R China
2.Peking Union Med Coll, Beijing 100730, Peoples R China
3.Shandong Prov Hosp, Dept Endocrinol, Jinan 250021, Peoples R China
4.Sichuan Univ, Div Endocrinol, West China Hosp, Chengdu 610041, Peoples R China
5.Peking Univ, Dept Endocrinol, Hosp 1, Beijing 100034, Peoples R China
6.Tianjin Med Univ, Dept Endocrinol, Gen Hosp, Tianjin 300052, Peoples R China
7.Chongqing Med Univ, Dept Endocrinol, Affiliated Hosp 2, Chongqing 400010, Peoples R China
8.Shanghai Chang Zheng Hosp, Dept Endocrinol, Shanghai 200003, Peoples R China
9.Nanjing First Hosp, Dept Endocrinol, Nanjing 210006, Jiangsu, Peoples R China
10.Northern Jiangsu Peoples Hosp, Dept Endocrinol, Yangzhou 225001, Peoples R China
推荐引用方式
GB/T 7714
Chen, Shi,Zhao, Jia-Jun,Tong, Nan-Wei,et al. Randomized, Double Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Tolvaptan in Chinese Patients with Hyponatremia Caused by SIADH[J]. JOURNAL OF CLINICAL PHARMACOLOGY,2014,54(12):1362-1367.
APA Chen, Shi.,Zhao, Jia-Jun.,Tong, Nan-Wei.,Guo, Xiao-Hui.,Qiu, Ming-Cai.,...&Gu, Feng.(2014).Randomized, Double Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Tolvaptan in Chinese Patients with Hyponatremia Caused by SIADH.JOURNAL OF CLINICAL PHARMACOLOGY,54(12),1362-1367.
MLA Chen, Shi,et al."Randomized, Double Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Tolvaptan in Chinese Patients with Hyponatremia Caused by SIADH".JOURNAL OF CLINICAL PHARMACOLOGY 54.12(2014):1362-1367.
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