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学科主题: 临床医学
题名:
Randomized, Double Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Tolvaptan in Chinese Patients with Hyponatremia Caused by SIADH
作者: 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
发表日期: 2014-12-01
DOI: 10.1002/jcph.342
卷: 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
项目资助者: Otsuka Pharmaceutical
WOS记录号: WOS:000344786900006
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/56265
Appears in Collections:北京大学第一临床医学院_内分泌内科_期刊论文

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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

Recommended Citation:
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.
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