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Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study
Si, Tianmei1; Zhang, Kerang2; Tang, Jisheng3; Fang, Maosheng4; Li, Keqing5; Zhuo, Jianmin6; Feng, Yu6
关键词Antipsychotic Long-acting Injectable Panss
刊名NEUROPSYCHIATRIC DISEASE AND TREATMENT
2015
DOI10.2147/NDT.S81760
11页:1483-1492
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Clinical Neurology ; Psychiatry
研究领域[WOS]Neurosciences & Neurology ; Psychiatry
关键词[WOS]ANTIPSYCHOTIC AGENTS ; DOUBLE-BLIND ; RISPERIDONE ; RELAPSE ; TOLERABILITY ; PREVENTION ; TRIAL ; TIME
英文摘要

This open-label, single-arm, multicenter, 13-week, prospective study explored the efficacy, safety, and tolerability of paliperidone palmitate (150 milligram equivalents [mg eq] [day 1], 100 mg eq [day 8], both deltoid injections; 75-150 mg eq, deltoid/gluteal injection) in Chinese patients with acute schizophrenia (Positive and Negative Syndrome Scale [PANSS] total score. 70), who previously had unsatisfactory therapeutic effect following oral antipsychotic treatment (without washout period). Primary efficacy endpoint was percentage of patients with >= 30% improvement in the PANSS total score at the end of 13 weeks. Secondary efficacy endpoints included change from baseline to end of week 13 in PANSS total score, PANSS subscale scores, Marder factor scores, Clinical Global Impressions-Severity score, and Personal and Social Performance Scale scores. Overall, 477/610 enrolled patients (full analysis set, 78.2%) completed the study (men: 55.1%; women: 44.9%; mean age: 31.5 years). Total, 443/610 (72.6%, full analysis set) patients achieved primary endpoint (mean [standard deviation] change from baseline: -30.9 [19.51]). All secondary endpoints demonstrated significant improvement at the end of 13 weeks. One death occurred during this acute phase. The most common (>5%) treatment-emergent adverse events were extrapyramidal disorders (8.4%). The efficacy and safety data are consistent with other short-term, placebo-controlled studies of paliperidone palmitate conducted in similar populations.

语种英语
WOS记录号WOS:000356594900001
引用统计
被引频次:6[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/400002259/56178
专题北京大学精神卫生研究所
北京大学精神卫生研究所_药理室
作者单位1.Peking Univ, Inst Mental Hlth, Key Lab Mental Hlth, Minist Hlth, Beijing 100871, Peoples R China
2.Shanxi Med Univ, Hosp 1, Taiyuan, Shanxi, Peoples R China
3.Mental Hlth Ctr Shandong Prov, Jinan, Shandong, Peoples R China
4.Huazhong Univ Sci & Technol, Tongji Med Coll, Mental Hlth Ctr, Wuhan, Hubei, Peoples R China
5.Mental Hlth Ctr Hebei Prov, Baoding, Hebei, Peoples R China
6.Janssen Res & Dev, Beijing, Peoples R China
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GB/T 7714
Si, Tianmei,Zhang, Kerang,Tang, Jisheng,et al. Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study[J]. NEUROPSYCHIATRIC DISEASE AND TREATMENT,2015,11:1483-1492.
APA Si, Tianmei.,Zhang, Kerang.,Tang, Jisheng.,Fang, Maosheng.,Li, Keqing.,...&Feng, Yu.(2015).Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study.NEUROPSYCHIATRIC DISEASE AND TREATMENT,11,1483-1492.
MLA Si, Tianmei,et al."Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study".NEUROPSYCHIATRIC DISEASE AND TREATMENT 11(2015):1483-1492.
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