肌内通用注射 (QLG2072) 与中国急性激动症患者的哈洛佩里多尔:一个3期多中心,随机,双盲,主动控制试验
Fang Dong1,2, Zhonggang Wang3, Chao Li4
1Department of Psychiatry, Beijing Anding Hospital, Capital Medical University, Beijing, People's Republic of China.
Drug design, development and therapy
|March 4, 2026
概括
通用 olanzapine 注射 (QLG2072) 有效地管理了中国精神分裂症或双相I型精神障碍患者的急性激动,显示出与 haloperidol 相比的非劣势性,神经副作用较少.
科学领域:
- 精神病学是一个精神病学.
- 临床药理学 临床药理学
- 神经科学是一个神经科学.
背景情况:
- 在精神分裂症和双相I型精神障碍中,急性动带来了重大的临床挑战.
- 有效和安全的管理选择对于患者的稳定和治疗坚持至关重要.
研究的目的:
- 评估通用 olanzapine 注射 (QLG2072) 与 haloperidol 对中国患者急性兴奋的疗效和安全性.
- 为了确定QLG2072与halooperidol的非劣等性.
主要方法:
- 这是一项多中心,随机,双盲,第三期试验,涉及318名中国患者.
- 患者在24小时内接受了QLG2072 (10毫克) 或利 (7.5毫克) 的肌肉内注射.
- 主要终点是注射后2小时阳性和阴性综合征尺度激发成分 (PANSS-EC) 评分的变化.
主要成果:
- QLG2072证明与利醇无劣,PANSS-EC得分的平均值降低相似 (-9.37对 -9.40).
- 在包括应答率在内的二次终点中,疗效相似.
- QLG2072显示,除金字塔外症状的发病率数量较低 (10.1%与27.2%相比),具有可比的整体不良事件.
结论:
- 通用 olanzapine 注射 (QLG2072) 是一种非劣质的替代品,以 haloperidol 管理急性兴奋.
- QLG2072具有良好的神经耐受性,支持其在中国精神病患者群体中的使用.
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