Panitch Hillel S, Thisted Ronald A, Smith Richard A, Wynn Daniel R, Wymer James P, Achiron Anat, Vollmer Timothy L, Mandler Raul N, Dietrich Dennis W, Fletcher Malcolm, Pope Laura E, Berg James E, Miller Ariel
Neurology Health Care Service, Fletcher Allen Health Care, University of Vermont, Burlington, 05401, USA.
Ann Neurol. 2006 May;59(5):780-7. doi: 10.1002/ana.20828.
To evaluate the efficacy and safety of DM/Q (capsules containing dextromethorphan [DM] and quinidine [Q]) compared with placebo, taken twice daily, for the treatment of pseudobulbar affect over a 12-week period in multiple sclerosis patients.
A total of 150 patients were randomized in a double-blind, placebo-controlled study to assess pseudobulbar affect with the validated Center for Neurologic Study-Lability Scale. Each patient also recorded the number of episodes experienced between visits, estimated quality of life and quality of relationships on visual analog scales, and completed a pain rating scale.
Patients receiving DM/Q had greater reductions in Center for Neurologic Study-Lability Scale scores than those receiving placebo (p < 0.0001) at all clinic visits (days 15, 29, 57, and 85). All secondary end points also favored DM/Q, including the number of crying or laughing episodes (p <or= 0.0077), quality of life (p < 0.0001), quality of relationships (p = 0.0001), and pain intensity score (p = 0.0271). DM/Q was well tolerated; only dizziness occurred with greater frequency than with placebo.
Results in multiple sclerosis patients were similar to those of a previous study in amyotrophic lateral sclerosis, demonstrating that DM/Q may be beneficial in treating potentially disabling pseudobulbar affect in a variety of neurological disorders.
在为期12周的时间里，评估右美沙芬（DM）/奎尼丁（Q）胶囊（含右美沙芬[DM]和奎尼丁[Q]）与安慰剂相比，每日服用两次，用于治疗多发性硬化症患者假性延髓情绪障碍的疗效和安全性。
共有150名患者被随机分配至一项双盲、安慰剂对照研究中，使用经过验证的神经学研究易激惹量表评估假性延髓情绪障碍。每位患者还记录了就诊期间经历的发作次数，通过视觉模拟量表评估生活质量和人际关系质量，并完成疼痛评分量表。
在所有门诊就诊时（第15、29、57和85天），接受DM/Q治疗的患者在神经学研究易激惹量表得分上的降低幅度大于接受安慰剂治疗的患者（p < 0.0001）。所有次要终点也都有利于DM/Q，包括哭笑发作次数（p≤0.0077）、生活质量（p < 0.0001）、人际关系质量（p = 0.0001）和疼痛强度评分（p = 0.0271）。DM/Q耐受性良好；只有头晕的发生频率高于安慰剂。
在多发性硬化症患者中得到的结果与先前在肌萎缩侧索硬化症中的一项研究结果相似，表明DM/Q可能有助于治疗各种神经系统疾病中潜在致残的假性延髓情绪障碍。
