Lecrubier Y, Judge R
INSERM, Hopital La Salpetriere, Paris, France.
Acta Psychiatr Scand. 1997 Feb;95(2):153-60. doi: 10.1111/j.1600-0447.1997.tb00389.x.
Paroxetine has been shown to be effective in panic disorder in three 10- to 12-week studies. This trial studied the longer term effects of paroxetine in patients with DSM-III-R defined panic disorder. Patients who satisfactorily completed a 12-week, double-blind, placebo-controlled study of paroxetine and clomipramine could choose to continue receiving their randomized treatment for a further 36 weeks. Efficacy assessments included the daily panic attack diary, the Clinical Global Impression Scale, the Hamilton Anxiety Rating Scale, the Marks Sheehan Phobia Scale and the Sheehan Disability Scale. In total, 176 patients were included in the intention-to-treat population. The number of full panic attacks decreased in all three groups during the 12-week study, and improvements continued with long-term therapy. Paroxetine was statistically significantly more effective than placebo throughout the long-term study with respect to reduction from baseline of full panic attacks, and at the end of treatment with respect to the proportion of patients who eventually experienced no panic attacks. There were no significant differences between paroxetine and clomipramine. The proportion of patients who withdrew from the study due to adverse effects was greater in the clomipramine group (19%) than in either the paroxetine group (7%) or the placebo group (9%). Paroxetine was significantly more effective than placebo and as effective as (but better tolerated than) clomipramine in the long-term treatment of panic disorder. Not only was efficacy maintained, but continued improvement was also seen, indicating the importance of long-term treatment in patients with panic disorder.
在三项为期10至12周的研究中，已证实帕罗西汀对惊恐障碍有效。本试验研究了帕罗西汀对符合DSM-III-R定义的惊恐障碍患者的长期影响。令人满意地完成了一项为期12周的帕罗西汀和氯米帕明双盲、安慰剂对照研究的患者，可以选择继续接受随机分配的治疗，为期36周。疗效评估包括每日惊恐发作日记、临床总体印象量表、汉密尔顿焦虑评定量表、马克斯·希恩恐惧症量表和希恩残疾量表。意向性治疗人群共纳入176例患者。在为期12周的研究中，所有三组的完全惊恐发作次数均减少，长期治疗后仍持续改善。在整个长期研究中，就完全惊恐发作次数从基线水平的减少而言，帕罗西汀在统计学上显著优于安慰剂；在治疗结束时，就最终未经历惊恐发作的患者比例而言，帕罗西汀也显著优于安慰剂。帕罗西汀与氯米帕明之间无显著差异。因不良反应退出研究的患者比例，氯米帕明组（19%）高于帕罗西汀组（7%）或安慰剂组（9%）。在惊恐障碍的长期治疗中，帕罗西汀显著优于安慰剂，且与氯米帕明疗效相当（但耐受性更好）。不仅疗效得以维持，而且还持续改善，这表明惊恐障碍患者长期治疗的重要性。
