Nguyen N, Fakra E, Pradel V, Jouve E, Alquier C, Le Guern M-E, Micallef J, Blin O
CPCET et Pharmacologie Clinique, Institut des Neurosciences Cognitives de la Méditerranée, Faculté de Médecine, UMR CNRS Université de la Méditerranée, Assistance Publique Hôpitaux de Marseille-Hôpital de la Timone, 13385 Marseille Cedex 5, France.
Hum Psychopharmacol. 2006 Apr;21(3):139-49. doi: 10.1002/hup.757.
Adjustment Disorders With Anxiety (ADWA) account for almost 10% of psychologically motivated consultations in primary care. The aim of this double-blind randomised parallel group study was to compare (non-inferiority test) the efficacies of etifoxine, a non-benzodiazepine anxiolytic drug, and lorazepam, a benzodiazepine, for ADWA outpatients followed by general practitioners. 191 outpatients (mean age: 43, female: 66%) were assigned to receive etifoxine (50 mg tid) or lorazepam (0.5-0.5-1 mg /day) for 28 days. Efficacy was evaluated on days 7 and 28 of the treatment. The main efficacy assessment criterion was the Hamilton Rating Scale for Anxiety score (HAM-A) on Day 28 adjusted to Day 0. The anxiolytic effect of etifoxine was found not inferior to that of lorazepam (HAM-A score decrease: 54.6% vs 52.3%, respectively, p=0.0006). The two drugs were equivalent on Day 28. However, more etifoxine recipients responded to the treatment (HAM-A score decreased by >or=50%, p=0.03). Clinical improvement (based on Clinical Global Impression scale CGI, Social Adjustment Scale Self-Report SAS-SR, and Sheehan scores) was observed in both treatment arms, but more etifoxine patients improved markedly (p=0.03) and had a marked therapeutic effect without side effects as assessed by CGI, p=0.04. Moreover, 1 week after stopping treatment, fewer patients taking etifoxine experienced a rebound of anxiety, compared to lorazepam (1 and 8, respectively, p=0.034).
焦虑性适应障碍（ADWA）在初级保健中因心理问题进行的咨询中占近10%。这项双盲随机平行组研究的目的是比较（非劣效性试验）非苯二氮䓬类抗焦虑药物依替福辛和苯二氮䓬类药物劳拉西泮对由全科医生随访的ADWA门诊患者的疗效。191名门诊患者（平均年龄：43岁，女性占66%）被分配接受依替福辛（50毫克，每日三次）或劳拉西泮（0.5 - 0.5 - 1毫克/天）治疗28天。在治疗的第7天和第28天评估疗效。主要疗效评估标准是第28天调整至第0天的汉密尔顿焦虑量表评分（HAM - A）。发现依替福辛的抗焦虑作用不劣于劳拉西泮（HAM - A评分降低分别为54.6%和52.3%，p = 0.0006）。两种药物在第28天等效。然而，更多接受依替福辛治疗的患者对治疗有反应（HAM - A评分降低≥50%，p = 0.03）。两个治疗组均观察到临床改善（基于临床总体印象量表CGI、社会适应量表自我报告SAS - SR和希恩评分），但更多依替福辛治疗的患者改善明显（p = 0.03），并且根据CGI评估，具有显著治疗效果且无副作用（p = 0.04）。此外，与劳拉西泮相比，停药1周后，服用依替福辛的患者出现焦虑反弹的较少（分别为1例和8例，p = 0.034）。
