Márquez Miguel, Arenoso Hector, Caruso Norberto
ADINEU (Care. Teaching and Research in Neurosciences) C.A.Buenos Aires, Argentina.
Actas Esp Psiquiatr. 2011 Mar-Apr;39(2):88-94. Epub 2011 Mar 1.
Panic disorder affects 2-5% of the general population. In Argentina, one million people would be affected with a 91% rate of psychiatric comorbidity. AIM; To compare efficacy parameters between sublingual (ALP-SL) and conventional (ALP-CT) tablets of alprazolam in the treatment of acute phase of panic disorder with and without agoraphobia.
A comparative, multicenter (6 sites), double blind, randomized study was carried out. A total of 190 outpatients with (n=117) and without (n=73) agoraphobia were treated with ALP-SL or ALP-CT for 12 weeks. Outcome was assessed with the Clinical Global Impressions (CGI-S/CGI-I), Hamilton Rating Scale for Anxiety (HAM-A), Arizona Sexual Experiences Scale (ASEX), Patient Global Impression (PGI), Psychological General Well-Being Index (PGWBI), Panic Disorder Severity Scale (PDSS) also by the number of panic attacks and extension and intensity of panic attacks and anticipatory anxiety. RESULTS. Both treatments resulted in statistically significant clinical improvement in all measures. ASEX presented no changes during the study. The average dose of alprazolam for 12 weeks was 1.36 ± 0.70 mg/day (1.39 ± 0.77 ALP-CT and 1.33 ± 0.64 ALP-SL). With ALP-SL, panic attacks were shorter (p < 0.05) with shorter extension (p=0.16) and intensity of anticipatory anxiety (p=0.14). The treatment was well tolerated, there being no differences between both groups.
Alprazolam has been demonstrated to have efficacy, safety and good tolerability in the treatment of the acute phase of panic disorder, the sublingual tablets showing some comparative advantages.
惊恐障碍影响2%至5%的普通人群。在阿根廷,有100万人会受到影响,且存在精神共病的比例为91%。目的:比较阿普唑仑舌下片(ALP-SL)和传统片剂(ALP-CT)在治疗伴有或不伴有广场恐惧症的惊恐障碍急性期时的疗效参数。
开展了一项多中心(6个地点)、双盲、随机对照研究。共有190例伴有广场恐惧症(n=117)和不伴有广场恐惧症(n=73)的门诊患者接受了12周的ALP-SL或ALP-CT治疗。采用临床总体印象量表(CGI-S/CGI-I)、汉密尔顿焦虑量表(HAM-A)、亚利桑那性体验量表(ASEX)、患者总体印象(PGI)、心理总体幸福感指数(PGWBI)、惊恐障碍严重程度量表(PDSS),并通过惊恐发作的次数、惊恐发作的持续时间和强度以及预期焦虑来评估疗效。结果:两种治疗方法在所有测量指标上均产生了具有统计学意义的临床改善。在研究期间,ASEX没有变化。12周内阿普唑仑的平均剂量为1.36±0.70毫克/天(ALP-CT为1.39±0.77,ALP-SL为1.33±0.64)。使用ALP-SL时,惊恐发作持续时间更短(p<0.05),预期焦虑的持续时间(p=0.16)和强度(p=0.14)也更短。该治疗耐受性良好,两组之间没有差异。
已证明阿普唑仑在治疗惊恐障碍急性期具有疗效、安全性和良好的耐受性,舌下片显示出一些比较优势。