Wang R I, Wiesen R L, Stockdale S, Hieb E
J Clin Pharmacol. 1977 May-Jun;17(5-6):269-75. doi: 10.1002/j.1552-4604.1977.tb04606.x.
Although anxiolytic sedatives are widely used in clinical practice, the methodology for assessing treatment effect of these compounds has not been well developed. The present double-blind study was designed to refine methodology for evaluating anxiolytics. Choice of rating scale, patient selection, maintenance of the double-blind status, the subjects' environment during the study, and the subjects' understanding of the study are discussed as considerations in reducing sources of variability and bias in the study of anxiolytics. After placebo prescreening, 14 subjects with diagnoses of anxiety recieved 3 to 6 mg lorazepam daily for four weeks, while 14 control subjects received placebo. The Hamilton Anxiety Rating Scale (HARS) and the Wang Anxiety Rating Scale (WARS), with its Anxiolytic Adjunct Scale (AAS), were used to assess changes in anxiety. The Wang and Hamilton ratings correlated well at both comparison periods. Lorazepam demonstrated significant superiority to placebo and produced no serious adverse effects. Anxiolytic efficacy did not differ significantly among the four weekly ratings.
尽管抗焦虑镇静剂在临床实践中被广泛使用，但评估这些化合物治疗效果的方法尚未得到充分发展。本双盲研究旨在完善评估抗焦虑药物的方法。作为减少抗焦虑药物研究中变异性和偏差来源的考虑因素，讨论了评分量表的选择、患者选择、双盲状态的维持、研究期间受试者的环境以及受试者对研究的理解。在安慰剂预筛选后，14名被诊断为焦虑症的受试者每天服用3至6毫克劳拉西泮，持续四周，而14名对照受试者服用安慰剂。使用汉密尔顿焦虑量表（HARS）和王焦虑量表（WARS）及其抗焦虑辅助量表（AAS）来评估焦虑的变化。在两个比较期，王量表和汉密尔顿量表的评分相关性良好。劳拉西泮显示出明显优于安慰剂，且未产生严重不良反应。在四周的评分中，抗焦虑疗效没有显著差异。
