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劳拉西泮与地西泮治疗急性酒精戒断综合征的疗效及安全性双盲比较。

A double-blind comparison of the efficacy and safety of lorazepam and diazepam in the treatment of the acute alcohol withdrawal syndrome.

作者信息

Miller W C, McCurdy L

出版信息

Clin Ther. 1984;6(3):364-71.

PMID:6722863
Abstract

The safety and efficacy of lorazepam and diazepam were compared in the treatment of the acute alcohol withdrawal syndrome during a five-day double-blind trial in alcoholic patients. The daily doses of lorazepam and diazepam were tapered from 6 or 8 mg to 2 mg and from 30 or 40 mg to 10 mg, respectively, during the first four days; no medication was given on day 5. Drug efficacy was measured by Total Severity Assessment Scores (TSAS), the three TSAS factor scores, and by the physician's global evaluation. Of the 55 inpatients enrolled, 47 completed the study. There were no statistically significant differences between the treatment groups in any of the efficacy assessment measures. The physical conditions of the majority of the patients treated with lorazepam (57%) and diazepam (59%) improved during therapy. There were no clinically significant differences between the treatment groups in vital signs or laboratory values. The results of this study indicate that lorazepam is as effective as diazepam in reducing the symptoms of acute alcohol withdrawal. When lorazepam and diazepam are compared in terms of their pharmacokinetics, lorazepam may have therapeutic advantages for the management of the acute alcohol withdrawal syndrome.

摘要

在一项针对酒精中毒患者的为期五天的双盲试验中,比较了劳拉西泮和地西泮治疗急性酒精戒断综合征的安全性和有效性。在前四天,劳拉西泮和地西泮的每日剂量分别从6或8毫克逐渐减至2毫克,从30或40毫克逐渐减至10毫克;第5天未给药。通过总严重程度评估评分(TSAS)、三个TSAS因子评分以及医生的整体评估来衡量药物疗效。在纳入的55名住院患者中,47名完成了研究。在任何疗效评估指标中,治疗组之间均无统计学显著差异。接受劳拉西泮治疗的大多数患者(57%)和接受地西泮治疗的大多数患者(59%)在治疗期间身体状况有所改善。治疗组在生命体征或实验室值方面无临床显著差异。本研究结果表明,劳拉西泮在减轻急性酒精戒断症状方面与地西泮同样有效。就药代动力学而言,劳拉西泮在治疗急性酒精戒断综合征方面可能具有治疗优势。

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