Gigliotti B, Multinu A, Lai V R
Department of Obstetrics and Gynaecology, A. Segni Hospital, Sardinia, Italy.
Arzneimittelforschung. 1997 Nov;47(11A):1317-21.
A multicenter, double-blind, controlled study of pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg) was conducted in 186 female patients (age: 33-79 years) suffering from climacteric syndrome. In these patients, climacteric syndrome was mainly constituted by symptoms of anxiety, often with mild symptoms of depression and sometimes with mild symptoms of cardiac somatization. The enrolled patients were randomized to two treatment groups: the first group was administered pivagabine, 900 mg/d, for 90 days in succession; the second group was administered placebo for the same period. The efficacy of the treatments was assessed by the Hamilton Depression Rating Scale (HDRS) and the Zung's Self-rating Anxiety Scale (SAS) before the start of treatment, after one month and at the end of treatment. At the end of the study, the physicians and the patients were also requested to evaluate the efficacy of the two treatments. Tolerability was evaluated by recording side effects and by assessing the course of arterial blood pressure, of heart rate and of selected laboratory parameters. The study showed that pivagabine was able to reduce symptoms of anxiety and depression. As a consequence, when asked to evaluate the efficacy, the physicians and the patients consistently stated that pivagabine was effective in controlling the symptoms of anxiety, often associated with mild symptoms of depression, that may arise during the climacterium. Furthermore, these results were obtained with a high safety margin, since the few side effects recorded were mild and transient and the laboratory results were normal as well as the physical examination findings.
对186名患有更年期综合征的女性患者（年龄33 - 79岁）进行了一项关于匹伐加宾（4 - [(2,2 - 二甲基 - 1 - 氧代丙基)氨基]丁酸，CAS 69542 - 93 - 4，Tonerg）的多中心、双盲、对照研究。在这些患者中，更年期综合征主要由焦虑症状构成，常伴有轻度抑郁症状，有时还伴有轻度心脏躯体化症状。入选患者被随机分为两个治疗组：第一组连续90天每日服用900毫克匹伐加宾；第二组在同一时期服用安慰剂。在治疗开始前、治疗一个月后和治疗结束时，通过汉密尔顿抑郁量表（HDRS）和zung氏自评焦虑量表（SAS）评估治疗效果。在研究结束时，还要求医生和患者评估两种治疗方法的疗效。通过记录副作用以及评估动脉血压、心率和选定实验室参数的变化过程来评估耐受性。研究表明，匹伐加宾能够减轻焦虑和抑郁症状。因此，在被要求评估疗效时，医生和患者一致表示，匹伐加宾在控制更年期期间可能出现的、常伴有轻度抑郁症状的焦虑症状方面是有效的。此外，这些结果是在高安全边际下获得的，因为记录到的少数副作用轻微且短暂，实验室检查结果以及体格检查结果均正常。
