Abate G, Angeleri F, Bartorelli L, Battistin L, Bergamasco B, Bertolini S, Bulfoni A, Capurso A, Cazzato G, Coccagna G
Neurologisch-geriatrische Universitäts-Krankenhaus-Zentren, Poli Industria Chimica S.p.A., Rozzano, Mailand, Italien.
Arzneimittelforschung. 1992 Nov;42(11A):1417-21.
Aim of the study was to assess the activity of dihydroergocristine (DHEC, CAS 17479-19-5) in aged patients with impaired cognitive function. Twenty-five university hospital centres and 250 physicians participated in the study. 2,600 patients (1,104 males and 1,496 females, age range 50-80 years) were admitted to the study. Each patient was administered 6 mg/d DHEC for 120 days. Clinical evaluation was made through the SCAG Rating Scale registered at basal time, after 60 and 120 days. Responsivity to treatment was considered high when the final score was reduced by 30% and none if less than 10%. Analysis of results demonstrated that at the end of the study responsivity was high in 73% of cases, moderate in 20.4% and absent in 6.5%. Tolerability was very good as side effects were reported only in 3.16% of patients. Most frequent side effects were: nausea (1.23%), gastralgia (1.11%), headache (0.29%), hypotension (0.12%), vertigo (0.12%) and rash (0.08%). Drop-outs for gastralgia were reported only in 0.53% of the patients.
本研究的目的是评估双氢麦角汀（DHEC，化学物质登记号17479 - 19 - 5）对认知功能受损老年患者的疗效。25家大学医院中心和250名医生参与了该研究。2600名患者（1104名男性和1496名女性，年龄范围50 - 80岁）纳入研究。每位患者每天服用6毫克双氢麦角汀，持续120天。通过在基线期、60天和120天后登记的SCAG评定量表进行临床评估。当最终评分降低30%时，认为治疗反应性高；若降低不足10%，则认为无反应。结果分析表明，在研究结束时，73%的病例反应性高，20.4%为中度，6.5%无反应。耐受性非常好，仅3.16%的患者报告有副作用。最常见的副作用为：恶心（1.23%）、胃痛（1.11%）、头痛（0.29%）、低血压（0.12%）、眩晕（0.12%）和皮疹（0.08%）。仅0.53%的患者因胃痛退出研究。
