Yamagami S, Koide S, Mui K, Perk S, Hirayama E, Kioka T, Soejima K, Inoue K, Nishiwaki S
Department of Neuropsychiatry, Osaka City University Medical School, Japan.
Int J Clin Pharmacol Res. 1995;15(1):1-7.
The therapeutic efficacy, utility and safety of bifemelane hydrochloride were studied in 52 elderly depressive patients. The drug was administered as a tablet containing 50 mg orally three times daily for 8 consecutive weeks. The final global improvement rating and global utility rating were respectively 80.8 and 73.1 percent for all patients. The improvement rates on the Hamilton depression rating scale (HAM-D) were more than 60% for depressed mood, guilt, suicide, middle insomnia, delayed insomnia, psychotic anxiety, gastro-intestinal symptom, hypochondriasis, depersonalization and derealization. The rates regarding global symptoms evaluated by the Psychoneurotic rating scale for doctor's use were more than 60% for tension, agitation, irritability and excitement, phobia, depression, hypochondria and nocturnal delirium in psychotic symptoms, and insomnia in addition to palpitation in somatic symptoms. A significant decrease was also observed in the symptoms covered by the Self-rating depression scale of Zung after treatment with this drug. There were no instances of side-effects, nor any abnormalities in laboratory tests, encountered throughout the trial. Therefore, bifemelane hydrochloride is of value for the treatment of geriatric depression.
对52例老年抑郁症患者研究了盐酸比芬美兰的治疗效果、效用及安全性。该药物以每片含50毫克的片剂形式口服，每日3次，连续服用8周。所有患者的最终总体改善评分和总体效用评分分别为80.8%和73.1%。汉密尔顿抑郁量表（HAM-D）中，抑郁情绪、内疚感、自杀观念、中度失眠、延迟性失眠、精神病性焦虑、胃肠道症状、疑病症、人格解体和现实解体等项目的改善率超过60%。医生用神经症评定量表评估的总体症状中，紧张、激动、易怒和兴奋、恐惧、抑郁、疑病症、精神病性症状中的夜间谵妄以及躯体症状中的失眠伴心悸等项目的改善率超过60%。服用该药物治疗后，Zung自评抑郁量表涵盖的症状也有显著下降。整个试验过程中未出现副作用，实验室检查也无异常。因此，盐酸比芬美兰对治疗老年抑郁症有价值。
