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Titolo:
Efficacy and safety of phospholipid liposomes in the treatment of neuropsychological disorders associated with the menopause: A double-blind, randomised, placebo-controlled study
Autore:
Rachev, E; Nalbansky, B; Kolarov, G; Agrosi, M;
Indirizzi:
Fidia Farmaceut SPA, Neurosci Dept, I-35031 Abano Terme, Pd, Italy Fidia Farmaceut SPA Abano Terme Pd Italy I-35031 1 Abano Terme, Pd, Italy Univ Hosp Sofia, Clin Endocrine Gynaecol, Sofia, Bulgaria Univ Hosp SofiaSofia Bulgaria Clin Endocrine Gynaecol, Sofia, Bulgaria Univ Hosp Sofia, Clin Gynaecol 3, Sofia, Bulgaria Univ Hosp Sofia Sofia Bulgaria Sofia, Clin Gynaecol 3, Sofia, Bulgaria
Titolo Testata:
CURRENT MEDICAL RESEARCH AND OPINION
fascicolo: 2, volume: 17, anno: 2001,
pagine: 105 - 110
SICI:
0300-7995(2001)17:2<105:EASOPL>2.0.ZU;2-Z
Fonte:
ISI
Lingua:
ENG
Soggetto:
PHOSPHATIDYLSERINE LIPOSOMES; ANTIDEPRESSANT DRUGS;
Keywords:
phospholipid liposomes; neurology; menopause;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
15
Recensione:
Indirizzi per estratti:
Indirizzo: Agrosi, M Fidia Farmaceut SPA, Neurosci Dept, Via Ponte della Fabbrica 3-A, I-35031 Abano Terme, Pd, Italy Fidia Farmaceut SPA Via Ponte della Fabbrica 3-A Abano Terme Pd Italy I-35031
Citazione:
E. Rachev et al., "Efficacy and safety of phospholipid liposomes in the treatment of neuropsychological disorders associated with the menopause: A double-blind, randomised, placebo-controlled study", CURR MED R, 17(2), 2001, pp. 105-110

Abstract

A double-blind, randomised, placebo-controlled clinical trial was performed to evaluate the efficacy and safety of phospholipid liposomes (Liposom* Forte) administered parenterally in the treatment of anxiety and depression linked to the menopause. A total of 64 females aged 40-60 years were randomised to receive the active drug or placebo intramuscularly; 58 patients completed the study. Treatment lasted 60 consecutive days. One IM administration of 2ml active drug orplacebo every other day was carried out. Efficacy was evaluated by the Hamilton Anxiety Scale (HAMA) and the Climacteric Index. An intention-to-treat analysis was performed, defined as all patients administered with at least one dose of the study medications with at least one return visit. A highly significant (p < 0.001) decrease in HAMA total score in both groups was noted. However, the decline in the HAMA score was significantly greater in patients administered phospholipid liposomes after 40 days (p = 0.006), 60 days of treatment (p < 0.001) and at the last follow-up visit (p < 0.001). Also, there were statistically significant differences between treatment groups after 60 days of therapy for individual items, such as anxious mood (p = 0.006), tension (p = 0.024) and fear (p = 0.009), with significantly less patients experiencing these symptoms in the phospholipid liposomes-treated group. When the Climacteric Index was evaluated, a highly significant (p < 0.001)decrease in the total score in both groups was noted. However, the declinewas significantly greater in patients administered phospholipid liposomes after 40 days of treatment (p = 0.017), 60 days of treatment (p = 0.0013) and at the last followup visit (p = 0.0012). Significant differences betweentreatment groups were recorded after 60 days in asthenia (p = 0.05), dizziness (p = 0.024) and restlessness (p = 0.019) in favour of the active treatment. Twelve patients reported at least one adverse event, nine in the phospholipid liposomes group and three in the placebo group (p = 0.062). The most commonly reported event was drowsiness with two reports in each group,These findings further demonstrate that phospholipid liposomes administered intramuscularly are active against mild anxiety and depressive symptoms in menopausal women.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 05/04/20 alle ore 06:02:01