摘要:

Lansoprazole is a new proton-pump inhibitor that has been proven safe and effective in the treatment of gastroesophageal reflux disease (GERD) and peptic ulcer disease. In rats, the drug inhibited testosterone synthesis and was associated with Leydig cell tumours. To determine the effect of a high therapeutic dose of lansoprazole (60mg day) on male hormone levels and gonadal function, a randomised double-blind parallel study was conducted. 32 healthy volunteers participated for 8 weeks. Endocrine profiles included serum testosterone, luteinising hormone (LH), follicle-stimulating hormone (FSH), sex hormone-binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEA-S), prolactin, estradiol, cortisol and thyroid function. As further evaluation of an effect on hormones, testes were monitored for changes in size and breasts for gynaecomastia. Sexual function parameters were assessed by semen analyses and a sexual function questionnaire. Testosterone levels tended to increase slightly in the lansoprazole group and decrease slightly in the placebo group. While the difference between groups was statistically significant, the magnitude of changes was small and not clinically significant. Overall, there were no clinically significant changes in hormone levels. All testicular and breast measurements remained within normal range. Similarly, no clinically significant differences between treatment groups occurred in either semen analysis or sexual-function parameters.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

Trough and peak concentrations as well as the elimination kinetics of the antimycotic agent terbinafine and 3 metabolites were investigated following multiple-dose administration of terbinafine 250mg daily for 4, 12 and 48 weeks. Plasma, sebum and tissues such as the stratum corneum, dermis-epidermis, hair and nails were analysed. The elimination of all compounds was multiphasic, being faster initially. Mean terminal elimination half-lives of the parent drug determined in plasma and tissues ranged from 18 to 28 days, and were in the same range as those of the metabolites (21 to 28 days). The slowest terminal elimination of terbinafine was observed from the dermis-epidermis and from keratinic tissues like hair and nails. Trough plasma concentrations of terbinafine were highly consistent in all studies, indicating an accumulation (12.6- to 18.5-fold) after multiple-dose treatment. However, peak concentrations of terbinafine accumulated only slightly (1.3-fold).In plasma, the kinetics of the metabolites were similar with regard to their terminal elimination half-life. Like the parent drug, trough concentrations of theN-demethylated metabolite accumulated (8- to 12.9-fold) after multiple-dose administration, but the peak concentrations did not. In contrast, the 2 carboxy metabolites accumulated only slightly (1.6- to 2.7-fold) under the same conditions.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

264 patients experiencing pain related to osteoarthritis of the hip and/or knee were enrolled in a double-blind randomised multicentre study. Those who reported moderate or severe pain despite taking paracetamol 4g daily during a 1-week lead-in period were randomised to treatment with tramadol HCl 100mg 3 times daily or dextropropoxyphene napsylate 100mg 3 times daily for 2 weeks. At the end of the second week of therapy, 71.6 and 70.4% of tramadol-treated patients and 53.2 and 50.5% of dextropropoxyphene-treated patients had symptom improvement during daily activities (p = 0.01) and on walking (p = 0.006), respectively. A larger proportion of tramadol-treated patients also reported improvement of pain during sleep as compared with patients administered dextropropoxyphene (tramadol: 44.3%; dextropropoxyphene: 30.3%; p = 0.04). Numerically, tramadol was also more effective than dextropropoxyphene for improvement of pain relief as measured on a visual analogue scale, but the difference did not reach statistical significance (tramadol: 48, dextropropoxyphene: 42; p = 0.12). No potentially serious adverse events were reported. Tramadol was associated with a significantly higher number of reported adverse events; the most commonly reported events were nausea, dizziness and vomiting, and more patients taking tramadol were withdrawn due to adverse events.In conclusion, tramadol was more effective than dextropropoxyphene in treating osteoarthritic pain, but tramadol was more often associated with adverse events. However, considering the nonserious nature of the events and the high number of fatal overdoses reported in the literature with dextropropoxyphene, tramadol appears to be a better alternative.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

The aim of this study was to investigate the modifying effect of diabetes on thein vitroserum binding of gliclazide at therapeutic concentrations, and to try to determine the role of albumin glycation. Sera were obtained from 20 patients with diabetes and 20 matched nondiabetic controls. Gliclazide was addedin vitroat a therapeutic concentration (5 mg/L). After equilibrium dialysis, gliclazide was assayed by high-performance liquid chromatography, while glycated albumin was assayed by affinity chromatography and laser-nephelemetry. The mean binding of gliclazide was lower in diabetics (82.6 ± 4.1%) than in controls (88.8 ± 4.8%) [p<0.001]. No correlation was observed between gliclazide binding and the percentage of albumin glycation. Sera were also obtained from the same diabetic patients 3 months later. There was no correlation between variation of glycated albumin and variation of gliclazide binding over 3 months. The protein binding of gliclazide was lower in diabetics than in matched controls. Furthermore, the decreased binding was not dependent upon the level of albumin glycation, and did not disappear when chronic hyperglycaemia was corrected.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

This was a multicentre, double-blind study in 454 patients to compare the effectiveness and tolerability of fluticasone propionate nasal spray (FPANS) 200μg used once daily for 8 weeks on its own or in combination with oral cetirizine 10mg once daily in the treatment of seasonal allergic rhinitis. The results showed no significant difference between treatments in any of the symptoms or in the proportion of symptom-free days. Watery eyes were recorded as being the most troublesome symptom in the previous hayfever season, whilst during the study patients were, on average, free of eye symptoms for 56% of the time. Additionally, no difference was detected between the two groups with regard to the use of rescue medication. More than 75% of patients concluded at the end of the study that their symptoms had been adequately controlled and, similarly, investigators rated both treatments as being successful for the majority of patients. Overall, this study suggests that there is no significant difference in efficacy between FPANS 200μg, taken once daily in the morning, and FPANS 200μg once daily in combination with oral cetirizine 10mg, in the prophylactic treatment of seasonal allergic rhinitis.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

In an open prospective parallel group multicentre study, 54 patients with irritable bowel syndrome were randomised to receive oral mebeverine slow release 200mg twice daily (n = 26) or mebeverine tablets 135mg 3 times daily (n = 28) for 3 weeks. Eight gastrointestinal symptoms and 3 nongastrointestinal symptoms were evaluated. The analysis of the data did not demonstrate a difference in efficacy between the treatment groups. Both mebeverine preparations, the tablet and the new slow release formulation in microgranules, were found to be safe and well tolerated. Of the 54 patients who entered the study, 6 discontinued medication prematurely, and 48 were included in the final analysis. Systolic and diastolic blood pressure and pulse rate did not show a significant change over time nor a difference between groups. No serious adverse drug event was reported. The investigator's global impression of compliance after 1 and 3 weeks of treatment did not show a significant difference between treatment groups. The idea of reducing the number of daily doses from 3 to 2 by using a slow-release formulation was confirmed in this study.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

The aim of this study was to describe the actual use of medicines in an elderly population and to relate that use to age, gender, type of housing, and type of cohabitation. We used data from the Kungsholmen project, an ongoing longitudinal study in Stockholm, Sweden. The Kungsholmen project focuses on the medical, psychological, and social problems of aging, with an emphasis on dementia. All inhabitants of the Kungsholmen parish aged 75 years or more were selected for the study. The participation rate was 76%. More than 80% of those living in their own homes1and more than 90% of those living in sheltered accommodation or in a healthcare institution used medicines. The mean number of medicines used was 3.2, ranging from 0 to 15. Women used a larger number of medicines than men, 3.4vs2.6. People in the age group 75 to 79 years used fewer medicines than those in the older age groups. People who were 85 years or older used significantly more medicines than those between 75 and 84 years. The number of medicines used by elderly persons in different age groups was different among women, but not among men. People living in sheltered accomodation used a larger number of medicines on average than those who lived in their own home or in nursing homes. The whole population, men and women, and those aged 80 to 84 years, living in their own homes, used fewer medicines than those living in sheltered accomodation. There was no difference between people living in different types of cohabitation with respect to the number of medicines used. The most commonly used groups of therapeutic medicines were psycholeptic agents, diuretic agents and cardiac drugs, accounting for 41% of the total medicines used. The therapeutic/pharmacological subgroups of medicines used by most people were hypnotic and sedative agents [Anatomical Classification System (ATC) group N05C], used by 26%; cardiac glycosides (ATC group C01A), used by 19%; and loop diuretics (ATC group C03C), used by 17%. Women used significantly more hypnotic, sedative and anxiolytic agents than men. In conclusion, our findings show that a higher proportion than has previously been shown of elderly people living in their own homes use medicines, that women use a higher number of medicines than men only in the age group 80 to 89 years, and that more women than men used psycholeptic agents. Furthermore, the number of medicines used increased only up to the age of 89 years. People living in sheltered accommodation used more medicines than those living in their own homes or nursing homes. Age and gender affect the number of medicines used when the person is living in his or her own home, but not when living in an institution.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS