Application and factor analysis of the menopause rating scale [MRS] in a post-marketing surveillance study of Climen.

OBJECTIVES: The menopause rating scale (MRS) has been developed as a modern tool for the assessment of menopausal complaints. It combines in practice excellent applicability and a good reliability, and there are normal values for the population available. For further practical evaluation, the MRS was applied in order to define the course of menopausal profiles in a large post-marketing surveillance study of a sequential oral hormone replacement therapy (HRT) preparation. MATERIALS AND METHODS: A total of 10904 pre- and postmenopausal women (median age 49 years) with menopausal symptoms who so far had not used the sequential preparation (Climen) were included in the study. Patients were admitted who were experienced with previous HRT (45.2%) or could be classified as never-users (54.8%). Users commonly switched over to Climen due to signs of androgenisation, irregular bleeding, other adverse drug effects as well as inadequate efficiency. Demographic data and medical history were recorded together with a listing of body weight, blood pressure, waist and hip circumference and any skin lesions. Following 3 and 6 months of application, the observation parameters were rechecked and data on tolerability, cycle pattern and adverse drug effects were recorded. Efficacy, tolerability, and reasons for withdrawal were documented. A total of 1801 gynaecologists took part, recruiting an average of six patients in each practice. Pre- and postmenopausal cases with a median age of 49 years were represented with similar frequency. A factorial analysis known as the varimax method was used to define the 'all-or-none' structure of the loadings in order to determine the structure of the variables and their relationship to the menopausal factors. RESULTS: The pre-treatment profile of the menopausal complaints by factor analysis splits up into four independent subscores of the MRS with the factors HOT FLUSHES, ATROPHY, psychological symptoms (PSYCHE), and somatic symptoms (SOMA). Current or ever-HRT did not alter the factorial profile of the MRS. Differences were observed in the intensity of the subscores with a tendency towards weaker symptoms following previous treatment with sequential preparations. SOMA appears to be related to increasing age, postmenopausal status, or co-morbidity requiring treatment. After six months of treatment, factorial loading of HOT FLUSHES, ATROPHY, PSYCHE and SOMA all dropped significantly. CONCLUSION: The MRS in its original ten-item profile suitably characterizes menopause-specific symptoms both with regard to profile and intensity of the symptoms. The MRS adequately monitors differentiated symptom variation with and without hormone replacement. Climen confirmed a wide spectrum of activity in all aspects of the MRS. The subscore structure of the factors remained stable during treatment. Only slight modulations were seen with marked emphasis on psychic aspects and sexual complaints.

[Synthesis and pharmacologic properties of pranolium and its optical isomers]. / Synthese und pharmakologische Eigenschaften von Pranolium und seinen optischen Isomeren.

Propranolol is a well-known powerful betareceptor-blocking agent. Its quaternary dimethyl derivative, designated as pranolium was firstly prepared by Lucchesi. Compared to propranolol it possesses no betareceptor-blocking activity and no local anaesthetic properties but shows the same antiarrhythmic action as the starting material. The synthesis of pranolium and its optical isomers starting from the corresponding propranolol derivatives is described. Their pharmacological activities have been tested. No significant differences regarding the pharmacological action could be observed.

Protection by antiarrhythmic drugs against ischemia-induced arrhythmias occurring during coronary artery occlusion in the rat.

Ligation of the left coronary artery in rats provides a relatively simple model for the assessment of antidysrhythmic compounds. This procedure results in severe arrhythmias in the initial postligation period (extrasystoles, bigeminae, tachycardia and fibrillation). Using this model we have compared the effectiveness of antiarrhythmic drugs which will be referred to class I, II and IV according to the VAUGHAN WILLIAM'S classification. All drugs have been shown to be antiarrhythmic against early occlusion arrhythmias. Especially the antiarrhythmics prevent the rhythm disturbances tachycardia and fibrillation. We conclude from the results that the coronary artery occlusion in rats is a valuable model to use in the screening of drugs for possible antidysrhythmic activity and with differing electrophysiological profiles.