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Biomedical subjects

R Grohmann

Publications and source records attributed to R Grohmann.

At least 55 records · Page 3Linked to original sources
PubMed1989

Adverse effects of clozapine.

Adverse effects related to clozapine were assessed within a post-marketing drug surveillance program, the AMUP study, in two university psychiatric departments. In a randomly selected sample of patients (intensive drug monitoring) ADRs of any type were observed in 76% of clozapine-treated inpatients. Sedation, hypersalivation, increase in transaminases, and EEG changes were most frequently observed, but only rarely required changes in therapy. In 8.1% of 959 patients exposed to clozapine in the total inpatient population of the participating hospitals ADR led to withdrawal of clozapine; in 3.9% reactions judged as severe and potentially life-threatening occurred. Among these latter toxic delirium prevailed. In addition, four cases of severe cardiovascular and respiratory dysregulation were observed with the combination of clozapine and benzodiazepines. These cases and one case of sudden death under clozapine and haloperidol treatment are presented in some detail. The results obtained for clozapine are compared to data from this drug surveillance program for other neuroleptics.

Adult↗
PubMed1989

Agranulocytosis and significant leucopenia with neuroleptic drugs: results from the AMUP program.

In the Federal Republic of Germany adverse drug reactions (ADR) have been continuously assessed at the departments of Psychiatry of Berlin and Munich since May 1979. About 13,000 neuroleptic-treated inpatients were monitored until August 1988. Approximately 1100 patients were exposed to clozapine, 6800 to haloperidol and 6000 to perazine, the two most frequently used neuroleptic drugs. In this 9-year period seven cases of agranulocytosis were observed, all in women. One case occurred with clozapine in monotherapy, the other six with perazine, three times in monotherapy, once in combination with trimethoprim/sulfamethoxazole and in one case each in combination with tricyclic antidepressants. Significant leucopenia (less than or equal to 3000/mm3) was observed in an additional eight cases. On four occasions each butyrophenones (twice in combination with TCA) and tricyclic neuroleptics (once in combination with TMS) were involved. The number of exposed patients per drug is too small for calculation of statistically valid incidence rates, especially in view of the frequent polypharmacy. The course of agranulocytosis was benign in all seven cases and required no other treatment than drug withdrawal in three cases. The early detection by regular WBCs is supposed to be mainly responsible for this and is therefore recommended at weekly intervals. This measure of safety appears most important for all medium potency tricyclic neuroleptics. As to treatment of agranulocytosis, additional measures (antibiotics, intensive medical care) depend upon the severity of the clinical picture.

Adult↗
PubMed1989

Benzodiazepine abuse and dependence in psychiatric inpatients.

Over a period of five and a half years, 792 inpatients with benzodiazepine (BZD) abuse and dependence in accordance with the WHO definition were registered at a university psychiatric hospital. One-quarter of them abused BZD exclusively, while three-quarters suffered from polytoxicomania or were alcohol dependent as well. It was possible to distinguish two groups of patients: one with primary, mainly low-dose, dependence preferring lorazepam and the other with secondary, often high-dose, dependence with diazepam as the main drug. In 108 patients with isolated BZD dependence, withdrawal symptoms of somatic, psychological, or perceptual quality were observed. The severity of the withdrawal syndrome seemed to depend on the time of consumption, dose, mode of withdrawal, and type of BZD compound. Following abrupt cessation, 11 patients with long-standing dependence on high BZD doses developed withdrawal psychoses, presenting a delirious, paranoid-hallucinatory, or depressive-anxious syndrome.

Adult↗
PubMed1989

Prevalence of benzodiazepine abuse and dependence in psychiatric in-patients with different nosology. An assessment of hospital-based drug surveillance data.

Frequencies of abuse and dependence assessed continuously within a drug surveillance system were analysed as a contribution to risk-benefit evaluations of benzodiazepines (BZDs). In 4.7% of 15,296 patients admitted to psychiatric hospitals between 1980 and 1985, BZDs had been involved in some kind of abuse or dependence. Primary BZD dependence, defined as physical dependence on BZDs in patients who had not been dependent before, was observed in about 1% of admitted patients. Linking these data with psychiatric diagnoses revealed a high risk of primary BZD dependence for in-patients (11.8%) with anxiety neurosis (ICD-9, 300.0), and a lower risk for neurotic (300.4) and for endogenous depressives (296.1) (risk 3.7% and 2.7% respectively). Older age was also related to primary BZD dependence. For depressive in-patients, the risk was twice as high in females as in males. Anecdotal observations advocate more systematic investigation of the emotional effects of long-term therapy with BZDs.

Affective Disorders, Psychotic↗
PubMed1989

A case of immune complex hemolytic anemia, thrombocytopenia, and acute renal failure associated with doxepin use.

A 46-year-old man suffering from neurotic depression complicated by alcohol and benzodiazepine dependence developed Coombs'-positive hemolytic anemia and thrombocytopenia with acute renal failure after 5 weeks of monotherapy with doxepin at a final dosage of 100 mg daily. The patient recovered completely after discontinuation of doxepin, blood exchange transfusion, and repeated hemodialyses. He had no history of hematologic abnormalities, exposure to other toxins, or glucose-6-phosphate dehydrogenase deficiency. Because other etiologic factors were ruled out, the short interval between the onset of the patient's hemolytic crisis and the administration of doxepin highly suggests that doxepin was associated with the complication. To the best of our knowledge, ours is the first report of this adverse effect following doxepin administration.

Acute Kidney Injury↗
PubMed1988

Benzodiazepine dependence--aetiological factors, time course, consequences and withdrawal symptomatology: a study of five cases.

The development and time course of benzodiazepine (BZD) dependence is reported for five case histories. The underlying psychiatric disorders, life-events as potential initiators of BZD use/abuse and psychosocial consequences are discussed. The abstinence symptoms appearing during a course of standardized withdrawal therapy are described in detail. The case reports clearly demonstrate the chronic nature of the development of BZD dependence and of the tendency to increase the dosage which may occur only after years of intake and the gradual appearance of negative effects of chronic BZD intake.

Adult↗
PubMed1986

Consistency of assessment of adverse drug reactions in psychiatric hospitals: a comparison of an algorithmic and an empirical approach.

Within an ongoing drug surveillance project (AMUP) in psychiatric hospitals, a comparative study was carried out to evaluate two methods commonly used in the field of adverse drug reaction assessment. Two raters, who have cooperated with the project since its inception, evaluated 80 randomly selected ADRs twice; first, by an empirical (implicit) approach, and second, 4 weeks later, by using an algorithm as proposed by Kramer et al. 1979. Agreement on medication and related probability ratings was obtained in 81% of all 80 cases for the empirical method (weighted Kappa = 0.41), and in 69% for the algorithmic method (weighted Kappa = 0.62), indicating that agreement exceeded chance for both methods. By comparison with assessments made in previous case conferences of the project, empirical ratings were found to be reliable over time due to homogeneous use of criteria by project raters. In contrast to the reports on the subject, agreement between raters appeared to be superior in the empirical method as compared to the algorithmic assessment. Analysis of disagreements suggested that probability ratings based on the empirical method were nonspecific, due to conventional criteria applied in the project. Inter-rater agreement was reduced by polypharmacy, especially in the case of algorithmic assessments. The consistency of assessment was also lowered by the fact that the 2 methods assigned different weights to particular assessment criteria.

Drug-Related Side Effects and Adverse Reactions↗
PubMed1986

Adverse drug reactions to first- and second-generation antidepressants: a critical evaluation of drug surveillance data.

We reviewed data on adverse drug reactions (ADRs) to first- and second-generation antidepressants, recorded by two different drug surveillance systems. The rate of ADRs that led to discontinuation of the drug in the individual case, assessed within a multi-centered hospital-based drug monitoring system (AMUP), was significantly higher in case of exposure to tricyclics (7.4%) than with the second-generation drugs (3.1%). On the basis of voluntary reports to the Medicines Commission of the German Medical Profession (AMK), profiles of ADRs to the drugs under survey were constructed and compared with data compiled by the WHO. The types of ADRs varied more between second-generation drugs than between tricyclics. Special attention was paid to rare but serious ADRs (e.g. seizures during treatment with maprotiline, and blood dyscrasias attributed to mianserin).

Adult↗
PubMed1986

[Critical remarks on the interpretation of the thermal reaction of the labyrinth to weightlessness and evidence for the validity of the extended Bárány theory].

The literature on the biophysics of the vestibular apparatus in weightlessness is reviewed. The results of caloric in the prone position are compared to those in the supine position. The rate of convection and expansion of the endolymph are evaluated. Bárány's theory continues to be valid, because the rate of convection forms a greater proportion of the effective total stimulus than expansion.

Caloric Tests↗
PubMed1985

Reliability of adverse drug reaction assessment in psychiatric inpatients.

Within an ongoing drug surveillance program in psychiatric hospitals the applicability of an algorithm for judgment on probability of causal relationship of adverse events and drug therapy was tested. Algorithmic interrater agreement was compared to agreement obtained with the conventional criteria used so far within the program in 80 cases by two raters, who had participated in the drug surveillance program since its beginning in 1979. With the use of the algorithm raters agreed on imputed drugs in 86% of all cases; total agreement on drugs and degree of probability was obtained in 69% (weighted kappa 0.618). Raters agreed on total score for the imputed medication in 49% and also on all subscores for the different axes of the algorithm in 43% of all cases. Differentiation of drug-related from illness-related changes, the use of judgmental terms within the algorithm and specific problems created by the frequent use of combinations of drugs with similar profiles of adverse drug reactions (ADR) in psychiatric patients were identified as the main sources of disagreement. Agreement on total judgment was comparable to results from similar studies in the literature using various algorithms, but in contrast to all these studies a higher percent of agreement (80%) was obtained with the use of the conventional criteria in this study.

Antidepressive Agents↗
PubMed1985

[Biophysical aspects on the result of the Spacelab experiment and consequences for Bárány's theory].

On testing the peripheral vestibular apparatus of astronauts with healthy labyrinths, nystagmus was observed when flushing the ears with hot or cold water even in the absence of gravitation. In the opinion of some scientists, this seems to refute Bárány's theory. They attempt to explain nystagmus as a result of compression. The hypothesis of Bárány, basing on terrestrial conditions, explains the peripheral impulse as the result of a convective flow caused by heating or cooling within the horizontal semicircular canal. However, if gravitation is absent any such circulation is excluded, because buoyancy is impossible without gravitation. The article shows, on the one hand, that the compression hypothesis cannot be correct, where as on the other Bárány's theory needs completion. For, in addition to the convective flow, the expansion of the endolymph resulting from heat must be considered. This effect occurs even in the absence of gravitation.

Aerospace Medicine↗
PubMed1985

[Evidence for the validity of an extended theory of Bárány].

The results published in literature of caloric tests in face-up position are compared to these obtained in face-down position. The rates of convective flow and expansion of the endolymph are evaluated. The theory of Bárány continues to be valid, because the rate of convection is greater than that of expansion. Together with the expansion effect the theory explains caloric nystagmus under terrestrial conditions and under conditions in space, i.e. in the absence of gravitation.

Aerospace Medicine↗