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Biomedical subjects

L Lasagna

Publications and source records attributed to L Lasagna.

At least 127 records · Page 7Linked to original sources
PubMed1977

Analgesic efficacy of an orally administered combination of pentazocine and aspirin. With observations on the use and statistical efficiency of GLOBAL subjective efficacy ratings.

The analgesic efficacy of a combination of pentazocine and aspirin (PA) in the ration 1:13 was compared with that of 650 mg of aspirin alone (A650) and with placebo (PBO), in 98 patients with postoperative pain. Two dose levels of the combination were compared: the lower dose (PA-L) consisted of pentazocine 25 mg and aspirin 325 mg, while the higher dose (PA-H) consisted of pentazocine 50 mg and aspirin 650 mg. All active treatments performed significantly better than PBO. PA-L performed as well as A650, while PA-H performed significantly better than A650. In addition to the usual subjective measures of analgesia, we obtained in 74 patients an evaluation of the overall (GLOBAL) performance of the treatment. This was rated on an ordinal scale of 1 ("poor") to 5 ("excellent"). On the GLOBAL scale, PBO had a mean score of 2.4 (fair-good); A650 and PA-L had scores of 3.6 and 3.9 respectively (good-very good): and PA-H had a score of 4.5 (very good-excellent). In five of six comparisons between treatment means, GLOBAL had the best discriminating power of all six measures. In the two comparisons of greatest interest (A650 against PBO and PA-H against A650), GLOBAL was more than twice as efficient as the TOTAL (summed pain score) measure. In comparing the statistical efficiency of different measures of the same analgesic effect, there is a problem in determining what are "clinically equivalent differences" on the various analgesic scales employed. We propose the use of the observed sample differences and the safeguard of repeating the comparisons over several studies to minimize the effect of random-origin bias.

Adult↗
PubMed1977

Toward the operational identification of adverse drug reactions.

The evaluation of adverse drug reactions in clinical practice is somewhat arbitrary and is characterized by considerable differences of opinion. This report presents a decision table algorithm approach toward the development of an operational system for the identification of adverse drug reactions. The algorithm incorporates an estimate of the certainty of the link between the untoward clinical event and the suspect drug, and examines the underlying causes of the identified drug reactions. Use of such a system is a first step toward reducing ambiguity in the evaluation of adverse drug reactions.

Documentation↗
PubMed1977

Free-living volunteer's motivations and attitudes toward pharmacologic studies in man.

Two groups of volunteers who had participated in pharmacologic studies were interviewed about their impressions of such studies. One group was from a university community, the other from the pharmaceutical industry. The differences between the two groups were correlated with their respective backgrounds. Both groups had favorable impressions about drug studies and investigators. Most were satisfied with the information given them about the nature and risks of the studies, but some believed that a written description of the study that they could consult at home would improve their understanding of the information. Financial reward was the primary reason given by both groups for volunteering, but the perceived risk of the study was the ultimate deciding factor. The volunteers disliked having their mobility restricted and for this reason might not be willing to participate in long-term studies, such as those formerly carried out in prisons. Alternative sources of volunteers for long-term studies will have to be found.

Adult↗
PubMed1977

The role of benzodiazepines in nonpsychiatric medical practice.

The benzodiazepines are widely prescribed by many physicians for patients with depression, anxiety reaction, circulatory disorders, digestive disorders, tension headache, and pain in chest and back. According to various studies there is reason to believe that benzodiazepines not only possess the anxiolytic effects universally attributed to them but may also ameliorate somatic complaints affecting such systems as the cardiovascular and the gastrointestinal. twhether the bensodiazepines affect organ systems known to be linked in important pathophysiological ways to the nervous system deserves further study.

Anti-Anxiety Agents↗
PubMed1977

Prisoner subjects and drug testing.

Objections to prison research are based more often on opposition to the evils of prison life than to unethical practices and to the memories of atrocities committed in the name of science in Nazi prison camps during World War II. The National Commission's pronouncements on prison research specifically illustrate this general phenomenon. Having decided that research on prisoners can be performed ethically, and having learned that most prisoner volunteers bitterly resent being deprived of the opportunity to participate in research, the Commission has nevertheless stipulated prison conditions that cannot realistically be met and thus has de facto eliminated such research. The most serious potential loss is the elimination of the unique facility in Lexington, Kentucky--the Addiction Research Center. Predicting the addiction liability of drugs is not likely to be feasible in any nonprison setting, so that the addiction potential of new marketed drugs will be established in the future as it was in the past--by trial-and-error in patients, who will become the unwilling, uninformed research subjects in this area.

Ethics, Medical↗
PubMed1976

Oral contraceptive patient information. A questionnaire study of attitudes, knowledge, and preferred information sources.

A questionnaire was designed to assess attitudes, knowledge, and views and sources of drug information on oral contraceptives, with particular attention to the role of the patient-oriented package insert. An analysis of 828 completed questionnaires shows that many women are apprehensive about the safety of oral contraceptives. The impact of the patient-oriented oral contraceptive insert on the women surveyed appears to be positive. The present labeling is read and found useful by most oral-contraceptive users. Patients were variably informed about the correct use and side effects discussed in current labeling, suggesting a need for improved transmission of important drug information. Patients preferred information from health professionals and printed sources over media sources. Balanced label information about risks of oral contraceptives should be made available to improve the likelihood of sound risk-benefit judgments.

Adolescent↗
PubMed1976

Adverse drug reactions-a matter of opinion.

The accurate identification of adverse drug reactions (ADRs) is difficult because ADRs usually present no unique clinical or laboratory findings that demarcate them from the manifestations of concurrent illnesses. The identification of ADRs depends on the clinical assessments of physicians-sometimes the clinician treating the patient and at other times a clinical pharmacologist. Considering the complex and subjective nature of clinically identifying ADRs, how accurately are ADRs identified? To answer this question, three clinical pharmacologists each independently evaluated 60 selected cases to determine if medication, alcohol, or "recreational" drugs had caused the hospitalization. The three clinical pharmacologists agreed on only 30 cases (50%), and 27 of these were thought to be unrelated to medications. In 19 of the 30 cases about which the clinical pharmacologists disagreed, they disagreed on whether or not a medication-or alcohol-related event had occurred at all. The clinical pharmacologists disagreed with the physicians treating the patient in 22% to 37% of the cases, but because of the differences among the pharmacologists, the treating physicians agreed with at least one of them in 95% of the cases. Complete agreement between the clinical pharmacologists and the treating physicians occurred in 47% of the cases. This degree of disparity in the clinical identification of ADRs shows that the evaluation of ADRs is subjective and imprecise. The accurate identification of ADRs awaits the development of an objective technique for recognizing ADRs.

Alcoholic Intoxication↗
PubMed1976

Clinical response and plasma levels: effect of dose, dosage schedules, and drug interactions on plasma chlorpromazine levels.

Plasma chlorpromazine (CPZ) levels of 50 psychotic inpatients were measured by gas liquid chromatography; the clinical progress of 29 of these patients with acute psychoses was also assessed. CPZ levels of 50-300 ng/ml were usually associated with clinical improvement; there was also a relationship between CPZ levels and increases in certain symptoms. The 50-300 ng/ml level was best attained by doses of 400-800 mg/day. Trihexyphenidyl decreased plasma CPZ by a mean of 44.7% in 12 of 15 patients. A single 400-800-mg dose of CPZ at bedtime produced steady states equal to or better than those achieved with multiple doses. Those patients who failed to attain CPZ levels of more than 70 ng/ml despite doses of 400-1000 mg/day were receiving lithium throughout the study and had discharge diagnoses of manic-depressive psychosis, manic type, and schizo-affective schizophrenia--a finding with implications for future research.

Acute Disease↗