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Biomedical subjects

H A Guess

Publications and source records attributed to H A Guess.

At least 109 records · Page 6Linked to original sources

Clinical profile of angioedema associated with angiotensin converting-enzyme inhibition.

Based on data from three studies with complete recording of adverse events in about 12,000 patients each, we determined that angioedema in association with the angiotensin converting-enzyme inhibitor enalapril maleate occurred during the first week of therapy at the rate of one case per 3000 patients per week. Thereafter, the incidence was 14-fold lower, without evidence of a temporal trend in incidence beyond the first week of therapy. The cumulative incidence was one case per 1000 patients treated (0.1%). An additional 138 case reports consistent with the diagnosis of angioedema were obtained from our overall controlled and marketed experience using enalapril in more than 1.2 million patients. These reports were examined to further characterize the reaction. The cases generally were mild, and they resolved on discontinuation of drug therapy. Seven patients experienced angioedema or urticaria in association with both enalapril and captopril, a structurally different angiotensin converting-enzyme inhibitor. This further suggested that the side effect is mechanism based. If angioedema is suspected, therapy with any angiotensin converting-enzyme inhibitor should be interrupted promptly, respiratory distress should be treated appropriately, and subsequent therapy should be initiated with an agent from an alternative class of medication.

Angioedema↗

Fatal upper gastrointestinal hemorrhage or perforation among users and nonusers of nonsteroidal anti-inflammatory drugs in Saskatchewan, Canada 1983.

We report a cohort study of fatal upper GI hemorrhage and/or perforation in relation to use of nonsteroidal anti-inflammatory drugs (NSAIDs) among the one million residents of Saskatchewan Canada in 1983. All hospitalized cases of GI hemorrhage and/or perforation with a fatal outcome were identified using the records linkage system of the Saskatchewan Department of Health. Discharge summaries and autopsy records were reviewed to select the cases of upper GI hemorrhage or upper GI perforation and to exclude cases in which known risk factors were present. The 134,060 residents who filled one or more prescriptions for an NSAID in 1983 were identified and individually linked to their hospital records by patient identification number. The age- and gender-specific incidence of fatal upper GI hemorrhage and/or perforation in the absence of risk factors in users was compared to that in nonusers, controlling for recent history of upper GI disease. Fatal upper GI hemorrhage or perforation in temporal association with NSAIDs is extremely rare in persons younger than 75 years of age. No temporally-related cases occurred in male NSAID users age 75 and older, but NSAID usage in this group was limited. Among women age 75 and older, the rate in users was higher than in nonusers, with the highest rate being in female NSAID users age 75 and older with a recent history of upper GI disease. Total mortality among women age 75 and older was slightly lower among users than among nonusers. Physicians who prescribe NSAIDs to patients age 75 and older should be aware of the potential risks, particularly in those with predisposing factors such as a history of upper GI disease.

Adult↗

Postmarketing surveillance for neurologic adverse events reported after hepatitis B vaccination. Experience of the first three years.

In 1982, the Centers for Disease Control, the Food and Drug Administration, and the manufacturer created a surveillance system to monitor spontaneous reports of adverse events occurring after inoculation with the new plasma-derived hepatitis B vaccine (Heptavax-B, Merck Sharp and Dohme, West Point, PA). In the three years between June 1, 1982 and May 31, 1985, an estimated 850,000 persons received the vaccine. During that period, a total of 41 reports were received for one of the following neurologic adverse events: convulsions (five cases), Bell's palsy (10 cases), Guillain-Barré syndrome (nine cases), lumbar radiculopathy (five cases), brachial plexus neuropathy (three cases), optic neuritis (five cases), and transverse myelitis (four cases). Half of these occurred after the first of three required vaccine doses. There were no deaths. Calculation of the relative risks of these illnesses after hepatitis B vaccination was highly dependent on diagnostic classification of the cases, estimates of the size of the vaccinated population, background incidence of the diseases, and the length and distribution of the hypothetical at-risk interval used in the analysis. Other factors important in judging the results of the study could not be measured, including underreporting. In some analyses, Guillain-Barré syndrome was reported significantly more often than expected (p less than 0.05, Poisson probability distribution). However, no conclusive epidemiologic association could be made between any neurologic adverse event and the vaccine. Even if such an association did exist, the preventive benefits of the vaccine in persons at high risk for hepatitis B would unequivocally outweigh the risk of any neurologic adverse event.

Evaluation Studies as Topic↗

Epidemiologic programs for computers and calculators. Exact binomial confidence intervals for the relative risk in follow-up studies with sparsely stratified incidence density data.

The authors present a computer program for hypothesis testing and calculation of exact binomial confidence intervals for the adjusted relative risk in follow-up studies involving multiple strata with incidence density (person-time) denominators and small or zero person-count numerators. The program is an extension to multiple tables of a single-table method by Rothman and Boice (NIH publication no. 79-1649, Washington, DC: US GPO, 1979) and represents a counterpart for person-time denominators to the program of Thomas (Comput Biomed Res 1975;8:423-46) for exact analysis of multiple tables with person-count denominators. Comparisons with asymptotic analyses of real and simulated data are given. Copies of the program are available from the authors on request.

Adolescent↗

Population-based studies of varicella complications.

Population-based data on varicella complications are presented using information both from national sample surveys of hospitalizations and physician office visits and from reviews of medical records for all cases occurring within one community (Olmsted County, Minnesota) during a specified period. Acute cerebellar ataxia is the most common neurologic complication of varicella and occurs about once in 4,000 varicella cases among children younger than 15 years of age. Among adults, varicella pneumonia is the most common complication and results in hospitalization about once in every 400 varicella cases. Overall, varicella accounts for approximately 4,000 hospitalizations and 364,000 physician office visits annually in the United States and represents an important continuing source of childhood and adult morbidity.

Age Factors↗

A nonlinear least-squares method for determining cerebrospinal fluid formation and absorption kinetics in pseudotumor cerebri.

Data from 14 patients with benign intracranial hypertension (pseudotumor cerebri) have been analyzed using a nonlinear least-squares regression model which was developed and programmed from in-hospital microcomputer use. The method of analysis permits rapid estimation of cerebrospinal fluid (CSF) formation and absorption rates as functions of pressure in individual patients using data from constant-rate infusion manometrics. The analysis predicts that prednisone therapy in pseudotumor cerebri reduces resting CSF pressure by increasing CSF absorption at all intracranial pressures studied, and decreasing CSF formation at high pressures. This result is in accordance with evidence suggesting that impaired CSF absorption plays a major role in the pathogenesis of increased intracranial pressure in pseudotumor cerebri.

Absorption↗

Epidemiology of herpes zoster in children and adolescents: a population-based study.

Medical records were reviewed for all 173 cases of herpes zoster diagnosed among residents of Rochester, Minnesota, less than 20 years of age during the period 1960 through 1981. The incidence of zoster increased with age from 20 cases per 100,000 person-years in those residents less than five years of age to 63 cases per 100,000 person-years in those aged 15 to 19. Morbidity was less than has been described in adults, as only two patients required hospitalization and no postherpetic neuralgia or other late complications were diagnosed. The single case of subsequent cancer found in 1,288 person-years of follow-up was not significantly different from the number expected based on cancer incidence in the general Rochester population. The incidence of childhood zoster in patients with acute lymphocytic leukemia was 122 times higher than in children without an underlying malignancy. Chickenpox in the first year of life was found to be a risk factor for childhood zoster, with a relative risk between 2.8 and 20.9. Neither chickenpox in the second year of life nor recent vaccinations were found to be risk factors for childhood zoster.

Adult↗

Live attenuated varicella virus vaccine. Efficacy trial in healthy children.

We conducted a double-blind, placebo-controlled efficacy trial of the live attenuated Oka/Merck varicella vaccine among 956 children between the ages of 1 and 14 years, with a negative clinical history of varicella. Of the 914 children who were serologically confirmed to be susceptible to varicella, 468 received vaccine and 446 received placebo. The vaccine produced few clinical reactions and was well tolerated. There was no clinical evidence of viral spread from vaccinated children to sibling controls. Approximately eight weeks after vaccination, 94 per cent of the initially seronegative children who received vaccine had detectable antibody to varicella. During the nine-month surveillance period, 39 clinically diagnosed cases of varicella, 38 of which were confirmed by laboratory tests, occurred among study participants. All 39 cases occurred in placebo recipients; no child who received vaccine contracted varicella. The vaccine was 100 per cent efficacious in preventing varicella in this population of healthy children (P less than 10(-9).

Adolescent↗

Chickenpox hospitalizations among residents of Olmsted County, Minnesota, 1962 through 1981. A population-based study.

Age-specific incidence rates were determined for hospitalizations resulting from complications of chickenpox. We reviewed medical records for all Olmsted County, Minnesota, residents hospitalized for chickenpox during the 20-year period 1962 through 1981. Incidence rates based on these 25 cases showed good agreement with national rates computed from information compiled by the Commission on Professional and Hospital Activities for 669 statistically selected patients, representing about 5% of US varicella hospitalizations from January 1979 through June 1982 (about 4,000 hospitalizations annually). The most common complications were bacterial superinfections in children younger than 5 years old, varicella encephalitis (mainly acute cerebellar ataxia) and dehydration in 5- to 9-year-olds, and varicella pneumonia in adults. The high prevalence of chickenpox and its association with infectious and neurologic complications make it a continuing source of morbidity.

Adolescent↗

Use of cost-effectiveness analysis in planning cancer chemoprophylaxis trials.

We present a conceptual framework for the use of cost-effectiveness analysis in planning cancer chemoprophylaxis trials and evaluating such choices as sample size, study design, diagnostic evaluation, and duration of follow-up. The approach is illustrated by cost-effectiveness calculations for a trial of synthetic retinoids as cancer prophylaxis agents. Our work emphasizes the need for studies large enough to have a reasonable power of detecting 10%-20% reductions in mortality. Conversely, we note that rare but serious idiosyncratic side effects such as those seen the the "swine-flu" vaccination program are likely to escape detection even in trials involving tens of thousands of subjects.

Cost-Benefit Analysis↗

Confidence intervals for the odds ratio in case-control studies: a calculator program for Cornfield's method.

A Hewlett-Packard 67 calculator program is given to compute confidence intervals for odds ratios in case-control studies, using the method of Cornfield and an algorithm of Fleiss. Recent work by Brown has shown Cornfield's method to be superior to other approximate methods of odds ratio confidence interval computation and to agree closely with Fisher's exact method. Although a calculator program for the exact method is available in the literature, the convergence times are frequently in excess of 30 min. The program for Cornfield's method given below typically yields upper and lower confidence limits in less than 2 min.

Computers↗

Hemolysis and acute renal failure following a Portuguese man-of-war sting.

Portuguese man-of-war stings occur frequently at North American beaches. Most produce only local pain and pruritus. A 4-year-old girl who developed a hemolytic reaction and acute renal failure following a severe sting is described. As neither sequela has been previously reported, it is speculated that either the large dose of venom or chance intravenous inoculation may have been responsible. Evidence of hemolysis should be sought in small children with extensive Portuguese man-of-war stings.

Acute Kidney Injury↗