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Biomedical subjects

N S Rawson

Publications and source records attributed to N S Rawson.

At least 37 records · Page 2Linked to original sources
PubMed1991

Randomised trial of epirubicin alone versus 5-fluorouracil, epirubicin and mitomycin C in locally advanced and metastatic carcinoma of the pancreas.

Sixty-nine unselected patients with locally advanced and metastatic carcinoma of the pancreas, who had not received previous chemotherapy or radiotherapy were randomised to receive either 5-fluorouracil, epirubicin and mitomycin C (FEM) or epirubicin. Survival was not significantly different in the two arms. Toxic reactions (WHO grade greater than 3) in the FEM and epirubicin arm respectively included nausea (2), (4), severe alopecia (1) (3) and leucopenia (1), (5), none of these were statistically significant. We therefore suggest that combination chemotherapy should not be used in preference to single agent chemotherapy as standard treatment for locally advanced or metastatic cancer of the pancreas.

Antineoplastic Agents↗
PubMed1991

Prescription-event monitoring of 10,895 patients treated with alprazolam.

'Prescription-event monitoring' (PEM) is one of two national systems of post-marketing surveillance in operation in Britain. It identified 22,065 patients who had received NHS prescriptions for alprazolam, and data available on 10,895 of these were analysed. The main reasons for treatment with alprazolam were anxiety and depression. The patients provided 3360 patient-years of treatment and 7540 patient-years of follow-up. No serious events clearly associated with treatment were recorded. The main events reported during treatment, albeit infrequently, were drowsiness and depression, although depression is more likely to be due to the disorder being treated than to the drug. Some of the other alleged unwanted effects of alprazolam in published reports were not encountered. Since PEM is unable to determine the dependence potential of alprazolam, further evaluation of this problem is called for.

Adult↗
PubMed1991

Sedative-hypnotic drug use in Canada.

Although many studies of sedative-hypnotic drug use have been performed in Canada, there has been no national study of the use of these drugs. We have attempted to correct this deficit in our knowledge by using data from an international survey of health care utilization performed in 1968-9 and from the Canada Health Survey (1978-9), the Health Promotion Survey (1985) and the National Alcohol and Other Drugs Survey (1989) to examine sedative-hypnotic use among individuals aged 15 or more. The results suggest that the use of these drugs in Canada is about average for an industrialized society. Several socioeconomic and health care correlates of sedative-hypnotic use were found. The rate of use of these drugs was higher among women, the elderly, separated, divorced or widowed individuals, those who had a secondary school education or less, individuals with a low family income, the retired, and the unemployed. Among women, higher rates of use were reported by those whose main activity was keeping house (as compared with those who were employed outside the home) and by those who lived alone. Higher rates of use were also found for individuals who had consulted a physician or been hospitalized recently, individuals taking multiple drugs, those who scored highly on an anxiety scale, persons in whom negative feelings predominated, and those who had experienced a high frequency of psycho-physiological symptoms of anxiety and depression. From a regional point of view, the highest rates of use for women were consistently reported from Quebec, while the lowest were consistently found in the Prairie provinces. No consistent pattern was found for men.

Adolescent↗
PubMed1990

Prescription-event monitoring: methodology and recent progress.

Event monitoring was first suggested 25 years ago as a way of detecting adverse reactions to drugs. Prescription-event monitoring (PEM), which has been developed by the Drug Safety Research Unit, is the first large-scale systematic post-marketing surveillance method to use event monitoring in the U.K. PEM identifies patients, who have been prescribed a particular drug, and their doctors from photocopies of National Health Service prescriptions which are processed centrally in England. A personalized follow-up questionnaire ("green form") is mailed to each patient's general practitioner, usually on the first anniversary of the initial prescription, asking for information about the patient, especially any "events" that he or she may have experienced since beginning treatment with the drug. The methodology of PEM is presented, together with examples of analyses that can be performed using results from recent studies. The problems and benefits of PEM are discussed.

Drug Prescriptions↗
PubMed1990

An overview of prognostic factors in small cell lung cancer. A report from the Subcommittee for the Management of Lung Cancer of the United Kingdom Coordinating Committee on Cancer Research.

Several studies of small cell lung cancer (SCLC) treatments have been performed in the United Kingdom. In some, prognostic factor analyses were carried out but the results were not entirely consistent. The Lung Cancer Subcommittee of the United Kingdom Coordinating Committee on Cancer Research (UKCCCR) consequently initiated an overview of these studies with the aim of identifying the important prognostic factors using a large number of patients. Information on almost 4,000 patients was available, but it was necessary to perform analyses on smaller subsets because the variables recorded in individual studies were inconsistent. A number of variables contributed significantly to the prediction of likely survival over the 6 months after starting treatment, but performance status (PS), alkaline phosphatase (AlkP) and disease stage were shown to be the most important; aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) may also be useful. A prognostic index was devised for this initial period and validated using independent data. For patients who survived the first 6 months, the pre-treatment variables important for prognosis in the 6-24 month period were stage, PS and plasma sodium (Na). The Subcommittee recommends that performance status, disease stage, AlkP, Na, AST and LDH should be measured in all future SCLC studies to assist comparisons between studies and possibly the selection of patients for different treatment strategies. The additional recording of five other variables would allow a more definitive overview to be performed at some future date.

Adult↗
PubMed1990

Adjuvant chemotherapy in head and neck cancer.

An overview is presented of 23 trials of adjuvant chemotherapy in squamous cell carcinoma of the head and neck. These were reviewed from the point of view of design of the trial, analysis of survival, response rates, meta-analysis, site of failure, toxicity and cost. The minimal increase in survival that could be detected ranged from 11 to 51%, with a median of 25%. No trial was big enough to detect the likely increase of survival, which is 5%. Many trials excluded some eligible patients before randomisation, the proportion being 21% in those series with details. A further 9% of treated patients were excluded from analysis. A response rate in four induction studies of 47% equated with a 6% increase in cancer mortality. Meta-analysis showed an insignificant overall improvement in cancer mortality of 0.5%. Induction chemotherapy, synchronous chemotherapy and induction/maintenance chemotherapy did not affect cancer mortality whereas synchronous/maintenance therapy did. Cisplatinum, methotrexate, bleomycin, 5-FU and a variety of other regimens did not affect the death rate from cancer, but the combination of VBM significantly increased it. Neither single agent nor combination chemotherapy produced a significant reduction of cancer deaths. The rate of locoregional failure was significantly lower in the treated arms, whereas the metastatic rate was similar in both arms. Only three papers gave full details of toxicity with grading: these showed a high toxicity rate. The mortality rate from chemotherapy in nine series averaged 6.5%.

Carcinoma, Squamous Cell↗
PubMed1990

Computerisation of urothelial carcinoma records: 16 years' experience with the TNM system.

Details of 554 patients with urothelial carcinomas have been recorded on computer forms between 1973 and 1988 inclusive. Essential information from initial assessment and follow-up examinations was printed out on specially designed urothelial update sheets, copies of which were given to patients and urologists as well as being filed in the hospital notes. The survival status of all patients was established as accurately as possible in the last 2 years of the study. Multivariate analysis of 462 bladder cancer patients with adequate follow-up indicated that T category was the most important discriminating variable, followed by histological grade. After replacing T category by microscopic depth of invasion and bimanual examination, the latter was found to be the most important single variable. The omission of the findings on bimanual examination from the 1987 revision of the TNM classification therefore appears to be wrong.

Aged↗
PubMed1988

Postmarketing surveillance of enalapril. I: Results of prescription-event monitoring.

To identify and measure the incidence of adverse effects of the angiotensin converting enzyme inhibitor enalapril 13,713 patients were studied for one year by prescription-event monitoring. Precise information about the duration of treatment was available for 12,543 patients. The frequency of many events was calculated, including dizziness (483 patients; 3.9%), persistent dry cough (360; 2.9%), headache (310; 2.5%) hypotension (218; 1.7%), and syncope (155; 1.2%). Less common reactions included angioedema, urticaria, and muscle cramps. Altogether 1098 (8%) patients died and the notes of 913 of them (83%) were obtained for detailed scrutiny. With the exception of a few patients with renal failure who deteriorated during treatment (reported on separately), no death was attributed to enalapril. Enalapril was considered to be effective, even in patients with advanced cardiac failure. These results for enalapril are reassuring and provide further evidence of the value of prescription-event monitoring.

Adolescent↗
PubMed1988

Postmarketing surveillance of enalapril. II: Investigation of the potential role of enalapril in deaths with renal failure.

The possibility that enalapril might damage renal function was investigated in 1098 deaths recorded in a prescription-event monitoring study. Case notes for 913 patients were examined. In seventy five there was a rise in the urea or creatinine concentration of 50% or more above pretreatment values. Enalapril appeared to have contributed to a decline in renal function and subsequent death in 10 of these patients. Several characteristics were identified among these patients, including old age, the use of high dose or potassium sparing diuretics, and pre-existing renal disease. Adding a non-steroidal anti-inflammatory drug was also associated with a deterioration in patients with previously stable renal function. No death was encountered of a patient with uncomplicated hypertension. Enalapril infrequently contributed to a substantial decline in renal function in certain vulnerable patients, especially those receiving other drugs known to be capable of adversely affecting renal function. Awareness of the characteristics of these patients and of their concomitant treatment may serve to reduce the risk.

Acute Kidney Injury↗
PubMed1986

Prescription-Event Monitoring. Recent experience with 5 NSAIDs.

The principles and methods of Prescription-Event Monitoring (PEM) are presented and illustrated by a study of general practice notes of 55,642 patients, who were prescribed one of five non-steroidal anti-inflammatory drugs (NSAIDs). PEM showed the expected side effects and a low incidence of serious adverse reactions. The general pattern of events during and following treatment was, with few exceptions, very similar. The incidence of side effects that have led to the withdrawal of three of the drugs from the market was extremely low. Complications of peptic ulcer were uncommon and deaths from this cause were rare. No difference was apparent in the incidence of serious gastrointestinal complications during or after stopping treatment or changing to another NSAID.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1983

Erythromycin estolate and jaundice.

Using prescription-event monitoring to determine whether erythromycin estolate was a more frequent cause of jaundice than erythromycin stearate or tetracycline 12 208 patients, for whom 5343 doctors had prescribed one of the three drugs, were identified by the Prescription Pricing Authority. Of the questionnaires sent to general practitioners about the possible occurrence of jaundice, 76% were returned. There were 16 reports of jaundice, of which four were attributable to gall stones, three to cancer, six to viral hepatitis, and only three were possibly related to an antibiotic. All three patients, in whom the antibiotic was a possible cause, had been treated with erythromycin stearate. No case was attributable to the estolate which had previously been suspected of being a more frequent cause of jaundice. Although the incidence is unknown, it is very unlikely to be more than one in 100.

Adolescent↗
PubMed1981

Pertussis immunisation and serious acute neurological illness in children.

The first 1000 cases notified to the National Childhood Encephalopathy Study were analysed. The diagnoses included encephalitis/encephalopathy, prolonged convulsions, infantile spasms, and Reye's syndrome. Eighty-eight of the children had had a recent infectious disease, including 19 with pertussis. Only 35 of the notified children (3.5%) had received pertussis antigen within seven days before becoming ill. Of 1955 control children matched for age, sex, and area of residence, 34 (1.7%) had been immunised with pertussis vaccine within the seven days before the date on which they became of the same age as the corresponding notified child. The relative risk of a notified child having had pertussis immunisation within that time interval was 2.4 (p less than 0.001). Of the 35 notified children, 32 had no previous neurological abnormality. A year later two had died, nine had developmental retardation, and 21 were normal. A significance association was shown between serious neurological illness and pertussis vaccine, though cases were few and most children recovered completely.

Acute Disease↗