Withholding nutrition and mistrusting nurturance: the vocabulary of In re Conroy.
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Biomedical subjects
Publications and source records attributed to R A Burt.
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We compared fenoprofen calcium, 200 mg; fenoprofen calcium, 400 mg; aspirin, 650 mg; and a placebo in 85 women for the relief of primary dysmenorrhea in a double-blind, clinical trial. The usefulness of these drugs was judged from data obtained over four consecutive menstrual periods on: restriction of daily activity, pain intensity scores, need for rescue analgesics, withdrawal due to lack of efficacy, and adverse events. Both fenoprofen, 200 mg, and fenoprofen, 400 mg, offered significant (P less than .01) pain relief when compared to placebo and aspirin. Analyses of data on 1, 2 and 3 indicated that aspirin was not significantly different from placebo. The aspirin-treated group reported the greatest number of adverse reactions, but the differences between the four groups were not statistically significant. Our study lends support to the concept of a "plateau analgesic effect" of nonsteroidal antiinflammatory drugs (NSAIDs): fenoprofen, 200 mg, appears to be as effective as fenoprofen, 400 mg. When this type of drug fails to provide relief for a woman suffering from primary dysmenorrhea, switching to another NSAID may be more appropriate than increasing the dosage and the probability of dosage-related side effects.
The evaluation of adverse drug reactions (ADR) in clinical practice is difficult and imprecise. Establishing a causal relationship may not be possible, and data on incidence cannot be obtained because the number of patients treated is not known. This article describes the ADR reported during the clinical trial program of cinoxacin, a synthetic antibacterial drug used to treat urinary tract infections. Results from 2,801 patients who received cinoxacin showed that 5 per cent reported ADR that were probably or definitely drug induced, and 10 per cent reported ADR in which the relationship was uncertain. There was no relationship between number of reports and patient's age, drug dose, or duration of treatment. Adverse drug reactions affecting the gastrointestinal system were reported by 5.5 per cent of the patients, those involving the central nervous system by 4.3 per cent, and hypersensitivity reported by 2.4 per cent. In the comparative studies, patients treated with cinoxacin reported fewer ADR than those treated with nalidixic acid, furadantin, amoxicillin, or trimethoprim-sulfamethoxazole. Although problems in the assessment and evaluation of ADR still exist, it is hoped that the results from the formal trial program will be representative of those seen in clinical practice.
This paper reviews the adverse events reported by 12,917 patients treated with cephalexin in formal clinical trials. Six percent of all patients reported adverse events, and in 3% the association with the drug was thought to be definite or probable. In the remaining 3%, the relationship was uncertain. The gastrointestinal system was most commonly involved, with diarrhoea being reported by 164 patients. Patients in the upper and lower age ranges reported more events than those in the middle range, and most events were reported 6-15 days after treatment started. Patients who received cephalexin 4 times a day reported more events than those who were treated twice daily. Four hundred and sixty-two patients had a known sensitivity to penicillin, and all except 21 of these were treated with cephalexin without developing a sensitivity reaction.
This prospective, double-blind, parallel, two clinic study compared fenoprofen calcium, 200 mg; ibuprofen, 400 mg; and placebo in the treatment of pain due to primary dysmenorrhea. By various criteria, the treatment groups, prior to treatment, were not significantly different (P greater than 0.05) in paired comparisons. However, after oral administration of the study medications, the pain scores were significantly greater (P less than 0.05) for the placebo group than for either other group. The posttreatment pain scores for the fenoprofen and ibuprofen treated groups were not significantly different (P greater than 0.05).
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Fifty-nine female patients with a history of at least three episodes of urinary tract infection in the preceding year were enrolled in a two-center, double-blind study comparing cinoxacin and placebo as preventive therapy. Evaluation of efficacy was based on the results from 41 patients for whom complete data were available. In the cinoxacin-treated group, 18 of 20 patients remained asymptomatic during the study, compared with 11 of 21 patients in the placebo group. This difference between the two treatment groups was significant (P = 0.031). One patient in the cinoxacin group and eight patients in the placebo group developed an infection during the study. This difference was also significant (P = 0.045). Nine patients spontaneously reported adverse reactions, four in the cinoxacin group and five in the placebo group. In four instances, these were sufficiently severe for the treatment to be withdrawn from one patient who received cinoxacin and three patients who received placebo. The results of this study have shown that cinoxacin was significantly more effective than placebo in preventing urinary tract infection in patients with a history of frequent recurrent infections.
A double-blind study comparing parenteral morphine, 8 mg, with parenteral placebo and with oral fenoprofen, 200 mg, for the relief of postoperative pain following outpatient surgery was undertaken in 90 patients. The study drugs were administered within 2 hours of the operation and the Visual Analogue Scale was used to assess pain intensity. Patients given placebos showed minimal change in mean pain intensity, whereas patients who received morphine had significantly less pain at all assessment periods. Pain relief in patients who received fenoprofen was, for the first 2 hours, better than following placebo but not as good as following morphine, but thereafter, there was no significant difference between the morphine and fenoprofen and both were significantly better than placebo. It is concluded that oral analgesics may be a useful alternative to the traditional parenteral analgesics for outpatient surgery.
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1 Benoxaprofen is a new acidic anti-inflammatory compound which was well absorbed after oral administration to man. 2 Single doses of 100, 200 and 400 mg produced mean peak concentrations in the plasma of 13.0, 33.5 and 45.3 microgram respectively, and the plasma half-life of the compound was between 30 and 35 hours. 3 Multiple dosing with 25 and 50 mg every 24 h achieved an equilibrium conentration in the plasma after 6-8 days, while dosing with 100 mg every 12 h enabled equilibrium to be reached in 3-6 days. Plasma concentrations between 35 and 45 microgram/ml were achieved by giving 100 mg doses every 12 hours. 4 Absorption of benoxaprofen was delayed when the drug was given with food, but the total amount absorbed remained the same. 5 The effect of milling the material to small particle size (19 micron) was to increase the rate of absorption compared to that of unmilled material (58 micron). 6 Benoxaprofen was well tolerated by healthy male subject in the doses given.
Cinoxacin, a synthetic antibacterial compound, was given orally in a dose of 500 mg to 8 patients undergoing transurethral prostatectomy. The drug was well absorbed and the peak plasma level (mean 13.9 mcg/ml) occurred 1 or 2 hours after administration. Concentrations of cinoxacin in the urine reached a peak (mean 236.5 mcg/ml) 4 to 6 hours after dosing, and remained higher than the mean MIC for most common urinary pathogens for 12 hours after administration. The concentration of cinoxacin in prostatic tissue 2.5-4 hours after administration varied between 0.6 and 6.3 mcg/g. The individual variations were unrelated to the concurrent plasma level and appeared to be influenced more by inter-subject variation than by the physicochemical properties of the drug. In 1 patient the cinoxacin level was estimated in renal tissue (70.1 mcg/g), in muscle (12.6 mcg/g), and in perirenal fat (4.7 mcg/g).
The authors delineate aspects of adolescent psychological development that should be considered in decisions regarding psychiatric residential treatment, reviewing the issue of consent to treatment in the context of developmental psychology. They state that rather than jettisoning the whole system of placing treatable disturbed young people in residential facilities without their explicit consent, the court should take as its proper role to ensure that adolescents placed in residential psychiatric facilities receive adequate treatment.
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