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PubMed1995

Premedication with midazolam in children. Effect of intranasal, rectal and oral routes on plasma midazolam concentrations.

We report a study performed to compare the time and plasma drug concentrations necessary to achieve a similar state of sedation after midazolam premedication given by various routes in children of 2-5 years old. Children were randomly allocated to one of three groups to receive midazolam 0.2 mg.kg-1 given intranasally, 0.5 mg.kg-1 given orally or 0.3 mg.kg-1 given rectally. Sedation was measured regularly until venepuncture was possible in a cooperative child. At this time, a first blood sample was taken to measure plasma concentration, followed by another 10 min later. Anaesthesia consisted of intravenous propofol supplemented with regional analgesia. At recovery from anaesthesia, a third blood sample was taken. Adequate sedation occurred sooner (7.7, SD 2.4 min) with intranasal than oral (12.5, SD 4.9 min) or rectal (16.3, SD 4.2 min) midazolam. The initial blood levels were lower when the drug was given by the alimentary routes despite higher doses (146, SD 51 ng.ml-1 in 11.5, SD 3.9 min; 104, SD 34 ng.ml-1 in 21 +/- 6 min; and 93, SD 63 ng.ml-1 in 23.1, SD 3.5 min for the intra nasal, rectal and oral routes respectively). Duration of surgical procedures, and of propofol infusion, and recovery from anaesthesia was similar for the three groups. The only problem arose in a 30-month-old boy in the intranasal group who developed respiratory depression with a plasma midazolam concentration of 169 ng.ml-1. Intranasal midazolam is an excellent alternative for rapid premedication provided that respiratory monitoring is used.

Administration, Intranasal↗
PubMed1979

A prospective, controlled trial of six forms of hormone replacement therapy given to postmenopausal women.

This study was undertaken to investigate the effect of various forms of hormone replacement therapy (HRT) upon postmenopausal women while controlling as many variables as possible. It was felt that the age, duration of amenorrhoea and the general health of the patients should be as comparable as possible and that each patient should provide her own pretherapy and post-therapy control data. In addition, it was felt that any placebo effect should be investigated and the patients were therefore randomly allocated to placebo tablets or one of six available forms of HRT. The age/sex registers of two large general practices were scrutinized and all women between 49 and 54 years of age were asked to cooperate; for a variety of reasons only 56 women were suitable and willing to take part in the project, yielding 8 women for each of the seven possible therapy groups. Blood samples were taken at 7-day intervals three times before therapy was given and the mean of the three values was used as the control value. The women returned on day 21 of each subsequent therapy cycle for six consecutive months and finally three months after discontinuing therapy. From the data the following broad conclusions can be drawn: (i) some women have classic symptoms of hot flushes and sweating despite high endogenous oestrogen concentrations; (ii) vaginal cytology is a relatively poor indicator of endogenous oestrogen status; (iii) while follicle stimulating hormone (FSH) and luteinizing hormone (LH) concentrations are reduced on HRT neither is decreased to anywhere near premenopausal values while prolactin is unaffected; (iv) plasma cholesterol levels are reduced on HRT, the pulse rate is slower and both systolic and diastolic blood pressure are reduced to a small but significant extent; (v) there is no adverse effect upon blood clotting; and (vi) most women experience significant or complete relief of symptoms on all forms of HRT as do some women taking a placebo. The combined preparations containing an oestrogen and progestogen produced vaginal bleeding in only 80 per cent of the women. Thus protection by regular endometrical shedding may not be afforded to all women. As vaginal bleeding is unacceptable to most women if they can achieve the same symptomatic relief without inducing menstruation, it is suggested that women have a low dose oestrogen preparation prescribed cyclically for 6 to 12 months. If therapy is to be maintained for a longer time, uterine curretage should be undertaken at regular intervals to exclude the possibility of endometrial carcinoma developing.

Climacteric↗
PubMed1997

Lack of effectiveness of adjuvant alternating chemotherapy in node-positive, estrogen-receptor-negative premenopausal breast cancer patients: results of a multicentric Italian study. The Breast Cancer Adjuvant Chemo-Hormone Therapy Cooperative Group (GROCTA).

A multicentric randomized trial was performed in premenopausal women with node-positive, estrogen-receptor-negative breast tumors to assess the potential superiority of alternating adjuvant chemotherapy over 'standard' CMF chemotherapy. Between January 1989 and June 1992, 107 patients were entered into the study and randomly allocated to receive either cyclophosphamide 100 mg/m2 per as on days 1-14, methotrexate 40 mg/m2 and 5-fluorouracil 600 mg/m2 intravenously (i.v.) on days 1, 8 (CMF), every 4 weeks for a total of 6 cycles, or the following regimens: CMF as previously; epidoxorubicin 75 mg/m2 i.v. on day 1 and vincristine 0.75 mg/m2 i.v. on days 1, 8 (EV); mitomycin-C 10 mg/m2 i.v. on day 1 and vindesine 2 mg/m2 i.v. on days 1, 8 (MVs). The three regimens were given every 4 weeks for a total of 6 cycles according to the following schedule: CMF, EV, MVs, CMF, EV, MVs. At a median follow up of 48 months (range 30-72), 40 patients have relapsed and 17 have died overall. More patients in the triple-combination arm have relapsed and more have died, the latter difference tending toward statistical significance (p = 0.06). There was no statistical difference in the site of relapse between the two groups. Total duration of adjuvant therapy was similar in the two arms (312 chemotherapy cycles in the triple arm and 308 in the CMF arm). Treatment toxicity was also comparable, although more patients in the triple-combination arm were still regularly menstruating 6 months after the completion of chemotherapy. This study failed to show any advantage ensuing from the use of alternating chemotherapy in patients with early breast cancer.

Adult↗
PubMed1992

Clinical effect of sizofiran combined with irradiation in cervical cancer patients: a randomized controlled study. Cooperative Study Group on SPG for Gynecological Cancer.

To evaluate the clinical effect of a biological response modifier (BRM), sizofiran (SPG), combined with irradiation, a randomized controlled study was performed in patients with stage II or III cervical cancer involving the collaboration of 52 institutes throughout Japan. Patients were randomly allocated to the control group (radiotherapy only) and the SPG group (radiotherapy + SPG). SPG was given intramuscularly, 40 mg once and 20 mg twice, a week concomitantly with radiotherapy. A total 315 patients were enrolled for the study but 23 were excluded from analysis. Of the remaining 292 patients, 121 were of stage II (43 controls and 78 SPG) and 171 of stage III (49 controls and 122 SPG). The results were as follows. (1) The complete response (CR) rate among stage II patients was higher in the SPG group (91.0%) than in the control group (79.1%); also the CR rate among stage III patients was significantly higher in the SPG group (77.9%) than in the control group (61.2%). (2) The SPG group showed a significantly rapid recovery from the decreased lymphocyte counts due to radiotherapy (P less than 0.05). (3) Side effects, probably associated with SPG administration, were observed in 11 cases (5.2%).

Adult↗
PubMed2005

[General practitioners' views on the cooperation with nursing homes].

BACKGROUND: In addition to the coordination between primary and secondary health care, the collaboration between the general practitioner (GP) and the community-based nursing services is a challenge. While the GPs are responsible for his or her list patients' needs, the organisational structure and resource allocation of nursing home services is a community-based responsibility. MATERIAL AND METHODS: Data on GPs' view on collaborative aspects of nursing home services was collected in a cross-sectional questionnaire survey among all Norwegian list-patient GPs in 2004 (N=1633). RESULTS: Out of the 1637/3338 (48%) responding GPs, 1180 (72%) performed community-based services; 462 (37%) of the latter as nursing home physicians. Four out of five GPs found physician-based services for their list patients satisfactory. The GPs had an influence on the provision of nursing and care services in approximately 50% of cases. The less satisfied GPs were less frequently informed when their list patients received nursing home beds and less frequently asked to contribute patient information when the need for nursing home facilities was assessed. These latter GPs were more often of the opinion that GPs should play a major role in the decision for home-based versus nursing home services. INTERPRETATION: Although there is a potential for improvement in the exchange of information between nursing homes and GPs, 80% of the GPs were satisfied with physician-based services in nursing homes.

Attitude of Health Personnel↗
PubMed1985

A randomized trial of adjuvant chemotherapy and immunotherapy in Stage I and Stage II cutaneous melanoma. An interim report.

Seventy patients with Stage I and II malignant melanoma were randomized to treatment with either intravenous dacarbazine alone or intravenous dacarbazine plus intradermal injection of the methanol-extracted residue of bacillus Calmette-Guerin (BCG). Analysis of treatment failed to reveal a statistically significant difference between these two forms of treatment in Stage I and II patients. It is possible that chemoimmunotherapy may increase survival in Stage II patients, but this possibility should be interpreted with caution.

Adult↗
PubMed1980

The management of the open perineal wound using a foam elastomer dressing: a prospective clinical trial.

In an attempt to improve the management of the perineal wound after abdominoperineal excision of the rectum we have assessed the value of foam elastomer, a catalysed silicone polymer dressing. The substance has already been used successfully in the treatment of open, granulating wounds at other sites (1). On the fourteenth postoperative day 50 patients with open perineal wounds were randomized to receive either conventional gauze packing or treatment with a foam elastomer dressing. Patients were received weekly until healing occurred. When no cavity remained, a dry dressing alone was used. Initial wound volume was calculated in all patients by forming a foam dressing the volume of which was measured by displacement of water. Healing times were shorter in patients who received foam elastomer, but not significantly so. However, less analgesia (P less than 0.01) and fewer district nurse visits (P less than 0.001) were required by patients in the foam elastomer group. This study suggests that foam elastomer dressing is a more comfortable alternative to a gauze pack in the management of the perineal wound and substantially reduces the amount of nursing supervision which is required. We recommend its routine use in the management of the open perineal wound particularly in the young and cooperative patient.

Adult↗
PubMed1985

A comparison of the effects of child management and planned activities training in five parenting environments.

This study compared the effects of two procedures designed to enhance the extratraining effects of behavioral parent training. Twenty parents of oppositional children were randomly assigned to either a child management training condition or a combined child management plus planned activities condition. A further 10 nonproblem children and their parents served as a social validation group. Observations of both parent and child behavior were conducted in each of five home observation settings (breakfast time, kindy (kindergarten) or school exit, a structured playtime, bathtime, and bedtime). Both training procedures resulted in changes in both child oppositional and parent aversive behavior in all observation settings. In addition, desired positive parenting behaviors also improved in all settings. Treatment effects were maintained in all settings at 3-month follow-up. Comparisons between oppositional children following treatment and children in the social validation group showed that they each displayed similarly low levels of oppositional behavior in all settings. The implications of the results for facilitating generalized changes in behavioral parent training are discussed.

Adult↗
PubMed1990

Observer reliability in detecting surreptitious random occlusions of the monaural esophageal stethoscope.

The esophageal stethoscope is used often during anesthesia to monitor ventilation and cardiac function. Deficiencies in observer vigilance may limit the effectiveness of this monitoring instrument. The aim of this study was to determine how long it took for an observer to detect a surreptitiously occluded monaural esophageal stethoscope in the setting of clinical anesthesia. During routine anesthesia, where an esophageal stethoscope was in use, a computer-guided device would artificially, silently, and at random time intervals, occlude the stethoscope tubing. Personnel using the stethoscope noted when they perceived the absence of stethoscope sounds. We studied 320 stethoscope occlusions in 32 patients. The time between stethoscope occlusion and detection was 34 +/- 59 seconds (mean +/- SD). Eighty-seven percent of detections were made in less than 60 seconds. However, 13% of detections were delayed for more than 60 seconds, and 2.3% for more than 240 seconds. While anesthesia personnel using an esophageal stethoscope could detect most stethoscope occlusions, failure to appreciate such episodes occurred in a small but significant number of cases. This suggests that the esophageal stethoscope has some definite limitations as a continuous monitor and that other monitoring techniques, such as oximetry, capnography, and ventilator disconnect alarms, as well as visual/tactile inspection of the patient, should be used as well.

Anesthesia, General↗
PubMed1988

Effects of captopril on survival in patients with heart failure.

Results from a large multicenter study and from the published literature suggest that captopril can improve survival in patients with advanced heart failure. The survival status of 105 patients with moderately severe heart failure who participated in a multicenter, double-blind comparison of captopril and placebo therapy was ascertained on an intention-to-treat basis. During the 90-day double-blind portion of this study, 21 percent (11 of 52 patients) of placebo-assigned patients died compared with four percent (two of 53 patients) of captopril-assigned patients (p less than 0.01). In addition, six previously published studies that provided comparative mortality data were identified. In one of these, the survival rate was reported to be improved in those who received captopril; in the other five studies, no conclusion could be drawn with respect to survival since death was an infrequent event within all treatment groups. Mechanisms by which captopril may improve survival include its favorable effects on hemodynamic parameters, its association with reduced ventricular ectopic activity, and its inhibitory effects on the renin-angiotensin and sympathetic nervous systems.

Captopril↗
PubMed1992

Asthenopia induced by computer-generated fusional vergence targets.

A questionnaire was used to evaluate asthenopia in 30 normal subjects (Ss). Then, each S experienced 3 min of continuous alternating convergent and divergent fusional vergence or a control condition which was identical to the experimental condition, but without any vergence demand, i.e., version. The stimulus was a computer-generated flat fusion red-blue anaglyph picture of a horse. The order of vergence and version conditions were randomized. Asthenopia measures and maximal fusional vergence ranges measures were repeated immediately after each condition. Results indicated a significantly higher rating of asthenopia after induced vergence than version. There were no differences in maximal fusional vergence ranges or recovery values after the two conditions. Correlations between pretreatment asthenopia scores and asthenopia scores after either induced vergence or version were also not significant. Post hoc analyses of Ss grouped as having either high or low asthenopia, according to baseline ratings, revealed no significant differences in vergence or version conditions. Alternative hypotheses for these results are presented.

Adult↗
PubMed1992

Acceptability of mifepristone for early pregnancy interruption.

It is the purpose of this article to review the current status of early pregnancy interruption with mifepristone (RU 486) combined with a prostaglandin analogue from the standpoint of its acceptability to women. Also discussed are the need for uniform terminology in acceptability studies, observations from clinical trials in California, France, and the United Kingdom, and comments on eventual utilization in developing countries.

Abortion, Induced↗
PubMed1986

Duodenal ulcer healing after presentation with haemorrhage.

Forty patients who were managed conservatively after haemorrhage from an endoscopically verified duodenal ulcer were randomised at discharge from hospital to enter a blind study of ranitidine therapy (150 mg bd) versus a placebo tablet. The patients were re-endoscoped after four weeks, ulcer status defined and the trial code broken revealing that five of 20 placebo patients had healed their duodenal ulcer compared with 16 of 20 ranitidine patients (p = 0.001). Lifestyle parameters of both groups improved during the study period but no directly related benefit in duodenal ulcer healing could be shown. We conclude that effective anti-ulcer therapy, such as ranitidine, is required to heal a duodenal ulcer which presents with haemorrhage.

Clinical Trials as Topic↗
PubMed2005

Enhancements and justice: problems in determining the requirements of justice in a genetically transformed society.

There is a concern that genetic engineering will exacerbate existing social divisions and inequalities, especially if only the wealthy can afford genetic enhancements. Accordingly, many argue that justice requires the imposition of constraints on genetic engineering. However, it would be unwise to decide at this time what limits should be imposed in the future. Decision makers currently lack both the theoretical tools and the factual foundation for making sound judgments about the requirements of justice in a genetically transformed society. Moreover, focusing on the uncertain inequities of the future may result in failure to give priority to more pressing inequities of the present. Especially in a country that recently has enacted tax legislation that will widen existing wealth disparities, concern about the distant threat of a genetic aristocracy appears misplaced.

Cognition Disorders↗