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PubMed1989

Serum levels of ciprofloxacin after single oral doses in patients with septicemia.

Ciprofloxacin serum levels were measured after administration of the drug to 36 patients with septicemia (at least one positive blood culture) who were able to take oral medication. Patients were randomly allocated to receive ciprofloxacin 500 mg p.o. (n = 21) or 200 mg i.v. over 30 min (n = 15). A first dose was administered 18-30 h after the last positive blood culture (day 1), and a second dose four days later (day 5) in some patients. In addition to ciprofloxacin, standard antibiotics were administered. Organisms isolated were Escherichia coli (15), other gram-negative bacteria (6), Streptococcus pneumoniae (7), Staphylococcus aureus (2), and other gram-positive bacteria (6). None of the patients vomited. Ciprofloxacin serum concentrations 1 h after oral administration were in the range 0.09-2.32 mg/l, and 2 h after administration in the range 0.5-7.27 mg/l. The average terminal half-life was 8.6 h. In individual patients serum concentrations and area-under-the-curve values were compared. Poor correlation was found between values measured on day 1 and day 5 after oral administration, whereas the correlation was excellent after i.v. administration. Serum levels 2 h after oral administration were 30-900 times the MICs for the gram-negative organisms, but were in the range of the MICs for the gram-positive organisms in some cases. In conclusion, ciprofloxacin serum levels are difficult to predict in septicemia patients after oral administration, but probably suffice to treat infections caused by gram-negative organisms.

Administration, Oral↗

PubMed1982

A double-blind study to establish the residual effects of zopiclone on performance in healthy volunteers.

A double-blind study was designed to establish the residual effects of zopiclone on performance in healthy volunteers. 10 healthy male volunteers aged 22-45 years (mean age 27.4 years) were included in this study. 6 of the volunteers were cigar/cigarette smokers and were asked to smoke as little as possible on the study days. The subjects were randomly allocated to a balanced design in which each subject received single oral doses of placebo, 2.5-, 5-, 7.5- and 10-mg tablets of zopiclone under double-blind conditions. A battery of tests were performed 10 and 13 h after overnight ingestion of the drug. The tests comprised: EEG, auditory reaction time, tapping rate, digit symbol substitution test, symbol copying test, mood rating scales, side effects rating scales, and subjective assessments of sleep and performance. Zopiclone is shown to have useful hypnotic properties but residual effects are detectable using EEG and psychological tests both 10 and 13 h after ingestion. The 10-mg dose significantly impairs performance the next day; the 5-mg dose is almost devoid of residual psychomotor effects but is only marginally effective in hastening onset of sleep and does not improve sleep quality. The 7.5-mg dose has definite effects on sleep and limited residual effects the next day. No significant side effects were reported. In this study, using single doses in healthy subjects, the best balance between wanted hypnotic effects and unwanted residual effects the next day was provided by the 7.5-mg dose of zopiclone. It is recommended that further studies with repeated doses in healthy volunteer subjects and in insomniac patients use the 7.5-mg dose as the reference point.

Adult↗

PubMed1989

Alkalinisation of bupivacaine for sciatic nerve blockade.

This double-blind study investigates the effect of pH adjustment of bupivacaine 0.5% with adrenaline 1:200,000 on block latency, duration of analgesia and systemic absorption of local anaesthetic after sciatic nerve blockade. Twenty-four adult patients were randomly allocated into one of two groups: Group A (n = 12) received bupivacaine with adrenaline 1:200,000 (pH 3.9) 2 mg/kg, while Group B (n = 12) received alkalinised bupivacaine with adrenaline 1:200,000 (pH 6.4) 2 mg/kg. Increasing the pH of the local anaesthetic solution significantly reduced block latency from 25 minutes in Group A to 12.5 minutes in Group B (p less than 0.001) and prolonged the duration of useful analgesia from 14.1 hours to 18.3 hours (p less than 0.001). There was no significant difference in plasma bupivacaine levels between the two groups. The results indicate that alkalinisation of bupivacaine reduces time to onset and prolongs the duration of useful analgesia when used for sciatic nerve blockade, without significantly increasing systemic absorption.

Anesthesia, Local↗

PubMed1987

Comparison of phenytoin and gold as second line drugs in rheumatoid arthritis.

Phenytoin has known immunosuppressive properties, and a recent pilot study has indicated that it may have a second line effect in rheumatoid arthritis (RA). To evaluate this role 60 patients with active RA were randomly allocated to receive either oral phenytoin or intramuscular gold. The two treatment groups were comparable at the outset (Mann-Whitney U test). Twenty four patients completed 24 weeks of therapy in each group and no unexpected side effects were encountered. All variables except haemoglobin (Hb) improved significantly in the gold group while in the phenytoin group significant improvement was limited to articular index, erythrocyte sedimentation rate (ESR), and Hb. Between group comparison (Mann-Whitney) at week 24 showed a significant advantage of gold over phenytoin for pain score and morning stiffness. Thus phenytoin appears to exert a less potent second line effect than gold and is unusual in influencing laboratory indicators of disease activity more than clinical variables. This is likely to limit its usefulness as a second line drug in RA.

Arthritis, Rheumatoid↗

PubMed1986

Consultation skills of young doctors: I--Benefits of feedback training in interviewing as students persist.

Thirty six young doctors who as medical students had been randomly allocated to either video feedback training or conventional teaching in interviewing skills during a psychiatry clerkship were reassessed five years later. Each doctor interviewed one patient with a psychiatric illness and two with a physical illness. Each interview was rated independently. Both groups had improved since the fourth year clerkship, but those given feedback training had maintained their superiority in the skills associated with accurate diagnosis. This superiority was as evident in their interviews with physically ill patients as it was with psychiatric patients. Both groups, however, still used "closed" questions and were more reluctant to cover psychosocial problems in physically ill patients. Those trained conventionally were clinically inadequate in both these aspects and in clarifying their patients' statements. Given these lasting benefits, all medical students should have feedback training in interviewing skills.

Education, Medical, Undergraduate↗

PubMed1990

Interaction of tertatolol with rifampicin and ranitidine pharmacokinetics and antihypertensive activity.

The interaction of the new beta-receptor antagonist tertatolol with rifampicin and ranitidine was investigated in ten patients with arterial hypertension (WHO stages I-II). They were treated orally with a single dose of tertatolol 5 mg alone and, after randomized allocation, with ranitidine 150 mg twice daily or rifampicin 600 mg once daily for 1 week each (tertatolol 5 mg was concurrently administered on the seventh day of the treatment phases). Following each therapeutic phase, circadian blood pressure values as well as kinetic parameters were obtained. On treatment with tertatolol alone, maximum plasma concentrations were 123.7 +/- 32.4 ng/ml (mean +/- SD) and were reached after 1.95 +/- 1.77 hours. The tertatolol elimination half-life was 9.0 +/- 7.1 hours. Coadministration of ranitidine did not significantly alter the kinetic parameters and antihypertensive effect of tertatolol. Rifampicin, however, decreased the maximum plasma levels of tertatolol to 80.6 +/- 18.5 ng/ml and markedly shortened the elimination half-life to 3.4 +/- 2.6 hours (p less than 0.01 compared with tertatolol alone). Urinary excretion of parent tertatolol and unchanged 4-hydroxy tertatolol was decreased under rifampicin, and a tendency to a reduction in the effect of tertatolol on circadian blood pressure values was observed. Twenty-four hours after administration, the heart rate in those patients on tertatolol alone (68 +/- 6 beats/min) was lower than in those on tertatolol plus rifampicin (74 +/- 7 beats/min). In conclusion, a pronounced pharmacokinetic interaction, with a limited consequence in terms of pharmacodynamic effects, was found in the present study when tertatolol was administered with rifampicin, but not with ranitidine.

Adrenergic beta-Antagonists↗

PubMed1990

Comparative study of aminosidine, etophamide and nimorazole, alone or in combination, in the treatment of intestinal amoebiasis in Kenya.

417 patients suffering from intestinal amoebiasis were randomly allocated to 6 different treatment groups in a controlled study in 3 District Hospitals in Kenya. The patients received either aminosidine (A), etophamide (E), nimorazole (N), or the combinations NA, NE, EA. Treatment in all cases was given twice daily for 5 days. Before and after treatment, rectosigmoidoscopy was done in each patient, and stool examination with characterization of invasive (IF) and non invasive (NIF) forms of amoeba was done daily throughout treatment, and on Days 15, 30 and 60 of follow-up. Clinical cure was good after all the treatments, varying from 90 to 100%; parasitological cure at the end of treatment was 100% in the NA and EA treatments groups, and 98% in A group. The incidence of relapses was nil in the EA group, followed by 3% in NA and 6% in A groups. Anatomical cure (healing of ulcers) was 97.8% in the NA group, 95.5% in the N group and 88.5% in the A group. Drug tolerance was excellent or good after all the treatments, except that the EA combination produced diarrhoea in 76.5% of patients. Overall analysis of the findings, including tolerance of the various treatments, showed that aminosidine either alone or in combination with nimorazole gave the best results. Ulcers seen on rectosigmoidoscopy were more common in patients excreting invasive forms of amoebae in their stools.

Acetamides↗

PubMed1988

Results of artificial insemination at home by the partner with cryopreserved donor semen: a randomized study.

The use of cryopreserved semen offers the possibility of home insemination by the instructed partner. A comparative study was designed whereby participants were randomly allocated to use home or clinic insemination for six cycles. If no pregnancy had occurred after six cycles, the site of insemination was switched to the opposite location for a maximum of six further cycles. Fifty-three women with primary infertility fulfilling all entry criteria entered the study. In the first 6 cycles out of 29 home starters, 13 pregnancies were conceived, whereas in 24 clinic starters 11 pregnancies occurred, yielding no statistical difference in pregnancy rate. Of 138 couples who did not meet the criteria in the same period, 45 opted for home insemination, resulting in 20 home-inseminated pregnancies. Again, for comparable subgroups no statistical difference in pregnancy rate between home and clinic insemination was found.

Evaluation Studies as Topic↗

PubMed1986

Cytotoxic chemotherapy of disseminated cutaneous malignant melanoma--a prospective and randomized clinical trial of procarbazine, vindesine and lomustine versus procarbazine, DTIC and lomustine.

Forty-three patients with measurable disseminated cutaneous malignant melanoma, stages III-IV, and without previous cytotoxic chemotherapy or immunotherapy, were randomly allocated from 30 June 1980 to 30 November 1984, to receive either a schedule of procarbazine (100 mg/m2 p.o., max 150 mg) days 1-10, vindesine (3 mg/m2 i.v., max 5 mg) days 1 and 8, and CCNU (150 mg/m2 p.o., max 200 mg) day 1, (regimen A), with 4-6 weeks interval between the courses, or a combination of procarbazine (100 mg/m2 p.o., max 150 mg) days 1-10, DTIC (250 mg/m2 i.v. max 400 mg) days 1-5, and CCNU (150 mg/m2 p.o. max 200 mg) day 1 (regimen B), also repeated every 4-6 weeks. Twenty-one patients were treated according to regimen A and 22, by regimen B. Objective responses (three PR, two CR) were seen in 5 out of 21 patients (23.8%) in group A and 8 out of 22 (four PR, four CR), (36%) in the group B, this difference not being statistically significant. The median duration of response was 8 and 10 months, respectively, and the estimated median survival 10 months for regimen A and 14 months for regimen B. Regimens A and B must be regarded as of no value in view of poor response rate and the unacceptable toxicity, respectively. Therefore, we are now conducting a further phase II study, to determine, prospectively, whether the previously noted high response rate obtained with our previous POC protocol can be reaffirmed.

Adult↗

PubMedDate not supplied

[Comparative study of radial and cubital arterial catheterization].

In this prospective study we evaluated catheterization of the cubital artery as an alternative to cannulation of the radial artery. Seventy six surgical patients were randomly allocated into two groups of 38 patients according to the intention to catheterize the cubital or the radial artery. The incidence of failure and the technical difficulties were significantly higher in cubital than in radial arterial catheterization (p less than 0.001 and p less than 0.05, respectively) and they were related to the cubital pulse palpation. There were no significant differences in the time elapsed to achieve the catheterization, time of stability of the catheter, nor in the incidence of complications. The qualification of the technician, the arterial blood pressure and the anatomic characteristics of the forearm did not influence the results. We conclude that whenever the cubital arterial pulse is appropriately perceived, catheterization of this artery is a good alternative to radial catheterization.

Arm↗

PubMed1983

Effect on intra-arterial blood pressure of slow release metoprolol combined with placebo or chlorthalidone.

Thirty patients with essential hypertension participated in a double blind crossover trial in which they were randomly allocated to treatment with either once daily slow release metoprolol (200 mg) with placebo or once daily slow release metoprolol (200 mg) with chlorthalidone (25 mg). Ambulatory intra-arterial blood pressure was recorded continuously for 24-48 hours before treatment and two months after each change in regimen. The response of blood pressure and pulse rate to a standard exercise protocol that included supine rest and tilt, isometric, and dynamic bicycle exercise was measured during the same recording periods. Both treatments appreciably reduced blood pressure and pulse rate; mean daytime intra-arterial blood pressure was reduced from 174/95 mm Hg to 158/85 mm Hg by metoprolol plus placebo and to 143/78 mm Hg by metoprolol plus chlorthalidone. This reduction with the combined treatment was significantly greater than with metoprolol and placebo (p systolic = 0.001, p diastolic = 0.004). Mean night time pressures were reduced from 148/78 mm Hg to 139/75 mm Hg by metoprolol plus placebo and to 116/61 mm Hg by metoprolol plus chlorthalidone. Again the reduction in blood pressure was significantly greater with combined treatment (p less than 0.001) than with metoprolol plus placebo. Once daily slow release metoprolol is effective in controlling blood pressure, but this effect is greatly enhanced by the addition of a diuretic.

Adult↗

PubMed1985

Treatment of essential hypertension: changes in blood pressure, echocardiography and electrocardiography on three therapeutic regimes.

Forty-three patients with essential hypertension were randomly allocated to one of the following treatment regimes; - atenolol, atenolol and hydralazine or methyl dopa. Blood pressure fell into the normal range at 3 months and was similar in all 3 groups. Blood pressure remained controlled over the period of study. M-mode echocardiography was assessed initially, at 3, 6 and 12 months. All groups showed a fall in the measured indices towards the normal range with a significant reduction in left ventricular wall thickness at 3 months in the methyl dopa group and left ventricular mass in the atenolol group alone of 6 months. In conclusion, no one treatment regime appeared to have sustained advantages over another and none of the groups showed any deterioration on echocardiographic criteria during the study.

Adult↗

PubMed1991

Rectal ketamine and midazolam for premedication in pediatric dentistry.

Rectally administered midazolam (0.30 mg/kg) and ketamine (5 mg/kg) were compared for preanesthetic medication in children undergoing dental extractions. Sixty patients between the ages 2 and 9 years were randomly allocated to three groups in this double-blind study. In one group of patients who received ketamine rectally, intravenous midazolam (0.05 mg/kg) also was administered immediately after induction of anesthesia. The results from this trial show that 30 minutes after rectal administration of the two drugs, good anxiolysis, sedation, and cooperation were obtained in most patients. Although midazolam appeared to be marginally more efficacious than ketamine in the majority of assessments made and seemed to have less adverse effects, no statistically significant differences could be shown. Ketamine showed a slight decrease and midazolam a slight increase in average blood pressures after premedication. These blood pressure differences were, however, considered to be of little clinical importance.

Administration, Rectal↗

PubMed1983

Immediate and long-term mental recovery from general versus epidural anesthesia in elderly patients.

The postoperative course of mental performance during the first week and at 3 months after operation was studied in 30 patients above the age of 60, undergoing total hip replacement arthroplasty. The patients were randomly allocated to receive either general anesthesia, epidural analgesia, or general anesthesia plus epidural analgesia. The surgically induced increase in plasma cortisol and glucose was inhibited in the two groups receiving epidural analgesia. Mental performance was studied with psychological methods. An equal degree of postoperative impairment of mental performance of 3-4 days' duration was found in all groups. Three months after surgery, mental function had improved slightly and to the same extent in all groups. We conclude that the after surgery, mental function had improved slightly and to the same extent in all groups. We conclude that the transient mental impairment occurring within the first postoperative week is caused by factors other than general anesthetic agents and the endocrine-metabolic response to surgery.

Aged↗

PubMed1988

The Canadian American Ticlopidine Study (CATS) in thromboembolic stroke. Design, organization, and baseline results.

The Canadian American Ticlopidine Study is a randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy and safety of ticlopidine hydrochloride in patients who have suffered a thromboembolic stroke no less than 1 week and no more than 4 months before entry into the study. The primary assessment of efficacy will be based on the cluster of outcome events recurrent stroke, myocardial infarction, or vascular death. Twenty-five clinical centers, 12 in Canada and 13 in the United States, entered a total of 1,072 patients during a 3-year recruitment period; these patients were randomly allocated to receive either 250 mg ticlopidine or identical-appearing placebo tablets twice daily for up to 3 years. Patient recruitment was completed in December 1986. Patients were followed for a maximum of 3 years or until the close of the study in December 1987; at that time an average follow-up of 25 months had been achieved. We summarize the protocol and organization of the study and document the methods of execution and analysis, with corresponding criteria, before disclosure of the treatment code to any of the study investigators. We also provide a clinical description of the patients at entry into the study.

Aged↗

PubMed1983

Controlled trial of faecal occult blood testing in the detection of colorectal cancer.

20 525 patients from general practitioners' lists were randomly allocated into test and control groups. The 10 253 test subjects were invited to perform haemoccult faecal occult blood testing over 3 days. 3613 (36 . 8%) of the 9807 who received their invitations completed the test. Compliance was improved by direct invitation from the general practitioner and by prior health education by letter or interview. 77 people (2 . 1%) had a positive test result, and 50% of these on investigation had neoplastic disease--12 had invasive carcinomas (9 Dukes' stage A, 2 stage B, 1 stage C) and 27 had 40 adenomas (12 over 2 cm, 2 of which contained areas of severe dysplasia). In the year following the screening test 1 carcinoma (stage C) has presented in the group which accepted the test, and 10 carcinomas (4 stage B, 4 stage C, 2 stage D) have presented in the control group. This respresents a 3 . 6 times greater detection rate per 1000 persons in the test group than in the control group. Only 8 adenomas have presented in the control and non-responding groups. Fibreoptic sigmoidoscopy identified the 10 carcinomas within its range and 39 of the 40 adenomas. Double-contrast barium enema identified only 9 of the 12 carcinomas and 24 (62%) of the 40 adenomas. All 3 carcinomas not identified by barium enema were polypoid Dukes' stage-A lesions.

Adenoma↗

PubMed1989

Controlled trial of twelve versus six courses of chemotherapy in the treatment of small-cell lung cancer. Report to the Medical Research Council by its Lung Cancer Working Party.

A total of 497 patients with histologically or cytologically confirmed small-cell lung cancer were prescribed initial treatment with six courses of etoposide, cyclophosphamide, methotrexate and vincristine at 3-week intervals. Patients with limited disease (74% of the total) also received radiotherapy (40 Gy in 15 fractions in 3 weeks) to the primary site between courses 2 and 3. At the end of this initial treatment, 265 patients still in complete or partial response were randomly allocated to six further courses of maintenance chemotherapy (M series: 131 patients) or to no maintenance chemotherapy (NoM series: 134 patients). Response, as assessed 3 weeks after the second course of initial chemotherapy, was achieved in 85% of the 264 patients assessed, a complete response in 11%. The median survival period from the date of start of chemotherapy was 39 weeks; 154 (31%) of the patients were alive at 1 year, 29 (6%) at 2 years and 17 (3%) at 3 years. The patients' general condition and extent of disease pretreatment correlated significantly with survival. Among the 131 M and 134 NoM patients there was no overall survival advantage to either series (P = 0.27, log rank test), although in 99 patients who had a complete response to initial chemotherapy as assessed at the time of randomisation there was a suggestion that survival was longer in the M series (P less than 0.05, log rank test), the median survival periods from the date of randomisation being 42 weeks for the M and 30 weeks for the NoM patients. Maintenance chemotherapy was associated with additional toxicity and a poorer quality of life as assessed intermittently by clinicians and daily by patients. In conclusion, no worthwhile clinical advantage was achieved by the policy of continuing chemotherapy beyond six courses, except possibly in patients with a complete response to the initial six courses.

Adult↗

PubMed1981

Randomized trial of drainage after cholecystectomy. Suction vaersus static drainage through a main wound versus a stab incision.

One hundred eighty-four patients who underwent biliary surgery were randomly allocated to four groups arranaed in a 2 by 2 design. In 92 patients the drain was brought out through the wound and in the other 92 through a stab incision. In half of the patients in each group the drain was connected to a suction system and in the other half to a sterile bag. Suction was found to impair rather than enhance intraperitoneal drainage. In patients who underwent elective cholecystectomy and early operation for acute cholecystitis, the amount of discharge was more than twice as large when suction was omitted than when it was applied. After common duct operations the amount of discharge was very large and there was little difference in cases with and without suction. Prolonged drainage, static or suction, resulted in an increase in the serum haptoglobin level. Analysis of out data suggested that after a few days the drain starts to act as a traumatic stimulus. No difference was found between cases with the drain brought out through a stab incision and those with the drain brought out through the main wound. A number of studies have ascertained the superiority of closed to open drainage. The results of the present trial lead us to recommend that after biliary surgery the closed us to recommend that after biliary surgery the closed drain should not be connected to a suction apparatus and that after elective cholecystectomy the drain should preferably be removed after a few days.

Adult↗