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PubMed1987

A randomized prospective controlled study of the metabolism and hepatotoxicity of halothane in humans.

In a randomized prospective controlled study in humans, the metabolism and hepatic effects of a single administration of halothane were compared with enflurane and meperidine. Pre- and postoperative antipyrine pharmacokinetics, intraoperative indocyanine green clearance, liver histology, and postoperative liver function tests were determined in 24 patients undergoing abdominal surgery who were randomly allocated to receive either halothane (0.5%, group I), enflurane (0.8%, group II), or meperidine (group III) as a supplement to a common basal anesthetic regimen consisting of thiopental, nitrous oxide/oxygen/muscle relaxant. In addition, end-tidal concentrations of the volatile reductive metabolites of halothane, chlorodifluoroethylene (CDF), and chlorotrifluoroethane (CTF) were determined in group I patients and serum and urinary inorganic fluoride were determined in both group I and II patients. Indocyanine green clearance was measured before anesthesia (stage I), during basal anesthesia (stage II), in the presence of surgical stimuli (stage III), and after introduction of the selected anesthetic agent (stage IV). CDF and CTF were detectable within 20 min of the start of halothane anesthesia in every patient receiving halothane. Peak serum fluoride concentrations occurred at 2 and 24 hr in the enflurane and halothane groups, respectively, whereas urinary fluoride excretion was elevated postanesthesia in the enflurane group only. There was no difference between the pre- and postoperative disposition of antipyrine in group II or III, but after anesthesia, antipyrine clearance was significantly decreased (P less than 0.02) and plasma half-life increased (P less than 0.05) in group I patients (halothane). Concentrations of serum alanine aminotransferase (ALT) and bilirubin were significantly elevated (P less than 0.5) postoperatively in groups I and II but unchanged from preoperative values in group III patients. Three of the 24 liver biopsies taken at the end of stage IV showed several foci of acute liver cell necrosis; of these, two patients were from group I and one from group II. There were no significant differences in liver cell morphology (P greater than 0.5) in biopsies taken at the end of stage IV compared with biopsies at the end of stage III, from groups I and II. The results of this study show that reductive metabolism of halothane occurs routinely in patients undergoing halothane anesthesia under conditions of normoxia. This may be the cause of the changes in antipyrine clearance after halothane anesthesia.

Antipyrine↗

PubMed1988

Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial.

From February 1983 to January 1985, 497 patients with advanced breast cancer were randomly allocated to receive either epirubicin or doxorubicin in the following combination chemotherapy regimen: fluorouracil (5-FU) 500 mg/m2 intravenous (IV) on days 1 and 8; epirubicin or doxorubicin 50 mg/m2 IV on day 1; cyclophosphamide 500 mg/m2 IV on day 1 (FEC or FAC). Cycles were repeated every 21 days until progression or to cumulative doses of 700 mg/m2 for epirubicin and 550 mg/m2 for doxorubicin. Dose reductions were applied according to the standard criteria. Activity was evaluated in 443 patients (222 in the FEC arm and 221 in the FAC arm). The two experimental groups were comparable in age, performance status, menopausal status, histology, previous treatments, and site of the disease. The overall response rate (complete response and partial response [CR + PR]) was not significantly different: 53.6% for FEC and 56.5% for FAC. The median time to progression was 273 days for FEC and 314 days for FAC; the median survival time was 591 and 613 days, respectively. Leukopenia, anemia, nausea, and vomiting were significantly lower in patients treated with FEC. As for cardiotoxicity, four cases of congestive heart failure (CHF) were recorded among patients treated with FAC while only one was observed in the FEC group. These results indicate that epirubicin in a combination chemotherapy regimen is as active as doxorubicin and is significantly less toxic.

Adult↗

PubMed1979

Maintenance treatment of duodenal ulcer patients with a single bedtime dose of cimetidine.

Fifty-eight patients with endoscopically verified duodenal ulcers were treated with cimetidine, 1 g/day, for 6--10 weeks. The ulcers healed in 52 out of the 54 patients completing the treatment (96.3%). Forty-seven of the patients with healed ulcer were randomly allocated to 1 year of maintenance treatment, 23 patients with cimetidine, 400 mg at night, and 24 patients with placebo tablets. In the cimetidine-treated group 2 out of the 20 patients (10%) completing the trial had recurrence of ulceration, whereas 16 out of the 23 patients (70%) completing the placebo treatment had ulcer recurrence (p less than 0.001). The drug was well tolerated and, except for a marked increase in serum transaminases in three patients, no serious side effects were seen.

Adult↗

PubMed1981

Long-term, double-blind, between patients comparison of indoprofen and indomethacin in rheumatoid arthritis.

Forty-one patients suffering from classical or definite rheumatoid arthritis were randomly allocated to either indoprofen (800 mg/day) or indomethacin (100 mg/day) treatment in a double-blind, comparative long-term study (6 months). Both drugs reduced the symptoms of rheumatoid arthritis. A marked improvement was generally achieved within the first month and was maintained thereafter. Indoprofen was somewhat better tolerated than indomethacin.

Adult↗

PubMed1991

Prophylaxis, cost and effectiveness of therapy of infections caused by gram-positive organisms in neutropenic children.

Gram-positive infections are being reported with increasing frequency in children with haematological malignancies. Staphylococcus epidermidis, once considered a non-pathogenic skin contaminant, is emerging as a major cause of severe infection. However, in infants Gram-negative septicaemias are more frequent than in older children. A teicoplanin and ceftriaxone combination was assessed for use as empirical therapy of febrile episodes in neutropenic children with acute leukaemias. Of 47 patients, fever was of unknown origin in 21, and documented in 26 with 28 strains isolated; 19 Gram-positive (all sensitive to teicoplanin) and nine Gram-negative. Within 48 h, 41 patients became afebrile and the pathogen was cleared if initially present. Mean duration of treatment was 16 days. Febrile relapse occurred in 24 patients with eight documented superinfections. The need for prophylactic cover against Gram-positive organisms at the time of intravenous catheter insertion is questionable. We studied 71 patients who were randomly allocated to receive teicoplanin when the central line was inserted and if febrile, with added ceftriaxone and amikacin (arm A) or the tri-antibiotic regimen when fever occurred (arm B). In arm A a febrile episode occurred after ten days in 34/35 patients with only one Gram-positive organism isolated. In arm B a febrile episode occurred in all 36 patients after five days and ten Gram-positive strains were isolated. Those patients in arm A also received fluconazole. Amphotericin B was administered in cases of failure or relapses in both groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Bacterial Infections↗

PubMed1985

Radiation therapy combined with Adriamycin or 5-fluorouracil for the treatment of locally unresectable pancreatic carcinoma. Gastrointestinal Tumor Study Group.

One hundred fifty-seven patients with locally unresectable pancreatic carcinoma were randomly allocated to therapy with radiation and 5-fluorouracil or radiation and Adriamycin (doxorubicin). A total of 138 of 143 analyzable patients have died, and no differences in the relative survival impact of the treatments have been observed (P greater than 0.8). Toxicity on the Adriamycin arm was more substantial (P less than 0.05) and primarily attributable to Adriamycin chemotherapy after the completion of radiotherapy.

Adenocarcinoma↗

PubMed1979

Randomised multicentre trial of early mobilisation after uncomplicated myocardial infarction.

In a multicentre trial 742 patients in 13 hospitals in Wales were randomly allocated on the fifth day after uncomplicated myocardial infarction to be mobilised on the fifth or the tenth day. The trial shows no difference in first year mortality, nor in morbidity assessed after a median period of 13 months. Follow-up after one year suggests an unexplained lower mortality during the second and third years in the late mobilisation group.

Adult↗

PubMed1991

Training general practitioners to teach psychiatric interviewing skills: an evaluation of group training.

Group teaching in problem-based interviewing based on video and audiotape feedback of the doctor's own consultations significantly improved the ability of experienced general practitioners to teach psychiatric skills to their trainees. When the GPs were randomly allocated to one of three further training experiences--video feedback of their tutorial sessions, discussion about how to teach and no further teaching, there were very few differences between the groups. The greatest impact on improving teaching skills was brought about by watching their own consultations in a group feedback setting.

Clinical Competence↗

PubMed1986

Probucol and cholestyramine combination in the treatment of severe hypercholesterolemia.

This study was carried out to evaluate the effect of the combined probucol and cholestyramine treatment on the lipoprotein pattern of hypercholesterolemic patients. Probucol was given in the dose of 1 g and cholestyramine in the dose of 16 g per day in 3 different sequences: Probucol, Cholestyramine, Probucol + Cholestyramine; Probucol + Cholestyramine, Probucol, Cholestyramine; Cholestyramine, Probucol + Cholestyramine, Probucol. After a period of dietary stabilization, 12 patients were randomly allocated to one of the treatment sequences to be followed for 9 months. Each treatment period lasted 3 months. During the cholestyramine period serum cholesterol decreased on the average by 18% and LDL cholesterol by 26%; during probucol, the mean decrease was 13% and 14%, and during the combined therapy 26% and 32%, respectively. Serum triglycerides and VLDL cholesterol showed a trend toward an increase during the cholestyramine period. HDL2 cholesterol significantly decreased during probucol treatment. Variation in both VLDL and HDL2 cholesterol observed when the drugs were given singly were no longer seen during the combination therapy.

Adult↗

PubMed1983

Decrease in renal function due to sulphinpyrazone treatment early after myocardial infarction.

Twenty-nine patients with recent myocardial infarction were randomly allocated to a placebo group (n = 14) and to a group (n = 15) who received sulphinpyrazone, 4 x 200 mg daily for 7 days. Renal function significantly and transiently deteriorated in the sulphinpyrazone group compared to the placebo group. In the sulphinpyrazone group the 24 hour-urinary prostaglandin E2 and kallikrein excretion were suppressed. These data suggest that the decrease in renal function caused by sulphinpyrazone early after myocardial infarction could be mediated by an inhibition of renal prostaglandin and/or kallikrein-kinin synthesis.

Acute Kidney Injury↗

PubMed1987

Third trimester placental grading by ultrasonography as a test of fetal wellbeing.

In a study of 2000 unselected pregnant women the development of a mature placental appearance (grade 3) on ultrasonography by 34-36 weeks' gestation, observed in 15% of cases, was associated with maternal smoking, low parity, low maternal age, and being white. These women had an increased risk of problems during labour and their babies had an increased risk of low birth weight, poor condition at birth, and perinatal death. The women were randomly allocated to two groups: in one group the result of the placental grading was reported to the clinician responsible for care; in the second the result was noted but not reported. There was a significant decrease in the risk of perinatal death in the group where the grading was known. This reduction was responsible for a difference in the principal outcome index, a heterogeneous group of measures of mortality and morbidity, but this difference was not significant. This study alone does not justify routine late scanning, and further, larger trials are required. Nevertheless, the results do provide a basis for the reporting of placental grading when ultrasound examination is performed during the third trimester.

Adult↗

PubMed1981

Evaluation of low back pain and assessment of lumbar corsets with and without back supports.

A method is described for evaluating the progress of patients with back pain. Various symptoms were scored on analogue scales and spinal motion was measured by various techniques. These data were integrated to make subjective and objective indices respectively. Reasonable reproducibility of the measurements was obtained. This technique was used to elucidate the role of the lumbar support in surgical corsets in relief of back pain. Sufferers from back pain were randomly allocated to corsets with and without lumbar supports. There was significant improvement in those with a support compared with those without. On the other hand objective changes measured with the corset removed did not differ between the 2 groups. This study indicates that the spinal support in a lumbosacral corset makes a significant contribution towards the relief of symptoms.

Adult↗

PubMed1980

Adjuvant chemotherapy and immunotherapy for colorectal cancer: preliminary communication.

Following surgical resection of Dukes' B or C colorectal cancers 72 patients have been randomly allocated to receive: 5-fluorouracil; or 5-fluorouracil and levamisole; or no treatment. Adjuvant treatment was continued for one year. 66 patients remain evaluable for up to 24 months. Preliminary results show no significant differences in survival or recurrence rates. Two patients receiving 5-fluorouracil and levamisole developed severe, but reversible, neutropenia. Other side effects were uncommon.

Clinical Trials as Topic↗

PubMed1990

A comparison of postoperative pain relief techniques in orchidopexy.

Fifty consecutive patients admitted to the Western General Hospital for orchidopexy, were randomly allocated to receive either a caudal bupivacaine block or peroperative wound instillation with bupivacaine, to provide postoperative analgesia. Bupivacaine wound instillation reduced the total operating time, gave more efficient postoperative pain relief in hospital and proved both inexpensive and simple in its application.

Adolescent↗

PubMed1985

Famotidine in the management of duodenal ulcer: experience in Italy.

A multicenter study that involved 15 Italian institutions was carried out to compare the efficacy and safety of famotidine 40 mg at bedtime, famotidine 20 mg b.i.d., famotidine 40 mg b.i.d., and ranitidine 150 mg b.i.d. in promoting the healing of acute duodenal ulcer. Two hundred and twenty-four patients with endoscopically proven duodenal ulcer were randomly allocated into four treatment groups. Efficacy results for the four groups were similar at weeks 2, 4, and 8 of therapy. At week 8, the percentage of patients healed in each group was as follows: 92% in the famotidine 40-mg bedtime group, 97% with 20 mg b.i.d., 93% with 40 mg b.i.d., and 90% with ranitidine 150 mg b.i.d. Day pain and night pain were markedly reduced in all four groups, antacid consumption fell considerably, and therapy was generally well tolerated. The adverse experiences evaluated by the investigator as possibly, probably, or definitely related to test medication were rare and moderate.

Adult↗

PubMed1989

Pharmacokinetic and pharmacodynamic interactions between the ACE inhibitor cilazapril and beta-adrenoceptor antagonist propranolol in healthy subjects and in hypertensive patients.

1. Six healthy subjects received cilazapril (2.5 mg once daily), propranolol (120 mg once daily), the combination of both and placebo for a period of 1 week each (wash-out phase 1 week). 2. Propranolol and cilazapril reduced systolic and diastolic blood pressure (BP) by 7 mm Hg at peak when compared with placebo. However after the combination, this reduction was more than doubled (18 mm Hg) and lasted longer. 3. There was a trend to lower and later peak concentrations for both drugs after administration of the combination. No clinically relevant pharmacokinetic interactions between cilazapril and propranolol were found. 4. The effects on blood pressure were confirmed in hypertensive patients (BP diastolic greater than 95 mm Hg). Thirteen patients were randomly allocated cilazapril (2.5 mg day-1) or propranolol (120 mg day-1] as part of a cross-over design. This was then followed by the combination. All treatment periods were of 3 weeks duration and all measurements were done 2 h after drug administration. 5. Cilazapril lowered the median sitting diastolic BP by 8 mm Hg, and propranolol by 9 mm Hg, whereas the combination reduced the diastolic BP by 19 mm Hg. 6. The results of these studies, attempting to elucidate drug-drug interactions, showed that combined use of propranolol and cilazapril resulted in a more pronounced and longer lasting blood pressure reduction, in healthy subjects and in patients with hypertension.

Adult↗

PubMed1988

Long-term open evaluation of amlodipine versus hydrochlorothiazide in patients with essential hypertension.

Amlodipine, a long-acting calcium antagonist, was compared with hydrochlorothiazide (HCTZ) in a long-term study of 139 patients. After a 2-week placebo run-in period, patients were randomly allocated to receive either amlodipine or HCTZ in a 2:1 patient ratio. After study week 12, those patients whose hypertension was not controlled with either monotherapy had atenolol added to their regimen. The daily dose range for amlodipine was 2.5-10.0 mg and for HCTZ was 25-100 mg. At study week 12, 24-h postdose blood pressure was reduced in both amlodipine (-16/-12 mm Hg supine; -14/-12 mm Hg standing) and HCTZ (-16/-11 mm Hg supine; -16/-10 mm Hg standing) groups. Response was defined as a supine diastolic blood pressure of less than 90 mm Hg or its decrease by greater than or equal to 10 mm Hg. Responder rates at the end of 12 weeks' monotherapy were 74.1% for amlodipine and 69.8% for HCTZ. Forty percent of patients randomized to amlodipine and 45% randomized to HCTZ achieved adequate blood pressure control ("response" as defined above) with monotherapy alone over the whole 50-week treatment period. The incidence of treatment-related side effects up to study week 12 was 46.7% with amlodipine monotherapy and 25.5% with HCTZ monotherapy. Two patients were discontinued from amlodipine and one from HCTZ for side effects during the first 12 weeks of the study, and a further four from amlodipine after week 12; none were discontinued from combination therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1988

The luteal phase and early pregnancy after combined GnRH-agonist/HMG treatment for superovulation in IVF or GIFT.

Endometrial biopsies showing inadequate development were observed after ovarian stimulation with the GnRH agonist Buserelin and HMG for IVF or GIFT when luteal supplementation was omitted. Ninety-one patients were randomly allocated to two luteal supplementation regimens: in 41 women HCG and in 50 women progesterone and oestradiol valerate. The pregnancy patients treated with a combination of the GnRH agonist and HMG a delay of implantation of 1.3 days was observed compared to pregnancies after clomiphene citrate-HMG stimulation. This delay was not due to slower preimplantation embryo development after GnRH agonist-HMG treatment. Temporarily defective function of the corpus luteum was evidenced by measuring serum progesterone, 17 beta-oestradiol and 17-hydroxyprogesterone in the patients receiving progesterone and oestradiol valerate. This inadequate corpus luteum function could be related to the prolonged blockage of pituitary gonadotrophic function after arrest of the GnRH agonist.

Buserelin↗