PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Random Allocation”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 379 records · Page 21Linked to original sources

Randomised controlled double blind study of role of recombinant erythropoietin in the prevention of chronic lung disease.

AIM: To evaluate the role of recombinant human erythropoietin (R-HuEpo) in reducing iron infusion, which may exacerbate free radical damage, leading to chronic lung disease. METHODS: A multicentre, randomised, placebo controlled, double blind study was carried out in four neonatal intensive care units in Yorkshire. Infants were randomly allocated and received either R-HuEpo (480 U/kg/wk) or placebo by twice weekly subcutaneous injection. The primary outcome measure was the number of days on respiratory support and a secondary outcome the number of blood transfusions required. RESULTS: Forty two very low birthweight (VLBW) infants were randomly allocated. There was little difference in the need for respiratory support one month after randomisation, but subsequently there was a trend towards a reduction in the proportion requiring respiratory support in the R-HuEpo group (difference at three months -0.50, 95% confidence interval -1.00, 0.17). During stay in hospital, the median number of blood transfusions was lower for infants in the R-HuEpo group (difference in medians -2, 95% CI -4, 0). The study was stopped early because of failure to recruit babies at the expected rate. CONCLUSIONS: R-HuEpo seems to reduce the number of days in oxygen for ill VLBW infants. These data could be used to construct a larger multicentre study to evaluate this effect further.

Blood Transfusion↗

Nurse-protocol management of low back pain. Outcomes, patient satisfaction and efficiency of primary care.

To test the validity of a nurse-administered protocol for low back pain, a prospective trial of 419 patients was undertaken in a walk-in clinic. In all, 222 patients were randomly allocated to a "nurse-protocol group" in which they were evaluated by one of five nurses using the protocol; the nurses independently managed 53 percent of the patients and referred to a physician patients with potentially complex conditions. In addition, 197 patients in a randomly allocated control group were managed by one of 32 physicians. Care in the experimental and control groups was compared by follow-up telephone contact and by a four-month chart review. There was no significant difference in symptomatic relief or the development of serious disease in the two groups. Nurse-protocol patients expressed greater satisfaction with the care they had received; patient satisfaction correlated positively with symptom relief. In over 95 percent of the patients, there were noncomplex, nonserious, nonchronic conditions as the cause of back pain. We conclude that nurse-protocol management of this generally benign condition in a primary care setting is both effective and efficient.

Adolescent↗

A randomised controlled trial to compare methods of milk expression after preterm delivery.

OBJECTIVES: Primary: to compare sequential and simultaneous breast pumping on volume of milk expressed and its fat content. Secondary: to measure the effect of breast massage on milk volume and fat content. DESIGN: Sequential randomised controlled trial. SETTING: Neonatal intensive care unit, North Staffordshire Hospital NHS Trust. SUBJECTS: Data on 36 women were analysed; 19 women used simultaneous pumping and 17 used sequential pumping. INTERVENTIONS: Women were randomly allocated to use either simultaneous (both breasts simultaneously) or sequential (one breast then the other) milk expression. Stratification was used to ensure that the groups were balanced for parity and gestation. A crossover design was used for massage, with patients acting as their own controls. Women were randomly allocated to receive either massage or non-massage first. MAIN OUTCOME MEASURES: Volume of milk expressed per expression and its fat content (estimated by the creamatocrit method). RESULTS: Milk yield per expression was: sequential pumping with no massage, 51.32 g (95% confidence interval (CI) 56.57 to 46.07); sequential pumping with massage, 78.71 g (95% CI 85.19 to 72.24); simultaneous pumping with no massage, 87.69 g (95% CI 96.80 to 78.57); simultaneous pumping with massage, 125.08 g (95% CI 140.43 to 109.74). The fat concentration in the milk was not affected by the increase in volume achieved by the interventions. CONCLUSIONS: The results are unequivocal and show that simultaneous pumping is more effective at producing milk than sequential pumping and that breast massage has an additive effect, improving milk production in both groups. As frequent and efficient milk removal is essential for continued production of milk, mothers of preterm infants wishing to express milk for their sick babies should be taught these techniques.

Cross-Over Studies↗

Platonin attenuates LPS-induced CAT-2 and CAT-2B induction in stimulated murine macrophages.

BACKGROUND: Platonin, a cyanine photosensitizing dye, is a potent immunomodulator that suppresses acute inflammation. Platonin not only inhibits interleukin (IL)-1beta, IL-6, and tumor necrosis factor (TNF)-alpha production but also improves circulatory failure in septic rats. In addition, platonin reduces plasma nitric oxide (NO) formation during sepsis. However, the effects of platonin on inducible NO synthase (iNOS) and cationic amino-acid transporter (including CAT-2, CAT-2 A, and CAT-2B) expressions during sepsis remain uninvestigated. METHODS: Five groups of confluent murine macrophages (RAW264.7 cells) were randomly allocated to receive a 1-h pretreatment of one of five doses of platonin (0.1 microM, 1 microM, 10 microM, 100 microM, or 1000 microM) followed by lipopolysaccharide (LPS; 100 ng ml(-1)). For negative, positive, and platonin control, three other groups of cell cultures were randomly allocated to receive phosphate-buffered saline, LPS, or platonin (1000 microM). The cultures were harvested after exposing them to LPS for 18 h or a comparable duration in those groups without LPS. NO production, L-arginine transport, and expression of the relevant enzymes were then evaluated. RESULTS: Platonin significantly attenuated LPS-induced up-regulation of iNOS expression and NO production in stimulated murine macrophages in a dose-dependent manner. Platonin also significantly inhibited up-regulation of CAT-2 and CAT-2B expression as well as L-arginine transport in LPS-stimulated murine macrophages in a dose-dependent manner. In contrast, CAT-2 A expression in murine macrophages was not affected by LPS and/or platonin. CONCLUSIONS: Platonin attenuates NO production and L-arginine transport in LPS-stimulated murine macrophages possibly through inhibiting iNOS, CAT-2, and CAT-2B expression.

Amino Acid Transport Systems, Basic↗

Effect of bisphosphonates on cartilage turnover assessed with a newly developed assay for collagen type II degradation products.

BACKGROUND: Animal studies of arthritis have suggested that bisphosphonates may have chondroprotective abilities. OBJECTIVE: To evaluate the effect of bisphosphonate treatment on cartilage degradation. METHODS: Type II collagen is almost exclusively localised in cartilage, where it is the major structural component of the tissue. Hence fragments derived from this protein should represent a specific index for cartilage degradation. The urinary concentration of collagen type II C-telopeptide degradation products (CTX-II) was measured by a new immunoassay (enzyme linked immunosorbent assay (ELISA)). The serum concentration of collagen type I C-telopeptide degradation products (CTX-I), a marker of bone degradation, was also measured by ELISA. PARTICIPANTS: Two groups were studied. The alendronate group included 63 healthy postmenopausal women aged 45-54 randomly allocated to receive three years' treatment with 1 mg, 5 mg, 10 mg, or 20 mg alendronate daily or placebo. In the third year the women receiving 20 mg were switched to placebo. The ibandronate group included 119 women at least 10 years after the menopause aged <75 randomly allocated to receive 12 months' treatment with 0.25 mg, 0.5 mg, 1.0 mg, 2.5 mg, or 5 mg ibandronate daily or placebo followed by 12 months without treatment. RESULTS: 20 mg of alendronate and 2.5 and 5 mg of ibandronate treatment produced significant decreases in urinary CTX-II to about 50% of baseline. The level reached after three months of treatment remained practically constant during the following 12-36 treatment months. When treatment was withdrawn CTX-II values returned towards baseline. Serum CTX-I also decreased rapidly within three months, but to a level of about 30% of baseline. CONCLUSIONS: The urinary excretion of CTX-II, a new marker of cartilage degradation, decreases significantly in response to bisphosphonate. This suggests that bisphosphonates may have chondroprotective effects in humans. By measurement of CTX-II it should be possible to monitor the effects of drugs that potentially inhibit cartilage destruction.

Alendronate↗

Neostigmine, pyridostigmine and edrophonium as antagonists of deep pancuronium blockade.

To compare the ability of equipotent doses of neostigmine, pyridostigmine and edrophonium to antagonize intense pancuronium neuromuscular blockade, one hundred and twenty ASA physical status I or II patients scheduled for elective surgery received 0.06 mg.kg-1 pancuronium during a thiopentone nitrous oxide-enflurane anaesthetic. Train-of-four stimulation was applied every 12 s and the force of contraction of the adductor pollicis muscle was recorded. In the first 60 patients, spontaneous recovery was allowed until ten per cent of initial first twitch height. Then neostigmine (0.005, 0.01, 0.02 or 0.05 mg.kg-1), pyridostigmine (0.02, 0.04, 0.1 or 0.2 mg.kg-1), or edrophonium (0.1, 0.2, 0.4 or 1 mg.kg-1) was injected by random allocation. Dose-response relationships were established from the measurement of first twitch height (T1) ten minutes later. From these, neostigmine, 0.04 and 0.08 mg.kg-1 was found to be equipotent to pyridostigmine, 0.2 and 0.38 mg.kg-1, and edrophonium, 0.54 and 1.15 mg.kg-1, respectively. These doses were given by random allocation to the next 60 patients, but at one per cent spontaneous recovery. Neostigmine, 0.04 mg.kg-1, produced a T1 of 73 +/- 4 per cent (mean +/- SEM), and a train-of-four ratio (TOF) of 39 +/- 3 per cent. This was significantly greater than with pyridostigmine, 0.2 mg.kg-1 (T1 = 50 +/- 6 per cent; TOF = 25 +/- 3 per cent), and edrophonium, 0.54 mg.kg-1 (T1 = 54 +/- 3 per cent; TOF = 17 +/- 2 per cent).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Established cell lines and their conditioned media support bovine embryo development during in-vitro culture.

These experiments were conducted to evaluate the ability of different somatic-cell monolayers or conditioned medium from somatic cells for supporting bovine embryo development in vitro. In the first experiment, bovine embryos (2- to 4-cells) were allocated randomly to a control (medium 199 with 10% fetal bovine serum and antibiotics) group or co-cultured with bovine oviduct epithelial (BOEC), buffalo rat liver (BRL), Madin Darby bovine kidney (MDBK) or African green monkey kidney (Vero) cells. In the second experiment, bovine embryos (1-cell) were allocated randomly to the following groups: control medium or conditioned medium from BOEC, BRL, MDBK and Vero monolayers. In both experiments, development to the blastocyst stage was assessed after 8 days of incubation at 39 degrees C and 5% CO2. In Experiment 1, coculture improved development to the blastocyst stage compared with control medium alone, and the highest development was observed after co-culture with BOEC. In Experiment 2, conditioned medium enhanced development to morulae and blastocysts compared with the control medium; however, no differences were detected among different cell supports. These results indicate that both co-culture and conditioned medium from different cell monolayers supported development to the blastocyst stage at a higher efficiency than control medium alone.

Animals↗

Investigation of effective anesthesia induction doses using a wide range of infusion rates with undiluted and diluted propofol.

BACKGROUND: The influence of infusion rate on the induction dose-response relation has not been investigated over a wide range of infusion rates. In this study, the authors defined the effect of different propofol infusion rates on the times and doses necessary to reach clinical induction of anesthesia. METHODS: The subjects of the study were 250 patients classified as American Society of Anesthesiologists physical status I or II aged 25-55 yr. For induction with undiluted propofol, 180 patients were allocated randomly to one of two groups of 90 patients each (A and B). Each group was further divided into nine subgroups (10 patients each) that were administered propofol infusion at rates of 10, 15, 20, 30, 40, 60, 100, 200, and 300 mg/kg-1/h-1. The remaining 70 patients (group C) were allocated randomly into seven subgroups (10 patients each), and these groups were induced with diluted propofol (0.5 mg/ ml) at the rates of 10, 15, 30, 60, 100, 200, and 300 mg/kg-1/ h-1. Group B was given crystalloid at the same infusion rates as group C via a catheter in the opposite arm. Induction time, induction dose, plasma arterial propofol concentration at loss of consciousness, and percentage decrease of systolic blood pressure were measured. A previously reported three-compartment model with an effect-site rate constant for propofol of 0.456/min was used to predict the induction time and dose at each infusion rate. RESULTS: The differences between predicted induction time and dose and the observed time and dose could be explained by factoring in the lag time from infusion site to central compartment (lag time circulation) and the amount of propofol in transit during this time (residual dose circulation). Residual dose circulation and lag time circulation correlated with infusion time from 20 to 60 s for undiluted and from 0 to 40 s for diluted propofol. At the infusion rates greater than 80 mg/kg-1/h-1, rapid circulation because of incomplete mixing in the central compartment decreased the excess induction time and dose. The use of diluted propofol significantly attenuated the decrease in systolic blood pressure provoked by the residual dose circulation. CONCLUSIONS: Induction dose and time are dependent on infusion rate in a complex manner, and residual dose circulation was a factor in overdose and hemodynamic depression. Hypotension during induction was attenuated by diluted propofol.

Adult↗

Outcome at 5-6 years of prematurely born children who received morphine as neonates.

AIM: To assess outcome at 5-6 years in a cohort of very preterm infants (< 34 weeks of gestation) who had been randomly allocated within a controlled clinical trial to receive morphine or non-morphine treatment in the neonatal period. METHODS: Assessments were made on 87 children at 5-6 years who had been recruited in the neonatal period to two sequential controlled studies (1989-92). Infants requiring mechanical ventilation had been randomly allocated to receive either morphine (n = 62) or other (n = 33) solutions starting on the first day of life. Each child was seen by a single experienced observer and assessed at 5-6 years using the WPPSI-R, Movement ABC, and the Child Behaviour Checklist. The performance of children exposed to morphine was compared with that of those in the non-morphine group. Blood samples for thyroid stimulating hormone (TSH) measurement were obtained from children whose parents gave consent. RESULTS: There was no significant difference in any of the three test scales between infants in the two groups, but there was a trend towards better performance in all three tests in the morphine group. Assessment of TSH values in a subgroup of the survivors showed no difference in thyroid function between the two groups. CONCLUSION: Exposure to morphine in the neonatal period to facilitate mechanical ventilation does not seem to have any adverse effects on intelligence, motor function, or behaviour when these children are assessed at 5-6 years of age.

Anesthesia↗

Manchester regional breast study--5 and 10 year results.

Patients with early breast cancer (n = 1022) were treated between March 1970 and October 1975 in a prospective clinical trial. The results are presented after follow-up of 5-10 years. Clinical stage I cancer cases (n = 714) were randomly allocated to treatment by simple mastectomy and postoperative radiotherapy, or simple mastectomy alone. There was no statistically significant difference in overall survival between the two groups. There was a significant reduction in the frequency of local recurrence in those who received early postoperative radiotherapy compared with those who did not. Clinical stage II cancer cases (n = 308) were randomly allocated to treatment by simple mastectomy and postoperative radiotherapy or radical mastectomy alone. There was no statistically significant difference in survival or in the frequency of local recurrence between the two groups.

Adult↗

A randomised controlled trial and cost-effectiveness study of systematic screening (targeted and total population screening) versus routine practice for the detection of atrial fibrillation in people aged 65 and over. The SAFE study.

OBJECTIVES: To determine the most cost-effective method of screening for atrial fibrillation (AF) in the population aged 65 years and over, as well as its prevalence and incidence in this age group. Also to evaluate the relative cost-effectiveness of different methods of recording and interpreting the electrocardiogram (ECG) within a screening programme. DESIGN: Multicentred randomised controlled trial. Purposefully selected general practices were randomly allocated to 25 intervention practices and 25 control practices. SETTING: Fifty primary care centres across the West Midlands, UK. PARTICIPANTS: Patients aged 65 years and over. INTERVENTIONS: GPs and practice nurses in the intervention practices received education on the importance of AF detection and ECG interpretation. Patients in the intervention practices were randomly allocated to systematic (n = 5000) or opportunistic screening (n = 5000). Prospective identification of pre-existing risk factors for AF within the screened population enabled comparison between targeted screening of people at higher risk of AF and total population screening. MAIN OUTCOME MEASURES: AF detection rates in systematically screened and opportunistically screened populations in the intervention practices were compared with AF detection rate in 5000 patients in the control practices. The screening period was 12 months. RESULTS: Baseline prevalence of AF was 7.2%, with a higher prevalence in males (7.8%) and patients aged 75 years and over (10.3%). The control population demonstrated higher baseline prevalence (7.9%) than either the systematic (6.9%) or opportunistic (6.9%) intervention population. In the control population 47 new cases were detected (incidence 1.04% per year). In the opportunistic arm 243 patients without a baseline diagnosis of AF were found to have an irregular pulse, with 177 having an ECG, yielding 31 new cases (incidence 0.69% per year). A further 44 cases were detected outside the screening programme (overall incidence 1.64% per year). In the systematic arm 2357 patients had an ECG yielding 52 new cases (incidence 1.1% per year). Of these, 31 were detected by targeted screening and a further 21 by total population screening. A further 22 cases were detected outside the screening programme (overall incidence 1.62% per year). In terms of ECG interpretation, computerised decision support software (CDSS) gave a sensitivity of 87.3%, a specificity of 99.1% and a positive predictive value (PPV) of 89.5% compared with the gold standard (cardiologist reporting). GPs and practice nurses performed less well. The only difference in performance between intervention populations and controls was that practice nurses from the control arm performed less well than with intervention practice nurses on interpretation of limb-lead (PPV 38.8% versus 20.8%) and single-lead (PPV 37.7% versus 24.0%) ECGs. The within-trial economic evaluation results showed the lowest incremental cost to be for the opportunistic arm, with an incremental cost-effectiveness ratio of 337 pounds Sterling for each additional case detected compared to the control arm. Opportunistic screening dominated both more intensive screening strategies. Model-based analyses showed small differences in cost and quality-adjusted life-years for different methods and intensities of screening, but annual opportunistic screening resulted in the lowest number of ischaemic strokes and greatest proportion of cases of AF diagnosed. Probabilistic sensitivity results indicated that there was a probability of approximately 60% that screening from the age of 65 years was cost-effective in both men and women. CONCLUSIONS: The results of the study indicated that in terms of a screening programme for atrial fibrillation in patients 65 and over, the only strategy that improved on routine practice was opportunistic screening, model-based analyses indicated that there was a probability of approximately 60% of annual opportunistic screening being cost effective. It is suggested that the following topics are worthy of further investigation: the effect of the implementation of a screening programme for AF on the uptake and maintenance of anticoagulation in patients aged 65 years and over; an evaluation of the role of CDSS in the diagnosis of cardiac arrythmias; the best method for routinely detecting paroxysmal AF; ways of improving healthcare professionals' performance in ECG interpretation; development of a robust economic model to incorporate data on new therapeutic agents for use as thromboprophylactic agents for patients with AF, and an evaluation of the relative risk of stroke for patients with incident as opposed to prevalent AF.

Aged↗

Sedatives for opiate withdrawal in newborn infants.

BACKGROUND: Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. OBJECTIVES: To assess the effectiveness and safety of using a sedative compared to a non-opiate control for NAS due to withdrawal from opiates, and to determine which type of sedative is most effective and safe. SEARCH STRATEGY: The standard search strategy of the Neonatal Review Group was used. This update included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2005), MEDLINE 1966-March 2005 and abstracts of conference proceedings. SELECTION CRITERIA: Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to sedative or control. Control could include another sedative or non-pharmacological treatment. DATA COLLECTION AND ANALYSIS: Each author assessed study quality and extracted data independently. Primary outcomes included treatment failure (failure to achieve symptom control or use of additional drug treatment), seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. MAIN RESULTS: Six studies enrolling a total of 305 patients met inclusion criteria (Coyle 2002; Finnegan 1984; Kahn 1969; Kaltenbach 1986; Khoo 1995; Madden 1977); however, two (Finnegan 1984; Kaltenbach 1986) may be sequential reports that include some identical patients. Methodological concerns included the use of quasi-random allocation methods in four studies, and sizeable, largely unexplained differences in reported numbers allocated to each group in three studies. Phenobarbitone compared to supportive care alone has not been shown to reduce treatment failure or time to regain birthweight (one study). However, the duration of supportive care given to infants was significantly reduced (MD -162.1 mins/day, 95% CI -249.2, -75.1). Comparing phenobarbitone to diazepam, meta-analysis of two studies found phenobarbitone produced a significant reduction in treatment failure (typical RR 0.39, 95% CI 0.24, 0.62). There was no significant difference in duration of treatment or hospital stay. Comparing phenobarbitone with chlorpromazine, one study found no significant difference in treatment failure rate. No data for neurodevelopment reported by treatment group of allocation were available. No trials were eligible that assessed clonidine for NAS. In infants treated with an opiate, a small quasi-random study reported a reduced severity of withdrawal. Infants were weaned from an opiate more quickly which allowed earlier hospital discharge and reduced hospital costs. These findings may reflect the low dose of opiate used for initial treatment and the policy of discharging infants home on phenobarbitone but not morphine. AUTHORS' CONCLUSIONS: In newborn infants with NAS, there is no evidence that phenobarbitone compared with supportive care alone reduces treatment failure; however, phenobarbitone may reduce the daily duration of supportive care needed. Phenobarbitone, compared to diazepam, reduces treatment failure. In infants treated with an opiate, the addition of phenobarbitone may reduce withdrawal severity. Further trials are required to determine if this finding is applicable when a higher initial dose of opiate is used, and determine the effects of phenobabritone on infant development. There is insufficient evidence to support the use of chlorpromazine or clonidine in newborn infants with NAS. Clonidine and chlorpromazine should only be used in the context of a randomised clinical trial. This review should be taken in conjunction with the review "Opiate treatment for opiate withdrawal in newborn infants" (Osborn 2002a) which indicates that an opiate is the preferred initial therapy for NAS.

Chlorpromazine↗

Comparison of the efficacy and safety of 2% dorzolamide and 0.5% betaxolol in the treatment of elevated intraocular pressure. Dorzolamide Comparison Study Group.

A multicenter, parallel-design, randomized, double-masked study was conducted to compare the efficacy and safety of 2% dorzolamide with those of 0.5% betaxolol in the treatment of elevated intraocular pressure (i.o.p). A total of 311 adults with ocular hypertension or open-angle glaucoma were randomly allocated to receive either 2% dorzolamide administered topically TID or 0.5% betaxolol administered topically BID plus placebo administered topically QD for 12 weeks. After the washout of previous ocular hypotensive drugs, patients with IOP > or = 23 mm Hg in at least one eye at 10 AM or 4 PM on study day 1 were randomly allocated to receive one of the study treatments. Throughout the study, IOP was measured 2 and 8 hours after instillation of study medication for the morning peak effect (hour 2) and afternoon trough effect (hour 8). After 12 weeks of therapy, the mean change in IOP was not significantly different between the dorzolamide and betaxolol treatment groups at hour 8 (-3.6 mm Hg in both groups) or hour 2 (-5.4 vs -5.3 mm Hg, respectively). The differences between treatments (and 95% CIs associated with these differences) in mean IOP changes from baseline were 0.02 mm Hg (-0.870 to 0.901) for hour 8 and -0.14 mm Hg (-0.959 to 0.685) for hour 2. The ocular adverse experience (AE) most frequently reported by patients was ocular burning and/or stinging, and the most frequently reported nonocular AEs were taste perversion, upper respiratory infection, and headache. Only the incidence of taste perversion was significantly different between treatment groups (14.6% for the dorzolamide group and 0.0% for the betaxolol group). Two percent of patients in each treatment group discontinued the study due to AEs. This study confirmed the similar IOP-lowering effect of 2% dorzolamide and 0.5% betaxolol. Both treatments were generally well tolerated, and their safety profiles were similar.

Adrenergic beta-Antagonists↗

Therapy of multidrug-resistant typhoid fever with oral cefixime vs. intravenous ceftriaxone.

We randomly allocated 80 children with suspected multidrug-resistant tyhpoid fever to therapy with either cefixime or ceftriaxone. Of these, an alternative diagnosis was subsequently made in 10 children and another 10 were excluded because cultures were negative. In 9 cases the typhoidal organisms isolated were susceptible to first-line drugs. In all, 50 children were randomly allocated to receive therapy with either intravenous ceftriaxone (65 mg/kg/day once daily, Group A, n = 25) or oral cefixime (10 mg/kg/day divided every 12 hours, Group B, n = 25) for 14 days. The two groups were comparable in their clinical characteristics, duration and severity of illness at the time of admission. The time to defervescence was comparable in both groups (8.3 +/- 3.7 vs. 8.0 +/- 4.1 days, P = not significant). An equal number (3 in each group) failed to respond and underwent a change in therapy. Three children in Group A and one in Group B relapsed. No adverse effects were seen in either group during the course of therapy. Our data suggest that oral cefixime can be used as effectively as parenterally administered ceftriaxone for management of typhoid fever in children.

Administration, Oral↗

A comparison of the efficacy and safety of ceftizoxime with doxycycline versus conventional CDC therapies in the treatment of upper genital tract infection with or without a mass.

It is well known that sexually transmitted infections of the upper genital tract are widespread. A variety of regimens are used to treat these conditions, many of which have not been subjected to randomized, prospective clinical trials (including the 1985 Centers for Disease Control [CDC] Guidelines for the treatment of upper genital tract infections [UGTI]). This investigation was undertaken to compare the 1985 CDC treatment guidelines with different doses of ceftizoxime, a third-generation cephalosporin with an intermediate half-life, plus doxycycline in patients with UGTI. The patients were divided into subgroups, depending on the presence or absence of a pelvic mass. Sixty-seven women participated in the study. They were older than 14 years of age and required hospitalization for the treatment of UGTI. These women had lower abdominal pain and tenderness, cervical motion or adnexal tenderness, and one of the following: temperature greater than 100.4 degrees F orally, leukocytosis greater than 10,500/mm3, or presence of a suspected inflammatory pelvic mass on pelvic examination or by ultrasound. Informed consent was obtained from all patients in a manner approved by the Institutional Review Board. Pelvic examinations and ultrasound evaluations of the pelvic soft tissues were performed on all patients at the time of admission. Those who were found not to have a pelvic mass or who had a pelvic mass less than 4 cm in transverse diameter were randomly allocated to receive either ceftizoxime 2 gm intravenously every 12 hours with doxycycline 100 mg intravenously twice daily (Rx 1, n = 13) or cefoxitin 2 gm intravenously every six hours with doxycycline 100 mg intravenously twice daily (Rx 2, n = 14). Those patients found to have a pelvic mass (greater than 4 cm in transverse diameter) were randomly allocated to receive either ceftizoxime 2 gm intravenously every eight hours with doxycycline 100 mg intravenously twice daily (Rx 3, n = 19) or clindamycin 900 mg intravenously every eight hours with a 2-mg/kg loading dose of gentamicin followed by 1.5 mg/kg intravenously every eight hours, with adjustments as necessary (Rx 4, n = 21). All UGTI patients without a mass treated with either Rx 1 or Rx 2 responded adequately. However, UGTI patients with a mass treated with Rx 4 were more likely than those treated with Rx 3 to require a change in antibiotics or need extirpative surgery in order to obtain a satisfactory clinical response (Fisher's exact test = 0.046, two-sided).(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗

Effect of suture technique on early healing of intestinal anastomoses in rats.

OBJECTIVE: To see if the site and tension of sutures had any influence on early breaking strength in intestinal anastomoses. MATERIAL: 161 Male Wistar rats. INTERVENTIONS: First experiment: after laparotomy and division of the ileum an inverted end to end anastomosis was made in a single layer with 14 interrupted sutures of 7/0 polypropylene. All sutures were inserted 3 mm from the cut edges. The rats were randomly allocated to one of four groups according to the size of the loop of suture used: tight (n = 38), 0.4 mm (n = 22), 0.9 mm (n = 35), or 2.0 mm (n = 24). Second experiment: the method used was the same except that sutures were placed 1.5 mm from the cut edges and the rats were randomly allocated to one of two groups according to the size of loop of suture--tight (n = 20), or 0.9 mm (n = 22). MAIN OUTCOME MEASURES: Breaking strength measured in a tensiometer (both experiments); and myeloperoxidase activity/g tissue, hydroxyproline content and solubility/biopsy specimen (first experiment only). RESULTS: Breaking strength decreased proportionally the tighter the sutures were tied, and the differences were significantly greater when the sutures were placed closer to the cut edges. Anastomotic myeloperoxidase activity, hydroxyproline content, and soluble: total hydroxyproline ratio were similar in all groups. CONCLUSION: Tight sutures may promote proteolytic tissue degradation by reducing the local availability of circulating proteinase inhibitors.

Anastomosis, Surgical↗

A comparison of the effects of bisoprolol and atenolol on lipoprotein concentrations and blood pressure.

Forty-two patients (28 men, 14 women, age range 27-65 years) with newly discovered mild to moderate hypertension were randomly allocated to treatment with either bisoprolol or atenolol for a double-blind comparison of these two beta 1-adrenoceptor blocking drugs. Two doses of each drug (10 and 20 mg/d for bisoprolol and 50 and 100 mg/d for atenolol) were given, each dose for a 3-month period, the dose to be given first being decided by random allocation of the patients. During the second 3-month period, the patient received the alternative dose. After treatment for 6 and 12 weeks with each dose, the blood pressure, heart rate, and lipoprotein concentrations were checked. Bisoprolol treatment (both 10 and 20 mg) resulted in a decrease in blood pressure in the supine position from 154/100 to 138/89 mm Hg; and atenolol treatment resulted in decreases from 161/102 to 145/90 mm Hg (50 mg/d) and 146/91 mm Hg (100 mg/d). The drugs and doses did not differ in their effect. The triglyceride content in very low density lipoproteins (VLDL) increased during treatment with bisoprolol (10 mg/d) from 1.04 to 1.31 mmol/l (p less than 0.05); during treatment with atenolol (100 mg/d) it increased from 0.90 to 1.14 mmol/l (p less than 0.05). The cholesterol content in low density lipoproteins did not change, but that in high density lipoproteins (HDL) decreased during treatment with both drugs (from 1.22 to 1.10 mmol/l with bisoprolol 20 mg/d, p less than 0.01: and from 1.21 to 1.13 mmol/l with atenolol 100 mg/d, p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists↗

Pilonidal sinus: a claim for simple track incision.

Ninety-six patients treated surgically for pilonidal sinus were examined in a two-part study. In the first part, 36 patients were randomly allocated according to the surgical techniques employed: marsupialization, incision, and excision without primary closure. Healing times and recurrences a year after operation were studied. The healing times of patients treated by excision were longer in comparison with those treated by incision or marsupialization. The recurrence rates were similar for all techniques used. In the second part of the study 60 patients were randomly allocated according to times of returning to work. Twenty-nine of these patients returned to work before their wound healed; 31 resumed work a week after epithelization of the wound. The wounds healed more quickly in patients who started working before they were closed. Incision of the sinus track, carried out using local anesthesia in the outpatient clinic, allowed the patient to return to work without pain sooner.

Anesthesia, Local↗