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PubMed2003

A recombinant 31.5 kDa keratinase and a crude exo-antigen from Microsporum canis fail to protect against a homologous experimental infection in guinea pigs.

A Microsporum canis recombinant 31.5 kDa keratinase and a M. canis crude exo-antigen were tested as vaccines in an experimental infection model in guinea pigs. Animals were vaccinated subcutaneously three times at two-week intervals with either the keratinase, the exo-antigen or the adjuvant alone. Cutaneous challenge was performed blindly. Both humoral and cellular-specific immune responses to M. canis antigens were evaluated every 14 days, while a blind evaluation of clinical lesion development and fungal persistency in skin were monitored weekly. Vaccination induced very high and significant (P < 0.01) antibody responses towards both antigens. High cell-mediated immune responses to both immunogens were also induced by vaccination. After challenge, however, scores reflecting the severity of dermatophytic lesions did not differ significantly between vaccinated and control groups at any time after challenge. These results suggest that, in the guinea pig, the induction of specific immune responses against the M. canis-secreted antigens used in this study are not protective against challenge exposure.

Animals↗
PubMed2006

Safety of meloxicam in aspirin-hypersensitive patients with asthma and/or nasal polyps. A challenge-proven study.

BACKGROUND: The anti-inflammatory actions of acetylsalicylic acid (ASA)/non-steroidal anti-inflammatory drugs (NSAIDs) are thought to be due to inhibition of COX-2, whereas the side effects such as gastric damage and aspirin-induced asthma are mediated through inhibition of COX-1. Therefore, a new class of drugs with COX-2 selectivity may be well tolerated by patients with ASA/NSAIDs hypersensitivity. OBJECTIVE: We investigated whether subjects with asthma and/or nasal polyps (NP) and analgesic intolerance proven by oral ASA provocation test tolerated the selective COX-2 inhibitor, meloxicam. METHODS: All subjects were first challenged with ASA using a 2-day, single-blind, placebo-controlled oral provocation test. Thereafter, the subjects showing positive response to ASA provocation underwent a single-blind, placebo-controlled challenge with a cumulative dose of 7.5 mg of meloxicam on 2 separate days. One and three fourths of the divided doses of placebo and the active drug were given at 1-hour intervals. Clinical symptoms, lung function, and blood pressure were monitored during these challenge protocols. RESULTS: Twenty-one patients with asthma and/or NP (10 males and 11 females; mean age: 38.4 +/- 2.9 years) who reacted to ASA challenges were enrolled in the study. Response to ASA provocation was rhinitis + bronchospasm in 13, and extrabronchial reactions in 8 (isolated rhinitis in 3) patients. Mean PD(20) was 163.4 +/- 39.9 mg ASA among patients who reacted with bronchospasm to ASA. Only 1 patient reacted to meloxicam challenge at a cumulative dose of 7.5 mg. CONCLUSION: This study indicates that 7.5 mg of meloxicam is a safe alternative treatment for ASA-hypersensitive asthma and/or NP patients with proven hypersensitivity via oral ASA challenges.

Adolescent↗
PubMed1983

Seasonal growth and development and the influence of the eyes and pineal gland on body weight of golden hamsters (M. auratus).

Golden hamsters, especially males, blinded at 42 days of age respond with a rapid increase in growth rate which varied seasonally. Eight weeks after blinding, maximum weights were achieved in the late summer, early fall and minimal weights in late winter, early spring. This seasonal response appears to be endogenous and not a consequence of photoperiod, temperature, age, sex or sexual activity. Long term studies indicate that blinding rapidly enhances the growth rates of males and also changes the stable adult weight (set-point) to a new, higher plateau similar to that of the normal female. This response is modified by pinealectomy. Little or no long term effects on organ weights by blinding and/or pinealectomy were evident. Circannual rhythms in body weights of either sex were not evident. Mortality over the 11 1/2 months of the study was increased in the blinded animals but was reversed by pinealectomy. Indeed, the pinealectomized females survived better than normal females.

Animals↗
PubMed1983

Evaluation of zopiclone physical dependence liability in normal volunteers.

The potential of zopiclone, a non-benzodiazepine sedative hypnotic, to induce physical dependence in normal human volunteers was investigated. 9 male subjects (age range 21-39 years) participated in a 56-day double-blind study with random assignment to initial treatment A or B: (A) zopiclone 7.5 mg p.o. nightly for 21 days followed by placebo for 7 days, and (B) placebo nightly for 21 days followed by placebo for 7 days. Heart rate, blood pressure, hand tremor and auditory-evoked EEG were repeatedly measured during the withdrawal periods. No differences in any of these variables between phases were found (beta = 0.90 for mean differences of 16% between phases). Subjects slept longer (mean 28 min, p less than 0.013) on zopiclone than on placebo. Symptoms of state anxiety were greater on days 2 and 4 after discontinuing zopiclone compared to all other withdrawal days (p less than 0.0021). The mean relative increase on days 2 and 4 was 30%. Sleep depth (self-rating scale) was no deeper on drug than on placebo, but during the withdrawal phases, sleep was less deep on days 2 and 4 of withdrawal from zopiclone compared to all other withdrawal days (p less than 0.0001). Subjects were unable to identify the pattern of drug administration on withdrawal, and none reported important symptoms. Discontinuation of zopiclone (7.5 mg for 21 days) is associated with detectable increase in state anxiety and lighter sleep on days 2 and 4 of withdrawal. Quantitatively, similar changes occur with other hypnotic drugs of relatively low dependence liability.

Adult↗
PubMed1982

Evaluation of zopiclone physical dependence liability in normal volunteers.

The potential of zopiclone, a non-benzodiazepine sedative hypnotic, to induce physical dependence in normal human volunteers was investigated. 9 male subjects (age range 21-39 years) participated in a 56-day double-blind study with random assignment to initial treatment A or B: (A) zopiclone 7.5 mg p.o. nightly for 21 days followed by placebo for 7 days, and (B) placebo nightly for 21 days followed by placebo for 7 days. Heart rate, blood pressure, hand tremor and auditory-evoked EEG were repeatedly measured during the withdrawal periods. No differences in any of these variables between phases were found (beta = 0.90 for mean differences of 16% between phases). Subjects slept longer (mean 28 min, p less than 0.013) on zopiclone than on placebo. Symptoms of state anxiety were greater on days 2 and 4 after discontinuing zopiclone compared to all other withdrawal days (p less than 0.0021). The mean relative increase on days 2 and 4 was 30%. Sleep depth (self-rating scale) was no deeper on drug than on placebo, but during the withdrawal phases, sleep was less deep on days 2 and 4 of withdrawal from zopiclone compared to all other withdrawal days (p less than 0.0001). Subjects were unable to identify the pattern of drug administration on withdrawal, and none reported important symptoms. Discontinuation of zopiclone (7.5 mg for 21 days) is associated with detectable increase in state anxiety and lighter sleep on days 2 and 4 of withdrawal. Quantitatively, similar changes occur with other hypnotic drugs of relatively low dependence liability.

Adult↗
PubMed1996

Anti-platelet effects of 100 mg alternate day oral aspirin: a randomized, double-blind, placebo-controlled trial of regular and enteric coated formulations in men and women.

AIM: While regular use of low-dose aspirin has been recommended for several groups of patients at risk of vascular occlusion, the optimal dose of aspirin to produce a cardiovascular benefit whilst minimizing side effects is uncertain. Further, while enteric coated preparations may reduce gastrointestinal symptoms, the antiplatelet effects of these formulations have not been completely tested. In addition, exceptionally few data relating to these issues have been available in women. METHODS: To determine whether a 100 mg alternate day dose of aspirin given in regular and enteric coated formulations for a 2-week period is sufficient to inhibit platelet function in men and women, a randomized, double-blind, placebo-controlled trial was conducted among 22 healthy volunteers evaluating the effects of these preparations on platelet aggregation induced by arachidonic acid, adenosine diphosphate, and epinephrine, and on plasma concentrations of thromboxane and prostacyclin. RESULTS: During the active aspirin phase of the study, all subjects demonstrated a clinical anti-platelet effect as evidenced by failure of the platelets to aggregate in the presence of at least one platelet agonist, and mean thromboxane and prostacyclin levels decreased to 7.5 and 15.6% of baseline, respectively (both P < 0.001). After cessation of active aspirin, all subjects had fully recovery of platelet function as well as thromboxane and prostacyclin production. There were virtually no differences between regular and enteric coated formulations, or between men and women. CONCLUSION: These data indicate that an alternate day regimen of 100 mg aspirin given in either regular or enteric coated formulation is adequate to achieve functional platelet inhibition. The clinical efficacy of this dose and formulation of aspirin is being tested in the ongoing Women's Health Study, a randomized, double-blind, placebo-controlled trial of 40000 female health professionals designed in part to assess the benefits and risks of 100 mg alternate day aspirin in the primary prevention of cardiovascular disease.

Adenosine Diphosphate↗
PubMed1980

Anxiolytic efficacy and safety of ketazolam compared with diazepam and placebo.

A 28-day, double-blind study involving 56 outpatients ws initiated to compare the anxiolytic efficacy and safety of ketazolam once a day at bedtime (HS) with diazepam given three times a day (TID) and placebo HS or TID. Ketazolam HS was at least equivalent, and in some respects superior, to diazepam TID with fewer, less severe side effects. The superiority of ketazolam over placebo was demonstrated on all five instruments used to evaluate efficacy, three rated by the physician and two by the patient. The efficacy of ketazolam was significant at all three follow-up evaluations, whereas significant results for diazepam were achieved mainly at weeks 1 and 2, with little seen at week f. Fewer side effects were reported with ketazolam than with diazepam and were mild in 84% of cases. One-third of the side effects reportd in the diazepam group were moderate or severe. The optimum daily dose was 54.5 mg ketazolam or 24.7 mg diazepam.

Adolescent↗
PubMed2006

Efficacy and tolerability of 10-day monotherapy with apricitabine in antiretroviral-naive, HIV-infected patients.

OBJECTIVE: Apricitabine (formerly AVX754 and SPD754) is a deoxycytidine analogue nucleoside reverse transcriptase inhibitor in clinical development for patients with HIV disease. This study evaluated the antiretroviral efficacy, tolerability and safety of apricitabine monotherapy, administered for 10 days in antiretroviral-naive, HIV-1 infected adults. METHODS: Adult patients (> or = 18 years) with HIV infection (CD4 count > or = 250 cells/microl; plasma HIV-1 RNA level 5000-100 000 copies/ml) were randomized to 10 days' double-blind oral therapy with placebo or apricitabine 400 mg/day, 800 mg/day, 1200 mg/day, or 1600 mg/day. RESULTS: At 7 days, all apricitabine doses produced statistically significant log10 reductions in plasma HIV RNA levels from baseline relative to placebo (n = 13; P < 0.0001), as follows: -1.16 (400 mg; n = 11), -1.28 (800 mg; n = 12), -1.44 (1200 mg; n = 14), -1.30 (1600 mg; n = 13). After 10 days, the log10 viral load reductions with apricitabine 1200 mg (-1.65; P = 0.01) and 1600 mg/day (-1.58; P = 0.04) were significantly greater than that with the 400-mg dose (-1.18). No clinically relevant changes were observed in CD4 or CD8 cell indices. Apricitabine was well tolerated and showed no tendency to select any particular resistance mutation. CONCLUSION: Apricitabine monotherapy showed promising antiretroviral efficacy, good tolerability and a low propensity for resistance selection in antiretroviral-naive HIV-infected patients treated for 10 days. These results warrant further evaluation of the long-term clinical efficacy and tolerability of apricitabine.

Administration, Oral↗
PubMed1998

Megestrol acetate for anorexia in patients with far-advanced cancer: a double-blind controlled clinical trial.

The aim of this study was to evaluate a low-dose regimen of megestrol acetate (MA; 320 mg/day) on appetite in advanced cancer patients. Out-patients with far-advanced non-hormone responsive tumours and loss of appetite were randomised in a phase III trial, with two consecutive phases: a 14-day double-blind placebo controlled phase (phase A) and a 76-day open phase (phase B). During phase A, patients were treated with MA, two 160 mg tablets/day, or placebo. In phase B, the MA dose was titrated to clinical response in both groups. Appetite, food intake, body weight, performance status, mood and quality of life were evaluated with standardised measures; patients' global judgement about treatment efficacy was also requested. Of 42 patients entering the study, 33 (17 MA and 16 placebo) were evaluable for efficacy. The appetite score improved significantly with MA after 7 days (P = 0.0023), and this effect was still significant at 14 days (P = 0.0064). Patients judged the treatment with MA effective in 88.2% of cases (14th day), whilst placebo was considered effective by 25% (P = 0.0003). None of the other measures showed significant changes during treatment. The remarkable effect on appetite evident after 7 days, without serious side-effects, shows that MA can produce significant subjective effects at a low-dose even in patients with far-advanced disease.

Adolescent↗
PubMed1976

A pilot study of the short-term psychotropic effects of GPA 2640.

Thirty-two anxious nonpsychotic inpatients participated in a four-day, double-blind repeat crossover study of a new drug, GPA 2640, and placebo. Each treatment period lasted for one day, and the study lasted for four days. Twenty patients completed the study, and 28 completed two or three days. The doses were individually adjusted and mostly ranged between 1100 and 1300 mg daily. Several valid observer-rating and self-rating scales were used. There was a slight trend for GPA 2640 to yield somewhat lower anxiety scores on drug days than on placebo days, but none of the differences between rating and self-rating scores reached a significant level. A few patients reported a marked improvement in mood after two to four days, but the significance of this finding cannot be evaluated from this design. Two patients developed temporary paranoid delusions which may have been drug related. Two patients had raised SGOT levels after the study. There were no significant differences in vital signs between drug days and placebo days. The results signify that the drug has no immediate antianxiety effects (such as have been demonstrated with benzodiazepines in two previous studies utilizing the same design). This does not preclude the possibility of delayed anxiolytic effects or of other delayed psychotropic effects such as can be observed with antipsychotic drugs or antidepressants.

Adult↗
PubMed1995

Influences of dietary and intraduodenal lipid on alertness, mood, and sustained concentration.

The effects of intraduodenal and dietary lipid on alertness, mood and performance in a task requiring sustained attention were investigated in two studies. The first experiment compared the effect of duodenal infusion of either 100 g/l Intralipid (8.36 kJ/min) or isotonic saline (9 g NaCl/l) in paired studies carried out on two non-consecutive days on five male volunteers. Two consecutive 3 h infusions, one of lipid, the other saline, were given blind on each day using a crossover design. Analysis of variance indicated that lipid significantly reduced alertness (P < 0.05) and affected the speed and accuracy of performance in a sustained attention task (P < 0.05). A second experiment compared the effects on eight male volunteers of two isoenergetic lunches of similar appearance, taste and protein content but differing fat and carbohydrate (CHO) contents (fat energy:CHO, 64:18 v. 7:76). Alertness was lower (P < 0.05) and responses to stimuli in a sustained attention task were slower after the high-fat meal than after the low-fat meal (P < 0.05). In conclusion, infusion of lipid into the small intestine, and the substitution of fat for carbohydrate while keeping energy and protein constant in a lunch, both cause an enhanced postprandial decline in alertness and concentration. This may be related to the presence of lipid in the small intestine.

Adult↗
PubMed1991

Double-blind randomized clinical trial on imidazole salicylate vs ibuprofen in osteoarthritis.

Imidazole salicylate (750 mg t.i.d.) was compared with ibuprofen (400 mg t.i.d.) in a 60-day double-blind parallel group clinical trial in 31 patients with osteoarthritis. Both drugs were effective in relieving joint pain and in reducing the duration of morning stiffness. A statistically significant reduction of the severity of these symptoms was observed already one week after the start of treatment, lasting until the end of the study. No significant differences in efficacy were demonstrated between the two drugs throughout the trial. The systemic tolerability, assessed by changes in tests of hematological, liver and kidney function, urinalysis and faecal occult blood was excellent with both treatments. The incidence of side effects (mostly gastrointestinal complaints) was fairly low in both groups, and less severe in the group treated with imidazole salicylate.

Adult↗
PubMed1989

Effect of sucrose-containing snacks on blood glucose control.

To determine whether ingestion of sucrose-containing snacks would affect blood glucose (BG) control, 16 subjects with insulin-dependent diabetes mellitus participated in a 5-day double-blind study at a diabetes camp. Eight subjects in the sucrose group ate sucrose-sweetened snacks twice a day, and 8 subjects in the control group ingested snacks that were sweetened with aspartame. The percentage of total daily calories derived from added sucrose was 7% for the sucrose group and 1% for the control group. Metabolic control was assessed by daily capillary BG measurements obtained before meals and the bedtime snack and by determination of serum fructosamine (F) concentrations on arrival at camp (day 0) and after 5 days on the study protocol (day 5). No significant difference was seen between the groups on day 0 (sucrose group [mean +/- SD]: BG 9.9 +/- 3.6 mM, F 3.54 +/- 0.38 mM; control group: BG 9.1 +/- 2.8 mM, F 3.74 +/- 0.71 mM) or day 5 (sucrose group: BG 8.8 +/- 2.6 mM, F 2.94 +/- 0.32 mM; control group: BG 7.4 +/- 2.8 mM, F 2.92 +/- 0.59 mM). We conclude that ingestion of sucrose, added to snacks in an amount up to 7% of total energy intake, does not adversely affect short-term BG control.

Adult↗
PubMed2006

Temazepam at high altitude reduces periodic breathing without impairing next-day performance: a randomized cross-over double-blind study.

The aim of the study was to examine the efficacy and safety of temazepam on nocturnal oxygenation and next-day performance at altitude. A double-blind, randomized, cross-over trial was performed in Thirty-three healthy volunteers. Volunteers took 10 mg of temazepam and placebo in random order on two successive nights soon after arrival at 5000 m, following a 17-day trek from 410 m. Overnight SaO(2) and body movements, and next-day reaction time, maintenance of wakefulness and cognition were assessed. Compared with placebo, temazepam resulted in a reduction in periodic breathing from a median (range) of 16 (0-81.3)% of the night to 9.4 (0-79.6)% (P = 0.016, Wilcoxon's signed-rank test), associated with a small but significant decrease in mean nocturnal SaO(2) from 78 (65-84)% to 76 (64-83)% (P = 0.013). There was no change in sleep latency (P = 0.40) or restlessness (P = 0.30). Temazepam had no adverse effect on next-day reaction time [241 (201-380) ms postplacebo and 242 (204-386) ms post-temazepam], maintenance of wakefulness (seven trekkers failed to maintain 40 min of wakefulness postplacebo, and four post-temazepam), cognition or acute mountain sickness. At high altitude temazepam reduces periodic breathing during sleep without an adverse effect on next-day reaction time, maintenance of wakefulness or cognition. The 2% reduction in mean SaO(2) post-temazepam is likely to be predominantly because of acclimatization, as by chance more trekkers took temazepam on the first night (19 versus 14). We conclude that at high altitude temazepam is effective in reducing periodic breathing, and is safe to use, without any adverse effect upon next-day performance.

Altitude Sickness↗
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↗
PubMed1977

Radiometric detection of bacteremia: requirement for terminal subcultures.

A radiometric procedure for rapid detection of bacteria in clinical blood specimens was utilized over a period of 1 year in this laboratory. Although in initial studies it was felt that all positive bacteremias would be detected by radiometric examination of cultures for 14CO2 evolution over a 7-day period, we found in the present study that a significant number of bacteria were not detected, except by blind subculturing on day 7 before discarding the culture sample. Microorganisms were detected in 490 individual specimens from 348 patients after examination of 6,200 individual blood specimens, both anaerobically and aerobically. All but 30 of the positive specimens were detected by the radiometric procedure, with an average detection time of 30.5 h. Thirty organisms, representing 6% of the total organisms isolated, were not detected by the BACTEC apparatus. The predominating organisms missed by the radiometric method were group D streptococci, both enterococcal and non-enterococcal species. These isolates represented two-thirds of the total number of organisms not detected by the radiometric procedure. A majority of bacteria detected only upon terminal subculture were isolates from a very small number of patients, suggesting that these organisms might have specific properties that preclude their detection by radiometric assay. Nevertheless, our study results indicate that it is essential that all radiometrically examined blood culture specimens be subcultured prior to discard in order to lessen the likelihood of missing a microbial pathogen.

Bacteria↗
PubMed1976

Propranolol in the treatment of alchoholism: a review.

In the withdrawal phase of chronic alcoholism, hyperkinetic circulation, characterized by increased cardiac output, is the rule. Even in alcoholics who have been sober for a long time, increased cardiac output is very common and these changes are similar to those seen in some patients with labile hypertension. This could be caused by psychic tension. In the withdrawal phase propranolol was found to normalize the circulation and to reverse the decreased peripheral vascular resistance. We observed that the patients seemed to be calm after 40 mg of propranolol by mouth. In a double blind study of propranolol and placebo this effect was confirmed and in another study 120 mg of propranolol a day was compared to 30 mg of diazepam a day (double-blind, crossover). Using different psychological methods all significant differences are in favour of propranolol. The findings are in agreement with other reports. It is our clinical impression that propranolol is a useful drug for psychic tension symptoms in chronic alcoholism. Very few side effects have been found.

Alcoholism↗
PubMed1983

Double-blind comparison of lorazepam and chlordiazepoxide in the treatment of the acute alcohol abstinence syndrome.

The anxiolytic efficacy and safety of lorazepam and chlordiazepoxide were evaluated and compared during a five-day double-blind trial in 50 male inpatients who were experiencing acute alcohol withdrawal symptoms. The total daily doses of lorazepam and chlordiazepoxide were tapered from 6 to 2 mg and from 150 to 50 mg, respectively, during the first four days; no medication was given on day 5. Drug effectiveness was measured by improvements in the total severity assessment score (TSAS), in the three composite TSAS factors, and by the physician's global rating. No drug-related adverse effects occurred during treatment. Vital signs remained stable, and laboratory test results remained within normal limits. The results indicate that lorazepam was as effective as chlordiazepoxide in reducing the symptoms of acute alcohol withdrawal. Because of its simpler and more predictable metabolic pathway and its insignificant accumulation in plasma during multiple-dose therapy, lorazepam may be the drug of choice if benzodiazepine therapy is required for chronic alcoholics with acute withdrawal symptoms.

Acute Disease↗