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PubMed1989

Physostigmine treatment of progressive supranuclear palsy.

Cognitive and extrapyramidal effects of cholinomimetic therapy were evaluated in 8 patients with progressive supranuclear palsy. Each was randomized to a 10-day double-blind crossover trial of physostigmine and placebo. Physostigmine treatment was associated with marginal and inconsistent changes in long-term memory, suggesting that cholinergic therapy alone is insufficient to restore cognitive function. Motor scores remained unchanged.

Aged↗
PubMed1989

Lack of ocular changes with dimethyl sulfoxide therapy of scleroderma.

Eighty-four patients with scleroderma hand ulcers were treated 3 times daily for 3 months in a randomized, double-blind clinical trial by immersing their hands into bags of topical 70% dimethyl sulfoxide (DMSO), topical 2% DMSO, or 0.85% normal saline. Fifty-five of the patients completed the study, 46 of whom received blinded initial (0 days) and final (12 weeks) full ophthalmologic examinations. This evaluation included past ocular history, past drug history, family ocular history, pupillary examination, cycloplegic refraction, motility study, applanation tension, indirect dilated funduscopic examination, and slit-lamp examination. No statistical difference in these ocular variables, including visual acuity, lenticular changes, and cataract development, were noted among the three groups, and in no patients were the DMSO-related lenticular changes reported in numerous animal studies found. The maximum theoretical dosage of DMSO administered was 2.6 g/kg/day, which is comparable to those used in the animal studies.

Administration, Topical↗
PubMed1990

Psychometric alterations in treatment with the MAO-A-inhibitor moclobemide.

Two groups of depressed patients were treated either with a selective MAO-A-inhibitor, moclobemide (n = 13) or a tetracyclic antide-pressant, maprotiline (n = 18), in a 28 days lasting double blind investigation. Before and after treatment psychopathologic symptoms were rated, motor performance was proven, and acoustic and visual sensomotoric performance were investigated. Deterioration of psychomotor performance were seen in patients without amelioration of their psychopathologic symptoms, especially when treated with moclobemide. These findings were regarded as a hint that possibly the therapeutic agent interacts with the wrong transmitter system and perhaps this is the reason for the deterioration of psychomotor functions.

Benzamides↗
PubMedDate not supplied

Comparison of loracarbef (LY163892) versus amoxicillin in the treatment of bronchopneumonia and lobar pneumonia.

Loracarbef (LY163892), a carbacephem, is the first of a new class of beta-lactam compounds. A 14-day, double-blind, randomized, parallel treatment study compared loracarbef (400 mg b.i.d.; n = 169) and amoxicillin (500 mg t.i.d.; n = 167) in the treatment of lobar pneumonia and bronchopneumonia. Forty-four patients in the loracarbef group and 40 patients in the amoxicillin group were evaluable for efficacy analysis. Streptococcus pneumoniae and Haemophilus influenzae were isolated from pure or mixed cultures in 45.5% of the evaluable patients, with S. pneumoniae being isolated most frequently. Favourable clinical responses (cure or improvement) in the loracarbef-treated group (42/44; 95.5%) were similar to those in the amoxicillin-treated group (38/40; 95%). A favourable bacteriological response was observed for 36/44 (81.8%) loracarbef-treated patients compared with 28/40 (70%) amoxicillin-treated patients (p = 0.2). Adverse events were similar in both groups. Withdrawal of treatment was required in three patients in each group due to gastrointestinal events or rash/allergic exanthema. These data support the conclusion that loracarbef and amoxicillin have comparable efficacy and safety in the treatment of bronchopneumonia and lobar pneumonia caused by susceptible pathogens. However, loracarbef can be administered twice daily, offering the advantage of improved patient compliance. It is also active against beta-lactamase producing organisms.

Adolescent↗
PubMedDate not supplied

Loracarbef versus penicillin V in the treatment of streptococcal pharyngitis and tonsillitis.

Ten-day, double-blind, randomized, parallel treatment regimens of loracarbef (200 mg capsule twice daily or 15 mg/kg/day oral suspension in two divided doses up to a maximum of 375 mg/day; n = 169) and penicillin V (250 mg capsule four times daily or 20 mg/kg/day suspension in four divided doses up to a maximum of 500 mg/day; n = 175) were compared in the treatment of group A beta-haemolytic streptococcal (GABHS) pharyngitis and tonsillitis. Post-therapy clinical responses were similar for evaluable patients in both treatment groups: 97.4% of the loracarbef group (101/115 patients cured and 11/115 improved) and 96.0% of the penicillin group (101/124 patients cured and 18/124 improved). A statistically significant difference in the pathogen elimination rate was noted between treatment groups: post-therapy throat cultures were negative for GABHS in 94.8% (109/115) of loracarbef-treated patients compared with 87.1% (108/124) of penicillin-treated patients (p = 0.040). Loracarbef and penicillin V were comparable in terms of safety. Headache and nausea/vomiting were the most common events reported during therapy (nausea/vomiting were slightly less common in the loracarbef group). Three patients in each group were discontinued from the study due to drug-related adverse events; one due to rash in the loracarbef group and one due to rash and one due to vomiting in the penicillin group. These data support the conclusion that loracarbef twice daily is more effective in eradicating GABHS than penicillin V four times daily, and the two drugs are comparable in safety and clinical efficacy in the treatment of GABHS pharyngitis and tonsillitis.

Administration, Oral↗
PubMed1975

[Survival time, capacity of action and radiological diagnosis after gunshot wounds of the cranium (author's transl)].

Three cases of suicidal temporal gunshots. Different circumstances in the clinical course and in the ability of action.--In one case there was a bullet tract in the lower temporal region with considerable destruction of the base of the skull, followed by immediate inability of action and early death. Another case with a transtemporal gunshot without radiological signs of a laceration of the base of skull showed severe disturbance of cerebral functions for some days and remaining blindness. In the third case there was a pistol shot in the temporal region with retained missile, full ability of acting and undisturbed consciousness. Causative for the differences in the effect of the gunshots are differences of weapons and amunition and the anatomical position of the wound track in the temporal region. Discussion about the role of concussion of the brain by different rate of transgression of energy from the missile to the skull. Reference to the importance of X-ray analysis and to a radiographic documentation of the findings in such cases.

Adult↗
PubMed2006

The effect of epidural needle type on postdural puncture headache: a randomized trial.

PURPOSE: A prospective, randomized trial in labouring parturients was undertaken to assess whether the 18G Special Sprotte epidural needle is associated with a lower incidence of accidental dural puncture (ADP) in comparison with the 17G Tuohy needle. A secondary purpose was to determine if the incidence of postdural puncture headache (PDPH ) differed between groups when ADP occurred. METHODS: Following Institutional Review Board approval 1,077 parturients requesting epidural analgesia at three tertiary obstetrical units were randomized to epidural catheter insertion with a 17G Tuohy or 18G Special Sprotte needle. Patients were followed for seven days by a blinded assessor to determine the occurrence of PDPH using standardized criteria. If postural headache or neck ache presented, an ADP was diagnosed even if cerebrospinal fluid (CSF) was not observed at insertion. This subgroup was followed daily to assess headache characteristics and response to blood patch. RESULTS: Six Tuohy group patients, and two patients in the Sprotte group were excluded. One of the six excluded in the Tuohy group had an ADP. Twenty-eight ADPs occurred, nine unrecognized by CSF visualization (1.8% Tuohy, 3.4% Sprotte, P = 0.12). The incidence of unrecognized ADPs was higher in the Sprotte group (40% Sprotte vs 20% Tuohy, P < 0.05). If ADP occurred, the incidence of PDPH was lower in the Sprotte group (100% Tuohy vs 55% Sprotte, P = 0.025). The ease of use, and user satisfaction were higher in the Tuohy group (84 +/- 17.3% Tuohy vs 68.2 +/- 25.3% Sprotte, P < 0.001). CONCLUSION: The incidence of ADP was not reduced with the Special Sprotte epidural needle in comparison with the Tuohy needle, but PDPH after ADP occurred less frequently in the Sprotte group.

Adult↗
PubMed2006

The effect of accelerated, brace free, rehabilitation on bone tunnel enlargement after ACL reconstruction using hamstring tendons: a CT study.

The mechanism of bone tunnel enlargement following anterior cruciate ligament (ACL) reconstruction is not yet clearly understood. Many authors hypothesized that aggressive rehabilitation protocols may be a potential factor for bone tunnel enlargement, especially in reconstructions performed with hamstrings autograft. The purpose of this study was to evaluate the effect of a brace free rehabilitation on the tunnel enlargement after ACL reconstruction using doubled semitendinosus and gracilis tendons (DGST): our hypothesis was that early post-operative knee motion increase the diameters of the tibial and femoral bone tunnels. Forty-five consecutive patients undergoing ACL reconstruction for chronic ACL deficiency were selected. All patients were operated by the same surgeon using autologous DGST and the same fixation devices. Patients with associated ligaments injuries and or severe chondral damage were excluded. The patients were randomly assigned to enter the control group (group A, standard post-operative rehabilitation) and the study group (group B, brace free accelerated rehabilitation). A CT scan was used to exactly determine the diameters of both femoral and tibial tunnels at various levels of lateral femoral condyle and proximal tibia, using a previously described method [17]. Measurements were done by an independent radiologist in a blinded fashion the day after the operation and at a mean follow-up of 10 months (range 9-11). Statistical analysis was performed using paired t-test. The mean femoral tunnel diameter increased significantly from 9.04 +/- 0.05 (post-operative) to 9.30 +/- 0.8 mm (follow-up) in group A and from 9.04 +/- 0.03 to 9.94 +/- 1.12 mm in group B. The mean tibial tunnel diameter increased significantly from 9.03 +/- 0.04 to 10.01 +/- 0.80 mm in group A and from 9.04 +/- 0.03 to 10.60 +/- 0.78 mm in group B. The increase in femoral and tunnel diameters observed in the study group was significantly higher than that observed in the control group. Our results suggest that bone tunnel enlargement after ACL reconstruction using hamstrings autograft can be increased by an accelerated, brace free, rehabilitation protocol.

Adolescent↗
PubMed1997

Evidence of acoustic startle hyperreflexia in recently detoxified early onset male alcoholics: modulation by yohimbine and m-chlorophenylpiperazine (mCPP).

Preclinical studies suggest that acoustic startle amplitude is increased during ethanol withdrawal. The current study evaluated the effects of intravenous infusion of the alpha 2-adrenergic antagonist, yohimbine (0.4 mg/kg), the serotonin partial agonist m-chlorophenylpiperazine (mCPP, 0.1 mg/kg), and placebo administered to 22 male patients meeting DSM-III-R criteria for alcohol dependence and 13 male healthy subjects. Patients and healthy subjects completed 3 test days under double-blind conditions in a randomized order. Patients were sober for 12-26 days prior to testing. On each test day, participants completed startle testing 80 min following drug infusion. Stimuli with varying intensities (90, 96, 102, 108, 114 dB) were presented in a randomized order balanced across four blocks. Stimuli consisted of 40-ms bursts of white noise administered every 45-60 s for 15-20 min through headphones. Analyses indicated that patients exhibited elevated acoustic startle magnitudes on the placebo day relative to healthy subjects. In patients, the magnitude of startle amplitudes elicited at 90 dB, but not 114 dB, correlated significantly with the number of previous alcohol detoxifications. Yohimbine increased startle magnitudes and reduced startle latencies relative to placebo and mCPP in both patients and healthy subjects. mCPP did not alter startle magnitude in either group. Yohimbine also increased the probability that a 90-dB stimulus produced a startle response in healthy subjects, but not in patients. Blunting of yohimbine effects on startle probability may reflect the baseline elevations in startle probability levels in patients, but may also be consistent with other evidence of reduced postsynaptic, but not presynaptic, noradrenergic function in these same patients. These data replicate and extend previous reports indicating that yohimbine facilitates the acoustic startle response in humans. They also further implicate the number of episodes of ethanol withdrawal as a factor influencing subsequent neurobiological responsivity in chronic alcoholic patients. Based on the current data, future research should explore whether measurement of the acoustic startle response provides an objective quantitative severity measure of ethanol withdrawal.

Acoustic Stimulation↗
PubMed1999

Transplantation of sciatic nerve segments into normal and glia-depleted spinal cords.

Although peripheral nerves are used as guides in attempts to enhance regeneration in the central nervous system (CNS), surprisingly little is known about the interface that develops between the host tissue and the transplanted or implanted peripheral nerve. This study examines host-nerve interfaces following transplantation of segments of sciatic nerve into the spinal cord under two differing conditions, one in which the spinal cord contains normal numbers of glia and one in which the glial population is reduced. The depletion of the glial population is achieved by exposing the lumbosacral region of the spinal cord in 3-day-old rats to X-rays, a model developed in this laboratory. Twenty days later, segments of fresh or frozen sciatic nerves harvested from other 3-day-old rats were transplanted into the lumbar region of spinal cord in irradiated animals and in their non-irradiated littermate controls. Following a 20-day postoperative period, the interfaces between host spinal cord and sciatic nerves were examined ultrastructurally, and pronounced differences were noted. A distinct scar composed of multiple layers of astrocyte processes completely enveloped the transplant in non-irradiated host spinal cord and confined Schwann cells and fibroblasts to the area enclosed by the scar. Terminals from axons that appeared to have traversed the transplant during this 20-day period ended blindly in the astrocytic scar. In contrast, a complete astrocytic scar failed to form around the transplant in the irradiated, glia-depleted hosts, and Schwann cells intermingled with host tissue. Some Schwann cells migrated away from the transplant, which was placed in the dorsal funiculus, along a perivascular route and extended into the gray matter. In some instances Schwann cells were observed in the ventral gray surrounding blood vessels and motoneurons. From these observations, it is clear that the formation of a distinct astrocytic barrier at the host-graft interface is greatly reduced irradiated host. The effects of astrocyte reduction on enhanced regeneration within the spinal cord are discussed.

Animals↗
PubMed2005

Preventing intra-abdominal adhesions with polylactic acid film: an animal study.

PURPOSE: The aim of this study was to evaluate the efficacy of an absorbable polylactic acid film (SurgiWrap) in preventing postoperative intra-abdominal adhesions in an animal model. METHODS: Forty-four female Sprague-Dawley rats underwent laparotomy with subsequent cecal wall abrasion and abdominal wall injury. Rats were divided equally between untreated and treated groups. Treated rats had a polylactic acid film (SurgiWrap) placed between the cecal and abdominal wall defects. Rats in the untreated group received no barrier material. The animals were killed on postoperative day 21. Two blinded observers, using predetermined criteria, graded the cecum-to-abdominal wall adhesions and estimated the percent of cecal surface area involved in the adhesion. The adhesions were classified as absent, moderate, or severe. RESULTS: Four rats died postoperatively. Of surviving rats, all of the rats in the untreated group had cecum-to-abdominal wall adhesions, whereas 42.1 percent of rats in the treated group had no adhesions between the cecum and the abdominal wall (two-tailed, P = 0.001). Altogether, 28.6 percent and 71.4 percent of untreated rats experienced moderate and severe adhesions, respectively, compared to 47.4 percent and 10.5 percent of treated rats (two-tailed, P < 0.001). CONCLUSIONS: Strategic placement of polylactic acid film during abdominal surgery is associated with a significantly reduced rate and severity of postoperative intra-abdominal adhesions in this model. A technique for film placement is suggested.

Abdomen↗
PubMed1989

Placebo-controlled trial with the somatostatin analogue SMS 201-995 in peptic ulcer bleeding.

A 5-day, double-blind, placebo-controlled, multicenter trial in 23 centers with a total of 273 patients [241 evaluable patients; 126 on placebo and 115 on a long-acting somatostatin analogue (SMS 201-995, octreotide, Sandostatin)] resulted in no difference in stopping bleeding and preventing rebleeding between placebo (70.6%) and SMS 201-995 (69.6%). Surgery rates, blood transfusion requirements, and time required before bleeding stopped were also not significantly different between the two groups. A retrospective subgroup analysis according to age, sex, localization of the ulcers, severity of the bleeding, and arterial spurting vs. oozing showed homogeneity and did not allow identification of a subgroup that might benefit from treatment with SMS 201-995. The tolerability of SMS 201-995 was very good. No difference was found between placebo and SMS 201-995 with regard to the side-effect profile.

Adult↗
PubMed1987

Positron emission tomography assessment of effects of benzodiazepines on regional glucose metabolic rate in patients with anxiety disorder.

Patients with generalized anxiety disorder (n = 18) entered a 21-day, double-blind, placebo-controlled random assignment trial of clorazepate. Positron emission tomography with 18F-deoxyglucose was carried out before and after treatment. Decreases in glucose metabolic rate in visual cortex and relative increases in the basal ganglia and thalamus were found. A correlation between regional changes in metabolic rate and regional benzodiazepine receptor binding density from other human autopsy studies was observed; brain regions highest in receptor density showed the greatest decrease in rate.

Adult↗
PubMed1982

Inhaled lidocaine aerosol changes resting human breathing pattern.

We compared resting breathing patterns in twelve normal humans before and after administration of aerosols of normal saline and 4% lidocaine. Experiments were performed in random order on two consecutive days in single blind fashion. At the time of the experiments, neither the subjects nor the people who analyzed the results knew the purpose of the study. Neither saline nor lidocaine aerosols produced changes in FEV1.0 or end-tidal PCO2, or, in the six subjects in whom measurements were made, changes in functional residual capacity or airway resistance. Aerosols of normal saline produced no change of ventilation (VI), breathing frequency (f), tidal volume (VT), duration of inspiration (Ti), mean inspiratory flow (VT/Ti) or the fraction of the breathing cycle devoted to inspiration (Ti/Tt). Lidocaine aerosols, on the other hand, were associated with a decrease in f (P less than 0.01), an increase in Ti (P less than 0.01), an increase in VT (P less than 0.02) and a decrease in VI (P less than 0.05), while VT/Ti and Ti/Tt were unchanged. We conclude that lidocaine aerosols, by compromising the function of vagal airway receptors, altered breathing pattern in normal resting humans, indicating that these receptors play a role in regulating breathing pattern under these circumstances. Though the changes we observed are most simply explained as being due to decreased stretch receptor activity, we cannot be certain that such was the case.

Adult↗
PubMed1989

Efficacy and safety of loratadine (10 mg once daily), terfenadine (60 mg twice daily), and placebo in the treatment of seasonal allergic rhinitis.

A total of 317 patients received loratadine, 10 mg once daily, terfenadine 60 mg twice daily, or placebo in a 14-day, double-blind, randomized study in seasonal allergic rhinitis. Four nasal and four nonnasal symptoms were evaluated. At the end point evaluation, mean total scores of combined nasal and nonnasal symptoms decreased from baseline (improved) 46%, 44%, and 35%, respectively, for loratadine, terfenadine, and placebo. The difference between loratadine and placebo treatment was significant (p = 0.03). Loratadine was particularly effective compared with placebo in relieving nasal discharge, sneezing, and itching/burning eyes. Therapeutic response to treatment was good or excellent in 66 (64%) of 103 loratadine-treated patients, 58 (56%) of 104 terfenadine-treated patients, and 48 (47%) of 102 placebo-treated patients. Adverse experiences reported during the study were usually mild or moderate and were not significantly different among the three treatment groups. Sedation (somnolence) was reported by 10 loratadine-treated patients, seven terfenadine-treated patients, and eight placebo-treated patients. Loratadine, 10 mg once daily, was comparable to terfenadine, 60 mg twice daily, and significantly superior to placebo in the symptomatic relief of seasonal allergic rhinitis.

Adolescent↗
PubMed1990

Challenging the amphetamine challenge test: report of an antidepressant treatment study.

The primary goal of this study was to determine whether the amphetamine challenge test (ACT) response, as measured by a subjective rating scale, the How I Feel Scale (HIF), could predict antidepressant treatment outcome. Following a 1-day non-blind ACT with dextroamphetamine (d-AMPH), patients were treated double-blind for 6 weeks with either desipramine, alprazolam, or a desipramine-alprazolam combination. Regression (true score) analyses were carried out on pre- and post-ACT HIF scores and on baseline and end of study Hamilton Depression Rating Scale (HDRS) scores to determine the magnitudes of improvement measured in response to the ACT and antidepressant treatment, respectively. Regression analyses were performed on the residuals (true scores of improvement) to determine the best fitting (linear) prediction equation. Improvement in the HIF total score predicted HDRS improvement for the whole sample. Possible sources of error contributing to the outcome are identified and the results are discussed in relation to previous clinical investigations of the potential usefulness of the ACT as a predictor of antidepressant response.

Adult↗
PubMed2005

Delta-9-tetrahydrocannabinol effects in schizophrenia: implications for cognition, psychosis, and addiction.

BACKGROUND: Recent advances in the neurobiology of cannabinoids have renewed interest in the association between cannabis and psychotic disorders. METHODS: In a 3-day, double-blind, randomized, placebo-controlled study, the behavioral, cognitive, motor, and endocrine effects of 0 mg, 2.5 mg, and 5 mg intravenous Delta-9-tetrahydrocannabinol (Delta-9-THC) were characterized in 13 stable, antipsychotic-treated schizophrenia patients. These data were compared with effects in healthy subjects reported elsewhere. RESULTS: Delta-9-tetrahydrocannabinol transiently increased 1) learning and recall deficits; 2) positive, negative, and general schizophrenia symptoms; 3) perceptual alterations; 4) akathisia, rigidity, and dyskinesia; 5) deficits in vigilance; and 6) plasma prolactin and cortisol. Schizophrenia patients were more vulnerable to Delta-9-THC effects on recall relative to control subjects. There were no serious short- or long-term adverse events associated with study participation. CONCLUSIONS: Delta-9-tetrahydrocannabinol is associated with transient exacerbation in core psychotic and cognitive deficits in schizophrenia. These data do not provide a reason to explain why schizophrenia patients use or misuse cannabis. Furthermore, Delta-9-THC might differentially affect schizophrenia patients relative to control subjects. Finally, the enhanced sensitivity to the cognitive effects of Delta-9-THC warrants further study into whether brain cannabinoid receptor dysfunction contributes to the pathophysiology of the cognitive deficits associated with schizophrenia.

Adult↗
PubMed2004

Gabapentin maintenance decreases smoked cocaine-related subjective effects, but not self-administration by humans.

Data from research with laboratory animals indicate that cocaine self-administration can be reduced by lambda-aminobutyric acid (GABA) agonists. Yet, the effectiveness of GABA agonists to decrease human cocaine self-administration has not been investigated under controlled laboratory conditions. The purpose of this study was to assess the effects of gabapentin, a GABA agonist, on cocaine-related behaviors, including self-administration, in human research participants under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of gabapentin (0, 600, and 1200 mg/d) maintenance on response to cocaine (0, 12, 25, and 50 mg) were investigated in seven cocaine abusers. Active cocaine significantly increased choice to self-administer cocaine, subjective-effect ratings (e.g., "Good Drug Effect"), blood pressure and heart rate (HR). Gabapentin did not reduce cocaine choice or cardiovascular measures, but it did decrease some subjective effects of cocaine (e.g., "Good Drug Effect" and "Anxious"). These data suggest that the cocaine-gabapentin combination was well-tolerated, and because some cocaine-related subjective effects were reduced by maintenance on relatively low gabapentin doses, future studies should test higher gabapentin doses.

Acetates↗