Biomedical subjects
Publications and source records attributed to P Donofrio.
An open-label dose-escalation trial was performed to assess the safety and tolerability of high doses of coenzyme Q10 (CoQ10) in ALS. CoQ10, a cofactor in mitochondrial electron transfer, may improve the mitochondrial dysfunction in ALS. In this study, CoQ10 was safe and well tolerated in 31 subjects treated with doses as high as 3,000 mg/day for 8 months.
BACKGROUND: Mitochondrial dysfunction occurs early in the course of ALS, and the mitochondria may be an important site for therapeutic intervention. Creatine stabilizes the mitochondrial transition pore, and is important in mitochondrial ATP production. In a transgenic mouse model of ALS, administration of creatine prolongs survival and preserves motor function and motor neurons. METHODS: The authors conducted a randomized double-blind, placebo controlled trial on 104 patients with ALS from 14 sites to evaluate the efficacy of creatine supplementation in ALS. The primary outcome measure was maximum voluntary isometric contraction of eight upper extremity muscles, with secondary outcomes including grip strength, ALS Functional Rating Scale-Revised, and motor unit number estimates. Patients were treated for 6 months, and evaluated monthly. RESULTS: Creatine was tolerated well, but no benefit of creatine could be demonstrated in any outcome measure. CI analysis showed that the study, although powered to detect a 50% or greater change in rate of decline of muscle strength, actually made an effect size of greater than 23% unlikely. It was also demonstrated that motor unit number estimation was performed with acceptable reproducibility and tolerability, and may be a useful outcome measure in future clinical trials. CONCLUSION: Any beneficial effect of creatine at 5 g per day in ALS must be small. Other agents should be considered in future studies of therapeutic agents to address mitochondrial dysfunction in ALS. In addition, motor unit number estimation may be a useful outcome measure for future clinical trials in ALS.
OBJECTIVE: To report our experience with the use of continuous electromyography (EMG) for placement of iliosacral screws. DATA SOURCES: Concurrently acquired data as well as patient charts, intraoperative EMG records, x-rays, and pelvic computed tomography (CT) scans. DESIGN: The monitored group of twenty-nine patients was studied prospectively. The control group consisted of twenty-two patients studied retrospectively. SETTING: Level One trauma center. METHODS: Continuous electromyograms were recorded for twenty-nine patients and compared with those from a group of twenty-two antecedent patients who were not monitored. The primary parameter of interest of this study was the presence or absence of neurologic change after iliosacral screw placement. This information was obtained prospectively in the study group and by retrospective review in the historical control. RESULTS: Four patients in the control group had postoperative and/or sensory motor changes prompting a postoperative CT scan; in each of these patients, a misdirected screw was identified and subsequently removed in a second procedure. There were no neurologic changes subsequent to placement in the twenty-nine patients who were monitored (7.5 percent versus 0 percent; p = 0.029, Fisher's exact test). All monitored patients had postoperative CT scans and showed the screw in a safe position with no significant violations of the S1 tunnel. CONCLUSION: Continuous EMG monitoring during iliosacral screw placement may be a useful neuroprotective tool.
OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of tramadol in treating the pain of diabetic neuropathy. BACKGROUND: The pain of diabetic neuropathy is a major cause of morbidity among these patients and treatment, as with other small-fiber neuropathies, is often unsatisfactory. Tramadol is a centrally acting analgesic for use in treating moderate to moderately severe pain. METHODS: This multicenter, outpatient, randomized, double-blind, placebo-controlled, parallel-group study consisted of a washout/screening phase, during which all analgesics were discontinued, and a 42-day double-blind treatment phase. A total of 131 patients with painful diabetic neuropathy were treated with tramadol (n=65) or placebo (n=66) tramadol, which were administered as identical capsules in divided doses four times daily. The primary efficacy analysis compared the mean pain intensity scores in the tramadol and placebo groups obtained at day 42 of the study or at the time of discontinuation. Secondary efficacy assessments were the pain relief rating scores and a quality of life evaluation based on daily activities and sleep characteristics. RESULTS: Tramadol, at an average dosage of 210 mg/day, was significantly (p < 0.001) more effective than placebo for treating the pain of diabetic neuropathy. Patients in the tramadol group scored significantly better in physical (p=0.02) and social functioning (p=0.04) ratings than patients in the placebo group. No statistically significant treatment effects on sleep were identified. The most frequently occurring adverse events with tramadol were nausea, constipation, headache, and somnolence. CONCLUSIONS: The results of this placebo-controlled trial showed that tramadol was effective and safe in treating the pain of diabetic neuropathy.
We report our experience of oral hairy leukoplakia in HIV seropositive patients. Etiopathogenesis and relationship between oral hairy leukoplakia and HIV infection are briefly discussed, as well as its prognostic value.
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A case of secondary syphilis in which the patients still had the primary chancre is reported. The unusual clinical feature was the location of the syphilitic on the arm.
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A case of twenty-nail dystrophy in an 7-year-old girl is presented. The histopathological findings were incompatible with lichen planus. The differential diagnosis is briefly discussed, and the literature reviewed.
An otherwise healthy 6-year-old girl, with lesions which clinically and histopathologically corresponded to the rare inherited disorder ichthyosis hystrix, is described. The classification of this disorder is briefly discussed.
A family is described in which female members of two generations were affected from birth from a flexion deformity of the fingers. The pedigree analysis suggests the possibility of a sex-limited autosomal dominant pattern of inheritance. This rare condition, which has been reported only once in the literature, is known by the term streblodactyly (streblos = Gr. twisted, crooked).
Two brothers with typical, symmetrical lesions of elastosis perforans serpiginosa are presented. Familial occurrence has been reported only once. In neither family was the disease associated with heritable disorders of the connective tissue. The pedigree analysis suggests an autosomal-recessive pattern of inheritance.
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OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of tramadol in a 6-month open extension following a 6-week double-blind randomized trial. RESEARCH DESIGN AND METHODS: Patients with painful diabetic neuropathy who completed the double-blind study were eligible for enrollment in an open extension of up to 6 months. All patients received tramadol 50-400 mg/day. Self-administered pain intensity scores (scale 0-4; none to extreme pain) and pain relief scores (scale -1-4; worse to complete relief) were recorded the first day of the open extension (last day of the double-blind phase) and at 30, 90, and 180 days. RESULTS: A total of 117 patients (56 former tramadol and 61 former placebo) entered the study. On the first day of the study, patients formerly treated with placebo had a significantly higher mean pain intensity score (2. 2+/-1.02 vs. 1.4+/-0.93, P<0.001) and a lower pain relief score (0. 9+/-1.43 vs. 2.2+/-1.27, P<0.001) than former tramadol patients. By Day 90, both groups had mean pain intensity scores of 1.4, which were maintained throughout the study. Mean pain relief scores (2. 4+/-1.09 vs. 2.2+/-1.14) were similar after 30 days in the former placebo and former tramadol groups, respectively and were maintained for the duration of the study. Four patients discontinued therapy due to ineffective pain relief; 13 patients discontinued due to adverse events. The most common adverse events were constipation, nausea, and headache. CONCLUSIONS: Tramadol provides long-term relief of the pain of diabetic neuropathy.
The distribution of peripheral blood T lymphocytes in 35 patients aged 16 to 49 years with genital warts was studied. Patients with genital warts were found to be less responsive than a control group, and this deficiency was related to duration of genital wart infection. 11 patients affected with long lasting genital warts were treated with interferon. The results are reported and briefly discussed.
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