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A study to determine the efficacy of treatments for hydrofluoric acid burns.

Hydrofluoric acid burns are characterized by progressive tissue destruction and severe pain. Fluoride ion chelators, such as salts of calcium and magnesium, have been used to treat these burns. This study was designed to compare the efficacy of several treatment methods that involve the use of these salts. Standard hydrofluoric acid burns were produced on the shaved hindquarters of rats. After being rinsed with water, the chemical burns were treated by one of seven experimental methods. The progress of the chemical burn damage was observed for 1 week by measuring the surface areas of the burns. Calcium gluconate burn jelly, 20% calcium gluconate in water, and 50% aqueous dimethyl sulfoxide did not significantly slow the spread of the burn area. However, subcutaneous injections of calcium gluconate or magnesium sulfate and topical applications of calcium gluconate in a solution of dimethyl sulfoxide significantly slowed the progress of the burns during the first 24 hours and enhanced tissue recovery for the remainder of the observation period. These results indicate that subcutaneous injections of magnesium or calcium salts appear to be more effective than conventional topical applications in the treatment of hydrofluoric acid burns. More significantly, topically applied calcium gluconate combined with a penetration enhancer, such as dimethyl sulfoxide, is as effective as injection treatments in reducing damage caused by hydrofluoric acid.

Administration, Topical↗

Determining the efficacy of glucosamine and chondroitin for osteoarthritis.

Glucosamine sulfate and chondroitin sulfate are being used by many patients for the treatment of osteoarthritis. Despite a number of studies supporting efficacy of these agents for palliation of joint pain in patients with osteoarthritis, the American College of Rheumatology Subcommittee on Osteoarthritis believes that it is too early to issue recommendations for use. Currently, the National Institute of Arthritis and Musculoskeletal and Skin Diseases in collaboration with the National Center for Complementary and Alternative Medicine have begun a pivotal study to thoroughly evaluate these agents.

Chondroitin↗

The use of mechanical etiology to determine the efficacy of active intervention in single joint lumbar intervertebral joint problems. Surgery and chemonucleolysis compared: a prospective study.

A group of patients were matched for clinical diagnosis, severity of symptoms, and duration and type of preoperative management. The patients all had intractible sciatica. They were submitted to this study by nine participating authors working independently in various centers in North America. Of these patients, those with spondylolysis or spondylolisthesis or those who had had previous surgery were excluded. The patients were treated by chemonucleolysis or by surgery. The information in the various parts of the protocol allowed: (1) identification of the joint at risk, (2) the generic type of injury (torsion or compression), and (3) the procedure of choice for each patient. The outcome was predicted from the operation report using a demerit system for each deviation from the procedure of choice. It was possible to predict from this information only, with a high degree of accuracy (94%), the outcome 2 years later. It was also possible to compare the efficacy of the various types of intervention, especially chemonucleolysis versus a variety of surgical procedures.

Biomechanical Phenomena↗

A randomized, controlled trial to determine the efficacy of paper tape in preventing hypertrophic scar formation in surgical incisions that traverse Langer's skin tension lines.

BACKGROUND: How a scar is managed postoperatively influences its cosmetic outcome. After suture removal, scars are susceptible to skin tension, which may be the trigger for hypertrophic scarring. Paper tape to support the scar may reduce multidirectional forces and prevent hypertrophic scarring. METHODS: Seventy patients who had undergone cesarean section at the Royal Brisbane and Women's Hospital were randomized to treatment and control groups. Patients in the control group received no postoperative intervention. Patients in the treatment group applied paper tape to their scars for 12 weeks. Scars were assessed at 6 weeks, 12 weeks, and 6 months after surgery using ultrasound to measure intradermal scar volume. Scars were also assessed using the International Clinical Recommendations. RESULTS: Paper tape significantly decreased scar volume by a mean of 0.16 cm3, (95 percent confidence interval, 0.00 to 0.29 cm3). At 12 weeks after surgery, 41 percent of the control group developed hypertrophic scars compared with none in the treatment group (exact test, p = 0.003). In the treatment group, one patient developed a hypertrophic scar and four developed stretched scars only after the tape was removed. The odds of developing a hypertrophic scar were 13.6 times greater in the control than in the treatment group (95 percent confidence interval, 3.6 to 66.9). Of the 70 patients randomized, 39 completed the study. Four patients in the treatment group developed a localized red rash beneath the tape. These reactions were minor and transient and resolved without medical intervention. CONCLUSIONS: The development of hypertrophic and stretched scars in the treatment group only after the tape was removed suggests that tension acting on a scar is the trigger for hypertrophic scarring. Paper tape is likely to be an effective modality for the prevention of hypertrophic scarring through its ability to eliminate scar tension.

Adult↗

Determinants of efficacy of atrial pacing in preventing atrial fibrillation recurrences.

INTRODUCTION: Several studies have shown that single or dual site atrial pacing is effective in reducing the frequency of recurrent atrial fibrillation (AF) in selected patients. However, it is still unclear what the best predictors are of long-term efficacy of atrial pacing. METHODS AND RESULTS: Forty-seven patients with paroxysmal AF requiring demand pacing underwent electrophysiologic study and dual chamber pacemaker implant. After 4 months of follow-up, patients were divided into two groups according to the presence (group 1) or absence (group 2) of symptomatic AF recurrences. Atrial pacing markedly reduced AF recurrences in all patients. Twenty-four patients were free of arrhythmia. The basal state conduction times (CTs) and the incremental conduction times (ICTs), during programmed electric stimulation between the high right atrium (HRA) and the coronary sinus ostium (CSos), but not between the HRA and the His-bundle region, were significantly longer in group 1. There was no statistical difference in the effective refractory period (ERP) recorded at the HRA, the low right atrium (LRA), and the CSos between the two groups, whereas the differences between the greatest and least recorded ERPs measured from the HRA, LRA, and CSos (deltaERP) were significantly greater in group 1 patients. Two parameters were selected by discriminant multivariate analysis, namely deltaCTos (ICT-CT between HRA and CSos) and deltaERP. The first had a greater relative importance in predicting AF recurrence (r2 = 0.33 and r2 = 0.1, respectively). CONCLUSION: Single site atrial pacing is effective in reducing AF recurrences, with decreasing efficacy in patients with greater right atrial conduction delay and wider refractoriness dispersion.

Aged↗

Activation PET as an instrument to determine therapeutic efficacy in Alzheimer's disease.

Forty patients with probable Alzheimer's disease (AD) were selected from a pool of 80 patients and assigned to 4 groups. Each received either social support, cognitive training only, or cognitive training in combination with pyritinol or phosphatidylserine. Treatment duration was 6 months. Before and after treatment the patients underwent neuropsychological testing as well as measurement of the regional cerebral metabolic rate for glucose using positron emission tomography (PET) and 2[18F]-fluoro-2-deoxy-D-glucose (FDG). Before treatment, the groups were comparable in respect to resting and activated glucose pattern achieved by a visual recognition task. They did not differ in scores of a neuropsychological test battery. After the treatment period the group with cognitive training + phosphatidylserine showed a significant glucose enhancement during the stimulation tasks in various brain regions, and an improvement in cognitive functioning compared to the other groups. The group with cognitive training + pyritinol had better stimulation effect as that of the social support group indicating that a combination of cognitive training + pharmacological intervention was superior than that of cognitive training alone.

Alzheimer Disease↗

Relative opioid efficacy is determined by the complements of the G protein-coupled receptor desensitization machinery.

G protein-coupled receptor regulation by G protein-coupled receptor kinases and beta-arrestins can lead to desensitization and subsequent internalization of the receptor. In in vitro and cellular systems, beta-arrestins do not seem to play a major role in regulating micro opioid receptor (microOR) responsiveness. Removal of the betaarrestin2 (betaarr2) gene in mice leads paradoxically to enhanced and prolonged microOR-mediated antinociception. The betaarr2 knockout (betaarr2-KO) mice also fail to develop morphine antinociceptive tolerance in the hot-plate test, further indicating that the betaarr2 protein plays an essential role in microOR regulation in vivo. In this study, the contribution of betaarr2 to the regulation of the microOR was examined in both human embryonic kidney 293 cells and in betaarr2-KO mice after treatment with several opiate agonists. A green fluorescent protein tagged betaarr2 was used to assess receptor-betaarr2 interactions in living cells. Opiate agonists that induced robust betaarr2-green fluorescent protein translocation produced similar analgesia profiles in wild-type and betaarr2-KO mice, whereas those that do not promote robust betaarr2 recruitment, such as morphine and heroin, produce enhanced analgesia in vivo. In this report, we present a rationale to explain the seemingly paradoxical relationship between beta-arrestins and microOR regulation wherein morphine-like agonists fail to promote efficient internalization and resensitization of the receptor.

Animals↗

Use of the surgical wound infection model to determine the efficacious dosing regimen of retapamulin, a novel topical antibiotic.

The effect of topically applied retapamulin ointment was evaluated using various dosing regimens in the Staphylococcus aureus and Streptococcus pyogenes wound infection model. Retapamulin (1%, wt/wt) was efficacious using twice-daily (b.i.d.) applications for 4 or 5 days. These data underpinned the decision to evaluate 1% retapamulin b.i.d. in clinical trials.

Administration, Topical↗

Liquid chromatographic determination of efficacy of incorporation of trimethoprim and sulfamethoxazole in brine shrimp (Artemia spp.) used for prophylactic chemotherapy of fish.

The brine shrimp Artemia, an excellent live food source in aquaculture, has been studied as a carrier to deliver selected chemotherapeutic agents to fish for prophylactic treatment of infectious diseases. To monitor the efficiency of incorporation of trimethoprim and sulfamethoxazole in Artemia franciscana, a sensitive and specific analytical method was developed. It is based on homogenization of Artemia nauplii in methanol, extraction of lipids with hexane, solid-phase cleanup on C18 cartridges, and reversed-phase liquid chromatography with detection at 210 nm. The method is sensitive (detection limit, on the order of 3 micrograms/g with a sample quantity of 30 mg [dry weight]) and reproducible (coefficients of variation, 2.2 and 1.8% for trimethoprim and sulfamethoxazole at levels of 79.6 and 257 micrograms/g of body weight, respectively). Preliminary quantitative data indicated excellent uptake and persistence of both therapeutic agents in A. franciscana, with levels of 115 micrograms/g for trimethoprim and 277 micrograms/g for sulfamethoxazole.

Animals↗

Killing of nongrowing and adherent Escherichia coli determines drug efficacy in device-related infections.

Antimicrobial therapy of device-related infections often fails, despite the in vitro susceptibility of the infecting strain. Therefore, alternative laboratory-based in vitro tests are required to predict the outcome. Fleroxacin, ciprofloxacin, aztreonam, and co-trimoxazole were tested against Escherichia coli ATCC 25922 in vitro and in the tissue-cage animal model. The importance of early treatment was evaluated by starting the drugs either 30 min before or 4, 12, and 24 h after bacterial challenge. Results were compared with the in vitro drug efficacy against nongrowing and adherent Escherichia coli ATCC 25922. The alternative in vitro tests correlated highly with the outcome in the tissue-cage animal model. In the prophylaxis group (drug given 30 min before bacterial challenge), co-trimoxazole was less efficacious than the other three drugs (P less than 0.001). In delayed treatment, ciprofloxacin showed the highest cure rate. It was also more potent than the other drugs against nongrowing and adherent E. coli ATCC 25922. The efficacies of aztreonan, fleroxacin, and ciprofloxacin dropped significantly (P less than 0.01) when the time interval between bacterial challenge and the start of treatment was delayed to greater than 4 h. These data emphasize (i) the need for proper timing of prophylaxis in patients undergoing implant surgery, and (ii) the possibility of successful treatment of established device-related infections with drugs which kill not only growing but also nongrowing and adherent bacteria.

Animals↗

New method for determination of efficacy of health care personnel hand wash products.

A method of studying the effects of health care personnel hand wash products is described. The fingernail regions of the hands of volunteers are inoculated with a mixture of Escherichia coli and Serratia marcescens, and the areas are dried for a standard time. After routine hand washing, each fingernail region is individually scrubbed with an electric toothbrush which moves longitudinally to the handle into collection fluid contained in a petri dish. The test bacteria in the fluid are then enumerated. (Bacillus subtilis spores may be included as tracers to show degree of physical removal of the procedure.) This method has several advantages over the frequently used glove juice technique. Experimental designs with large numbers of volunteers, multiple sampling sites, and many hand wash products may be performed. Ten sampling sites (fingers) are available, versus the two gloved hands for testing products. (Efficiency is almost 100% in the recovery of spore tracers placed on the fingernails.) Many commercial health care personnel hand wash products containing antimicrobial agents substantive to the skin do not rapidly reduce numbers of inoculated bacteria in the fingernail regions to any greater extent than nonantimicrobial hand washes. Products containing isopropanol or ethanol are very effective in decreasing bacteria in areas around and under the fingernails.

Alcohols↗

Double blind, randomised, placebo controlled, crossover, multicentre study to determine the efficacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome.

BACKGROUND/AIMS: Hyaluronan (sodium hyaluronate) has been shown to confer objective and subjective improvement in patients with dry eye syndrome. This study compared the efficacy and safety of a 0.1% solution of hyaluronan with 0.9% saline, when administered topically to the eye, in the treatment of symptoms of severe dry eye syndrome. METHODS: A randomised, double blind, crossover clinical trial in which subjects were randomised to receive either hyaluronan or saline, applied as one or two drops to the eye, three or four times a day or as required. After 28 days' treatment, subjects crossed over to the other study medication for a further 28 days' treatment. RESULTS: 70 subjects were included in the analyses of efficacy and significant improvements in Schirmer's score (p=0.0006) and rose bengal staining score (p=0.0001) were observed during treatment with hyaluronan. In a subjective assessment of the effectiveness of two treatments, a majority of subjects felt that hyaluronan was more effective than saline in alleviating the symptoms of burning and grittiness (p<0.001). No adverse events attributable to hyaluronan treatment were reported. CONCLUSION: The study demonstrates a clear benefit of hyaluronan over saline, in both subjective and objective assessments of dry eye syndrome. Hyaluronan was shown to be well tolerated.

Adult↗

Field trial to determine the efficacy of two doses of 1 alpha-hydroxycholecalciferol in the prevention of milk fever.

The efficacy of 1 alpha-hydroxycholecalciferol (1 alpha-HCC) for the prevention of milk fever has been tested in a controlled field trial using a total of 601 cows on 18 farms with a history of a high incidence of milk fever. The trial protocol proposed two doses of 1 alpha-HCC with the first injection seven days before the predicted calving date and a second injection five to seven days later if the cow had not calved. Of 301 cows receiving either one or two injections of 1 alpha-HCC, 70 had milk fever, and of 300 cows that received a placebo, 102 had milk fever. The difference in incidence between the two groups was statistically significant (P = 0.005) and indicated an overall efficacy of 32 per cent for treatment with 1 alpha-HCC. An improved efficacy was demonstrated in 67 cows that received two injections of 1 alpha-HCC with the second injection administered either on the day of calving or one day previously (60 per cent efficacy). For 42 cows that received a single injection of 1 alpha-HCC between two and five days before calving an efficacy of 79 per cent was achieved.

Animals↗