administration topical

  • 文章类型: Journal Article
    OBJECTIVE: Tranexamic acid (TXA) has been shown to be effective in reducing blood loss after total knee replacement. The purpose of this study was to prospectively assess the effectiveness of topical TXA use, to reduce blood loss after primary total knee replacement without tourniquet, and to compare these outcomes with a control group that did not receive tranexamic acid.
    METHODS: This is a prospective, randomized study to assess the effect of a 2-g topical tranexamic acid in 50 mL physiological saline solution in total knee replacement without tourniquet and drain. Primary outcomes were total blood loss. Secondary outcomes were hemoglobin and hematocrit level, hemoglobin and hematocrit drop, transfusion rates, length of hospital stay, deep vein thrombosis, and pulmonary embolism events.
    RESULTS: Preoperative and intraoperative data were similar between the two groups. The mean total blood loss was 620 mL in the topical tranexamic acid group and 1094 mL in the control group with significant differences (p = 0.001), which meant 43% reduction in total blood loss. The hemoglobin and hematocrit postoperative value was significantly higher in the topical tranexamic acid group than in the control group (p = 0.002). Transfusion rates were 0% in the topical tranexamic group and 4.3% in the control group. The length of stay was significantly lower in the topical tranexamic acid group (p = 0.01). There were no DVT or PE in any group.
    CONCLUSIONS: A single dose of 2-g TXA in 50 mL topical administration significantly reduces blood loss and improves postoperative blood chemistries in patients undergoing unilateral primary cemented TKA without tourniquet and drain compared to a control group, without increasing the risk of thromboembolic complications.
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  • 文章类型: Journal Article
    OBJECTIVE: Tranexamic acid has been shown to be effective in reducing blood loss after total hip replacement. The purpose of this study was to prospectively assess the effectiveness of topical TXA use to reduce blood loss after primary total hip replacement and to compare these outcomes with those of a matched control group from a similar cohort that did not have received tranexamic acid.
    METHODS: This is a prospective matched control study to assess the effect of a 2 g topical tranexamic acid in 50 mL physiological saline solution in total hip replacement. Primary outcomes were hemoglobin and hematocrit drop, and total blood loss. Secondary outcomes were transfusion rates, length of hospital stay, deep vein thrombosis, and pulmonary embolism events.
    RESULTS: We could match 100 patients to a control group. There were no statistical significantly differences between the two groups. The hemoglobin and hematocrit postoperative values were significantly higher in topical tranexamic acid group than in control group (P < 0.001). The mean total blood loss was 769 in topical tranexamic acid group and 1163 in control group with significant differences (P = 0.001), which meant 34% reduction in total blood loss. Length of stay was lower in topical tranexamic acid group. The risk of deep vein thrombosis and pulmonary events did not increase.
    CONCLUSIONS: A single dose of 2 g tranexamic acid in 50 mL physiological saline solution topical administration was effective and safe in reducing bleeding in patients undergoing unilateral primary non-cemented total hip replacement compared to a matched control group.
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  • 文章类型: Clinical Trial, Phase III
    Onychomycosis is a highly prevalent and intractable disease. The first-line treatment agents are oral preparations, but an effective topical medication has long been desired. The objective was to investigate the efficacy and safety of luliconazole 5% nail solution, an imidazole antifungal agent, for the treatment of patients with onychomycosis. A multicenter, double-blind, randomized phase III study was conducted in Japanese patients with distal lateral subungual onychomycosis affecting the great toenails, with 20-50% clinical involvement. Patients were randomized (2:1) to luliconazole or vehicle once daily for 48 weeks. The primary end-point was the complete cure rate (clinical cure [0% clinical involvement of the nail] plus mycological cure [negative results on direct microscopy]). The adverse event incidence was monitored to evaluate safety. The complete cure rate significantly favored luliconazole (14.9%, 29/194 subjects) versus vehicle (5.1%, 5/99) (P = 0.012). Similarly, the negative direct microscopy rate was significantly higher with luliconazole (45.4%, 79/174) than with vehicle (31.2%, 29/93) (P = 0.026). There were no serious adverse drug reactions. We conclude that once daily topical luliconazole 5% nail solution demonstrated clinical efficacy and was confirmed to be well tolerated.
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  • 文章类型: Journal Article
    Topical application of NSAIDs is an alternative route to systemic administration when a local anti-inflammatory effect of the underlying tissue is a treatment option. The aim of the present microdialysis study was to assess and compare plasma and tissue levels of diclofenac when topically applied with or without iontophoresis in healthy adults. Fourteen healthy adults (26±9.4 years) were randomized to diclofenac applied by iontophoresis, or by a gel, in a crossover design. Diclofenac concentrations were measured in plasma and in microdialysis perfusates from the underlying tissues. Iontophoretic application resulted in the highest plasma concentration of 3.4±0.5 ng/ml (SEM given) compared to 0.4 ng/ml (at the detection limit) with gel, whereas no differences were observed between tissue concentrations for the two application methods, both being very low, below or around the detection limit. Iontophoresis caused skin reactions in 25% of the participants. Iontophoresis of diclofenac as compared to traditional topical application was not superior in order to increase the NSAID concentration locally and appears to have a higher frequency of skin reactions.
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