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Comparable Clinical Efficacy (comparable + clinical_efficacy)
Selected AbstractsRAPA: a novel in vitro method to evaluate anti-bacterial skin cleansing productsINTERNATIONAL JOURNAL OF COSMETIC SCIENCE, Issue 2 2010S. A. Ansari Synopsis Development of efficacious anti-bacterial skin cleansing products has been limited by the availability of a pre-clinical (in vitro) method to predict clinical efficacy adequately. We report a simple and rapid method, designated as rapid agar plate assay (RAPA), that uses the bacteriological agar surface as a surrogate substrate for skin and combines elements of two widely used in vivo (clinical) methods (Agar Patch and Cup Scrub). To simulate the washing of the human hand or forearm skin with the test product, trypticase soy agar plates were directly washed with the test product and rinsed under running tap water. After air-drying the washed plates, test bacteria (Staphylococcus aureus or Escherichia coli) were applied and the plates were incubated at 37°C for 18,24 h. Using S. aureus as the test organism, anti-bacterial bar soap containing triclocarbanilide showed a strong linear relationship (R2 = 0.97) between bacterial dose and their per cent reduction. A similar dose-response relationship (R2 = 0.96) was observed for anti-bacterial liquid hand soap against E. coli. RAPA was able to distinguish between anti-bacterial products based on the nature and level of actives in them. In limited comparative tests, results obtained by RAPA were comparable with the results obtained by clinical agar patch and clinical cup scrub methods. In conclusion, RAPA provides a simple, rugged and reproducible in vitro method for testing the relative efficacy of anti-bacterial skin cleansing products with a likelihood of comparable clinical efficacy. Further testing is warranted to improve the clinical predictability of this method. Résumé Le développement des produits de nettoyage de peau antibactérienne efficace a été limité par la disponibilité d'une méthode (in vitro) préclinique pour prévoir en juste proportion l'efficacité clinique. Nous rapportons une méthode simple et rapide, indiquée comme analyse rapide de plat d'agar (RAPA) ce des utilisations la surface bactériologique d'agar comme substrat de remplacement pour la peau et combinons des éléments de deux méthodes (cliniques) in vivo employées couramment (correction d'agar et la tasse frottent). Pour simuler le lavage de la peau humaine de main ou d'avant-bras avec le produit d'essai, des plats de l'agar de soja de trypticase ont été directement lavés avec le produit d'essai et rincés sous l'eau du robinet courante. Après l'air séchant les plats lavés, les bactéries d'essai (S. doré Ou Escherichia coli) étaient appliquées et des plats ont été incubées au °C 37 pendant 18,24 heures. Utilisant S. doré Comme organization d'essai, le triclocarbanilide contenant du savon de barre antibactérienne a montré un rapport linéaire fort (R2 = 0.97) entre la dose bactérienne et leur réduction de pour cent. On a observé un rapport semblable de réponse à dose donnée (R2 = 0.96) pour le savon liquide antibactérien de main contre E. coli. RAPA pouvait distinguer les produits antibactériens basés sur la nature et le niveau des actives dans eux. Dans les essais comparatifs limités, résultats obtenus par RAPA étaient comparables aux résultats obtenus par la correction clinique d'agar et la tasse clinique frottent des méthodes, en conclusion, RAPA fournit à une méthode in vitro simple, raboteuse et reproductible pour examiner l'efficacité relative des produits de nettoyage de peau antibactérienne la probabilité de l'efficacité clinique comparable. Davantage d'essai est justifié pour améliorer la prévisibilité clinique de cette méthode. [source] Two-Year Clinical Registry Follow-up of Endothelial Progenitor Cell Capture Stent Versus Sirolimus-Eluting Bioabsorbable Polymer-Coated Stent Versus Bare Metal Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Elevation Myocardial InfarctionJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2010ERIC CHONG M.B.B.S., F.A.M.S., M.R.C.P. Background: Endothelial progenitor cell (EPC) capture stent is designed to promote rapid endothelization and healing and is potentially useful in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). We studied the intermediate-term efficacy and safety of EPC stent and compared that with sirolimus-eluting bioabsorbable polymer stent (CURA) and bare metal stent (BMS) in AMI patients. Methodology: Patients presenting with AMI who underwent primary PCI with the respective stents between January 2004 and June 2006 were enrolled in the single-center clinical registry. The study end-points were major adverse cardiac events (MACE) and stent thrombosis. Results: A total of 366 patients (EPC = 95, CURA = 53, BMS 218) were enrolled. Baseline demographics including age, gender, diabetes, renal impairment, predischarge left ventricular ejection fraction, and creatinine kinase level were comparable among the groups. Procedural success rate was 99.5%. Post-procedural thrombolysis in myocardial infarction (TIMI) 3 flow was achieved in EPC 91.6%, CURA 96.2%, and BMS 88.5% (P = 0.209). At 2 years, the MACE rate was EPC 13.7%, CURA 15.1%, and BMS 19.7% (P = 0.383). Target vessel revascularizations (TVR) were EPC 4.2%, CURA 9.4%, and BMS 6.0% (P = 0.439). Nonfatal myocardial infarctions were EPC 1.1%, CURA 3.8%, and BMS 4.1% (P = 0.364). One patient in the EPC group had acute stent thrombosis. There was no late stent thrombosis in the EPC group. Conclusion: EPC stent appeared to be safe and had comparable clinical efficacy with a BMS when used in the AMI setting. At 2-year follow-up, the EPC group showed favorable, single-digit TVR rate and stent thrombosis remained a low-event occurrence. (J Interven Cardiol 2010;23:101-108) [source] Pharmacological properties and clinical efficacy of a recently licensed systemic antifungal, caspofunginMYCOSES, Issue 4 2005Georg Maschmeyer Summary Caspofungin, a semisynthetic derivative of the pneumocandin B0, is the first licensed compound of a new class of antifungal agents, the echinocandins. It attacks the fungal cell by selective inhibition of the beta-(1,3)- d -glucan synthase, which is not present in mammalian cells. In vitro studies have indicated a potent fungicidal effect on Candida species, and in vivo studies in immunocompromised animals with invasive candidiasis demonstrated a favourable outcome. In randomized clinical trials in patients with oropharyngeal/oesophageal and invasive candidiasis, caspofungin was at least as effective as amphotericin B deoxycholate, yet showed a significantly superior safety profile. Of patients with invasive aspergillosis refractory to or intolerant of other antifungal agents, 45% showed a partial or complete response to caspofungin given as a salvage treatment. Also, it demonstrated comparable clinical efficacy but superior tolerability in the empirical antifungal therapy in neutropenic patients compared with liposomal amphothericin B. Caspofungin has an excellent tolerability and a low potential for drug interactions. Thus, caspofungin represents an interesting and clinically valuable new antifungal drug that broadens the available therapeutic armamentarium for the treatment of invasive fungal infections. [source] Bronchodilator effect of salbutamol from two different spacer devicesPEDIATRIC PULMONOLOGY, Issue 4 2006Albert M. Li MB Abstract Our aim was to compare the bronchodilator effect of salbutamol delivered via a new holding chamber (Volumatic Soft, VS) with that of an established device (Volumatic, V) in asthmatic children. Children with stable asthma were recruited. They inhaled 100 µg, and 10 min later, 300 µg of salbutamol aerosol delivered via VS or V on day 1, and vice versa on day 2. Spirometry was measured at baseline, 10 min after 100 µg, and 15 min after 300 µg of salbutamol were given. The preference for either device was assessed by visual analogue score. Forty-four children with a median age of 9.2 years (interquartile range, 8.0,10.7) completed the study. There were significant improvements in forced expired volume in 1 sec (FEV1) with time throughout the study period for both V and VS (linear and quadratic trend P,<,0.001). There was a statistically significant difference in postbronchodilator FEV1 between V and VS (P,=,0.013). VS gave an overall greater change in FEV1 than V, by 1.8%. The preference scores for V and VS were 7.0 (IQR 5.0,8.0) and 9.0 (IQR 8.0,10.0) (p,<,0.0005), respectively. In conclusion, comparable clinical efficacy was found for V and VS with respect to changes in FEV1 after salbutamol. Patients also showed a strong preference for the new device. Pediatr Pulmonol. © 2006 Wiley-Liss, Inc. [source] | ||||||||||