RESUMEN
Background: The guideline for antibiotic prophylaxis in pediatric cardiac surgery is currently unavailable, and the effects of cardiopulmonary bypass (CPB) may result in low plasma cefazolin concentrations and subsequent postoperative surgical site infections (SSIs). Aims: To demonstrate the calculated-unbound plasma concentrations of cefazolin during uncomplicated pediatric cardiac surgery. Settings and Design: A prospective observational study that included 18 patients Asunto(s)
Procedimientos Quirúrgicos Cardíacos
, Cefazolina
, Antibacterianos
, Puente Cardiopulmonar
, Niño
, Escherichia coli
, Humanos
, Staphylococcus aureus
RESUMEN
BACKGROUND: The herbal formula (Sahatsatara, STF), the Thai traditional poly-herbal recipe, has been used for treatment of muscle pain, anti-flatulence and numbness on hands and feet, with the caution when used in hypertensive patients. However, there is no scientific evidence to prove its effects on cardiovascular system. Piperine is the proposed major active compound in STF. It is shown to have antihypertensive effect in the L-NAME-induced endothelial dysfunction rats. PURPOSE: This study investigated the pharmacokinetics, mechanism of action, as well as the hemodynamic and vasoactive effect and toxicity of STF and piperine using spontaneously hypertensive rats (SHR) and normal Wistar rats (NWR). METHODS: The amount of piperine in STF was measured by ultra performance liquid chromatography (UPLC). SHR and NWR were gavaged with piperine (50mg/kg/day) or STF (100, 300, or 1000mg/kg/day) alone or together with L-NAME (in drinking water) for 28 days. Hemodynamic effects were monitored by noninvasive tail cuff every 7 days. Vasorelaxation effect on the thoracic aorta in organ chamber was observed through force transducer at the end of the experiment. Biochemical parameters for kidney and liver toxicity were measured. In addition, pharmacokinetic study was performed using non-compartment analysis. RESULTS: The amount of piperine in STF was 1.29%w/w. Both STF and piperine did not affect blood pressure and heart rate in both SHR and NWR. Interestingly, STF and piperine increased acetylcholine-induced vasorelaxation of isolated thoracic aorta and have vascoluprotective effect in nitric oxide (NO) impaired rats. No liver or kidney toxicity was found in this study. Non-compartment pharmacokinetic analysis showed that the time to reach maximum concentration (Tmax) of plasma piperine after administration of piperine and STF were 3.9 and 1.7h, respectively. This result suggested that piperine in the recipe had better absorption than the pure standard piperine. CONCLUSIONS: STF had no effect on blood pressure in both SHR and NWR. However, it was able to relax isolated thoracic aorta and had the potential for vasculoprotective effect in hypertensive and NO impaired condition. The effects of STF were comparable to those of piperine.
Asunto(s)
Alcaloides/uso terapéutico , Antihipertensivos/uso terapéutico , Benzodioxoles/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Hipertensión/tratamiento farmacológico , Piperidinas/uso terapéutico , Extractos Vegetales/uso terapéutico , Plantas Medicinales/química , Alcamidas Poliinsaturadas/uso terapéutico , Vasodilatación/efectos de los fármacos , Alcaloides/farmacología , Animales , Antihipertensivos/farmacología , Benzodioxoles/farmacología , Masculino , Fitoterapia , Piperidinas/farmacología , Extractos Vegetales/farmacología , Alcamidas Poliinsaturadas/farmacología , Ratas , Ratas Endogámicas SHR , Ratas Endogámicas WKY , Ratas Wistar , TailandiaRESUMEN
OBJECTIVE: To evaluate the bioequivalence of50 mg cilostazol tablets manufactured locally (Citazol®) and originally (Pletaal®) in healthy Thai volunteers. MATERIAL AND METHOD: An open-label, single dose, randomized, two-period, two-sequence, crossover study in 30 healthy volunteers. Each volunteer received a 50 mg cilostazol tablet of bothformulations with a washoutperiodofat least 14 days. Blood samples were obtained atpre-dose and over 48 hours after dosing. Cilostazolplasma concentrations were quantified by using liquid chromatography with tandem mass spectrometry (LC-MS/MS). RESULTS: The 30 volunteers completed the entire study. The geometric mean ratios (GAM) (test/reference) between the two formulations of cilostazol were 112.38% (101.70%-124.19%) for Cmax; 103.66% (96.06%-111.86%) for AUC0-48; and 95.14% (86.12%-105.12%)forAUC0-∞. There was no statistical difference ofthe Tmax between the twoformulations (p>0.05). No serious adverse events related to the studied drugs were found. CONCLUSION: No significant difference in the analyzed pharmacokineticparameters was found between the twoformulations of 50 mg cilostazol tablets. Therefore, it can be concluded that these two cilostazol tablet formulations were considered bioequivalent.
Asunto(s)
Ayuno , Inhibidores de Fosfodiesterasa 3/farmacocinética , Tetrazoles/farmacocinética , Química Farmacéutica , Cromatografía Liquida , Cilostazol , Estudios Cruzados , Espectrometría de Masas en Tándem , Tailandia , Equivalencia TerapéuticaRESUMEN
BACKGROUND: There have been few reports describing antibiotic related fever especially in the beta-lactam class of antibiotics. The present report is a case of postoperative immediate-onset cefazolin-related fever in a lumbar spine surgery patient. CASE REPORT: A 58-year-old woman presented with progressive low back pain and neurogenic claudication of both extremities for six months. Magnetic resonance imagese (MRI) of the lumbar spine indicated central canal stenosis with nerve root compression from L4 to S1. After decompressive laminectomy, pedicular screw fixation, and posterolateral fusion were performed, the patient experienced-postoperative fever without obvious evidence of infection. The blood and tip of drain bacterial culture grew no organisms. After propholactic cefazolin was discontinued in postoperative day 5, the fever began to declined and returned to normal on postoperative day 9. CONCLUSION: Postoperative drug fever that is caused by prophylactic cefazolin may be delayed in diagnosis because drug fever is usually diagnosed by exclusion after the elimination of other potential causes. The research authors would like to encourage physicians to be aware of this entity. Prompt cause identification can obviate unnecessary diagnostic procedures and inappropriate treatments.