RESUMEN
Cerebral vasospasm considered to be a serious cause of morbidity and mortality following subarachnoid haemorrhage [SAH].Despite several available therapeutic options, current protocols do not prevent major consequences of vasospasm. Inflammation is believed to play an important role in post-haemorrhagic vasospasm. Meloxicam is a non-steroidal anti-inflammatory drug. The aim of this study was to compare the efficacy of meloxicam versus placebo on vasospasm in patients with SAH. In this randomized, double-blind, placebo-controlled trial, SAH patients randomly received 7.5 mg meloxicam or placebo twice daily for 7 days. End points were, middle cerebral artery velocity obtained with transcranial doppler, in-hospital mortality, hospital stay and discharge Glasgow Outcome Scale. Eighty-one patients enrolled in the study. [40 received meloxicam, 41 received placebo]. Baseline characteristics were similar between the groups. There were no differences in length of hospitalization [17.4 +/- 3.1 vs 18.6 +/- 4.2 days; p = 0.145], in-hospital mortality rate [15 vs 22%; p-value=0.569], or GOS [p = 0.972] between the two groups. MCA velocity were slightly less in patients who had received meloxicam, but not to a significant degree [p-value=0.564[. No side effect has been detected for meloxicam. This study did not prove meloxicam efficacy in vasospasm of SAH patients. But it demonstrated that clinical trial of meloxicam in these patients is feasible and probably safe. The effectiveness of meloxicam on cerebral vasospasm has to be studied in larger trials
Asunto(s)
Humanos , Femenino , Masculino , Tiazoles , Placebos , Vasoespasmo Intracraneal , Hemorragia Subaracnoidea , Método Doble CiegoRESUMEN
The purpose of this study was to characterize the pharmacokinetic parameters of mycophenolic acid [MPA] in Iranian kidney transplant patients. Plasma MPA concentration of mycophenolate mofetile [MMF] 1 gram two times a day was measured in 21 Iranian kidney transplant recipients receiving treatment. Patients who entered the study had been transplanted for more than 3 months and their drug level was supposed to be at steady state. MMF concentration was measured with High- Performance Liquid Chromatography [HPLC]. The plasma MPA concentration-time curve was characterized by an early sharp peak at about 1 hour postdose. The mean Area Under Curve [AUC], Cmax and Tmax were 47.0 +/- 18.3 microg.h/ml, 18.6 +/- 8.5 microg/ml and 1.0 +/- 0.5 hours respectively. The plasma MPA concentration-time curve pattern of Iranian patients was similar and consistent with previously reported profiles in other populations taking the same dose.