Cyclosporine is a potent immunosuppressive drug. It has a narrow therapeutic index, and therefore the measurement of cyclosporine’s blood concentration is essential to obtain optimal therapy. Measurement of the area under the blood concentration-time curve (AUC) is reflective of total drug exposure. However, for organ transplant patients, the measurement of AUC involves many problems and difficulties. Thus, it is more clinically acceptable to use a single blood sample as a surrogate index of total drug exposure. Fifty-four adults bone marrow transplant Iraqi patients were given cyclosporine every 12 h as prophylaxis using Neoral® oral solution. Steady-state blood concentrations were monitored for each patient at zero time and then at 1, 2, 3, 4, 6, 8, 10, and at 12 h post-dosing. Cyclosporine blood levels were determined by using AXSYM automated immuno-analyzer which is a fluorescence polarization immunoassay (FPIA). The present investigation demonstrated the best correlation between C2 and the corresponding AUC0–4h and AUC0–12h compared to other concentrations. After two months of cyclosporine therapy, no unexpected biochemical changes and adverse effects were registered. It is concluded from this study that a single blood sample obtained at 2 h post-dosing (C2) and possibly at 3 h post dosing (C3) are ideal surrogate indexes for reflecting total drug exposure, and therefore may be used in clinical practice for predicting therapeutic and toxic effects of cyclosporine.
Hypercholesterolemia is one of the most important risk factors for atherosclerosis and subsequent cardiovascular diseases. In the present study, the therapeutic effects of ginger and fish oil supplementation on serum lipid profile and kidney functions in high cholesterol diet-induced hypercholesterolemia in rats have been evaluated. The animals were divided into 4 groups of 12 rats each. Group I served as the control. Rats in groups II, III and IV were fed with an atherogenic diet for 8 weeks, group III received atherogenic diet supplemented with 5% ginger, group IV received atherogenic diet supplemented with 10 % fish oil. The treatment with ginger and fish oil results in significant reduction in elevated serum total cholesterol, triglycerides(TG), low density lipoproteins (LDL) and very low density lipoproteins (VLDL) and elevation in high density lipoproteins (HDL), marked modulation of atherogenic index (AI) has been noted. Also, there was significant reduction in serum urea, uric acid and creatinine levels which was markedly elevated by atherogenic diet. We concluded that dietry supplementation with ginger and/or fish oil have favorable effects on serum lipid parameters and kidney functions in hypercholesterolemic male rats.
Objective: The study was aimed to find out the correlation between cyclosporine blood concentrations and (Clusters of Differentiation 4) CD4 Thelper cell count (percentage) in order to use the latter parameter as an alternative marker for cyclosporine dosing. Besides, the study was also aimed to find out the optimum dosing strategy for Iraqi patients requiring cyclosporine therapy in Iraqi hospitals using TDM approach. Methods:One hundred and twenty subjects participated in the study. The subjects are involved two groups; group A was 80 patients (53 males and 27 females) using cyclosporine twice daily (Sandimmune Clinical Pharmacy, Baghdad Teaching Hospital, Medical City, Baghdad, Iraq Email: drhaltemimi@dr.com ® oral solution containing cyclosporine 100 mg/ml) and they had kidney transplantation for more than one year. The ages of the patients were 15-45 y (mean±SD =31.962±8.8207); and. Group B included 40 healthy control subjects (24 males and 16 females) with ages of 15-45 y (mean±SD =31.666±8.1606). According to the condition and the need of the patients, they were administered cyclosporine dose range of 1-10 mg/kg/d. Ten ml blood samples were withdrawn from each patient after fasting for about 12 h for monitoring trough/minimum blood concentration (C0) of cyclosporine and for determination of (Clusters of Differentiation 4) CD4 T-helper cells count at C0. Other 10 ml of blood was then withdrawn after 2 h of cyclosporine administration to be used for monitoring maximum/peak cyclosporine blood cyclosporine (Cmax) after 2 h of drug intake (C2) and for determination of (Clusters of Differentiation 4) CD4 T-helper cells count at C2. Five ml of blood samples were withdrawn from each control subject for determination of (Clusters of Differentiation 4) CD4 T-helper cells count.Results: Good correlations were found between cyclosporine dose administered to each patient and the resulted C0 and C2. The majority of patients (66 patients=82.5%) had C0 of 150-200 ng/ml and C2 of 700-900 ng/ml, which are within the therapeutic range. The range of cyclosporine doses that produce therapeutic C0 and C2 was 4.1-9 mg/kg/d. The mean total lymphocyte count and percentage decreased significantly in all patients compared to the control subjects (1.26±0.60 vs.1.98±0.66 e 3 Keywords: Cyclosporine, Kidney transplantation, TDM, (Clusters of Differentiation 4) CD4 T-helper cell, Trough blood concentration of cyclosporine (C0), Maximum blood concentration of cyclosporine (C2) /uL) and (19.92±13.77 vs. 28.88±10.22), respectively. A similar trend was found for the total lymphocyte count and percentage of patients with cyclosporine C0, and C2 within the therapeutic range (66 patients) compared to the control subjects (1.34±0.57 vs. 1.98±0.66) and (18.98±10.93 vs. 28.88±10.22), respectively. Good negative correlations were found between lymphocyte count and percentage versus C0 for all patients and for patients with C0 within the therapeutic range. Similarly, good negative correlations were found between lymphocyte count and percent...
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