Pharmacokinetic Comparison of Omeprazole Granule and Suspension Forms in Children: A Randomized, Parallel Pilot Trial.

Although, omeprazole is widely used for treatment of gastric acid-mediated disorders. However, its pharmacokinetic and chemical instability does not allow simple aqueous dosage form formulation synthesis for therapy of, especially child, these patients. The aim of this study was at first preparation of suspension dosage form omeprazole and second to compare the blood levels of 2 oral formulations/dosage forms of suspension & granule by high performance liquid chromatography (HPLC). The omeprazole suspension was prepared; in this regard omeprazole powder was added to 8.4% sodium bicarbonate to make final concentration 2 mg/ml omeprazole. After that a randomized, parallel pilot trial study was performed in 34 pediatric patients with acid peptic disorder who considered usage omeprazole. Selected patients were received suspension and granule, respectively. After oral administration, blood samples were collected and analyzed for omeprazole levels using validated HPLC method. The mean omeprazole blood concentration before usage the next dose, (trough level) were 0.12±0.08 µg/ml and 0.18±0.15 µg/ml for granule and suspension groups, respectively and mean blood level after dosing (C2 peak level) were 0.68±0.61 µg/ml and 0.86±0.76 µg/ml for granule and suspension groups, respectively. No significant changes were observed in comparison 2 dosage forms 2 h before (P=0.52) and after (P=0.56) the last dose. These results demonstrate that omeprazole suspension is a suitable substitute for granule in pediatrics.

Tumour regression induced by co-administration of MIP-3α and CpG in an experimental model of colon carcinoma.

CCL20/macrophage inflammatory protein-3α (MIP-3α) represents one of the potent chemoattractive proteins for dendritic cells (DCs). Herein, we investigated whether in vivo genetic modification of tumour cells aimed at intratumoural production of MIP-3α might lead to accumulation of DCs in tumour tissue. Mice injected with CT26, received recombinant adenovirus (Ad) vectors (AdMIP-3α) expressing MIP-3α protein. This was complemented by injections of CpG. Interestingly, MIP-3α gene therapy combined with CpG injections resulted in specific cytotoxicity. This was associated with significant suppression of tumour growth rate. These findings demonstrate the potential of strategies that utilize in vivo overexpression of chemokines.

Temporary and permanent level shifts in distortion product otoacoustic emissions following noise exposure in an animal model.

BACKGROUND: Noise-induced hearing loss (NIHL) is one of the most common occupational illnesses. Most of the studies on NIHL were conducted at high noise levels that people are rarely exposed to but in industries. The function of the outer hair cells (OHCs) is impaired after exposure to industrial noise. Distortion product otoacoustic emissions (DPOAEs) are useful in examination of noise-induced level shifts. OBJECTIVE: To assess the function of OHCs by DPOAE temporary and permanent level shifts (TLSdp and PLSdp) in rabbits exposed to white noise at realistic levels typically found in industrial settings over a broad range of frequencies. METHODS: 12 albino rabbits were divided into two groups: the experimental group rabbits which were exposed to 95 dB SPL white noise at 500-8000 Hz for 8 hrs/day for 5 consecutive days, and the control group rabbits with no exposure to noise. The function of OHCs was examined by DPOAE level (Ldp) in different occasions. The study groups were compared for DPOAE temporary and permanent level shifts (TLSdp and PLSdp) to assess the effect of noise on OHCs function. RESULTS: Noise-induced DPOAE levels (Ldp) were decreased up to 20.65 dB (on day 8) and 18.93 dB (on day 11) at 5888.50 Hz (p = 0.081). TLSdp and PLSdp were significantly decreased up to 17.99 dB and 16.27 dB, respectively in the experimental group. The most and least Ldp were significantly different (p<0.05); they occurred at 5888.50 and 588.00 Hz, respectively. There were significant differences between temporary and permanent threshold shift at various frequencies (p<0.05). These differences were mainly related to 5888.50 Hz compared to other frequencies in each ear (p<0.05). CONCLUSION: DPOAEs are an attractive tool for obtaining information about small temporary or permanent threshold shifts, even when the pure tone audiogram is normal.

Noise-induced Outer Hair Cells' Dysfunction and Cochlear Damage in Rabbits.

BACKGROUND: Outer hair cells' (OHCs') dysfunctions as the extent of temporary and permanent threshold shifts (TTS and PTS) and cochlear damage were assessed in rabbits exposed to continuous noise METHODS: Twelve New Zealand white rabbits were studied in noise (N) (n=6; exposed to continuous noise; 95 dB SPL, 500-8000 Hz for 8 h per day during 5 consecutive days) and control (C) (n=6; not exposed to noise). OHCs' functions were assessed by distortion product otoacoustic emission (DPOAE) level (Ldp) measurements in different periods and comparing TTS and PTS. Animals were anaesthetized by CO2; cochleae were extracted, fixed in 10% formaldehyde for 48 hours, decalcified by 10% nitric acid for 24 hours, and dehydrated, embedded, sectioned 5 µm thickness and stained by Hematoxylin and Eosin for light microscopy. RESULTS: The most and least Ldp or TTS or PTS were related to 5888.50 Hz and 588.00 Hz respectively in noise subjected rabbits (P<0.05). TTS and PTS were decreased up to 17.79 dB and to 16.01 dB respectively. TTS were more than PTS over all test frequencies, especially at 5888.50 Hz (P<0.05). Ldp or TTS or PTS were found to be equal across ears (P>0.05). Severely vacuolated OHCs, pyknotic IHCs, swollen SC, and slightly thickened BM were found. CONCLUSION: Continuous noise extensively led to OHCs' dysfunctions as decreased Ldp (both TTS and PTS) and highly damage to cochlea.

Effect of statins on estrogen and androgen levels in postmenopausal women treated with estradiol.

OBJECTIVE: A considerable number of postmenopausal women who receive estrogen therapy are also treated for hypercholesterolemia with cholesterol-lowering statins. Statins and steroid hormones can compete for the same steroid-metabolizing enzymes. We investigated whether long-term administration of statins had an effect on serum estrogen and androgen levels in postmenopausal women receiving and not receiving oral estrogen therapy. METHODS: A subgroup analysis from the Estrogen in the Prevention of Atherosclerosis Trial, a randomized, double-blind, placebo-controlled trial, was performed. A total of 222 women were randomized to receive either placebo or 1 mg of oral micronized 17ß-estradiol daily for 2 years. In both the placebo and treatment groups, participants with low density lipoprotein cholesterol levels >160 mg/dl were treated with statins. Blood samples were obtained at baseline and every 6 months during the trial. Serum levels of dehydroepiandrosterone, androstenedione, testosterone, estrone and 17ß-estradiol were measured by radioimmunoassay. RESULTS: Among 86 placebo- and 90 estradiol-treated subjects with baseline and on-trial hormone measurements, no significant differences were observed between the statin-free and statin-treated groups in mean changes from baseline to on-trial levels in any of the androgens or estrogens, whether or not the postmenopausal women were treated with estrogen. CONCLUSION: The results suggest that estrogen therapy and statins can be used simultaneously with no deleterious effects on circulating hormone levels.

Evaluating yield quality and quantity of garlic as affected by different farming systems and garlic clones.

In order to study the effects of different farming systems and garlic (Allium sativum L.) clones on yield quality and quantity of garlic, an experiment was conducted with split plot arrangement with three completely randomized blockes in the 2005 growing season at the experimental research station of Shahid Beheshti University at Zirab, north of Iran. Two factors were involved in the experiment: farming systems in three levels (intensive, conventional and organic farming), as main plots and garlic clones in three levels (Atoo, Hamedani and Khorassani) as sub-plots. The studied factors in this experiment consisted of leaf number, LAI, stem height and diameter, bulb yield, weight of bulbs, number of cloves, weight of cloves and level of allicin. Results showed that the farming systems had significant effect (p<0.05) on LAI, number of plant and bulb yield, but the effect on the other factors was not significant. The highest and lowest bulb yields were obtained in intensive (9.5 ton ha(-1)) and organic (7.4 ton ha(-1)) systems, respectively. All of the top factors were significantly (p< or =0.01) affected by garlic clones. Maximum and minimum yields were obtained from Hamedani, Atoo (9.2 ton ha(-1)) and Virani (7.1 ton ha(-1)) clones, respectively. Level of allicin was not significantly affected by farming systems but, differences among garlic clones were significant. Maximum and minimum allicin yields were obtained from Hamedan (5.96 mg g(-1)) and Virani (4.52 mg g(-1)) clones, respectively. As a result, however, organic farming systems can not influence the yield in short term, but can increase it by applying crop rotation, use of organic fertilizer and cover crops in the long term.

Diagnostic accuracy of body coil MRI in describing the characteristics of perianal fistulas.

OBJECTIVE: The purpose of this study was to determine the accuracy of synergic body coil MRI using SPIR technique without contrast, in the determination of fistula characteristics in patients with clinically positive signs. METHOD AND SUBJECTS: This was a case-series prospective study including 29 consecutive patients with clinically suspected fistulas-in-ano. The standard synergic body coil was used and all patients had T2-weighted SPIR sequences. One radiologist, without prior knowledge of the clinical examination, analysed images and noted the presence of the fistula, its classification and the presence and number of any collections or extensions. The surgeon noted the MRI findings and looked for lesions suggested on MRI. The results of the MRI and surgical assessments were then compared. Results of surgical exploration while the surgeon was aware of MRI results were considered as the gold standard of surgical anatomy. RESULTS: Twenty-three (79.31%) of 29 fistula tracks were seen on MRI which correctly determined the type of all fistulas. In the six cases where the fistula was not seen on MRI, five were low trans-sphincteric and one was rectovaginal. MRI identified 8 of 10 collections. CONCLUSION: The synergic body coil MRI with SPIR sequencing without endoanal coils had a high accuracy in the diagnosis of high fistulas collections, complex fistulas and extensions.

Evaluation of the end colostomy complications and the risk factors influencing them in Iranian patients.

INTRODUCTION: The aim of this study was to assess the prevalence of end colostomy complications and the evaluation of factors influencing outcome. PATIENTS AND METHODS: Three hundred and thirty patients with end colostomy were studied. All patient were recalled for examination for recent complications. Early complications included stoma site pain, early dermal irritation (during the first month after surgery), mucosal bleeding, stomal prolapse and psychosocial complications. Late complications included peristomal hernia, stomal stenosis, late dermal irritation (after the first month), stomal retraction, stomal necrosis and other stoma complications (perforation, fistula etc.). Probable underlying factors were studied. To evaluate risk factors affecting complications, univariable analysis and then multivariable analysis by binary logistic regression was performed. RESULTS: One hundred and one (30.6%) patients had no complications and the remainder had at least one of early or late complications. Overall, psychosocial complications, 56.4%; mucosal bleeding, 34.5%; early dermal irritation, 23.5% were the most frequent complications. Peristomal hernia (11.2%) was the most common late complication. Those aged > 40 years had significant associations with psychosocial problem (OR = 2.77), mucosal haemorrhage (OR = 2.19), and early dermal irritation (OR = 3.14). The risks of peristomal hernia and early dermal irritation are greater in the patients with BMI > 25 kg/m2 (OR = 2.08 and 2.55, respectively). CONCLUSION: The risk of most prevalent complications of colostomy construction increases in elder patients. The high prevalence of psychosocial and skin problems in patients with a colostomy, needs special attention especially from the viewpoint of education by trained stoma nurses and preparation of standard equipment.