The Medical Journal of Basrah University

Background
Low vitamin D levels had been reported to be associated with a wide range of health problems, one of them is tuberculosis. the aim is to estimate vitamin D serum concentration among patients with tuberculosis at baseline, 2 and 5 months after starting anti-tuberculosis treatment.
Methods
The study was carried out at the TB Center and College of Medicine in Basrah (Iraq), during the period from September 2018 to June 2019. Participants were newly diagnosed tuberculosis patients, and their matched apparently healthy controls. Total 25-hydroxy vitamin D in serum was estimated using chemiluminescent microparticle immunoassay. Calcium, phosphorus, alkaline phosphatase, parathyroid hormone, and others, were also measured.
Results
There were no statistically significant difference in the mean levels of vitamin D between tuberculosis patients at baseline (n=56) and control subjects (n=57). The prevalence of vitamin D deficiency was high in patients and their controls at baseline where more than 80% of them had a vitamin D level below 20 ng/ml.
When patients were followed two months after starting anti-tuberculosis treatment, the mean serum vitamin D level was significantly lower than that at baseline. Despite the wide spread vitamin D deficiency among TB patients, all smear-positive pulmonary TB patients, except 3, had sputum conversion after 2 months of treatment.
Conclusions
The prevalence of vitamin D deficiency is high with no significant difference between tuberculosis patients at baseline and their matched normal controls. Vitamin D deficiency did not seem to affect the response of patients to anti-TB treatment.

Background: Low vitamin D levels had been reported to be common in normal subjects worldwide. Studies in the Middle East had reported extremely low levels of serum vitamin D, despite high exposure to sunlight. Aim: To estimate vitamin D serum concentration in a sample of apparently healthy subjects from Basrah, by 2 methods (chemiluminescent and fluorescent assays). Methods: The study was carried out on apparently healthy subjects during the period from September 2018 to February 2019. Quantitative determination of the total 25-hydroxy vitamin D in serum was made using chemiluminescent microparticle immunoassay and enzyme-linked fluorescent assay. Other parameters (calcium, phosphorus, alkaline phosphatase, parathyroid hormone, hemoglobin, and erythrocyte sedimentation rate and body mass index) were also measured. Results: The mean level of vitamin D measured by the two methods, was 11.57±6.63 ng/ml and 13.31±6.52 ng/ml by chemiluminescent and fluorescent assays respectively. The prevalence of vitamin D deficiency was high, where more than 80% of the 57 subjects had vitamin D level below 20 ng/ml. If the cut-off point of vitamin D deficiency was taken as 10 ng/ml, around 46% of the subjects were found deficient in both methods. Although the two methods of vitamin D assay were well correlated with each other, fluorescent assay gave, on average, a significantly higher levels compared with the chemiluminescent method. Serum parathyroid hormone, showed a negative correlation with vitamin D serum levels. After excluding children and females, no significant difference was found between adult smokers and non-smokers when vitamin D was measured by both methods.Conclusion: Vitamin D deficiency is common (> 80%) among normal subjects. The enzyme-linked fluorescent assay resulted in higher mean level than chemiluminescent assay. The use of a deficiency cut-off point of 10 ng/ml may be more appropriate.

Background: Studies investigating the effect of antibiotics on the pharmacokinetics of non-steroidal anti-inflammatory drugs are few. Such interaction could be clinically significant in conditions like diabetic nephropathy.
Objectives: To study the effect of amoxicillin and cefalexin on the pharmacokinetics of diclofenac sodium when taken concomitantly.
Subjects and Methods: Eleven healthy subjects participated in this single dose cross-over study. Each volunteer randomly joined one of the three treatment groups and received a single dose of diclofenac sodium (50mg enteric-coated tablet), diclofenac sodium + amoxicillin 500mg capsule, and diclofenac sodium + cefalexin 500mg capsule successively with one week washout interval. Blood samples were taken immediately before, at 30 minutes and at 1, 1.5, 2, 2.5, 3, 4 and 6 hours after drug administration and analyzed using high performance liquid chromatography (HPLC) system with ibuprofen as internal standard.
Results: Diclofenac sodium produced a maximum concentration of 1.34 µg/ml with a half life of 0.5 hour and area under plasma concentration versus time curve up to 6 hours (AUC0-6) of 1.24 µg.h/ml. Although the AUC0-6 and maximum plasma concentration of diclofenac sodium increased by more than 20% after co-administration of amoxicillin, this increase is not statistically significant. Cefalexin, on the other hand, when given with diclofenac sodium significantly increased the AUC0-6 and maximum plasma concentration of diclofenac by 51.9% and 68.5% respectively.
Conclusion: Amoxicillin and cefalexin can change some of the pharmacokinetic parameters of diclofenac tablet when administered concomitantly and cefalexin did that to a greater extent. Such interaction must, therefore, be considered in conditions where diclofenac might be harmful.

Background: Poor quality medicines could be substandard, degraded or counterfeit medicines. One of the measures used to detect poor quality drugs is comparison with a reference product taking pharmacokinetic end points in consideration.
Objectives: To compare the bioavailability of three brand products of diclofenac sodium 50mg oral tablets in healthy volunteers. One of these brands is locally manufactured. The other two are from known foreign drug manufacturers.
Methods: A randomized, three-way, cross-over bioavailability study was performed on 10 apparently healthy male volunteers. Each received successively, a single oral tablet of 50 mg diclofenac sodium from the three sources with a washout interval of one week. Blood samples were taken until six hours after drug administration and analyzed using HPLC system (Agilant, model 1200-USA, with an Agilent 1200 variable wavelength detector and a Zorbax Eclipse XBD-C18 column). Quantitation was achieved by measurement of the peak height ratios of the drug to ibuprofen as internal standard. The amount of diclofenac sodium in each of the three drug products was also measured in vitro.
Results: Maximum plasma concentration (Cmax) was significantly different among the three tablets with the main difference was between the locally manufactured tablet and the two other tablets (0.72 µg/ml for the locally manufactured product compared with 1.55 and 1.24 µg/ml for the reference products). Time to reach maximum concentration (Tmax) showed no significant difference between the three brands of diclofenac sodium tablets. The area under the curve differs significantly between the three products. The area under plasma concentration-time curve (AUC) of the locally manufactured product represented 64.7% and 74% of the AUC of the two reference brands. The plasma elimination half life (t½) differs among the three different types of products but these differences ran short of statistical significance (P<0.058). In vitro assay of the amount of diclofenac sodium in each tablet showed no significant differences between the three types of tablets.
Conclusion: The locally manufactured enteric coated diclofenac tablet is not interchangeable with the two reference foreign brand products, although they contain approximately the same amount of diclofenac sodium. It is speculated that differences in bioavailability and in peak drug levels might be attributed to pharmaceutical factors such as the rate of disintegration and dissolution which can be affected by the types of additives and the coating materials in each tablet.

Background: Metabolic syndrome (MetS) is clustered risk factors that arise from insulin resistance and is associated
with risk of coronary heart disease, as well as diabetes. American Heart Association (AHA) defined MetSon the basis
of 5 components: fasting blood glucose, blood pressure, triglycerides, HDL-C, and waist circumference. Highsensitivity
CRP (hs-CRP) is a measure of systemic inflammatory conditions and is considered as a risk factor in
diabetes mellitus.
Aim: To investigate the correlation of hs-CRP with the number and type of components of MetS diagnostic criteria in
Iraqi patients and to find out the cutoff point for hs-CRP level that might predict the development of metabolic
syndrome.
Methods: This study involved 78 diabetic patients consulting the outpatient clinic at Al Sadr Teaching Hospital. For
all patients anthropometric measures were obtained and fasting blood samples were taken for determination of blood
glucose, lipid profile and hs-CRP level.
Results: Mets was diagnosed in 48 patients. The level of hs-CRP was found to be significantly increased with
increasing number of components of MetS. The lowest value of (0.07 mg/dl) was found in people with absent
components of metabolic syndrome and the highest level of (4.05 mg/dl) in subjects with 4 components. A significant
positive correlation was observed between hs-CRP and waist circumference, FBG, and triglycerides(r=0.514, 0.531,
0.592 respectively, P<001) and a negative correlation with HDL-cholesterol (r=-0.332, p=0.021). Using the level of
0.65 mg/dl, hs-CRP can predict the development of metabolic syndrome with sensitivity and specificity of 81.3% and
93.3% respectively.
Conclusion: Hs-CRP shows a significant correlation with the number of MetS components and its level correlates
well with waist circumference and other biochemical features of MetS. Hs-CRP can predict the development of MetS
with high sensitivity and specificity.

ABSTRACT
Background: Diabetic retinopathy is the most frequent cause of new cases of blindness among adults aged 20–74
years. Magnesium deficiency is a possible metabolic factor involved in the pathogenesis of diabetic micro - and macro
- vascular complications.
Aim: To assess magnesium level in relation to the stages of diabetic retinopathy.
Methods: The study enrolled 136 diabetic patients consulting Ophthalmology Outpatient Department. The
ophthalmologist assigned the patients into 5 categories; background, preproliferative, proliferative, advanced and
maculopathy. Serum magnesium, random blood glucose and glycated hemoglobin were determined.
Results: Among the 136 patients with diabetes mellitus, 94 patients had diabetic retinopathy and 42 had no
retinopathy. There is a significant statistical differences (P-value <0.05) between diabetic retinopathy and control
groups in serum magnesium, random blood glucose, glycated hemoglobin and duration of diabetes. It had been found
that serum magnesium remained statistically significant among the groups of patients with different stages of
retinopathy. Patients with maculopathy had the lowest value for the serum magnesium level (1.35 mg/dl)
Conclusions: Serum magnesium level decreased in patients with diabetic retinopathy with lowest level being
observed in patients with advanced retinopathy and maculopathy.