Publications by authors named "Jamshid Salamzadeh"

74 Publications

Buccal Buspirone as add-on Therapy to Omeprazole Versus Omeprazole in Treatment of Gastroesophageal Reflux Diseases (GERD).

Iran J Pharm Res 2020 ;19(4):113-120

Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Proton pump inhibitors (PPIs) are recommended as first line treatments for gastroesophageal reflux disease (GERD). Failure to PPIs has been mentioned as a problem in pharmacotherapy of GERD. The present study compared the symptom relief, quality of life (QoL) and adverse drug reactions (ADRs) of omeprazole plus buccal buspirone with that of omeprazole alone.This was a prospective, randomized trial between buccal buspirone (10 mg/d) plus omeprazole (20 mg/d) and omeprazole (20 mg/d) plus placebo administered for 4 weeks to patients with GERD symptoms. Patients who had GERD symptoms enrolled in this study. 67 patients were randomly assigned to either the buspirone plus omeprazole group (n = 33) or the placebo plus omeprazole group (n = 34). Finally, 58 patients completed the study (29 in each group). Treatment response rates in each drug group were evaluated according to the Frequency Scale for the Symptoms of GERD (FFSG). The QoL and ADRs have been also evaluated too.The treatment score rates for symptom relief according to the FFSG were 7.13 ± 5.13 in the buspirone group and 15.34 ± 8.17 in the placebo group. Regarding FFSG score, there is a significant difference between the groups ( 0.0001). QoL were 6.86 ± 6.65 and 27.2 ± 20.95 in placebo and buspirone group, respectively after four weeks and there is a significant difference in two groups ( 0.0001).The total incidence of ADRs were similar in the buspirone and placebo groups ( 0.36).A combination of buccal buspirone plus omeprazole may be a more effective treatment for GERD than omeprazole alone.
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http://dx.doi.org/10.22037/ijpr.2020.113320.14231DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8019891PMC
January 2020

Aflibercept therapy for exudative age-related macular degeneration resistant to bevacizumab and ranibizumab.

Int J Retina Vitreous 2021 Apr 1;7(1):26. Epub 2021 Apr 1.

Department of Ophthalmology, Gavin Herbert Eye Institute, University of California Irvine, Irvine, CA, USA.

Background: Despite the good outcomes achieved with intravitreal angiogenic therapy, a subset of neovascular age-related macular degeneration (AMD) patients experience resistance to therapy after repeated injections. Switching drugs could offer benefit to this group of patients.

Purpose: To determine visual and anatomical outcomes in a cohort of neovascular AMD patients resistant to repeated injections of bevacizumab/ranibizumab after switching to aflibercept therapy.

Methods: This was a retrospective chart review of patients who had a diagnosis of neovascular AMD and persistent intraretinal (IRF) and/or subretinal fluid (SRF) on optical coherence tomography (OCT) for at least 3 months despite monthly bevacizumab and/or ranibizumab injections prior to transition to aflibercept. We reviewed patients' records and OCT images obtained at baseline, 1, 3, 6 and 12 months after transition to aflibercept. Data collected included demographics, best-corrected visual acuity (BCVA), number of injections received and the occurrence of any adverse events. Studied OCT parameters included central macular thickness (CMT) values and the presence or absence of SRF, IRF and/or pigment epithelial detachment (PED) at each visit.

Results: We included 53 eyes of 48 patients. Mean change in BCVA from baseline was 0.05 ± 0.13 (P = 0.01) at M1, 0.04 ± 0.16 (P = 0.08) at M3, 0.01 ± 0.22 (P = 0.9) at M6, and 0.02 ± 0.28 (P = 1) at M12, while the mean change in CMT from baseline was 64 ± 75 μm (P < 0.0001) at M1, 42 ± 85 μm (P = 0.002) at M3, 47 ± 69 μm (P < 0.0001) at M6, and 46 ± 99 μm (P = 0.001) at M12. The percentage of eyes with SRF decreased from 77.4% at baseline to 39.6% at M1, then increased to 47.2% at M3, then decreased to 43.4% at M6, and to 41.5% at M12 (All p < 0.001, compared to baseline). Compared to baseline, there was a statistically significant decrease in the percentage of eyes having IRF from 47.2 to 20.8% at M1 (p < 0.001), 30.2% at M3, 24.5% at M6 and 26.4% at M12 (p < 0.01, each). The number of bevacizumab and/or ranibizumab injections (7.36 ± 1.85) was significantly higher than that of aflibercept (6.47 ± 2.45, p = 0.001). A significant direct relationship between CMT reduction and BCVA improvement was demonstrated at M1 (p = 0.01, r = 0.36), M3 (p = 0.03, r = 0.30) and M12 (p = 0.03, r = 0.30). Eyes with IRF had significantly poorer BCVA than eyes without IRF at baseline (p = 0.02) and M3 (p = 0.04).

Conclusion: Switching to intravitreal aflibercept therapy in a cohort of neovascular AMD patients resistant to chronic bevacizumab and/or ranibizumab injections can lead to significant visual improvement in the short term and sustained reduction of central macular thickness over 1 year of followup.
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http://dx.doi.org/10.1186/s40942-021-00299-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8017745PMC
April 2021

Comparison of Mirtazapine and Olanzapine on Nausea and Vomiting following Anthracycline-cyclophosphamide Chemotherapy Regimen in Patients with Breast Cancer.

Iran J Pharm Res 2020 ;19(3):451-464

Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

We evaluated and compared the efficacy and safety of mirtazapine (MTZ) with olanzapine (OLP) for preventing chemotherapy-induced nausea and vomiting (CINV) following anthracycline plus cyclophosphamide (AC) regimen. Eligible participants were chemotherapy-naive early-stage breast cancer patients who were scheduled to undergo adjuvant AC. The patients were randomized to take oral MTZ or OLP in combination with aprepitant (A), dexamethasone (D), and granisetron (G), (ADG). The endpoints included rates of complete response (CR), complete control (CC), total control (TC), and adverse events during the acute, delayed, and overall phases in the two cycles of chemotherapy. The influence of CINV on the quality of life (QoL) was evaluated on day 6 of chemotherapy. Of 82 patients, 60 were randomized. In the first cycle, CR rates in cycle 1 were 83.3% and 76.6% during the acute period, 80% and 86.6% during the delayed period, and 66.6% and 63.3% during the overall period, for the ADG-M and ADG-O, respectively. High efficacy of both groups was maintained over 2 cycles. More patients in the ADG-M group noted minimal or no impact of CINV on daily life in cycle 2 (89.7% 67.9%; 0.044). Incidence of somnolence and fatigue was more frequent with the olanzapine group. In this study, there was no substantial difference between mirtazapine and olanzapine in preventing CINV. Further large randomized trials are essential to demonstrate the anti-emetic effect of mirtazapine in chemotherapy.
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http://dx.doi.org/10.22037/ijpr.2020.113955.14584DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7757993PMC
January 2020

Novel Application of Near-infrared Spectroscopy and Chemometrics Approach for Detection of Lime Juice Adulteration.

Iran J Pharm Res 2020 ;19(2):34-44

Food Safety Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

The aim of this study is to investigate the novel application of a ‎handheld near infra-red spectrophotometer coupled with classification methodologies as a screening approach in detection of adulterated lime juices. For this purpose, a miniaturized near infra-red spectrophotometer (Tellspec) in the spectral range of 900-1700 nm was used. Three diffuse reflectance spectra of 31 pure lime juices were collected from Jahrom, Iran and 25 adulterated juices were acquired. Principal component analysis was almost able to generate two clusters. Partial least square discriminant analysis and -nearest neighbors algorithms with different spectral preprocessing techniques were applied as predictive models. In the partial least squares discriminant analysis, the most accurate prediction was obtained with SNV transforming. The generated model was able to classify juices with an accuracy of 88% and the Matthew's correlation ‎coefficient ‎value of 0.75 in the external validation set. In the -NN model, the highest accuracy and Matthew's correlation ‎coefficient in the test set (88% and 0.76, respectively) was obtained with multiplicative signal correction followed by 2-order derivative and 5 nearest neighbor. The results of this preliminary study provided promising evidence of the potential of the handheld near infra-red spectrometer and machine learning methods for rapid detection of lime juice adulteration. Since a limited number of the samples were used in the current study, more lime juice samples from a wider range of variability need to be analyzed in order to increase the robustness of the generated models and to confirm the promising results achieved in this study.
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http://dx.doi.org/10.22037/ijpr.2019.112328.13686DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7667562PMC
January 2020

Medication adherence and its possible associated factors in patients with acne vulgaris: A cross-sectional study of 200 patients in Iran.

Dermatol Ther 2020 11 20;33(6):e14408. Epub 2020 Oct 20.

Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.

There are several etiologic factors involved in the pathogenesis of acne vulgaris. Therefore, current treatment guidelines recommend applying different classes of medications for it. This makes medication adherence a challenging issue in acne patients. The current study was designed to assess medication adherence and its possible associated factors in patients with acne vulgaris. This study was performed on patients with acne vulgaris in two dermatology clinics of Imam Khomeini Hospital and Razi Hospital. A validated questionnaire (ECOB, Elaboration d'un outil d'evaluation de l'observance des traitements medicamenteux) was applied to evaluate adherence to topical and oral therapies. We assessed relationship between patients' medication adherence and their sociodemographic, medication, and medical histories. A total of 200 patients, 136 females (68%), and 64 males (32%), with a mean age of 22 years were entered into the study. Overall, only 30 out of 200 patients (15%) were adherent to their treatments. Based on the bivariate analyses, food exacerbations, and severity of the disease by the patient's opinion was significantly associated with overall medication adherence (P = .03). Moreover, patients who were more adherent to topical treatment were more adherent to systemic treatment, as well (P = .007). The current study showed that treatment adherence was very low among patients with acne vulgaris. It is recommended to educate patients on the proper use of anti-acne medications. Besides, it is highly recommended that physicians and pharmacists use ECOB questionnaire regularly to guide patients accurately with the use of their drug regimens.
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http://dx.doi.org/10.1111/dth.14408DOI Listing
November 2020

Development of a Sensitive and Rapid Method for Determination of Acrylamide in Bread by LC-MS/MS and Analysis of Real Samples in Iran IR.

Iran J Pharm Res 2020 ;19(1):413-423

Food Safety Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

A new sample preparation procedure and a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method were developed for the quantitative analysis of acrylamide in bread. The method is based on sample extraction in methanol, purification with Carrez solutions and clean- up with Primary Secondary Amine (PSA).The developed method offers an efficient, inexpensive, easy sample preparation and very sensitive procedure for determination of acrylamide in bread. The use of spiked calibration curves for constructing the calibration curve substantially reduced adverse matrix-related effects. Recoveries were between 96 and 105.3%. Good results were obtained with respect to repeatability (RSDs <11%). The limit of detection and quantification of the method was 0.3 and 1 ng/g, respectively, which shows the method is very sensitive. The developed method was used for the determination of acrylamide in 26 traditional bread samples (Sangak) collected from Shiraz. The results showed that about 96% of Sangak bread samples were contaminated with acrylamide that 64.3 and 33.3 of semi-industrial and traditional Sangak bread were higher than benchmark levels (50 µg/kg), respectively. There are a few reports concerning contamination of Sangak bread samples with acrylamide in Iran. Therefore, this method could be used for a comprehensive survey of acrylamide in Sangak bread samples in the country.
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http://dx.doi.org/10.22037/ijpr.2019.111994.13474DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462498PMC
January 2020

Early Graft Function in Deceased Donor Renal Recipients: Role of N-Acetylcysteine.

Iran J Pharm Res 2020 ;19(1):57-67

Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Reduced graft function (RGF) in donor renal transplant recipients is caused by oxidative damage due to extensive ischemia-reperfusion (I/R) injury during transplantation. Neutrophil gelatinase-associated lipocalin (NGAL) is a promising biomarker to detect tubular injury early after renal transplantation. N-acetylcysteine (NAC) is a potent antioxidant that can reduce I/R injury by improving oxidative damage. The aim of the present study is to assess the efficacy of NAC in improving graft function and reducing renal tubular injury in deceased donor renal transplant recipients. A double-blind, randomized clinical trial was conducted on 50 deceased donor renal transplant recipients. The patients were randomized into two groups, receiving either 600 mg NAC twice daily, or placebo (days 0 to 5). Results were assessed based on the rate of RGF, levels of plasma NGAL (p-NGAL) and the estimated glomerular filtration rate (eGFR). The rate of RGF was significantly lower in the patients receiving NAC vs. placebo (21.4% vs. 50%). The measurement of p-NGAL levels showed that the patients in the NAC group had significantly greater reduction of p-NGAL by both days 1 and 5 post-transplantation than those in the placebo group. A near steady-state eGFR level was reached by week 1 in the NAC group, however, the improvement of eGFR was significantly slower in the placebo group and a near steady-state was only achieved by week 4. NAC has promising potential in reducing tubular injury and improving graft function, evidenced by significant reduction in the rate of RGF and levels of p-NGAL.
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http://dx.doi.org/10.22037/ijpr.2019.15546.13167DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462497PMC
January 2020

Promising effects of tocilizumab in COVID-19: A non-controlled, prospective clinical trial.

Int Immunopharmacol 2020 Nov 4;88:106869. Epub 2020 Aug 4.

Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address:

Background: The clinical presentation of SARS-CoV-2 infection ranges from mild symptoms to severe complications, including acute respiratory distress syndrome. In this syndrome, inflammatory cytokines are released after activation of the inflammatory cascade, with the predominant role of interleukin (IL)-6. The aim of this study was to evaluate the effects of tocilizumab, as an IL-6 antagonist, in patients with severe or critical SARS-CoV-2 infection.

Methods: In this prospective clinical trial, 76 patients with severe or critical SARS-CoV-2 infection were evaluated for eligibility, and ultimately, 42 patients were included. Tocilizumab was administered at a dose of 400 mg as a single dose via intravenous infusion. Primary outcomes included changes in oxygenation support, need for invasive mechanical ventilation, and death. Secondary outcomes included radiological changes in the lungs, IL-6 plasma levels, C-reactive protein levels, and adverse drug reactions. The data were analyzed using SPSS software.

Results: Of the 42 included patients, 20 (48%) patients presented the severe infection stage and 22 (52%) were in the critical stage. The median age of patients was 56 years, and the median IL-6 level was 28.55 pg/mL. After tocilizumab administration, only 6 patients (14%) required invasive ventilation. Additionally, 35 patients (83.33%) showed clinical improvement. By day 28, a total of 7 patients died (6 patients in the critical stage and 1 patient in the severe stage). Neurological adverse effects were observed in 3 patients.

Conclusions: Based on the current results, tocilizumab may be a promising agent for patients with severe or critical SARS-CoV-2 infection, if promptly initiated during the severe stage.
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http://dx.doi.org/10.1016/j.intimp.2020.106869DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7402206PMC
November 2020

Assessment of Outpatients' Knowledge and Adherence on Warfarin: The Impact of a Simple Educational Pamphlet.

Iran J Pharm Res 2019 ;18(Suppl1):315-320

Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Warfarin is a critical medication that is broadly used for the treatment and prevention of thromboembolic disorders. Due to warfarin's narrow therapeutic index, it is crucial that patients follow an appropriate dosage regimen. Patient knowledge is one of the most important factors to safe and effective use of warfarin. Due to the obvious risks of anticoagulants administration, evaluating patients' awareness seems to be crucial. The purpose of this article was to evaluate the effects of intervention by an informative pamphlet on knowledge and adherence of patients who consumed warfarin. Two-hundred and fifty patients receiving warfarin were assigned to the study. They were asked to fill in the questionnaire. Then patients were provided with an educational pamphlet. In the second interview, patients filled the questionnaire again. Obtained data were assessed and analyzed by Excel software and SPSS version 18.0. Out of 250 patients who entered the study, 150 patients attended for the second interview. Data analysis revealed that out of 13 explanatory factors, only patients' literacy level and income were the predictors which inversely correlated with the patients' adherence (r = -0.44; = 0.00040). Our educational intervention had a positive impact on patients' knowledge regarding anticoagulation ( < 0.0001). Our findings revealed that a written informative pamphlet could effectively increase patients' anticoagulation knowledge. Since, poorly literate patients had a lesser level of knowledge before and after educational intervention, it is recommended to develop appropriate educational programs especially designed for this group of patients.
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http://dx.doi.org/10.22037/ijpr.2020.14766.12641DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7393044PMC
January 2019

The Potential Effect of Intravenous Calcitriol on the Ischemia-Reperfusion Process and Inflammatory Biomarkers in Patients Following Percutaneous Coronary Intervention (PCI).

Iran J Pharm Res 2019 ;18(Suppl1):282-290

Clinical Pharmacy Department, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

This study aimed to investigate the efficacy of calcitriol on Ischemia-reperfusion Injury (IRI) and inflammatory biomarkers in patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) undergoing elective Percutaneous Coronary Intervention (PCI). A total of 72 patients with NSTEACS were randomly divided into two groups: (1) the calcitriol-treated group, treated with three mcg intravenous calcitriol administered before PCI (n = 36) and (2) the control-treated group (n = 36) The serum high-sensitivity C-reactive protein (hs-CRP), high-sensitivity interleukin-6 (hs-IL-6), creatinine kinase (CK)-MB and cardiac troponin I (cTnI) levels were measured before PCI and 24 h after PCI in both groups. The patients were followed up for the detection of the prevalence of major adverse cardiac events (MACE) in 180 days after PCI in both groups. Compared to pre-PCI, the serum hs-CRP, hs-IL-6, CK-MB, and cTnI levels were increased at 24 h after PCI (all < 0.05) in both groups. However, change in the levels of hs-CRP and hs-IL-6 were significant ( = 0.04 and = 0.02, respectively). Changes in the levels of CK-MB and cTnI were non-significant ( = 0.15 and = 0.39, respectively). No MACE (death, Q wave MI, target vessel revascularization, ischemic stroke) was detected in any patient in any group during a 3-month follow-up. Administration of calcitriol in patients with non-ST-segment elevation acute coronary syndromes undergoing elective PCI can attenuate the increase in serum inflammatory biomarkers in the serum (hs-CRP and hs-IL-6) and thus decrease the inflammatory reaction caused by PCI.
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http://dx.doi.org/10.22037/ijpr.2019.112469.13778DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7393057PMC
January 2019

A comparative study of the analgesic effects of intravenous ketorolac, paracetamol, and morphine in patients undergoing video-assisted thoracoscopic surgery: A double-blind, active-controlled, randomized clinical trial.

Ann Card Anaesth 2020 Apr-Jun;23(2):177-182

Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: Opioids are traditionally used as the drug of choice for the management of postoperative pain. However, their use is limited in patients undergoing Video-assisted thoracic surgery (VATS), due to their side effects, such as respiratory depression, nausea, and vomiting.

Aim: In this double-blind active-controlled randomized study, we have compared the analgesic effects of ketorolac and paracetamol to morphine.

Methods: Patients were randomly chosen from a pool of candidates who were undergoing VATS and were divided into three groups. During the first 24 h postsurgery, patients in the control group received a cumulative dose of morphine 20 mg, while patients in two treatment groups received ketorolac 120 mg and paracetamol 4 g in total. Doses were administered as bolus immediately after surgery and infusion during the first 24 h. Patients' pain severity was evaluated by visual analogue scale rating (VAS) at rest and during coughing episodes.

Results: The average pain score at recovery time was 2.29 ± 2.13 and 2.26 ± 2.16 for ketorolac and paracetamol, respectively, and it was significantly lower than the morphine group with an average pain score of 3.87 (P = 0.003). Additionally, the VAS score during cough episodes was significantly higher in the control group throughout the study period compared to study groups. Comparison of mean morphine dose utilized as liberation analgesic (in case of patients had VAS >3) between three groups was not significantly different (P = 0.17).

Conclusion: Our study demonstrates the non-inferiority of ketorolac and paracetamol to morphine in controlling post-VATS pain without causing any significant side effects. We also show that ketorolac and paracetamol are superior to morphine in controlling pain during 2 h postsurgery.
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http://dx.doi.org/10.4103/aca.ACA_239_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7336963PMC
March 2021

Study of the Relationship between ERCC1 Polymorphisms and Response to Platinum-based Chemotherapy in Iranian Patients with Colorectal and Gastric Cancers.

Iran J Pharm Res 2019 ;18(4):2163-2171

Food Safety Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

This study was designed to evaluate the effect of excision repair cross complementing group 1 (ERCC1) rs11615 codon 118C/T gene polymorphisms on treatment outcomes in Iranian patients receiving oxaliplatin-based regimens for colorectal (CRC) and gastric cancers (GC). Patients, who were candidates to receive oxaliplatin-based chemotherapy, entered into the study. In 2-week intervals, the patients received combination regimen of oxaliplatin, fluorouracil, and leucovorin (FOLFOX) for 3 months. ERCC1 rs11615 codon 118C/T polymorphism was tested by restriction fragment length polymorphism polymerase chain reaction (RFLP-PCR) method using patients' peripheral blood lymphocytes. The tumor response to chemotherapy was evaluated by examining the size of the tumor using CT scan. Association between response rates, according to the RECIST criteria, and patients' genotypes was evaluated. Any relationship between response rate and possible explanatory factors was also determined. Overall, 40 patients (13 females (32.5%), and 27 males (67.5%)) enrolled in the study. Four patients (10.0%) carried the homo-zygous mutation (T/T genotype), ten patients (25.0%) were heterozygous (C/T genotype), and twenty-six patients (65%) were homo-zygous (C/C genotype). Response rate were 30.77%, 20.00%, and 0.00% for the genotypes C/C, C/T, and T/T, respectively. No significant association between response rate and genotypes was observed ( = 0.64). Patients with well- and moderately-differentiated histological grade of the tumor showed a better response rate (100.00% of 2 patients and 66.66% of 12 patients, respectively) compared to those with poorly differentiated (0.00% of 26 patients) histological grade ( < 0.001). Further multicenter studies are recommended to confirm conclusively our findings.
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http://dx.doi.org/10.22037/ijpr.2019.1100827DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7059040PMC
January 2019

Antibiotic Prescribing Trends Before and After Implementation of an Audit and Feedback Program in Internal Ward of a Tertiary Hospital in Tehran.

Iran J Pharm Res 2019 ;18(4):2136-2143

Department of Pulmonary and Critical Care Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

We implemented a post prescribing review and feedback program to investigate its effect on appropriateness of antimicrobial use and antimicrobial consumption rate. A pre-post interventional study conducted in internal ward of Imam Hossein teaching hospital. For nine months of intervention phase, medical file of all patients who received intravenous antibiotic were reviewed by a clinical pharmacy specialist. Discrepancies from international and local guidelines were discussed with physicians. Outcome measures included appropriateness of antimicrobial usage, length of stay, and broad-spectrum antimicrobial usage rate. A total of 198 antibiotic courses (154 in intervention phase and 44 in pre-intervention phase) were reviewed. One-hundred sixty-seven recommendations in treatment course of 75.3% of patients were made. The most common recommendations were discontinuing antibiotics and changing from intravenous to oral therapy (35% and 22%). The acceptance rate was 80.2%. Rate of discrepancies from guidelines was compared between pre-intervention and two last months of intervention period which showed a significant reduction in antibiotic choosing (47%, -value < 0.001), de-escalation (48%, -value < 0.001), on time changing intravenous to oral therapy (60%, -value < 0.001) and dosing schedule (30%, -value = 0.003). Hospital length of stay showed a significant reduction from 16.1 days to 11.6 days (-value < 0.05) between pre-intervention and post-intervention group. Mortality rate was not different in the patients that intervention in their treatment was accepted rejected (-value = 1.00). There was a reduction trend in consumption rate of Carbapenems, Vancomycin, and Ciprofloxacin. Therefore, prospective audit and feedback program effectively decreased inappropriate treatment and hospital length of stay with no effect on mortality.
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http://dx.doi.org/10.22037/ijpr.2019.1100833DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7059028PMC
January 2019

Effects of High-Dose Vitamin D Replacement on the Serum Levels of Systemic Inflammatory Biomarkers in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease.

COPD 2019 08 25;16(3-4):278-283. Epub 2019 Sep 25.

Chronic Respiratory Disease Research Center, National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences , Tehran , Iran.

Chronic Obstructive Pulmonary Disease (COPD) is associated with increased inflammatory responses to noxious particles, which can be further enhanced during Acute Exacerbation of COPD (AECOPD). Considering the important immunoregulatory function of vitamin D, high prevalence of Vitamin D Deficiency (VDD) in COPD patients and a negative link between vitamin D levels and inflammatory biomarkers, suggests the seemingly interesting mechanism of vitamin D effects on inflammation resolution during the conventional treatment of AECOPD. The admitted AECOPD patients with VDD were recruited and randomly allocated to receive either 300,000 IU of intramuscular vitamin D ( = 35) or placebo ( = 35). Primary outcomes included inflammation resolution dynamics, which were assessed by monitoring the serum levels of IL-6, IL-8, and hs-CRP. Symptom recovery was evaluated based on the modified Medical Research Council (mMRC) dyspnea scale on the 1st and 6th days of admission. Secondary outcomes included the length of hospital stay (LOS) and 30-day mortality rates. Inflammatory biomarkers were highest at Day 1. Baseline vitamin D levels were 11.25 ± 3.09 and 10.59 ± 3.90 ng/ml ( = 0.45), which reached 11.35 ± 3.16 and 18.17 ± 4.24 by Day 6 ( < 0.001) in the placebo and, vitamin-D groups, respectively. IL-6 levels significantly decreased in the vitamin-D vs. placebo group on the 6 day ( = 0.02); however, no significant differences were observed in IL-8 ( = 0.15) and hs-CRP ( = 0.24) levels, mMRC scale ( = 0.45), LOS ( = 0.20), and mortality rates ( = 0.61). Vitamin D replacement as adjunctive therapy may accelerate inflammation resolution in hospitalized AECOPD patients. Further studies were needed to establish vitamin D exact role on inflammation resolution in AECOPD.
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http://dx.doi.org/10.1080/15412555.2019.1666812DOI Listing
August 2019

Main Factors Affecting Physicians' Prescribing Decisions: The Iranian Experience.

Iran J Pharm Res 2018 ;17(3):1105-1115

Faculty of Medicine, AJA University of Medical Sciences, Tehran, Iran.

Prescription decision making is a complicated phenomenon influenced by many factors including drug strength, the patient's context, prescriber characteristics, health facilities, payment type, and pharmaceutical marketing. To evaluate the associations between each influenced factor and drug prescription method of Iranian physicians, we conducted an exploratory research, utilizing a questionnaire as quantitative research instrument. A sample of 460 physicians was asked to fill out the questionnaire, yielding 84% response rate. The statistical analysis from the collected data demonstrated that Iranian physicians mostly paid attention to the payment type, the patients' individual factors and the products' characteristics while prescribing a medicine. In addition, it was revealed that marketing expenditures did not have a high influence on the physicians' demand for pharmaceutical products in Iran. The obtained results may be useful for Iranian pharmaceutical companies' marketing strategy planners as well as the patients who are the exact consumers of the prescribed medicines.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6094427PMC
January 2018

Occurrence of multiclass pesticide residues in tomato samples collected from different markets of Iran.

J Environ Health Sci Eng 2018 Jun 7;16(1):55-63. Epub 2018 May 7.

3Vice-Chancellor for Food and Drug Affairs, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: Pesticides are a reason for popular concern due to their possible unfavorable results on human safety. Most pesticide residues are present in food owing to the direct application of a pesticide to a crop. The aims of this study were; development a multiresidue method for analysis of 81 pesticides in tomato using GC/MS, and detection and quantitation of the studied pesticides in tomato samples gathered from various stores of Iran.

Methods: The pesticides were assessed concurrently in a single run applying GC/MS after extraction with QuEChERS method. Homogenized tomato samples were weighed into centrifuge tubes. The studied pesticides were extracted using acetonitrile, followed by the addition of a mixture of anhydrous magnesium sulfate and sodium acetate. In order to remove excess water and other components of tomato a combination of primary secondary amine and magnesium sulfate was applied, and then the extracted components were analyzed by GC-MS.

Results: The calibration curves for all analytes were linear in the range of 20-200 ng/g with a determination coefficient (R) in the range between 0.993 and 0.999. The LODs and LOQs were in the range between 2.5-6.7 and 7.5-20 ng/g respectively, and the mean recoveries obtained for three fortification levels (25,50 and 100 ng/g -five replicates each) were 72-116% with RSD < 20%. Six residues were found in 31 (20.7%) samples. Iprodione was the most common detected residues (6.0%), followed by permethrine (4.7%), esfenvalerate (4.7%), chlorpyrifos (3.3%), diazinon (2.0%), and penconazole (1.3%).

Conclusions: Among the detected pesticides, only Iprodione, permethrine, chlorpyrifos and diazinon are registered for tomato production in Iran. With exception of Chlorpyrifos and diazinon the concentrations of iprodione and permethrine were found below the maximum residue levels (MRLs) established by Iranian National Standard Organization (INSO). Esfenvalerate and penconazole are not registered for tomato production in Iran. Therefore, it is necessary to control and management of their residues in tomato.
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http://dx.doi.org/10.1007/s40201-018-0296-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6021478PMC
June 2018

Role of Vitamin D Replacement on Health Related Quality of Life in Hospitalized Patients with "Acute Exacerbation of Chronic Obstructive Pulmonary Disease".

Iran J Pharm Res 2018 ;17(2):801-810

Department of Internal Medicine, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.

Burden of Chronic Obstructive Pulmonary Disease (COPD) is substantial and increasing in the world. There are controversial reports regarding vitamin D supplementation in COPD. We investigated relationship between vitamin D3 (Cholecalciferol) supplementation with Health Related Quality of Life (HRQOL) and symptom recovery in AECOPD patients with concurrent Vitamin D Deficiency (VDD). A placebo-controlled randomized clinical trial was designed. AECOPD patients with VDD were randomly allocated to receive either vitamin D 300,000 IU (n = 35) or placebo (n = 35) by intramuscular injection. Primary outcomes included the HRQOL assessed by St. George's Respiratory Questionnaire (SGRQ), and the symptom recovery evaluated by the modified Medical Research Council (mMRC) Dyspnea scale, determined at baseline and at days 30 and 120 post-intervention. Secondary endpoints were length of hospital stay (LOS), rehospitalization and mortality rates. Sixty-two patients, 30 patients in the vitamin D and 32 patients in the placebo groups, with mean ± SD age of 63.42 ± 8.48 years accomplished the study. Baseline vitamin D levels in the vitamin D and placebo groups were 10.59 ± 3.39 and 11.12 ± 3.17 ng/mL, respectively. These levels reached 36.85 ± 11.80 and 12.30 ± 3.66 in the vitamin D and placebo groups, respectively, at day 120 ( 0.001). Correction of vitamin D levels in the intervention group resulted in statistically significant improvement in patients' HRQOL by day 120 compared to that of the placebo group ( 0.001); however no significant difference was observed in LOS, rehospitalization, and mortality rates. Single parenteral high dose of vitamin D as adjunctive therapy could improve HRQOL in hospitalized AECOPD patients with deficient levels of vitamin D.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5985196PMC
January 2018

The Effects of House Cooking Process on Residue Concentrations of 41 Multi-Class Pesticides in Rice.

Iran J Pharm Res 2018 ;17(2):571-584

Food Safety Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

In current study, the effects of Iranian rice cooking method (Kateh) on residue levels of 41 pesticides were investigated. The pesticides were selected according to Iranian National Standards Organization (INSO) regulations and covered 18 permitted and 23 banned pesticides belonging to different chemical classes such as organophosphate, triazole, and carbamate. A 250 g portion of rice sample was soaked in 2.5 L spiked tap water containing studied pesticides at final concentration 2 μg/mL and then, the effects of washing and cooking were investigated. The pesticides were analyzed simultaneously in a single run using positive electrospray ionisation with multiple reaction monitoring (MRM) after extraction with QuEChERS method. The results showed that washing removed different portions of pesticide residues in the range between 12.0-88.1%. Washing effect was not associated with the water solubility of the pesticides but amount of residue binding to rice matrix was a major factor for residue reduction. In Iranian method of rice preparation, cooking process includes boiling and steam cooking. In this study, the amount of the pesticide residues was decreased in the range of 20.7-100%. Under these conditions, volatilization, hydrolysis, and thermal degradation caused the reduction of the pesticide residues.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5985175PMC
January 2018

The Availability and Affordability of Cardiovascular Medicines for Secondary Prevention in Tehran Province (Iran).

Iran J Pharm Res 2018 ;17(Suppl):64-72

Islamic Azad University, Ahar Branch, Ahar, Iran.

Availability and affordability of medicines are crucial to achieving success in prevention programs, particularly in developing countries. The aim of this study was to determine the availability and affordability of cardiovascular medicines for secondary prevention in Tehran province of Iran. A cross-sectional survey was conducted in Tehran province in 2015, using the 2nd edition of the World Health Organization/Health Action International methodology. Data on the availability and affordability of 21 selected cardiovascular medicines were collected from the public and private healthcare sectors. A total of 120 facilities were included in the survey and the medicines in this survey were both original and lowest-price generic. Lowest-price generic equivalent medicines were highly available (> 80%) in almost all pharmacies of both public and private sectors, while the availability of original brand medicines was highly poor in public and private pharmacies. The median price ratios were 0.72 to 0.76 for generic medicines. The treatment of cardiovascular diseases with lowest-price generic equivalent medicines was generally affordable; moreover, less than a single day's wage was adequate to purchase a monthꞌs supply of the lowest priced generic of the surveyed medicines. The availability of the selected generic medicines for the secondary prevention of cardiovascular diseases is high in both public and private sectors and they were affordable for low-paid unskilled government workers in the province. The result of this study demonstrates that the supply policies pertaining to generic medicines have been implemented successfully.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5958325PMC
January 2018

Association Between Delayed Graft Function (DGF) Biomarkers and Long-term Outcomes After Living Donor Kidney Transplantation.

Rev Recent Clin Trials 2018 ;13(4):312-318

Department of Clinical Pharmacy, School of Pharmacy, Shohadaye-7 Tir Hospital, Iran University of Medical Sciences, Tehran, Iran.

Background And Objectives: The association between preoperative Urine Neutrophil Gelatinase-associated Lipocalin (uNGAL) and interleukin-18 (uIL-18) with poor 1-year allograft function has been shown in deceased-donor kidney transplant recipients previously, and also these markers could predict 3-month allograft function. However, it is unknown whether there is an association between these postoperative biomarkers with important recipient outcomes beyond this time in livedonor transplants.

Methods: NGAL and IL-18 four and 24 hours were measured in live-donor kidney transplant recipients after transplantation. The relationships between changes in these markers with clinical outcomes as well as kidney function were examined at 1 month and 2 years. Moreover, the association between delayed graft function with clinical outcome and Serum Creatinine (SrCr) was evaluated during this period.

Results: The Mean age for kidney recipients was 23.9 years. Significant interaction was observed between uNGAL 24 hr (pvalue=0.01) and uIL-18 four and 24 hr after transplantation (pvalue=0.04, 0.03; respectively) with patients' outcome after 1 month and changes in uNGAL with outcomes after 2 years (pvalue= 0.04).

Conclusion: Changes in urine NGAL postoperative are associated with worst outcomes, 2 years after kidney transplantation, suggesting its potential role in identifying patients that are at high risk for diminished allograft function, outcome and survival.
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http://dx.doi.org/10.2174/1574887113666180522082930DOI Listing
April 2019

N-acetylcysteine decreases urinary level of neutrophil gelatinase-associated lipocalin in deceased-donor renal transplant recipients: a randomized clinical trial.

Biomarkers 2018 Sep 4;23(6):589-596. Epub 2018 May 4.

f Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences , Tehran , Iran.

Context: Acute kidney injury (AKI) is a common complication after kidney transplantation (KT), especially in recipients from deceased donors. Urinary neutrophil gelatinase-associated lipocalin (u-NGAL) is an early and sensitive marker of AKI after transplantation.

Objectives: We assessed the renoprotective effect of N-acetylcysteine (NAC) on u-NGAL levels as an early prognostic marker of graft function immediately after transplantation.

Materials And Methods: A double-blind, randomized, placebo-controlled trial was conducted on 70 deceased-donor KT recipients ( www.irct.ir , trial registration number: IRCT2014090214693N4). Patients received 600 mg oral NAC or placebo twice daily from day 0 to 5 and urine samples were taken before, and on the first and fifth days after transplantation. U-NGAL and early graft function were compared between the two groups.

Results: NAC significantly reduced u-NGAL levels compared to placebo (p value = 0.02), while improvement in early graft function with NAC did not reach statistical significance.

Conclusions: This study showed that NAC administration in deceased-donor KT recipients can reduce tubular kidney injury, evidenced by u-NGAL measurements. Improvement in early graft function needs a larger sample size to reach a statistical conclusion.
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http://dx.doi.org/10.1080/1354750X.2018.1468823DOI Listing
September 2018

Impact of Corporate Reputation on Brand Differentiation: An Empirical Study from Iranian Pharmaceutical Companies.

Iran J Pharm Res 2017 ;16(4):1658-1670

Department of Pharmacoeconomics and Pharmaceutical Management, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

The influence of company reputation or what is often referred to as corporate reputation on branding strategy and producing intangible asset for different industries has been researched in western countries, but there is a gap for the generalizability of findings to countries out of the United State and Europe. To establish the western researcher's external validity of theories in other countries and to obtain a better understanding of the influences of branding and company reputation on pharmaceutical business markets, the researchers applied this study for Iran, a country in the Middle East. The obtained results using SEM (by P.L.S. 2.0 software) showed a good relationship between value creation and brand differentiation (β =0.360 and t-value = 3.167), between corporate communication and brand differentiation (β = 0.022 and t-value = 3.668), and between strategic resources and brand differentiation (β = 0.289 and t-value = 2.247). This study is a pioneering attempt in Iran to measure the impact of corporate reputation on brand differentiation strategy.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5843328PMC
January 2017

Study of The Effects of N-Acetylcysteine on Oxidative Stress Status of Patients on Maintenance-Hemodialysis Undergoing Cadaveric Kidney Transplantation.

Iran J Pharm Res 2017 ;16(4):1631-1638

Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.

N-acetylcysteine (NAC) is a potent antioxidant that acts through regenerating glutathione stores and scavenging oxygen-free radicals. This study assesses the short-term effects of NAC in cadaveric kidney transplant (KT) recipients. A double blind, randomized, placebo controlled trial was designed and patients were randomly assigned to receive either NAC or placebo. Glutathione peroxidase (GPX) activity in erythrocytes and serum malondialdehyde (MDA) levels were measured and serum creatinine levels and estimated glomerular filtration rate (eGFR) determined in the early phase after transplantation, were also compared between two study groups. Thirty-seven males and 20 females, with mean ± SD age of 44.6 ± 12.4 years completed the study. Significant difference ( = 0.02) was seen between GPX activity reduction in the placebo group, and that of the NAC group and on the levels of MDA there was no significant difference between two study groups ( = 0.53). Significant improvement in immediate graft function (IGF), (68% versus 40%, = 0.05) and the first week eGFR were observed in the NAC group compared to the placebo group (52.46 ± 2.77 versus 38.75 ± 19.67 mL/min/1.73 m, = 0.02). It seems that the protective mechanisms of NAC, other than its antioxidant properties, can be favorable in KT patients.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5843325PMC
January 2017

Protection from Reperfusion Injury with Intracoronary N-Acetylcysteine in Patients with STEMI Undergoing Primary Percutaneous Coronary Intervention in a Cardiac Tertiary Center.

Am J Cardiovasc Drugs 2018 Jun;18(3):213-221

Tehran Heart Center, Tehran University of Medical Sciences, North Kargar Street, P.O. Box: 1411713138, Tehran, Iran.

Background: Evidence suggests that oxidative stress plays a principal role in myocardial damage following ischemia/reperfusion events. Recent studies have shown that the antioxidant properties of N-acetylcysteine (NAC) may have cardioprotective effects in high doses, but-to the best of our knowledge-few studies have assessed this.

Objectives: Our objective was to investigate the impact of high-dose NAC on ischemia/reperfusion injury.

Methods: We conducted a randomized double-blind placebo-controlled trial in which 100 consecutive patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) were randomly assigned to the case group (high-dose NAC 100 mg/kg bolus followed by intracoronary NAC 480 mg during PCI then intravenous NAC 10 mg/kg for 12 h) or the control group (5% dextrose). We measured differences in peak creatine kinase-myocardial band (CK-MB) concentration, highly sensitive troponin T (hs-TnT), thrombolysis in myocardial infarction (TIMI) flow, myocardial blush grade (MBG), and corrected thrombolysis in myocardial infarction frame count (cTFC).

Results: The peak CK-MB level was comparable between the two groups (P = 0.327), but patients receiving high-dose NAC demonstrated a significantly larger reduction in hs-TnT (P = 0.02). In total, 94% of the NAC group achieved TIMI flow grade 3 versus 80% of the control group (P = 0.03). No significant differences were observed between the two groups in terms of changes in the cTFC and MBG.

Conclusions: In this study, NAC improved myocardial reperfusion markers and coronary blood flow, as revealed by differences in peak hs-TnT and TIMI flow grade 3 levels, respectively. Further studies with large samples are warranted to elucidate the role of NAC in this population. ClinicalTrials.gov identifier: NCT01741207, and the Iranian Registry of Clinical Trials (IRCT; http://irct.ir ) registration number: IRCT201301048698N8.
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http://dx.doi.org/10.1007/s40256-017-0258-8DOI Listing
June 2018

The study of vitamin D administration effect on CRP and Interleukin-6 as prognostic biomarkers of ventilator associated pneumonia.

J Crit Care 2018 04 12;44:300-305. Epub 2017 Sep 12.

Clinical Pharmacy Department, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address:

Purpose: In regard with the effect of immune-stimulants in the treatment of infectious diseases, the effect of vitamin D administration on the outcome of patients with Ventilator-Associated Pneumonia (VAP) with a high rate of mortality, was studied.

Material And Method: In this trial, 46 adult patients suffering from VAP and vitamin D deficiency were enrolled. The first group of patients received single intramuscular injection of vitamin D (300000Unit), while the other group were given the placebo.

Results: Administration of vitamin D significantly enhanced its levels (P<0.0001) in the treated patients (12.28±8.26) in comparison with placebo group (1.15±1.50). Serum Interleukin-6 levels were significantly reduced in the treated group compared to placebo (P=0.01). Although C-Reactive protein (CRP) levels showed an improving trend in the vitamin D group, no significant difference between groups (P=0.12) was found. Interestingly, the mortality rate of patients that treated with vitamin D (5/24) was significantly lower (p=0.04) than that of the placebo group (11/22).

Conclusion: Our results indicate that vitamin D administration can significantly reduce the IL-6 as prognostic marker in VAP patients, and must be considered as adjunct option in the treatment of VAP patients.
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http://dx.doi.org/10.1016/j.jcrc.2017.08.040DOI Listing
April 2018

Effect of Vitamin D Supplementation on Procalcitonin as Prognostic Biomarker in Patients with Ventilator Associated Pneumonia Complicated with Vitamin D Deficiency.

Iran J Pharm Res 2017 ;16(3):1254-1263

Clinical Pharmacy Department, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Ventilator-associated pneumonia (VAP) is a common and serious problem that develops after more than 48 h of mechanical ventilation. Improving the activity of immune system with vitamin D, and its consequent impact on prognostic biomarkers of VAP was studied in the current study. A randomized double blind placebo controlled clinical trial was designed. A total of 46 patients with VAP, who were suffering from vitamin D deficiency, were randomly allocated into the study groups of placebo (n=22) and treatment (n=24) The treatment group received 300,000 units of intramuscular vitamin D. Serum levels of procalcitonin and vitamin D along with SOFA and CPIS scores were determined at baseline and on day 7 after intervention. The mortality rate of patients was also monitored for the succeeding 28 days after the injection. The administration of vitamin D significantly enhanced its levels (P<0.0001) in the treated patients (12.28 ± 8.26) in comparison to placebo group (1.15 ± 1.50). The levels of PCT were significantly decreased (p=0.001) in the treatment group (- 0.02 ± 0.59 ng/mL) compared to that of placebo group (0.68 ± 1.03 ng/mL). However, changes in (SOFA) and CPIS scores were not significantly different between study groups (p=0.63 and p=0.32, respectively). Interestingly, the mortality rate of patients in the treatment group (5/24) was significantly lower (p=0.04) than that of the placebo group (11/22). In conclusion, our results indicate that vitamin D supplementation can significantly reduce the procalcitonin in (VAP) patients, and must be considered as a preventive and/or therapeutic strategy.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5610782PMC
January 2017

Evaluation of Renal Toxicity of Colistin Therapy With Neutrophil Gelatinase-associated Lipocalin: a Biomarker of Renal Tubular Damage.

Iran J Kidney Dis 2017 Nov;11(6):447-455

Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Introduction: Nephrotoxicity has been a concern with new dosing regimens of colistin. This study was designed to compare nephrotoxicity of high dose and conventional dose of colistin and the ability of detecting it using neutrophil gelatinase-associated lipocalin (NGAL).

Materials And Methods: A randomized clinical trial was carried out on 40 patients with multidrug-resistant gram-negative infections assigned into 2 groups to receive high and conventional doses of colistin. Blood samples were taken 4 times for measuring serum NGAL. The incidence of acute kidney injury was also evaluated based on the risk, injury, failure, loss, end-stage renal disease (RIFLE) criteria.

Results: Baseline levels of NGAL were not significantly different between the patients on the high dose and conventional dose of colistin. The mean NGAL levels on day 10 were 762.14 ± 415.44 pg/mL and 623.67 ± 272.61 pg/mL, respectively.  However, between-group analysis did not show a significant difference in the NGAL levels. The prevalence of acute kidney injury was 60% and 15% based on the RIFLE criteria, in the high-dose and conventional-dose groups, respectively (P = .003).

Conclusions: Although colistin-induced nephrotoxicity was not confirmed with NGAL levels, our findings, however, showed a higher incidence of acute kidney injury associated with high-dose colistin, defined by the RIFLE criteria. Higher levels of NGAL in the acute kidney injury patients were associated with high-dose regimen of colistin.
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November 2017

Incidence of Ganciclovir Resistance in CMV-positive Renal Transplant Recipients and its Association with UL97 Gene Mutations.

Iran J Pharm Res 2017 ;16(2):805-810

School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Human cytomegalovirus (CMV) remains the most common infection affecting organ transplant recipients. Despite advances in the prophylaxis and acute treatment of CMV, it remains an important pathogen affecting the short- and long-term clinical outcome of solid organ transplant recipient. The emergence of CMV resistance in a patient reduces the clinical efficacy of antiviral therapy, complicates therapeutic and clinical management decisions, and in some cases results in loss of the allograft and/or death of the patient. Common mechanisms of CMV resistance to ganciclovir have been described chiefly with the UL97 mutations. Here we evaluate Incidence of ganciclovir resistance in 144 CMV-positive renal transplant recipients and its association with UL97 gene mutations. Active CMV infection was monitored by viral DNA quantification in whole blood, and CMV resistance was assessed by UL97 gene sequencing. Six mutations in six patients were detected. Three patients (2.6%) of 112 patients with history of ganciclovir (GCV) treatment had clinical resistance with single UL97 mutations at loci known to be related to resistance (including mutations at codon 594, codon 460, and codon 520). three patients who were anti-CMV drug naïve had single UL97 mutations (D605E) without clinical resistance. Our results confirm and extend our earlier findings on the specific mutations in the UL97 phosphotransferase gene in loci that have established role in ganciclovir resistance and also indicate that clinical ganciclovir resistance due to UL97 gene mutations is an issue in subjects with history of with ganciclovir treatment. D605E mutations remains a controversial issue that needs further investigations.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5603891PMC
January 2017

Nephrotoxicity of High and Conventional Dosing Regimens of Colistin: A Randomized Clinical Trial.

Iran J Pharm Res 2017 ;16(2):781-790

Pathologist director of Khatam laboratory, Khatam hospital, Tehran, Iran.

Nephrotoxicity has been a major long-standing concern about colistin.This study was designed to compare nephrotoxicity of high dose and conventional dose of colistin. A randomized open-labeled clinical trial on 40 patients with multi-drug resistant gram negative infections was designed. Patients were allocated into two equal-size groups receiving high (a loading dose of 9 million international units (MIU) and maintenance doses of 4.5 MIU every 12 h) and conventional dose (2 MIU every 8 h) of colistin. Blood samples were taken on day 1, 3, 5, 7 and 10 of treatment for measuring serum cystatin C (Cys C) levels. Incidence of acute kidney injury (AKI) was also evaluated based on RIFLE criteria. Mean ± sd of the difference between baseline and day 10 Cys C levels in high dose and conventional dose groups were 1.61 ± 0.90 and 1.32 ± 0.48, respectively (P = 0.30). Within group analysis showed increase in Cys C levels in both groups (P = 0.001),however, no significant difference in Cys C levels was seen in between groups analysis (P = 0.13). Prevalence of AKI based on RIFLE criteria was 60% and 15% in high dose and conventional dose groups, respectively (P = 0.003). Comparison of Cys C between AKI (mean ± sd) and non-AKI (mean ± sd) patients, irrespective of colistin dosage regimens, confirmed a significant difference (P < 0.0001). Although, colistin-induced nephrotoxicity, determined by Cys C levels, was not confirmed by our findings, however, higher incidence of AKI in high-dose group, defined by RIFLE criteria, along with higher levels of Cys C in AKI patients are supportive of the higher risk of renal toxicity associated with high-dose regimen of colistin. More RCTs with a larger sample size are recommended.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5603888PMC
January 2017