Publications by authors named "Shahram Ala"

39 Publications

Evaluating the Effect of Dexmedetomidine on Hemodynamic Status of Patients with Septic Shock Admitted to Intensive Care Unit: A Single-Blind Randomized Controlled Trial.

Iran J Pharm Res 2020 ;19(4):255-263

Directr of Medical Education Development Center, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.

Septic shock, known as the most severe complication of sepsis, is a serious medical condition that can lead to death. Clinical symptoms of sepsis include changes in body temperature in the form of hypothermia or hyperthermia, tachypnea or hyperventilation, tachycardia, leukocytosis or leukopenia, and variations in blood pressure, as well as altered state of consciousness. One of the main problems in septic shock is poor response along with reduced vascular reactivity to vasopressors used to increase blood pressure. Therefore, low vascular response associated with reduced sensitivity or lower number of alpha-1 agonist receptors can result in shock and death. In addition to being the state-of-the-art treatment including volume load and vasopressor, use of alpha-2 agonists . dexmedetomidine (DXM) in septic shock can reduce vasopressors needed to restore adequate blood pressure. They can further moderate massive release of endogenous catecholamine. Therefore, the purpose of this study was to investigate the effect of DXM on outcomes of patients with septic shock, especially their needs for vasopressors and impacts on their hemodynamic status. This single-blind randomized controlled trial was performed on a total number of 66 patients with septic shock admitted to the intensive care unit (ICU) of Imam Khomeini Teaching Hospital in the city of Sari, in northern Iran. To this end, DXM (0.6 µg/kg/h) and normal saline (6 mL/kg/h) were infused for 12 h in the study and control groups, respectively. The results revealed that DXM could increase mean arterial pressure (MAP) ( = 0.021), systolic blood pressure (SBP) ( = 0.002), and reduced heart rate ( < 0.001) but diastolic blood pressure (DBP) ( =0.32) and norepinephrine dose requirement didn't change statistically in septic shock patients ( = 0.12).
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http://dx.doi.org/10.22037/ijpr.2019.112343.13699DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8019859PMC
January 2020

Efficacy of sucralfate ointment in the prevention of acute proctitis in cancer patients: A randomized controlled clinical trial.

Caspian J Intern Med 2020 ;11(4):410-418

Gastrointestinal Cancer Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.

Background: Acute radiation proctitis (ARP) is a usual adverse effect in patients undergoing pelvic radiotherapy. The symptoms include diarrhea, rectal blood or mucus discharge, fecal urgency and tenesmus with pain. Sucralfate, an aluminum-based salt of sucrose octasulfate, is a cytoprotective agent that forms a coating barrier at injured sites by adhering to mucoproteins. It has been used in topical management of a wide variety of local lesion. This study was designed to evaluate the preventive effect of rectal sucralfate on acute radiotherapy induced proctitis.

Methods: Seven percent sucralfate ointment was prepared for topical use. Drug quantification, chemical stability and microbial limit tests were performed carefully. In this randomized double blind placebo controlled trial, fifty-seven patients with pelvic malignancies undergoing radiotherapy were allocated to receive either 1 g of sucralfate or 1 g of placebo, given as a twice daily ointment, one day before and during radiotherapy for six weeks. The eligible patients were evaluated based on RTOG acute toxicity criteria and the following ARP symptoms weekly: rectal hemorrhage, diarrhea, rectal pain, and fecal urgency. The influence of symptoms on lifestyle was also recorded weekly.

Results: Acute proctitis was significantly less prevalent in patients in the sucralfate group. The incidence of rectal bleeding (P=0.003), diarrhea (P=0.002), rectal pain (P=<0.001) and fecal urgency (P=0.002) was significantly less common in the sucralfate group. No statistical significant difference was observed for radiotherapy induced cystitis in the placebo and sucralfate groups (P=0.27).

Conclusion: This study suggests that sucralfate7% ointment reduces the incidence of symptoms associated with acute radiation proctitis.
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http://dx.doi.org/10.22088/cjim.11.4.410DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7911762PMC
January 2020

The comparison of the effect of flaxseed oil and vitamin E on mastalgia and nodularity of breast fibrocystic: a randomized double-blind clinical trial.

J Pharm Health Care Sci 2021 Jan 6;7(1). Epub 2021 Jan 6.

Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Km 18 Khazarabad Road, Khazar sq., Sari, Mazandaran Province, 4815733971, Iran.

Background: Fibrocystic changes are a common benign condition in women aged 20-50. The medical intervention aims to stop fibrocystic disease progress and relieve the breast's pain and tenderness. In the long-term, reversing the fibrocystic changes is also desirable.

Methods: In this randomized double-blind clinical trial, the effect of flaxseed oil on the severity of pain and breast nodularity was investigated against vitamin E. This study was conducted on 100 women with mastalgia. The intervention group received Flaxseed oil pearls and the control group received vitamin E pearl 200 IU twice a day for 2 months. The duration and severity of breast pain were evaluated by Cardiff chart and VAS (Visual Analogue Scale). The nodularity was assessed by Lucknow-Cardiff scale at baseline, then the first and second months of intervention.

Results: At baseline, there was no statistically significant difference between the two groups in characteristics. The breast pain improved in both groups during the first and second months of intervention (P-value within group< 0.001). However, the mean breast pain was not significantly different between the two groups at the end of the first and second month (P1= 0.54, P2= 0.73). Furthermore, the breast pain during four phases of the menstrual cycle showed no difference between vitamin E and flaxseed oil groups (menstruation phase= 0.76, follicular phase= 0.48, the first week of luteal phase= 0.86, the second week of luteal phase=0.30). The breast nodularity also decreased during the first and second months of intervention, yet no significant difference between the two groups was found (p= 0.9).

Conclusions: This study showed that flaxseed oil and vitamin E both could be effective in breast pain-relieving and decreasing nodularity with minimal side effects in contrast with the baseline. But there are no significant differences between these two agents. Larger scale prospective studies are needed to evaluate these effects in the long-term.

Trial Registration: IRCT201612243014N18 , Registration date: 2017-10-15.
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http://dx.doi.org/10.1186/s40780-020-00186-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789497PMC
January 2021

Tocilizumab for treatment patients with COVID-19: Recommended medication for novel disease.

Int Immunopharmacol 2020 Dec 16;89(Pt A):107018. Epub 2020 Sep 16.

Departemernt of Anesthsia, Faculty of Allied Medical Sciences, Iran University of Medical Sciences, Tehran, Iran. Electronic address:

The coronavirus disease 2019 (COVID-19) virus has spread all over the world. Scientists are trying to discover drugs as effective treatment for patients with COVID-19. So far about 30 drugs have been introduced that one of them is Tocilizumab. Recently Tocilizumab has been introduced to treat patients with COVID-19 and researchers are investigating further the efficacy of this drug for different are patients. In Iran and China, some reports showed a positive effect of Tocilizumab on Saturation of Peripheral Oxygen (SPO2) but results of CT scan in patients in different. In some patients, CT scan showed reduced infiltration, however in other no change was observed. Unfortunately, until now there has been no definitive and effective treatment for patients with COVID-19. Although Tocilizumab has been accepted by China Health Commission to treat infected patients, its positive effects still cannot be predicted in all patients. Based on evidence of the Tocilizumab's effect on the SARS COV 2, researchers hope this drug will make effective and promising treatment to improve lung tissue inflammation in patients with the fatal COVID-19 virus. The present study provides an overview of respiratory inflammation with COVID-19 and probable effect of Tocilizumab on SARS-COV 2.
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http://dx.doi.org/10.1016/j.intimp.2020.107018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7494278PMC
December 2020

Evaluation of Neuroprtective Effects of L-Carnitine and Fat Emulsion in the CVA Patients: A Prospective, Randomized, Double Blind, Clinical Trial.

Iran J Pharm Res 2020 ;19(1):111-119

Department of Neurology, Bu Ali Sina General Hospital, Mazandaran University of Medical Sciences, Sari, Iran.

Cerebral infarction presents with neurological deficits caused by the death of neurons in a focal area of the brain. S100B is a biomarker that increases in brain damage. Neuroprotectives can reduce the brain sequels after neurological insult. The purpose of this study was to evaluate the neuroprotective effects of L-carnitine and Fat emulsion (Lipofundin) alone and in combination in patients with ischemic stroke. In a prospective, RCT, and double-blind study 100 patients with MCA ischemic cerebrovascular accident who were admitted in the first 24 h of injury entered the study. The patients were randomly assigned into four groups of L-carnitine, fat emulsion, L-carnitine plus fat emulsion and control. Fat emulsion 10%, 500 mL, was infused over 6 to 12 h and 1 gr of L-carnitine (10 mL of solution) was administered orally to patients in addition to common therapies, according to the American Heart Association and American Stroke Association (AHA/ASA) guidelines. The patients in the control group received only the usual treatment according to stroke guidelines. Blood samples before the intervention, then after 24 h, 48 h, and 7 days later were taken and immunoenzymatic colorimetric method was used for quantitative determination of S100B concentration in the patients' serum. In the within group analysis, all of our treatment interventions (except control group) have decreased S100B levels statistically significant ( < 0.05). Moreover, changes in observed levels of S100B before and after intervention were different between the groups and the observed differences were statistically significant ( = 0.01). In the GEE model, it was found that S100B levels in the L-carnitine plus fat emulsion group decreased more than the control group and this decline has been statistically significant [ = 0.02, 20.47 (CI 95%: 6.25-34.41)], but in comparison of L-carnitine and fat emulsion group with control group, did not reached statistical significance ( > 0.05). Based on the results obtained from this study, it seems that L-carnitine with fat emulsion could lead to neuroprotective effects with a significant reduction in the S100B biomarker.
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http://dx.doi.org/10.22037/ijpr.2020.1100952DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462480PMC
January 2020

Helicobacter pylori eradication in the management of glaucoma.

Caspian J Intern Med 2020 ;11(2):143-149

Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.

Background: To investigate the possibility that the eradication of infection is associated with a reduction in the risk of glaucoma.

Methods: Sixty-five successive patients with elevated intraocular pressure (IOP) or glaucoma were included in the study. Serum samples from all subjects were analyzed for the presence of - antibodies using ELISA. Forty patients with positive serologic test were included. Half of the patients enrolled into intervention group and the other half registered as control. Intervention arm was referred to the Gastroenterology Clinic for eradication of and evaluated for the effect of regimen eradication on IOP and glaucoma over 2 months of follow-up. The age-matched controls did not receive treatment. Urea breath test was applied to confirm eradication.

Results: There was a significant (p=0.005) reduction in IOP after complete eradication in the intervention group. This value was not significant in control patients (p=0.08). The mean IOP before treatment of glaucoma in the control group was 23.60±2.37 mmHg and after treatment with anti-glaucoma drugs was 14.25±1.48 mmHg on the onset of study, and 13.55±2.01 mmHg after follow up. The mean IOP before treatment of glaucoma in the intervention group was 24.55±3.6 mmHg and after treatment with anti-glaucoma drugs was 15.15±1.8 mmHg, and 14.3±1.6 mmHg after the eradication of H pylori with a drug regimen. However, after the treatment of glaucoma in all patients, the overall comparison of mean IOP differences showed no statistical difference (P=0.65).

Conclusion: eradication therapy may have a positive effect on the management of glaucoma.
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http://dx.doi.org/10.22088/cjim.11.2.143DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7265522PMC
January 2020

Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in Pelvic Cancer patients.

BMC Complement Med Ther 2020 May 13;20(1):146. Epub 2020 May 13.

Gastrointestinal Cancer Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.

Background: Acute radiation-induced proctitis (ARP) is the most common side effect following radiotherapy for malignant pelvic disease. This study evaluated the efficacy of Aloe vera ointment in prevention of ARP.

Methods: Forty-two patients receiving external-beam radiotherapy (RT) for pelvic malignancies were randomized to receive either Aloe vera 3% or placebo topical ointment during radiotherapy for 6 weeks. These patients were evaluated based on the severity (grade 0-4) of the following symptoms weekly: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. RTOG acute toxicity criteria and psychosocial status of the patients were also recorded weekly. Lifestyle impact of the symptoms, and quantitative measurement of C-reactive protein (CRP), an indicator of systemic inflammation, were also measured.

Results: The results of present study demonstrated a significant preventive effect for Aloe vera in occurrence of symptom index for diarrhea (p < 0.001), rectal bleeding (p < 0.001), and fecal urgency (p = 0.001). The median lifestyle score improved significantly with Aloe vera during RT (p < 0.001). Intervention patients had a significant lower burden of systemic inflammation as the values for quantitative CRP decreased significantly over 6 weeks of follow-up (p = 0.009).

Conclusion: This study showed that Aloe vera topical ointment was effective in prevention of symptoms of ARP in patients undergoing RT for pelvic cancers.

Trial Registration: IRCT201606042027N6. Registration date: 2016-09-04.
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http://dx.doi.org/10.1186/s12906-020-02935-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7222341PMC
May 2020

Clinical effectiveness of high dose versus standard dose of meropenem in ventilator-associated pneumonia caused by multidrug-resistant bacteria: a randomized single-blind clinical trial.

Infect Disord Drug Targets 2020 Feb 26. Epub 2020 Feb 26.

Department of Clinical Pharmacy, Faculty of Pharmacy, Pharmaceutical Research Center, Mazandaran University of Medical Sciences, Sari. Iran.

Background: Meropenem standard doses are based on the minimum inhibitory concentration of sensitive pathogens and the pharmacokinetic parameter of not critically ill patients. We compared the efficacy of high versus standard dose of meropenem in ventilator-associated pneumonia (VAP).

Methods: 24 out of 34 eligible patients were randomized to receive meropenem 3 g q8h (high dose group, 11 patients) or 2 g q8h (standard dose group, 13 patients) as a 3h infusion. Primary outcome was considered as clinical success that was defined as stable hemodynamic, improved sequential organ failure assessment (SOFA) score, stable or improved PaO2/FiO2 after 7 days. A sputum culture was taken before intervention.

Results: Clinical success rate was not significantly different between the high and standard dose group (54.5% vs. 38.5%, P= 0.431). There was a significant difference in reduction of clinical pulmonary infection score (CPIS) compared to high dose with standard group (P=0.038). SOFA score declined significantly in high dose group through the study (P=0.006). A shorter duration of VAP treatment was recorded in high dose group (P=0.061). We did not observe any significant adverse event related to meropenem. Acinetobacter spp. (34.8%), Klebsiella spp. (32.6%) and, Pseudomonas aeruginosa (19.5%) isolated more frequently from sputum cultures.

Conclusion: Treatment with high dose of meropenem seems to be safe. However, it did not provide significantly higher clinical success rate in comparison with the standard dose, but could be considered as an appropriate empirical treatment in patients with severe infection due to reducing in SOFA and CPIS.
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http://dx.doi.org/10.2174/1871526520666200227102013DOI Listing
February 2020

Efficacy of gabapentin mouthwash in managing oral mucositis pain in patients undergoing chemotherapy: a prospective, randomised, double-blind, controlled clinical trial.

Scott Med J 2020 Feb;65(1):12-18

Professor of Clinical Pharmacy, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.

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http://dx.doi.org/10.1177/0036933019897237DOI Listing
February 2020

Effects of Minocycline on Neurological Outcomes In Patients With Acute Traumatic Brain Injury: A Pilot Study.

Iran J Pharm Res 2019 ;18(2):1086-1096

Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.

Traumatic brain injury (TBI) is a public health problem worldwide. Secondary damage of brain injury begins within a few minutes after the trauma and can last a long time. It can be reversible, unlike primary injury. Therefore, therapeutic intervention can be used. The aims of this study were to assess the effects of minocycline on neurological function and serum S100B protein and neuron-specific enolase (NSE) levels in patients with moderate to severe TBI. Patients with acute onset of TBI and surgical evacuation of hematoma were randomized to receive either minocycline 100 mg orally twice daily or placebo for 7 days. The primary outcomes included changes in level of S100B and NSE at different time points during the trial. Additionally, changes in Glasgow coma scale (GCS) score were evaluated. The Glasgow Outcome Scale-Extended (GOS-E) score at 6 months after injury was assessed in discharge patients. Thirty four patients were randomized into the placebo (n = 20) and treatment (n = 14) groups. There was a marginal statistically significant differences in the normalized value of S100B between groups ( < 0.1). The reduction in serum NSE level from baseline to day 5 was statistically significant ( = 0.01) in minocycline group while it was not significantly decrease in placebo group ( = 0.2). Also, GCS improvement over time within the minocycline group was significant ( = 0.04) while was not significant in placebo group ( = 0.11). The GOS-E scores were not significantly different between minocycline and placebo group. Based on this study, it seems that the use of minocycline may be effective in acute TBI.
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http://dx.doi.org/10.22037/ijpr.2019.1100677DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6706715PMC
January 2019

Evaluation of Cholestyramine 15% Ointment in Relieving Pruritus and Burning After Ileostomy: A Rrandomized, Double-Blind Placebo-Controlled Clinical Trial.

J Invest Surg 2020 Oct 20;33(9):795-802. Epub 2019 Mar 20.

Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.

Skin irritation is a common ileostomy problem that causes burning and pruritus among patients due to the leakage of intestinal discharge around the stoma. This clinical trial was performed to evaluate the efficacy of topical cholestyramine (15%) on the reduction of the levels of burning and pruritus after an ileostomy. The patients were randomly divided into two groups of treatment and control ( = 15). The intervention group was subjected to one fingertip of cholestyramine, whereas the other group received the placebo ointment (approximately 0.5 g) on the skin immediately after the surgery and twice a day for 2 months. The primary outcome measure was the severity of burning and pruritus measured by a visual analog scale at different times after an ileostomy. Out of 34 patients, four cases were excluded due to the inappropriate completion of the questionnaire ( = 2) and unwillingness to attend the follow-up visits ( = 2). Therefore, 30 patients were included in the study. The levels of burning among patients in the cholestyramine were lower in weeks 3, 4, and 8 compared to the placebo group. Moreover, lower levels of pruritus were observed among patients in the treatment group in weeks 4 and 8 after an ileostomy. No side effects were reported among the patients. Topical cholestyramine was found to be effective in the management of burning and pruritus resulting from an ileostomy among the population under study.
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http://dx.doi.org/10.1080/08941939.2019.1578442DOI Listing
October 2020

Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial.

J Gastrointest Surg 2020 02 19;24(2):405-410. Epub 2019 Feb 19.

Department of Clinical Pharmacy, Nephrology and Kidney Transplant Research Center, Faculty of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran.

Background: Baclofen is an agonist for a subtype of gamma-amino butyric acid (GABA-B) receptors and traditionally been used for the systemic treatment of spasticity. Topical application of baclofen has been shown to reduce pain in patients with localized neuropathic pain.

Objectives: In this study, we investigate the efficacy of baclofen cream (5%) in reducing postoperative pain and analgesic requirement after open hemorrhoidectomy.

Design: The patients were randomly assigned to either baclofen (5%) cream or placebo immediately after surgery and then every 12 h for 14 days.

Patients: A total of 66 patients with third- and fourth-degree hemorrhoids undergoing open hemorrhoidectomy were randomly assigned to this trial.

Setting: This study was conducted at a single educational hospital.

Primary And Secondary Outcome Measures: The primary outcomes were intensity of pain, measured with a visual analog scale, and the analgesic requirement, measured by the amount of the acetaminophen consumption.

Results: No significant difference was found in baseline characteristics between the two groups. Postoperative pain score of the baclofen group was significantly lower on week 1 (P = 0.01) and week 2 (P = 0.02) than the placebo group. Similarly, patients in the baclofen group consumed significantly less analgesic medication on week 1 (P = 0.025) and week 2 (P = 0.024) than the control group.

Conclusion: Topical application of baclofen effectively relieves pain after hemorrhoidectomy with minimal side effects.
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http://dx.doi.org/10.1007/s11605-019-04147-7DOI Listing
February 2020

The Effect of Ultra-low-dose Intrathecal Naloxone on Pain Intensity After Lumbar Laminectomy With Spinal Fusion: A Randomized Controlled Trial.

J Neurosurg Anesthesiol 2020 Jan;32(1):70-76

Neurosurgery.

Background: Despite advances in pain management, several patients continue to experience severe acute pain after lumbar spine surgery. The aim of this study was to assess the safety and effectiveness of single ultra-low-dose intrathecal (IT) naloxone in combination with IT morphine for reducing pain intensity, pruritus, nausea, and vomiting in patients undergoing lumbar laminectomy with spinal fusion.

Materials And Methods: In this double-blind trial, patients scheduled for lumbar laminectomy with spinal fusion were randomly assigned to receive single ultra-low-dose IT naloxone (20 μg) and IT morphine (0.2 mg) (group M+N) or IT morphine (0.2 mg) alone (group M). The severity of postoperative pain, pruritus and nausea, and frequency of vomiting were assessed at recovery from anesthesia and, subsequently, at 1, 3, 6, 12, and 24 hours postoperatively using an 11-point (0-10) visual analogue scale.

Results: A total of 77 patients completed the study, and there were significant differences in postoperative pain, pruritus, and nausea visual analogue scale between the groups (P<0.05). After adjusting for body mass index and surgery duration, IT naloxone administration reduced the pain score (coefficient=1.84; 95% confidence interval [CI], 1.05-2.63; P<0.001), and the scores of pruritus and nausea (coefficient=0.9; 95% CI, 0.44-1.37; P<0.001 and coefficient=0.71; 95% CI, 0.12-1.31; P=0.02, respectively) compared with IT morphine alone. No serious adverse effects were observed.

Conclusions: The addition of ultra-low-dose IT naloxone to IT morphine provides excellent postoperative pain management and effectively controls pruritus and nausea in patients undergoing laminectomy with spinal fusion.
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http://dx.doi.org/10.1097/ANA.0000000000000537DOI Listing
January 2020

Cotreatment with Furosemide and Hypertonic Saline Decreases Serum Neutrophil Gelatinase-associated Lipocalin (NGAL) and Serum Creatinine Concentrations in Traumatic Brain Injury: A Randomized, Single-Blind Clinical Trial.

Iran J Pharm Res 2018 ;17(3):1130-1140

Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.

Acute kidney injury (AKI) occurs both after traumatic brain injury (TBI) and after hypertonic saline administration; furosemide may be useful in preventing AKI indirectly. Serum neutrophil gelatinase-associated lipocalin (sNGAL) is superior to serum creatinine (sCr) in diagnosing early AKI. We compared the administration of hypertonic saline plus furosemide (HTS+F) versus hypertonic saline (HTS), using sCr and sNGAL to investigate kidney injury in patients with TBI. This randomized, single-blind clinical trial was conducted from August 2016 to July 2017 in a neurosurgical intensive care unit, and included patients with a Glasgow Coma Score (GCS) 7-13 and brain edema. One group (n = 22) received hypertonic saline 5% (100 mL over 60 min then 20 mL/h) plus furosemide (40 mg over 60 min then 0.05 mg/kg per hour) for 72 h. The other group (n 21) received only hypertonic saline 5%, in the same dose as noted above. The sCr and sNGAL concentrations, GCS, and length of stay were measured. Mean ± SD differences were -51.15 (47.07) and 9.96 (64.23) ng/mL for sNGAL and -0.12 (0.22) and -0.005 (0.2) mg/dL for sCr in HTS+F group and HTS group respectively (both < 0.001). The incidence of stage one AKI according to Improving Global Outcomes (KDIGO) criteria was 4.5% in the HTS+F group and 19.0% in the HTS group ( = 0.16). Hypokalemia was common in both groups. HTS+F group, compared with HTS group, was associated with lower concentrations of sCr and sNGAL. Incidence AKI (KDIGO criteria) did not have difference between groups.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6094412PMC
January 2018

Effectiveness of Topical Sucralfate in the Management of Pressure Ulcer in Hospitalized Patients: A Prospective, Randomized, Placebo-Controlled Trial.

Am J Ther 2019 Jan/Feb;26(1):e5-e11

Departments of Clinical Pharmacy and.

Background: The aim of this study was to evaluate the effectiveness of topical sucralfate in the management of pressure ulcer (PU) in hospitalized patients.

Methods: Forty hospitalized patients with stage II PU were included in this prospective, double-blind, randomized, placebo-controlled trial and were randomly divided into 2 groups receiving either sucralfate gel or placebo, on a daily basis. The patients were visited every day for 14 days, the ulcer was evaluated using the Pressure Ulcer Scale for Healing (PUSH) and changes to the measured scores over time were used as an indicator of wound healing.

Results: There were no statistically significant differences in any of the demographic characteristics between both groups. Both of the interventions reduced the average PUSH score, and at the end of the trial, all but 2 patients were healed. One in each group discontinued the trial because of exacerbation of the ulcer. No significant between-group difference in the average PUSH score reduction was observed (6.36 ± 2.11 vs. 5.89 ± 1.41, P = 0.42). Although the average healing time was less in the sucralfate group (6.05 ± 2.17 vs. 7.78 ± 3.42), the difference was not statistically significant (P = 0.07).

Conclusions: Sucralfate gel does not improve healing of PU compared with placebo.
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http://dx.doi.org/10.1097/MJT.0000000000000531DOI Listing
April 2019

Randomized double-blind clinical trial of combined treatment with megestrol acetate plus celecoxib versus megestrol acetate alone in cachexia-anorexia syndrome induced by GI cancers.

Support Care Cancer 2018 Jul 13;26(7):2479-2489. Epub 2018 Feb 13.

Gastrointestinal Cancer Research Center, Mazandaran University of Medical Sciences, Sari, Iran.

Purpose: Previous studies reported promising efficacy for celecoxib in the treatment of cancer cachexia. We designed this study to test the hypothesis that combination therapy with megestrol acetate (MA) plus celecoxib is superior to MA alone.

Methods: Ninety eligible gastrointestinal cancer patients randomly received either MA 320 mg/day plus placebo (arm1) or MA 320 mg/day plus celecoxib 200 mg/day (arm2). Patients were evaluated at baseline, then 1 and 2 months after starting interventions. The primary outcome was body weight. Secondary outcomes were quality of life, grip strength, appetite score, performance status, plasma albumin, CRP, IL-6, and Glasgow Prognostic Score.

Results: Patients were comparable at baseline. Sixty patients were assessable for the first month and 33 patients for the second month. After 2 months, patients in arm1 (MA + placebo) and arm2 (MA + celecoxib) experienced 4.0 ± 3.4 and 2.2 ± 3.6Kg of weight gain respectively (P = 0.163). Changes relative to baseline were statistically significant in both arms of the study (P = 0.001). Regarding secondary outcomes, comparisons between groups did not show any statistically significant difference, but within-group changes were significant in both arms of the study.

Conclusion: Since both MA alone and MA plus celecoxib are associated with improvement of cachexia in GI cancer patients, this study failed to show that adding celecoxib (200 mg/day) to megestrol (320 mg/day) could enhance anti-cachexic effects of megestrol.
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http://dx.doi.org/10.1007/s00520-018-4047-yDOI Listing
July 2018

Topical Minoxidil Versus Topical Diltiazem for Chemical Sphincterotomy of Chronic Anal Fissure: A Prospective, Randomized, Double-Blind, Clinical Trial.

World J Surg 2018 07;42(7):2252-2258

Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, 18th Km Farahabad Boulevard, Sari, Mazandaran Province, 48175861, Iran.

Background: Anal fissure is a common anorectal problem causing severe pain and discomfort to the patients. Chemical sphincterotomy has emerged as a noninvasive alternative to the surgical methods of fissure treatment. The objective of this study was evaluation of the efficacy and the adverse effects of topically applied minoxidil in chemical sphincterotomy of chronic anal fissure in comparison with topical diltiazem.

Methods: A total of 88 patients with chronic anal fissure aged between 15 and 65 years were included in this double-blind, randomized clinical trial and were randomly assigned to either 0.5% minoxidil cream or 2% diltiazem cream twice daily for 2 weeks. The pain intensity, bleeding, wound healing, itching, headache, dizziness, significant drop in blood pressure, allergy and fissure relapse were assessed on a monthly basis for 2 months.

Results: Both diltiazem and minoxidil reduced the pain, bleeding and improved fissure healing with no significant difference. There were no between-groups differences in the frequencies of adverse effects, except for itching which was slightly higher with minoxidil during the first month. Allergy occurred in two patients in the minoxidil group, which was not severe and did not lead to discontinuation of the trial.

Conclusion: Topically administered minoxidil is of equal efficacy as diltiazem in the treatment of chronic anal fissure with low frequency of adverse effects. Thus, it can be considered as an agent for chemical sphincterotomy of anal fissure, but the itching at the beginning of the treatment can affect the adherence of the patient to treatment. Trial registration number IRCT2015041414483N6 (the full trial protocol could be accessed online at www.irct.ir ).
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http://dx.doi.org/10.1007/s00268-017-4449-xDOI Listing
July 2018

Successful Treatment of Acute Radiation Proctitis with Aloe Vera: A Preliminary Randomized Controlled Clinical Trial.

J Altern Complement Med 2017 Nov 15;23(11):858-865. Epub 2017 Jun 15.

6 Gastrointestinal Cancer Research Center, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari, Iran .

Background: Acute radiation proctitis (ARP) is a common side-effect that affects up to 50% of patients receiving radiotherapy. The aim of this study was to evaluate the role of a topical preparation of Aloe vera in the treatment of ARP induced by radiotherapy of pelvic area.

Subjects And Interventions: In this double-blind placebo-controlled trial, 20 consecutive patients with ARP after external-beam radiation therapy (46-72 Gy) of pelvic malignancies were randomized to receive either Aloe vera 3% or placebo ointment, 1 g twice daily for 4 weeks. These patients presented with at least two of the following symptoms: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. These symptoms were rated by the patients in terms of their severity (grade 0-4) for each of the symptoms mentioned earlier at baseline and then weekly for 4 weeks. A symptom index was calculated by the addition of the scores (16 most symptomatic). Radiation Therapy Oncology Group (RTOG) acute toxicity criteria and psychosocial status of the patients were also recorded weekly. The lifestyle impact of the symptoms was assessed by questionnaire grading from 0 (no effect on daily activity) to 4 (afraid to leave home).

Results: There was a significant (p < 0.05) improvement in the symptom index (before treatment vs. after treatment with Aloe vera) for diarrhea (median score: 0.67 vs. 0.11), fecal urgency (median score: 0.89 vs. 0.11), clinical presentation total (median score: 4.33 vs. 1.22), RTOG total (median score: 2.89 vs. 0.89), and lifestyle (median score: 1.1 vs. 0.33). Hemorrhage and abdominal/rectal pain did not improve significantly. The odds ratios for advantage of Aloe vera over placebo for "clinical presentation total" and "RTOG total" were 3.97 (1.3-11.9) and 5.9 (1.6-21.6), respectively.

Conclusion: A substantial number of patients with radiation proctitis seem to benefit from therapy with Aloe vera 3% ointment.
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http://dx.doi.org/10.1089/acm.2017.0047DOI Listing
November 2017

Conjugate and 23-valent pneumococcal polysaccharide booster vaccination in asplenic patients with thalassemia major: A randomized clinical trial study.

Caspian J Intern Med 2017 ;8(1):16-22

Pharmaceutical Sciences Research Center, Mazandaran University of Medical Sciences, Sari, Iran.

Background: Pneumococcal vaccine provides protection against invasive pneumococcal disease in population at risk. This study was conducted to compare the antibody response to 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in patients with thalassemia major.

Methods: A randomized cross-over clinical trial was performed on 50 asplenic patients with thalassemia major who referred to thalassemia center at Bouali Sina Hospital, Sari, Iran from 2013 to 2014. Patients were divided into two equal groups. The first group received 13-valent pneumococcal conjugate vaccine (PCV) injected into the deltoid muscle at first and received 23-valent polysaccharide vaccine (PPV) by the same way two months later. The second group received PPV vaccine at first and PCV13 two months later. Levels of serum antibody were checked and measured by enzyme-linked immunosorbent assay (ELISA) before vaccination, and then 8 weeks after the first injection and 2 months after the second injection in all patients. Each time 0.5-ml dose of the vaccine was injected.

Results: Of the 50 patients, three cases were excluded due to lack of cooperation and avoidance of vaccination. From 47 patient participants, 28 (59.6%) were males and 19 (40.4%) were females with age ranged between 20 to 44 years (average age of 29.6±1.4 years). Pneumococcal IgG levels in a group that used PCV before PPV (Group A) increased from 114.5±87.7 to 1049±720 U/ml (p=0.0001) and in another group that used PPV before PCV (Group B) increased from 115±182.2 to 1497.3±920.3 U/ml (P=0.0001).

Conclusion: It can be concluded that PCV vaccine before PPV can be more effective in asplenic thalassemia major patients as a booster dose.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5412244PMC
January 2017

Effectiveness of Vitamin D Supplement Therapy in Chronic Stable Schizophrenic Male Patients: A Randomized Controlled Trial.

Iran J Pharm Res 2016 ;15(4):941-950

Department of Pharmacotherapy, Faculty of Pharmacy and Psychiatry and Behavioral Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran.

In this study, the aim was to determine whether adding vitamin D to the standard therapeutic regimen of schizophrenic male patients with inadequate vitamin D status could improve some aspects of the symptom burden or not. This study was an open parallel label randomized clinical trial. Eighty patients with chronic stable schizophrenia with residual symptoms and Vitamin D deficiency were recruited randomly and then received either 600000 IU Vitamin D injection once along with their antipsychotic regimen or with their antipsychotic regimen only. Serum vitamin D was measured twice: first at the baseline and again on the fourth month. Positive and Negative Syndrome Scale (PANSS) was assessed at the baseline and on the fourth month. During the study, the vitamin D serum changes in vitamin group and control group were 22.1 ± 19.9(95%CI = 15.9-28.8) and 0.2 ± 1.7(95%CI = 0.2-0.8) (ng/mL) (p<0.001) respectively. The changes of PANSS positive subscale score (P) were -0.1±0.7 (95%CI =-0.3-0.1) and 0.00 ± 0.8 (95%CI = -0.2-0.2) in vitamin D and control group respectively (p=0.5). The changes of PANSS negative subscale score (N) were -0.1 ± 0.7 (95%CI = -0.3-0.05) and -0.1 ± 0.5 (95%CI = -0.2-0.04) in vitamin D and control group respectively (p = 0.7) and there was a negative but not significant correlation between serum vitamin D level changes and PANSS negative subscale score (r = -0.04, p = 0.7). We did not find a relationship between serum vitamin D level changes and the improvement of negative and positive symptoms in schizophrenic patients and more randomized clinical trials are required to confirm our findings.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5316275PMC
January 2016

Efficacy of 10% sucralfate ointment after anal fistulotomy: A prospective, double-blind, randomized, placebo-controlled trial.

Int J Surg 2016 Dec 17;36(Pt A):13-17. Epub 2016 Oct 17.

Department of Clinical Pharmacy, Nephrology and Kidney Transplant Research Center, Faculty of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran.

Introduction: The most frequent problems after anal fistulotomy are pain, bleeding, and delayed or impaired wound healing. Topical Sucralfate preparation has been used to treat a wide variety of wounds. In this study, we investigate effects of 10% sucralfate ointment on wound healing and postoperative pain after fistulotomy.

Methods And Materials: A total of 41 patients undergoing anorectal fistulotomy were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate ointment (every 12 h) or placebo. The patients were visited weekly for up to 5 weeks. The intensity of pain and the wound healing were assessed.

Results: The sucralfate group had significantly less pain at rest (1.92 ± 0.88 vs 2.96 ± 0.98; P = 0.002) and on defecation (1.68 ± 0.92 vs 3.08 ± 1.12; p < 0.001) than the placebo group from 1st to 5th post-operative visits. Complete wound healing was achieved after 8.15 ± 1 weeks in placebo group versus 5.9 ± 0.8 weeks in sucralfate group (p < 0.001). There were no significant differences in the frequencies of postoperative complications between the two groups.

Conclusion: Compared with placebo, sucralfate ointment reduced postoperative pain at rest and on defecation and improves wound healing in patients undergoing fistulotomy.
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http://dx.doi.org/10.1016/j.ijsu.2016.10.017DOI Listing
December 2016

Effects of cabergoline on blood glucose levels in type 2 diabetic patients: A double-blind controlled clinical trial.

Medicine (Baltimore) 2016 Oct;95(40):e4818

Diabetes Research Center Faculty of Medicine Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.

Background: Cabergoline is a long-acting agonist of dopamine, which has a high affinity to dopamine receptors (type 2). Treatment using a dopaminergic agonist reduces hypothalamic stimulation that increases during liver gluconeogenesis, lipids synthesis, and insulin resistance. Our aim was to evaluate the effects of cabergoline on blood glucose levels in patients with type 2 diabetes mellitus (DM).

Methods: This study was a double-blind, controlled clinical trial in patients with type 2 DM. The patients received treatments of a placebo (control group; n = 20) or cabergoline 0.5 mg (cabergoline group; n = 20) using the sequential method, once per week for 3 months, while using previously prescribed glucose-lowering drugs. All tests, such as levels of fasting blood glucose, 2-hour post-prandial glucose, complete lipid profile, prolactin, alanine amino transferase, aspartate amino transferase, creatinine, blood urea nitrogen, and serum insulin, and homeostasis model assessment insulin resistance were measured at baseline and at 3-month follow-up.

Results: The fasting blood sugar levels were significantly different between placebo and cabergoline groups after 3 months of treatment (P = 0.004). The prolactin levels were significantly different from beginning of the treatment to 6 months later (P = 0.001). In the cabergoline group, there was a significant decrease in glycosylated hemoglobin (HbA1C) levels after 3 months (P = 0.003). Overall, 65%and 45% patients in the cabergoline and control groups, respectively, responded to treatment (HbA1C<7%).

Conclusion: Cabergoline may be useful as a long-acting antidiabetic agent in patients with type 2 diabetes mellitus.
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http://dx.doi.org/10.1097/MD.0000000000004818DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5059036PMC
October 2016

Effects of Topical Atorvastatin (2 %) on Posthemorrhoidectomy Pain and Wound Healing: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

World J Surg 2017 02;41(2):596-602

Department of Clinical Pharmacy, Faculty of Pharmacy, Pharmaceutical Research Center, Mazandaran University of Medical Sciences, Sari, Mazandaran Province, Iran.

Background: Atorvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor widely used in treatment of hypercholesterolemia and prevention of coronary heart disease and has various pleiotropic effects. In this study, the efficacy of atorvastatin emulgel (2 %) in reducing postoperative pain at rest, pain during defecation and analgesic requirement after open hemorrhoidectomy was investigated.

Methods: A total of 66 patients with third- and fourth-degree hemorrhoids undergoing open hemorrhoidectomy were included in this prospective, double-blind, randomized controlled trial. The patients were randomly assigned to either atorvastatin emulgel or placebo immediately after surgery and then every 12 h for 14 days. The primary outcomes were intensity of pain at rest and during defecation, measured with a visual analog scale, and the analgesic requirement, measured by amount of pethidine and acetaminophen consumption, and percent of wound healing.

Results: There was no significant difference in the average postoperative pain scores in the first 48 h (P  = 1, P  = 0.128 and P  = 0.079) after the surgery between the two groups, but at the week 1 the pain scores during defecation were considerably lower in the atorvastatin group than in placebo group (P = 0.004), which also was the same at the week 2 (P = 0.03). There was no significant difference in the average pethidine and acetaminophen (mg) administration at 12 h and 24 h between the two groups after surgery. Regarding the data about wound healing, at the week two the healing was much better in the treatment group than it was in control group and the difference was statistically significant (P = 0.04).

Conclusions: Compared with placebo, atorvastatin emulgel reduced postoperative pain at rest and on defecation and could improve the healing process after open hemorrhoidectomy.

Trial Registration Number: IRCT201404013014N8.
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http://dx.doi.org/10.1007/s00268-016-3749-xDOI Listing
February 2017

Comparison of Dabigatran vs. Warfarin in Acute Vnous Thromboemboly: Systematic Review.

Iran J Pharm Res 2016 ;15(2):611-7

Department of Clinical Pharmacy, Faculty of Pharmacy, Thalassemia Research Center, Mazandaran University of Medical Sciences, Sari, Iran.

Acute Venous Thromboembolism (VTE) is a common disease associated with the significant morbidity and mortality. We reviewed clinical outcomes systematically with Dabigatran as a direct oral anticoagulants (DOAC) for treatment of acute VTE. We used Ovide, PubMed, Cochrane (CENTRAL), EMBASE, Scopus, Science Direct, LILAC(for article written not English) and also Iranian database; Magiran, Isc, Iran Medex, Iran DOC, Doaj up to May 2014 to identify randomized clinical trials of Dabigatran compared with conventional treatment for VTE. Two investigators extracted data independently. Number of 5107 patients including two trails were selected. The risk of recurrent VTE was similar with the Dabigatran and standard treatment (Hazard Ratio, 95% confidence interval 1.09 (0.76-1.57). Dabigatran reduced the risk of minor bleeding in comparison with standard treatment; Warfarin (0.62) (0.50-0.76). Finally-in minor bleeding-the Dabigatran seemed as effective as, and probably safer than standard treatment of acute VTE. But in some aspects such as adherence to treatment, pregnant patient, impact on quality of life, new researches are needed to be clarified.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5018290PMC
September 2016

Negative Correlation between Serum S100B and Leptin Levels in Schizophrenic Patients During Treatment with Clozapine and Risperidone: Preliminary Evidence.

Iran J Pharm Res 2016 ;15(1):323-30

Department of Pharmacotherapy, Faculty of Pharmacy, Mazandaran University Medical Sciences, Sari, Mazandaran, Iran.

Recently, extensive efforts have been made to understand the rate of energy expenditure and the weight gain associated with atypical antipsychotic treatment, including identification of markers of obesity risk. In recent years, leptin, an adipocyte hormone, has gained significant interest in psychiatric disorders. S100B has been considered as a surrogate marker for astrocyte-specific damage in neurologic disorders. Also, S100B has been detected in adipose with concentration as high as nervous tissue as a second release source. In this study we evaluated the relationship between S100B and leptin in schizophrenic patients under treatment with clozapine and risperidone.This study included 19 patients meeting the DSM-IV-TR criteria for schizophrenia, having body mass index (BMI) of 16- 25 kg/m(2) and suffering schizophrenia for more than 3 years and from this study. Twenty five healthy controls were group matched for age and gender whose BMI was 16-25 kg/m(2). Serum S100B and leptin levels and positive and negative symptom scale (PANSS) were assessed at admission and after six weeks. During the study, S100B showed a strong and negative correlation with leptin (r = -0.5, P = 0.01). Also, there were negative correlation between serum S100B level and PANSS negative subscale after 6 weeks of treatment (r = -0.048, P = 0.8). Positive correlation between leptin level and PANSS suggested a potential role for leptin which can mediate the link between antipsychotic induced weight gain and therapeutic response in schizophrenia.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4986131PMC
September 2016

Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial.

Nutr Cancer 2016 23;68(3):456-63. Epub 2016 Mar 23.

a Department of Clinical Pharmacy , Faculty of Pharmacy, Mazandaran University of Medical Sciences , Sari , Mazandaran Province , Iran.

Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapy-induced stomatitis and mucositis in a number of studies, but the results are contradictory. To answer such discrepancies, the present study was designed to evaluate the efficacy of sucralfate mouthwash in prevention of 5-fluorouracil (5-FU)-induced oral mucositis in patients with gastrointestinal malignancies. Patients with gastrointestinal cancers receiving 5-FU-based chemotherapy regimens were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate mouthwash (every 6 h) or placebo. The patients were visited at fifth and tenth day of trial; the presence and severity of oral mucositis and the intensity of pain were assessed. The patients receiving sucralfate experienced lower frequency and severity of mucositis (76% vs. 38.5%, P = 0.005 and 84 vs. 38.5%, P < 0.001, respectively) and less intense pain (2.5 ± 2.2 vs. 5.08 ± 3.82, P = 0.004 and 1.33 ± 0.86 vs. 4.12 ± 3.5, P = 0.001, respectively) compared with the placebo group both at day 5 and day 10. Within the sucralfate group, a decrease in frequency and severity of mucositis was observed throughout the trial period, while in the placebo group no such effect was observed. Sucralfate mouthwash reduced the frequency and severity of 5-FU-induced oral mucositis in patients with gastrointestinal malignancies compared with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis.
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http://dx.doi.org/10.1080/01635581.2016.1153666DOI Listing
January 2017

Role of C-reactive Protein and Tumor Necrosis Factor-Alpha in Differentiating between Ventilator-Associated Pneumonia and Systemic Inflammatory Response Syndrome without Infectious Etiology.

Tanaffos 2016 ;15(4):205-212

Centre for Heart Lung Innovation, University of British Columbia, Vancouver, BC, Canada.

Background: Differential diagnosis of systemic inflammatory response syndrome (SIRS) with or without infectious cause is critically important in terms of initiating antimicrobial agents in case of infectious etiology such as ventilator-associated pneumonia (VAP). The aim of this study was to determine the diagnostic and prognostic roles of C-reactive protein (CRP) and tumor necrosis factor-alpha (TNF-α) in differentiating between ventilator-associated pneumonia and SIRS without infectious etiology.

Materials And Methods: In this prospective observational study, 91 adult intensive care unit (ICU) patients were enrolled. According to established diagnostic criteria, they were classified into three groups of "non-SIRS non-VAP", "SIRS non-VAP" and "SIRS-VAP". Serum CRP and TNF-α were measured on days 1, 3 and 7 of the study and compared using repeated measures ANOVA.

Results: With respect to diagnosis, there was no significant difference in the values of these biomarkers between groups (P>0.05). There was no statistically significant "time trend" for C-reactive protein and TNF-α (P>0.05). Considering both group effect and Time effect, the changes were not significantly different for CRP (P= 0.86) and TNF-α (P=0.69). In contrast, the clinical score and the clinical pulmonary infection score (CPIS) ≥ 6, had 100% specificity for diagnosing VAP. With respect to prognosis, only an unchanged or decreasing TNF-α from day 1 to day 3 was marginally associated with 28-day survival. However, day 1 and day 3 acute physiology and chronic health evaluation II (APACHE II) scores were highly associated with 28-day survival.

Conclusion: Unlike clinical scoring system including CPIS and APACHE II, TNF-α and CRP levels were not useful as diagnostic or prognostic biomarkers for differentiating between SIRS with VAP etiology and SIRS without infectious etiology.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5410116PMC
January 2016

Dose administration time from before breakfast to before dinner affect thyroid hormone levels?

Caspian J Intern Med 2015 ;6(3):134-40

Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. ; Student Research Committee, Mazandaran University of Medical Sciences, Sari, Iran.

Background: Levothyroxine is commonly used in the treatment of patients with hypothyroidism. Levothyroxine is often administered in the morning, on an empty stomach, to increase its absorption. However, many patients have trouble for taking levothyroxine in the morning. The aim of this study was to evaluate the effect of changing administration time of levothyroxine from before breakfast to before dinner on serum levels of TSH and T4.

Methods: Fifty hypothyroidism patients aged 18-75 years old were included in the study and randomly divided into two groups. Each group received two tablets per day blindly (one levothyroxine tablet and one placebo tablet) before breakfast and before dinner. After two months, the administration time for the tablets was changed for each group, and the new schedule was continued for a further two-month period. The serum TSH and T4 levels were measured before and after treatment in each group.

Results: Changing the levothyroxine administration time, resulted in 1.47±0.51 µIU/mL increase in TSH level (P=0.001) and 0.35±1.05µg/dL decrease in T4 level (P=0.3).

Conclusion: Changing the levothyroxine administration time from before breakfast to before dinner minimally reduced the therapeutic efficacy of levothyroxine.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4650787PMC
December 2015

A triple-blinded, randomized, placebo-controlled trial to examine the efficacy of buspirone added to typical antipsychotic drugs in patients with chronic schizophrenia.

J Res Med Sci 2015 Feb;20(2):140-5

Associated Professor of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.

Background: The purpose of this study was to test the hypothesis that the addition of buspirone, a partial agonist of 5HT1A receptor, to ongoing treatment with typical antipsychotics would improve the positive and negative symptoms in patients with chronic schizophrenia.

Materials And Methods: In this study, 50 patients including 40 male and 10 female were recruited with chronic schizophrenia who were inpatients at psychiatric teaching hospital or asylums, aged between 18 and 65 years (mean age = 47 ± 10.02). All patients were on the stable dose of typical antipsychotics for at least 1-month, and their acute symptoms were controlled. Patients were allocated in a random fashion: 25 patients to buspirone at 30 mg/day plus typical antipsychotic and 25 patients to placebo plus typical antipsychotic. The positive and negative syndrome scale (PANSS), Simpson-Angus extrapyramidal rating scale (SAS) and mini mental state examination (MMSE), were administered at baseline, and 2, 4, and 6 weeks after the addition of buspirone.

Results: The 30 mg/day buspirone was well-tolerated, and no clinically important adverse effects were seen. There was no statistically significant difference between the two groups in MMSE and SAS scales. There was a significant reduction in subscales of negative, general, positive, and total of PANSS over the 6-week trial in buspirone group. There was a statistically significant difference between the two groups negative subscale (mean ± standard deviation [SD] = 14.08 ± 1.4 in buspirone group) P = 0.0219, general subscale (mean ± SD = 27.42 ± 2.1 in buspirone group) P = 0.0004, and total subscale (mean ± SD = 55.63 ± 3.9 in buspirone group) P = 0.0298, of PANSS in the 6-week of trial.

Conclusion: The results suggest that adjunctive treatment with 5HT1A agonist such as buspirone may improve the negative symptoms of schizophrenia. Further studies are indicated to determine the efficacy of 5HT1A agonist treatment in chronic schizophrenia.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4400707PMC
February 2015