Evaluating the effects of duloxetine on prophylaxis of oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer: A randomized double-blind placebo controlled clinical trial.

BACKGROUND: Oxaliplatin is a key drug in treatment of gastrointestinal (GI) cancer. Peripheral neuropathy (PN) is a troublesome and dose-dependent adverse effect of oxaliplatin. It can occur in two distinct forms: acute and chronic. Its incidence is estimated about 65-98%, of which 22% of cases need to stop chemotherapy. In some cases, PN has a long-lasting effect on patient's quality of life (QOL). Therefore, this study was done to evaluate efficacy of duloxetine on prevention of oxaliplatin- induced peripheral neuropathy (OIPN) in patients with GI cancer. METHODOLOGY: In this randomized and double -blind clinical trial study conducted in a tertiary teaching hospital, eligible patients were divided into two groups. Treatment group received duloxetine the day before initiation of chemotherapy regimen at a dose of 30 mg/day for one week and then, the dose was titrated up to 60 mg/day until 12 weeks. For placebo group, one placebo capsule was prescribed daily for one week followed by 2 capsules daily until 12 weeks. In each of chemotherapy courses, PN was assessed using national cancer institute-common terminology criteria for adverse effects (NCI-CTCAE v4.03). Also, chemotherapy -related QOL at the baseline and 12 weeks was assessed by functional assessment of cancer treatment gynecologic oncology group - neurotoxicity (FACT/GOG-NTX). RESULTS: Forty patients were randomly assigned to treatment and placebo groups which were similar to each other in terms of chemotherapy regimen, type, and stage of cancer. Analysis of results obtained from the NCI-CTCAE (v4.03) showed that duloxetine could prevent worsening of paresthesia more than placebo (P = 0.025) and patients in duloxetine group experienced less peripheral sensory neuropathy (P = 0.001) than placebo group. Analysis of results obtained from the FACT/GOG-NTX demonstrated a significant worsening of tingling and discomfort in hands (P = 0.002, 0.001, respectively) and feet (P = 0.017, 0.019, respectively) in placebo group compared to duloxetine group. Also, patients experienced more cold temperature -induced pain in extremities (P = 0.001) in placebo group compared to duloxetine group. On the other hand, duloxetine could not improve QOL (P = 0.06) and had not significant effects on trouble feeling the shape of small objects in hand (P = 0.420) or trouble buttoning buttons (P = 0.086). The P-value < 0.05 was considered to be statistically significant.

Promising clinical outcomes of nano-curcumin treatment as an adjunct therapy in hospitalized COVID-19 patients: A randomized, double-blinded, placebo-controlled trial.

Different immunomodulation strategies have been used to manage COVID-19 due to the complex immune-inflammatory processes involved in the pathogenesis of this infection. Curcumin with its powerful anti-inflammatory and antiviral properties could serve as a possible COVID-19 therapy. In this study, a randomized, double-blinded, placebo-controlled trial was performed to investigate the effectiveness and safety of nano-curcumin oral soft gels as a complementary therapy in moderate-severe COVID-19 patients. Hydroxychloroquine (HCQ) plus sofosbuvir was routinely administered to all 42 COVID-19 patients, who were randomly assigned to receive 140 mg of nano-curcumin or placebo for 14 days. CT scans of the chest were taken, and blood tests were run for all patients at time points of 0, 7, and 14 days. Our results indicated that C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) levels significantly decreased from baseline in the nano-curcumin-treated group on day 7. Furthermore, blood levels of D-dimer, CRP, serum ferritin, ESR, and inflammatory cytokines including IL-6, IL-8, and IL-10 decreased more significantly in the nano-curcumin-treated group after 14 days. Additionally, the nano-curcumin group showed significant improvements in chest CT scores, oxygen saturation levels, and hospitalization duration. Based on our data, oral administration of nano-curcumin may be regarded as a promising adjunct treatment for COVID-19 patients due to its ability to speed up chest clearance and recovery.

Azithromycin oral suspension in prevention and management of oral mucositis in patients undergoing hematopoietic stem cell transplantation: a randomized controlled trial.

OBJECTIVES: This study aimed to investigate the effects of azithromycin suspension on oral mucositis in patients undergoing hematopoietic stem cell transplantation (HSCT). METHODS AND MATERIAL: The study was designed as a single-blind randomized controlled trial in Taleghani medical center affiliated to Shahid Beheshti University of Medical Sciences Tehran Iran. Patients undergoing HSCT were randomly assigned to intervention or control groups. Azithromycin suspension was administered twice daily by gargling for 30 s and swallowing, on the first day of chemotherapy for patients in the intervention group. Graded oral mucositis (OM) occurrence based on National Cancer Institute Common Toxicity Criteria (NCI-CTC) scale (grade 0 to 5) was considered the main outcome, and the Numerical Rating Scale (NRS:0-10) measured the severity of OM symptoms. RESULTS: In a duration of 15 months, 88 patients were randomly assigned and finally 70 patients were evaluable for study outcomes (randomized 1:1 to azithromycin versus no-azithromycin). The incidence and duration of the mucositis significantly improved in the intervention group compared to the control. Azithromycin use was consistent with a lower rate of dryness (P < 0.001), dysphagia (P < 0.001), and loss of sense of taste (P < 0.001). Also, in the intervention group, lower intensity of pain due to mucositis (P = 0.01) and lower duration of mucositis were observed (p = 0.045). No significant adverse drug reaction was observed in patients receiving azithromycin. CONCLUSION: Based on the result from this study, azithromycin suspension is an effective option in the prevention and treatment of chemotherapy-induced OM. Further study is needed to assess the effect of azithromycin and comparison with other therapeutic options. TRIAL REGISTRATION: Iranian Registry of Clinical Trials: IRCT201603093210N13.

The effects of vitamin E on colistin-induced nephrotoxicity in treatment of drug-resistant gram-negative bacterial infections: A randomized clinical trial.

INTRODUCTION: Nephrotoxicity remains a major long-standing concern for colistin, and it is critical to find agents that can prevent it. The present study aims to investigate the effect of vitamin E on the prevention of colistin-induced nephrotoxicity based on its antioxidant and free radical scavenging properties. METHODS: A randomized clinical trial was designed for 52 patients taking colistin. These patients were categorized into two groups of equal size, receiving colistin or colistin plus vitamin E (α-Tocopherol). Vitamin E with doses of 400 units was administrated daily either orally or by a nasogastric tube if needed. The incidence of Acute Kidney Injury (AKI) and its duration was recorded based on RIFLE criteria. RESULTS: The Incidence of AKI based on RIFLE criteria was 42.3% and 46.2% in intervention and control groups, respectively. The analysis showed no significant difference in the prevalence of AKI for the two groups (P = 0.78). There was no significant difference in the duration of AKI neither (P = 0.83). CONCLUSION: Although vitamin E is a powerful biological antioxidant, the effects of Vitamin E prophylaxis on colistin-induced nephrotoxicity was not taken into consideration in this study.

Efficacy and Safety of a DOAC Compared to Unfractionated Heparin and A Low Molecular Weight Heparin in the Prevention of Thromboembolism in Hematopoietic Stem Cell Transplant Recipients.

Background: Hematopoietic stem cell transplantation (HSCT) patients are at risk of thromboembolic events, making thromboprophylaxis crucial. Objectives: This study aimed to compare apixaban, a direct factor Xa inhibitor (DOAC), with dalteparin and unfractionated heparin for thromboprophylaxis in HSCT recipients. The safety outcome included the assessment of hemorrhagic events. Methods: In this open-label randomized clinical trial, 182 HSCT recipients were divided into three groups: Apixaban (n = 61, 2.5 mg two times a day), dalteparin (n = 59, 5000 IU daily), and unfractionated heparin (n = 62, 5000 IU twice daily). These anticoagulant regimens were administered after central vein catheterization and during hospitalization. The primary clinical outcome was the risk of thrombosis, and the secondary outcome was the rate of bleeding. Relevant laboratory results were analyzed using appropriate statistical tests. Results: Among the 61 patients in the apixaban group, six experienced thrombosis (9.83%), with four (6.65%) of them on anticoagulants. In the dalteparin group, three patients (5%) developed thrombosis, two of whom (3.38%) were on anticoagulants. In the heparin group, all four thrombosis cases (6.4%) occurred in patients on anticoagulants (P = 0.543 overall and P = 0.776 in anticoagulant users). Only two cases of bleeding were reported (1.09% overall), one in the dalteparin group (1.69%) and the other in the apixaban group (1.63%). Conclusions: Apixaban, dalteparin, and heparin demonstrated similar effectiveness in preventing thromboembolism in HSCT recipients. Furthermore, the comparison of bleeding rates across the study groups did not reveal significant differences. Larger studies with higher event rates may yield more precise conclusions.

Comparison between cytisine and Nicotine Replacement Therapy in smoking cessation among inpatient psychiatric patients.

Introduction: Smoking is more common among people with mental disorders and is associated with adverse effects. Some compounds, including nicotine and cytisine, have been used in many individuals to increase success in smoking cessation. In this study, the effect of cytisine on the smoking status of patients hospitalized in the psychiatry department was investigated.Method: Forty-seven patients, hospitalized in the psychiatry ward, motivated to quit smoking, participated in this open-label randomized trial. Thirty patients used nicotine gums 2 mg (Nicolife®) for eight weeks, and the remaining took cytisine pills (Tabex®) according to the manufacturer's instructions for 25 days. All patients were followed up for six months. The primary outcome was smoking cessation, measured by the mood and physical symptoms scale (MPSS), the AUDIT alcohol consumption questions (AUDIT-C), confirmatory factor analyses, and reliability of the modified cigarette evaluation questionnaire at the end of the 1st week and at 1st, 2nd and 6th months after quit day.Findings: Only two out of 30 patients (6.66%) in the group taking Nicotine Replacement Therapy (NRT) could quit smoking entirely (no cigarettes after six months). In contrast, three out of 17 patients (17.64%) managed to do so in the cytisine group. The number of cigarettes smoked by the patients in both groups decreased, but the reduction was significant in the cytisine group.Conclusion: Cytisine is an effective and suitable agent for smoking cessation in patients with psychological problems, with fewer adverse effects and more success rate compared to NRT.

Hepatotoxicity Induced by Azole Antifungal Agents: A Review Study.

Context: Fungal infections are very common, and several medications are used to treat them. Azoles are prescribed widely to treat fungal infections. In addition to therapeutic effects, any drug can be accompanied by side effects in patients. One of the most important complications in this regard is liver injury. Therefore, hepatotoxicity induced by azole antifungal drugs were reviewed in this study. Evidence Acquisition: English scientific papers were evaluated to review the effects of hepatotoxicity by azole antifungal agents, and the related studies' results were summarized using a table. The systematic search was implemented on electronic databases, including PubMed, Google Scholar, and Science Direct. Original articles and review articles that were published before April 1, 2022, were included in the study. Those articles without available full text or non-English articles were excluded. Also, articles that reported pediatric data were excluded. Results: Most studies have reported the effects of hepatotoxicity by azole antifungal agents, and their mechanisms have been described. Conclusions: Clinical evaluations regarding the hepatotoxicity of antifungal agents provided in the literature were reviewed. Therefore, it is recommended to prescribe these drugs with caution in high-risk patients suffering from liver diseases, and patients should be monitored for hepatotoxicity. However, more research is needed to evaluate the hepatotoxicity of azole antifungal agents and select appropriate drugs according to cost-effectiveness and the side effects' profiles, relying on lower incidence of this liver complication.

Assessment of Effectiveness and Adverse Effect of New Combination Chemotherapy (irinotecan, cisplatin, and dexamethasone) in Relapse and Refractory Hodgkin Lymphoma.

Background: Chemotherapy with Adriamycin, Bleomycin, Vinblastine, and Dacarbazine (ABVD regimen) cannot cure all patients with Hodgkin lymphoma. In this study, we evaluated the efficacy and adverse effect of a new regimen consist Irinotecan, Cisplatin, and Dexamethasone (ICD) in relapsed and refractory Hodgkin lymphoma as the second to fifth line of treatment. Materials and Methods: We performed a retrospective study in 26 relapsed or refractory patients with Hodgkin lymphoma receiving at least the first-line chemotherapy regimen (ABVD) and (ICD) as salvage therapy in Thaleghany Hospital from 2012 to 2018. This regimen consisted of Irinotecan 65mg/m2 D1, D8, Cisplatin 30mg/m2 D1, D8, and dexamethasone 40mg D1, 2, 8, and 9 was administered every 3 weeks for 6 cycles.  Treatment was discontinued in cases of disease progression or severe toxicity. Response to treatment was evaluated after two cycles. Patients with complete and partial remission were candidates for high-dose chemotherapy and autologous stem cell transplantation. Twenty-four patients were enrolled in the study. The mean age of 22 patients was 31.5 (19-67) years. Seven patients (29.1%) were in the first recurrence, and 17 (70.8%) were in the second or subsequent recurrence. Results: According to this study, three patients (12.5%) had complete response, 13 (45%) had partial response, four (16.6%) had stable disease, and four (16.6%) had progressive disease. Nine patients (37.5%) received high-dose chemotherapy and autologous stem cell support after ICD regimen. None of the cycles of chemotherapy were delayed due to treatment-related adverse event. Overall survival after six months in all patients was 91%, and mortality rate was 8.3% at the end of the study. Conclusion: The goal of salvage chemotherapy in relapsed or refractory Hodgkin Lymphoma is achieving CR or PR preparation patients for stabilization with BMT. Thus, we recommend ICD as one of the most effective protocols with overall response rate of 66% in this population.

The Evaluation of Melatonin Effects on Mobilization and Engraftment in Autologous Hematopoietic Stem Cell Transplant Recipients; A Randomized, Double-blind and Placebo-controlled Trial.

Mobilization and engraftment of Hematopoietic Stem Cells (HSCs) are challenging issues in Autologous HSC transplantation (AHSCT) so several attempts such as colony-stimulating factors (CSF) and plerixafor have been used for enhancement of HSCs mobilization and engraftment. In this randomized, double-blind and placebo-controlled study, we evaluated the melatonin's efficacy and safety, as endogenous CSF inducer, co-administered with Filgrastim in mobilizing and engraftment of HSC. AHSCT patients were randomized to receive either Melatonin or placebo plus filgrastim. Of Fifty-one patients, 26 patients received the melatonin (In mobilization phase 3 mg sublingual twice daily, then 9 mg single dose 30 min before apheresis session and then 3 mg twice daily from +1 until engraftment) and 25 patients received the placebo. The mean number of CD34 cells/kg × 106 in the melatonin group was 6.54 versus 4.22 in the placebo group (p = 0.025). The mean day to neutrophil engraftment in the melatonin group was 11.69 ± 2.093, whereas 12.68 ± 2.42 days in the placebo group (p = 0.021). In this study, the second apheresis session requirement, the use of plerixafor and hospital stay duration, were comparable between the two groups. Considering the result of the study, it could be suggested that melatonin plus Filgrastim can be effectively used in AHSCT patients to enhance the number of peripheral CD34 cells/kg × 106 and decrease the day number of neutrophil engraftment.

The Effects of Melatonin on the Oxidative Stress and Duration of Atrial Fibrillation after Coronary Artery Bypass Graft Surgery: A Randomized Controlled Trial.

BACKGROUND: Atrial Fibrillation (AF) is a common complication following Coronary artery bypass graft (CABG) Surgery, which may be due to oxidative stress, necrosis and inflammation during CABG and can lead to increases the length of hospital stay and the risk of morbidity and mortality. Melatonin is a hormone with anti-oxidant and anti-inflammatory properties in the cardiovascular system. This study assessed the efficacy of sublingual consumption of melatonin in reducing necrosis and inflammation, in patients undergoing CABG with respect to C-reactive protein (hs-CRP), Creatine Kinase-Muscle-Brain subunits (CK-MB) and cardiac Troponin T (cTnT) levels. METHODS: One hundred and two patients were enrolled and twenty-six patients were excluded during the study process and finally seventy-six patients undergoing CABG surgery randomly assigned to melatonin group (n = 38, 12 mg sublingual melatonin the evening before and 1 hour before surgery, or the control group which did not receive Melatonin, n = 38). Three patients in the melatonin group and three patients in the control group were excluded from the study because of discontinued intervention and lost to follow up. The samples were collected before and 24 hours after surgery. hs-CRP, CK-MB, and cTnT levels were measured in all patients with the Elisa method. RESULTS: There was no significant difference in influencing variables among the groups at the baseline. The incidence of AF following CABG surgery was not statistically significant between the two groups, (p-value = 0.71). However, the duration of AF (p-value = 0.01), the levels of hs-CRP (p-value = 0.001) and CK-MB (p-value = 0.004) measured, 24 hours after surgery were significantly lower in the melatonin group. cTnT levels measured 24 hours post-CABG did not show any significant difference in both groups (p-value = 0.52). CONCLUSION: Our findings suggest that the administration of melatonin may help modulate oxidative stress, based on the reduction of the levels of hs-CRP, CK-MB, and the duration of AF following CABG surgery.

An Intelligent Clinical Decision Support System for Predicting Acute Graft-versus-host Disease (aGvHD) following Allogeneic Hematopoietic Stem Cell Transplantation.

BACKGROUND: Acute graft-versus-host disease (aGvHD) is a complex and often multisystem disease that causes morbidity and mortality in 35% of patients receiving allogeneic hematopoietic stem cell transplantation (AHSCT). OBJECTIVE: This study aimed to implement a Clinical Decision Support System (CDSS) for predicting aGvHD following AHSCT on the transplantation day. MATERIAL AND METHODS: In this developmental study, the data of 182 patients with 31 attributes, which referred to Taleghani Hospital Tehran, Iran during 2009-2017, were analyzed by machine learning (ML) algorithms which included XGBClassifier, HistGradientBoostingClassifier, AdaBoostClassifier, and RandomForestClassifier. The criteria measurement used to evaluate these algorithms included accuracy, sensitivity, and specificity. Using the machine learning developed model, a CDSS was implemented. The performance of the CDSS was evaluated by Cohen's Kappa coefficient. RESULTS: Of the 31 included variables, albumin, uric acid, C-reactive protein, donor age, platelet, lactate Dehydrogenase, and Hemoglobin were identified as the most important predictors. The two algorithms XGBClassifier and HistGradientBoostingClassifier with an average accuracy of 90.70%, sensitivity of 92.5%, and specificity of 89.13% were selected as the most appropriate ML models for predicting aGvHD. The agreement between CDSS prediction and patient outcome was 92%. CONCLUSION: ML methods can reliably predict the likelihood of aGvHD at the time of transplantation. These methods can help us to limit the number of risk factors to those that have significant effects on the outcome. However, their performance is heavily dependent on selecting the appropriate methods and algorithms. The next generations of CDSS may use more and more machine learning approaches.

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

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% vs. 67.9%; p = 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.

Evaluation of Cyclosporine Pharmacokinetic, Monitoring, and Dosing Parameters for GVHD Prophylaxis in Hematopoietic Stem Cell Transplant (HSCT) Recipients.

Allogeneic hematopoietic stem cell transplantation (AHSCT) is a major method of treatment for different hematologic and congenital disease. Graft versus host disease (GvHD) is a life-threatening adverse effect of AHSCT. Cyclosporine is the most important and common agent for GvHD prophylaxis. Because of variable and unpredictable pharmacokinetics of cyclosporine that produces different responses in each patients group and clinical setting, there are still lots of uncertainties about its optimal method of administration and monitoring of this drug. Frequent blood samples in eight different times were taken for cyclosporine quantification in twenty AHSCT recipients and pharmacokinetic parameters determined in both intravenous (IV) and oral administration and monitoring parameters assessed accordingly. Of pharmacokinetic parameters mean ± SD area under concentration - time curve (AUC), clearance, and half-life were estimated to be 5492 ± 1596 ng.h/mL, 19.44 ± 6.61 L/h, and 11.8 ± 5.4 h for IV and 7637.7 ± 2739.8 ng.h/mL, 19.42 ± 6.62 L/h, and 11.16 ± 5.9 h for oral administration, respectively. Appropriate oral to intravenous dosing ratio found to be about 1.6. Of monitoring parameters, C0.5 h and C6 showed the highest coefficient of determination for regression between single points and total area under curve. Evaluation of pharmacokinetic parameters derived from concentration versus time curve showed that the appropriate oral/IV is 1.6 for maintenance GvHD prophylaxis for outpatients could be helpful. Cyclosporine plasma concentration at 0.5 and 6 h after IV administration showed the highest correlation with AUC of this drug.

Analysis of apoptosis related genes in nurses exposed to anti-neoplastic drugs.

BACKGROUND: Anti-neoplastic agents are widely used in the treatment of cancer and some non-neoplastic diseases. These drugs have been proved to be carcinogens, teratogens, and mutagens. Concern exists regarding the possible dangers of the staff handling anti-cancer drugs. The long-term exposure of nurses to anti-neoplastic drugs is still a controversial issue. The purpose of this study was to monitor cellular toxicity parameters and gene expression in nurses who work in chemotherapy wards and compare them to nurses who work in other wards. METHODS: To analyze the apoptosis-related genes overexpression and cytotoxicity effects, peripheral blood lymphocytes obtained from oncology nurses and the control group. THE RESULTS: Significant alterations in four analyzed apoptosis-related genes were observed in oncology nurses. In most individual samples being excavated, Bcl-2 overexpression is superior to that of Bax. Prominent P53 and Hif-1α up-regulation were observed in oncology nurses. Moreover, all cytotoxicity parameters (cell viability, ROS formation, MMP collapse, Lysosomal membrane damage, Lipid peroxidation, Caspase 3 activity and Apoptosis phenotype) in exposed oncology nurses were significantly (p < 0.001) higher than those of unexposed control nurses. Up-regulation of three analyzed apoptosis-related genes were observed in nurses occupationally exposed to anti-cancer drugs. CONCLUSION: Our data show that oxidative stress and mitochondrial toxicity induced by anti-neoplastic drugs lead to overexpression of apoptosis-related genes in oncology nurses.

Cytarabine and Doxorubicin-Induced Palmoplantar Erythrodysesthesia Syndrome: The Possible Role of Voriconazole Interaction.

Palmoplantar Erythrodysesthesia Syndrome (PPES) caused by chemotherapeutic agents is rarely life threatening and requires a reduction in dose or discontinuation of chemotherapy. The use of cytarabine and doxorubicin in the treatment of acute myeloid leukemia (AML) along with voriconazole can potentially alter the metabolism of the drugs and cause some interactions. In this study, we presented a case of AML who received cytarabine and doxorubicin as a chemotherapy regimen and voriconazole as a prophylactic anti-fungal. In this combination, voriconazole probably inhibits the P-glycoprotein pump, which leads to an increase in the cytarabine concentration. The emphasis of this report is the awareness of clinicians and pharmacotherapists about these interactions.

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

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 (p = 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 (p < 0.001). Further multicenter studies are recommended to confirm conclusively our findings.

Correction to: Effect of sertraline on complications and survival after hematopoietic stem-cell transplantation, a double-blind, placebo-controlled clinical study.

The correct name of the corresponding author should be ''Maryam Mehrpooya'', and not ''Mehrpooya Maryam'' as given in the original publication of the article.

Study of the Effect of Memantine on Negative Sign in Patients with Schizophrenia and Schizoaffective Disorders.

Memantine, an uncompetitive antagonist of glutamate receptor of the N-methyl-D-aspartate type is approved for the treatment of moderate to severe Alzheimer disease (1). A growing body of evidence supports a link between the glutamatergic neurotransmission and schizophrenia (2). The aim of this study was to examine the efficacy and safety of memantine as an adjunctive treatment for antipsychotics in patient with psychopathology of schizophrenia and schizoaffective. In this study, we assessed the effect of memantine on the pro-inflammatory cytokines such as IL6, TNFα and CRP. In this double-blind, placebo-controlled study, participants were assigned to receive (5-20 mg/day) memantine (n = 29) or placebo (n = 29), in addition to continuing treatment with antipsychotic for 12 weeks. The primary efficacy measure was the level of pro-inflammatory cytokines (TNFA, IL6, CRP). Safety was assessed by means of physical examination, clinical laboratory evaluation, recording of adverse event (AEs), and measure of extrapyramidal symptoms. At end point, comparison of biomarkers (IL6, TNFα and CRP) in two groups before and after treatment showed a significant decrease of TNFα (P < 0.001), but the difference was not significant in CRP and IL6 level (p = 0.92 and p = 0.77, respectively). The frequency of serious AEs in the memantine vs. placebo group was similar.

Exposure to Antineoplastic Agents Induces Cytotoxicity in Nurse Lymphocytes: Role of Mitochondrial Damage and Oxidative Stress.

Cytotoxicity and mitochondrial parameters were studied in isolated lymphocytes and their mitochondria obtained from occupationally exposed nurses through inhalation exposure to antineoplastic drugs and results were compared to those of unexposed nurses. The group of occupationally exposed nurses consisted of 50 individuals ranging in age from 30 to 35 years. The control group included 50 nurses who were not occupationally exposed to the preparation and handling of antineoplastic drugs and their anthropometric and biochemical characteristics were similar to those of the expose group. All cytotoxicity and mitochondrial parameters evaluated in exposed group were significantly increased (P < 0.05) compared to the unexposed control group. Finally, the results of our study suggest that using antioxidant, mitochondrial and lysosomal protective agents can be promising drug candidates for the hospital staff in the risk of exposure to exposure to antineoplastic drugs.

Effect of sertraline on complications and survival after hematopoietic stem-cell transplantation, a double-blind, placebo-controlled clinical study.

Previous studies have found a connection between psychiatric problems and post-hematopoietic stem-cell transplantation (HSCT) complications. We sought to evaluate the effect of sertraline on engraftment time, hospitalization period, mortality, and post-transplantation complications in HSCT recipients with depression and/or anxiety. We recruited adults aged 18-60, who were candidates for autologous or allogeneic HSCT with major depression and/or anxiety disorder. They were administered 50 mg of sertraline or placebo daily for the first week, and then 100 mg for the following seven weeks. We documented occurrence and severity of early post-HSCT complications, including infection, mucositis, nausea and vomiting, diarrhea, pain, renal toxicities and liver complications, acute graft-versus-host disease, and veno-occlusive disease, as well as time to engraftment, length of hospitalization and 6-month mortality. Overall, 56 patients participated in the study (sertraline group n = 30, placebo group n = 26). Of the complications, only mortality and readmission up to 6 months post-transplantation were significantly higher in the placebo group compared to sertraline group (P values = 0.040, 0.028, respectively). There were no significant differences for other complications between the groups. Mean engraftment time was significantly lower in the sertraline group (P value = 0.048). This study provides evidence that sertraline positively influences engraftment time, readmission, and mortality after HSCT.