Inflammatory Potential of Diet and Odds of Lung Cancer: A Case-Control Study.

Lung cancer is one of the common types of malignant disorders and the most prevalent cause of cancer mortality worldwide. Few studies have examined the association of dietary inflammatory index (DII) with lung cancer and findings from these studies are conflicting. Moreover, no study has examined this association in the Middle East. Therefore, the current case-control study was conducted to examine the association between DII and lung cancer among Iranian adults. We recruited 140 pathologically confirmed cases of lung cancer and 140 healthy controls who were matched with cases in terms of age. Dietary intakes were assessed using a 142-item Willett-format dish-based semi-quantitative food frequency questionnaire. DII scores were calculated using the method developed by Shivappa et al. Overall, we found a significant positive association between DII and lung cancer so that after controlling for potential confounders, individuals in the highest tertile of DII scores had 2.03 times more odds of lung cancer compared to those in the lowest tertile (OR: 2.01; 95% CI: 1.02-4.01). This significant positive association was also seen in men, but not in women. In conclusion, adherence to a pro-inflammatory diet was associated with increased odds of lung cancer in adults, particularly in male adults.

Evaluating the safety and effectiveness of PegaGen® (pegfilgrastim) for the prevention of chemotherapy-induced febrile neutropenia: a post-marketing surveillance study.

PURPOSE: Phase IV clinical trials are required to evaluate the real-world safety and effectiveness of drugs. This study aimed to evaluate the safety and effectiveness of once-per-cycle administration of PegaGen® (pegfilgrastim, CinnaGen, Iran) in cancer patients. METHODS: In this open-label, multicenter, prospective, real-world, post-marketing surveillance study, patients with any type of cancer receiving chemotherapy regimens with a high risk of febrile neutropenia (FN) were included if they were prescribed pegfilgrastim for FN prophylaxis. The primary objective of this study was to assess the safety and the secondary objective was to assess the effectiveness of pegfilgrastim in the prevention of FN in cancer patients. RESULTS: A total of 654 patients (51.73 ± 15.12 years of age) were enrolled and 3615 cycles of pegfilgrastim injections were recorded. The most common malignancies among the study patients were breast cancer (n = 192, 29.36%), lymphoma (n = 131, 20.03%), and gastric cancer (n = 65, 9.94%). The median (Q1, Q3) number of pegfilgrastim cycles per patient was 6 (4, 7). A single 6 mg dose was injected in 99.17% of the cycles. A total number of 816 adverse events (AEs) were reported in 246 patients (37.62%). Bone pain was recorded in 141 patients (21.56%) and in 440 cycles (12.17%). Among all patients, 45 patients (6.88%) experienced FN 51 times, and FN frequency was 1.4% among cycles. Moreover, 14 (2.14%) patients were hospitalized following FN. Antibiotics were administered to 24 patients (3.67%) for FN treatment. CONCLUSION: The results from this post-marketing surveillance study support the safety and effectiveness of PegaGen® used for the prevention of chemotherapy-induced FN in patients with various types of cancer and treatment regimens. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04460079.

Post-Marketing Surveillance of a generic Oxaliplatin (AlvoxalⓇ) in Iranian Patients with Cancer.

BACKGROUND: CRC is the second and third most common cancer in women and men, respectively. The national comprehensive cancer network guidelines recommend oxaliplatin-based chemotherapy as a preferred regimen for patients with advanced or metastatic colon cancer. Oxaliplatin is also used in the off-label treatment of gastric cancer. FDA uses post-marketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. It is necessary to perform safety monitoring after marketing authorization is received; such monitoring can be done by means of characterizing the safety of drugs in patients being treated in real-world clinical practice settings. OBJECTIVES: This Phase IV study aimed to evaluate the safety profile of a brand-name formulation of the generic drug oxaliplatin (AlvoxalⓇ, NanoAlvand, Tehran, Iran) in Iranian patients diagnosed with either colorectal or other, different types of cancer. METHODS: Patients with colorectal cancer, gastric cancer, or other malignancies receiving oxaliplatin as a part of their treatment were included in this open-label, multicenter, observational Phase IV study. This study aimed to assess the safety profile of oxaliplatin in patients diagnosed with different cancers. FINDINGS: A total of 483 patients from 16 cities in Iran were enrolled. The most common malignancy was colorectal cancer (55.49%), followed by gastric cancer (28.16%). Based on the results, 405 patients experienced at least 1 adverse event. Most of these adverse events were grade 1 or 2, and the most commonly reported adverse event was anemia (60.66%). During the study, 26 serious adverse events occurred in 15 (3.11%) patients, which were perhaps related to oxaliplatin. There were no remarkable differences in the incidences of adverse events in the system organ classes of blood and lymphatic system disorders, gastrointestinal disorders, or nervous system disorders among patients with different malignancies (ie, colorectal cancer, gastric cancer, and other malignancies) or between genders. The results of this open-label, multicenter, observational, postmarketing surveillance study demonstrated no unexpected safety findings from the use of this oxaliplatin product (AlvoxalⓇ) in Iranian patients diagnosed with different types of cancer. CONCLUSIONS: This Phase IV study provides data on the safety profile of a number of chemotherapy regimens containing an oxaliplatin product given to Iranian patients diagnosed with different types of cancer.

A Post-Marketing Surveillance Study to Evaluate the Safety Profile of AlvotereⓇ (Docetaxel) in Iranian Patients Diagnosed with Different Types of Cancers Receiving Chemotherapy.

BACKGROUND: Docetaxel is a clinically well established antimitotic chemotherapy medication. Labeled docetaxel indications are breast cancer, gastric cancer, head and neck cancer, non-small cell lung cancer, and prostate cancer. OBJECTIVE: This is a Phase IV study to evaluate the safety profile of docetaxel (Alvotere; NanoAlvand, Iran) in Iranian patients diagnosed with different types of cancers receiving chemotherapy regimens with docetaxel. METHODS: Patients who received Alvotere as a part of their chemotherapy regimen were enrolled in this Phase IV, observational, multicenter, open-label study. Alvotere was administrated as a single agent or in combination with other chemotherapy agents. Safety parameters in each cycle were assessed, and the related data were recorded in booklets. FINDINGS: A total of 411 patients with different types of cancers were enrolled from 25 centers in Iran. The most common malignancies among participants were breast cancer (49.88%), followed by gastric cancer (22.63%). Participants' mean age was 53.33 years, and the mean total dose used in each cycle was 132 mg. According to the results, 341 patients experienced at least 1 adverse event, that the most common was alopecia (41.12%). In total, 92 (22.38%) patients had at least 1 adverse event of grade 3 or 4, and 25 (6.08%) patients showed 54 serious adverse events, which the causality assessment for all was possibly related to Alvotere. There was a significant difference between men and women in the incidence of skin and subcutaneous tissue disorders (55.63% in women vs 41.73% in men; P = 0.009). Also, the incidence of gastrointestinal disorders, nervous system disorders, skin and subcutaneous tissue disorders, hepatic enzymes increase, and fluid retention was significantly higher (P < 0.05) in patients receiving anthracyclines in their chemotherapy regimens. CONCLUSIONS: The findings of this open-label, observational, multicenter, postmarketing surveillance showed that Alvotere appears to have an acceptable safety profile in Iranian cancer patients receiving chemotherapeutic regimens. (Curr Ther Res Clin Exp. 2022; 82:XXX-XXX) © 2022 Elsevier HS Journals, Inc.

Evaluation of Progression-Free Survival and Overall Survival of Epidermal Growth Factor Receptor-Positive Metastatic Lung Adenocarcinoma Patients Treated with Erlotinib.

Background: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) such as erlotinib and gefitinib have shown promising efficacy and tolerability in patients with advanced NSCLC. Identifying subgroups of patients who benefit from EGFR-TKI treatment may help achieve better treatment responses. Therefore, this study was performed to evaluate the indicators of response to treatment, including progression-free survival (PFS) and overall survival (OS) of patients. Methods: The study was performed as a prospective cohort in patients referred to Hazrat Rasoul Akram Hospital in Tehran for two years (April 2019-April 2021). Erlotinib was administered to patients at 100-150 mg daily. After completion or discontinuation of erlotinib, patients were followed up every three months to evaluate clinical outcomes. Independent t-test or Man-Whitney test was used to compare quantitative variables, chi-square or Fisher exact test was used to compare qualitative variables, and correlation test was used to determine the relationship between quantitative data. Analysis of overall survival and progression-free survival was performed using the Kaplan-Meier test. Significant levels less than 0.05 were considered. Results: Thirty-two patients participated in the final analysis. Out of 32patients, 21 (65.6%) were female, and 11 (34.4%) were male. The mean age was 59.12±14.17years (32-89years). The mean PFS was 11.44±9.35months and, the OS of patients was 21.78±14.35months. Of the 32 patients, 4 (12.5%) had a history of smoking and, the rest had no history of smoking. Conclusion: Finally, according to the findings of the present study, the use of erlotinib can be considered as an effective first-line treatment option with controllable toxicity in patients with advanced or metastatic NSCLC with positive EGFR. In addition, metastatic progression asymptomatic disease has been identified as the predominant pattern of disease progression. It can be stated that smoking history can play a risk factor in reducing PFS time.

Genotyping and In Vitro Antifungal Susceptibility Profile of Neoscytalidium Species Isolates from Respiratory Tract.

The fungus genus Neoscytalidium is mainly distributed in (sub) tropical regions of the world and has been essentially considered as a phytopathogen. There are however several reports of human infection caused by Neoscytalidium spp. through direct or indirect contact with contaminated plants or soil. Reliable and accurate identification to species level is critical for implementing proper therapeutic strategies. In the present study we investigated the genotypes and in vitro antifungal susceptibility patterns of Neoscytalidium species identified from respiratory tracts of patients with various underlying diseases. The identity and diversity of the isolates were done using PCR and sequencing of five different loci (the ITS region, D1/D2 domains of 28S rRNA gene, and part of the beta tubulin, elongation factor 1α and chitin synthase genes). The in-vitro antifungal susceptibility was also performed using the Clinical and Laboratory Standards Institute (CLSI) M38-Ed3-2017 guidelines. Overall, 13 isolates were identified as Neoscytalidium species (eight N. dimidiatum and five N. novaehollandiae). Two sequence types (STs) were identified by the alignment of 1846 combined base pairs among 13 clinical isolates. All isolates classified as N. dimidiatum were clustered in ST6 (61.5%) and those of N. novaehollandiae were in ST7 (38.5%). Luliconazole was the most active antifungal in vitro against species. This is the first report of N. novaehollandiae isolation from respiratory tracts samples. Further study from other regions of the world with a larger set of clinical specimens is required to provide additional insight into diversity of Neoscytalidium species.

A preliminary study to propose a diagnostic algorithm for PET/CT-detected incidental breast lesions: application of BI-RADS lexicon for US in combination with SUVmax.

OBJECTIVES: To develop a diagnostic algorithm for positron emission tomography (PET)-detected incidental breast lesions using both breast imaging reporting and data system (BI-RADS) and maximum standardized uptake value (SUVmax) criteria. METHODS: Fifty-six PET-detected incidental breast lesions from 51 patients, which were subsequently investigated by breast ultrasound within 1 month of the PET study, constituted the study cohort and they were finally verified by tissue diagnosis or a 2-year follow-up. Based on the maximum specificity with sensitivity > 60.0% and maximum sensitivity with specificity > 60.0%, two SUVmax cutoff values were calculated at 2 and 3.7. BI-RADS ≥ 4 was considered as highly suspicious for malignancy. The diagnostic accuracies were estimated for SUVmax levels above or below the cutoff points combined with the BI-RADS suspicion level. RESULTS: Overall, 46 benign and 10 malignant lesions were studied. The diagnostic characteristics of SUVmax ≥ 2, SUVmax ≥ 3.7, and BI-RADS ≥ 4 were 80.0%, 60.0%, and 80.0% for sensitivity, 73.9%, 95.7%, and 92.7% for specificity, and 75.0%, 89.3%, and 90.2% for accuracy, respectively. When the SUVmax threshold was set at 2, combined with BI-RADS suspicion level, the sensitivity, specificity, and accuracy were 100.0%, 69.6%, and 75.0%, respectively. The results for SUVmax threshold set at 3.7 combined with BI-RADS were 90.0%, 91.3%, and 91.1% for the sensitivity, specificity, and accuracy, respectively. A diagnostic algorithm was accordingly generated. CONCLUSION: The need for biopsy should be justified in low BI-RADS lesions presenting with high SUVmax at 3.7 or higher. The biopsy of patients with high B-IRADS and low SUVmax could be preserved. KEY POINTS: • A diagnostic algorithm was developed for PET-detected incidental breast lesions using both BI-RADS and SUVmax criteria. • Diagnostic performance was calculated separately and conjunctively for SUVmax ≥ 2, SUVmax ≥ 3.7, and BI-RADS ≥ 4. • The need for biopsy can be justified in BI-RADS < 4 lesions with SUVmax ≥ 3.7. Lesions with BI-RADS < 4 and indeterminate SUVmax (2 < SUVmax < 3.7) benefit from a short-interval follow-up. BI-RADS < 4 lesions with SUVmax < 2 may confidently be scheduled for routine screening.

Alvopem® (pemetrexed) safety assessment in patients with non-small cell lung cancer or malignant pleural mesothelioma: a post-marketing surveillance.

BACKGROUND: Lung cancer is the leading cause of cancer deaths worldwide in both men and women, and non-small cell lung cancer (NSCLC) accounts for the majority (~ 85%) of lung cancers. This post-marketing surveillance (PMS) study aimed to evaluate the safety of Pemetrexed (Alvopem®, NanoAlvand, Iran) in Iranian patients with lung cancer or mesothelioma. METHODS: The present study is an observational, single-center, open-label, and post-authorization study. All eligible non-squamous NSCLC and malignant pleural mesothelioma (MPM) patients who received pemetrexed based on the physicians' decision, were enrolled. RESULTS: A total of 199 patients with non-squamous NSCLC [186 patients (93.47%) or MPM (12 patients (6.03%)] were enrolled from March 2016 to February 2020. The most common reported adverse event (AE) was anemia (89.39%), followed by neutropenia (28.79%) and leukopenia (24.75%). The most important grade 3 AEs were anemia and neutropenia, with the incidence rate of 3.54% and 7.58%, respectively. No grade 4 AEs were reported. Moreover, the results of our study showed negative statistically significant correlations between patients' age and mean neutrophil count (r = - 0.17; P = 0.0156) and hemoglobin (r = - 0.16; P = 0.0201) in all six visits. CONCLUSIONS: The results of this open-label, observational PMS showed that Pemetrexed (Alvopem®) is safe in patients with non-squamous NSCLC patients receiving pemetrexed-containing regimens. TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (NCT04843007) in April 13th, 2021.

Diagnostic value of [ 68 Ga]Ga-Pentixafor versus [ 18 F]FDG PET/CTs in non-small cell lung cancer: a head-to-head comparative study.

OBJECTIVE: In this study, we aimed to compare the diagnostic value of [ 68 Ga]Ga-Pentixafor and [ 18 F]FDG PET/CT in the evaluation of non-small cell lung cancer (NSCLC) patients. METHODS: Patients with pathology-proven NSCLC were prospectively included. Patients underwent [ 18 F]FDG and [ 68 Ga]Ga-Pentixafor PET/CT within 1 week. All suspicious lesions were interpreted as benign or malignant, and the corresponding PET/CT semi-quantitative parameters were recorded. A two-sided P -value <0.05 was considered significant. RESULTS: Twelve consecutive NSCLC patients (mean age: 60 ±â€…7) were included. All patients underwent both [ 18 F]FDG and [ 68 Ga]Ga-Pentixafor PET/CT scans with a median interval of 2 days. Overall, 73 abnormal lesions were detected, from which 58 (79%) were concordant between [ 18 F]FDG and [ 68 Ga]Ga-Pentixafor PET/CT. All primary tumors were clearly detectable in both scans visually. Also, [ 68 Ga]Ga-Pentixafor PET/CT demonstrated rather comparable results with [ 18 F]FDG PET/CT scan in detecting metastatic lesions. However, malignant lesions demonstrated significantly higher SUVmax and SUVmean in [ 18 F]FDG PET/CT ( P -values <0.05). Regarding the advantages, [ 68 Ga]Ga-Pentixafor depicted two brain metastases that were missed by [ 18 F]FDG PET/CT. Also, a highly suspicious lesion for recurrence on [ 18 F]FDG PET/CT scan was correctly classified as benign by subsequent [ 68 Ga]Ga-Pentixafor PET/CT. CONCLUSION: [ 68 Ga]Ga-Pentixafor PET/CT was concordant with [ 18 F]FDG PET/CT in detecting primary NSCLC tumors and could visualize the majority of metastatic lesions. Moreover, this modality was found to be potentially helpful in excluding tumoural lesions when the [ 18 F]FDG PET/CT was equivocal, as well as in detecting brain metastasis where [ 18 F]FDG PET/CT suffers from poor sensitivity. However, the count statistics were significantly lower.

Clinical Effectiveness of Erlova in EGFR-Mutated Non-Small Cell Lung Cancer: An Affordable Price with Clinical Benefit.

BACKGROUND: Thyrosin kinase inhibitors (TKIs) is approved for the first line treatment of non-small cell lung cancer (NSCLC) patients with  epidermal growth factor receptor (EGFR) mutation. This study performed to assess clinical effectiveness and safety of Erlova (generic form of Erlotinib). METHODS: Somatic mutations of EGFR gene were studied in tumor tissue by polymerase chain reaction (PCR) and bi-directional sequencing in 513 chemonaive and histologically verified lung adenocarcinoma Iranian patients. Patients  with EGFR mutation received Erlova at 150 mg/day  as first line treatment. Primary endpoint was progression free survival (PFS). RESULTS: About 21% (n=109) cases had EGFR mutation. Most EGFR mutations were  occurred at exon 19. Among them, sixty nine patients treated with Erlova. Median PFS was 11.4 months and objective response rate (ORR) was about  88%. Most frequent treatment related adverse events was  skin rash. CONCLUSION: Our findings showed Erlova had remarkable effectiveness. In  mutation-positive patients with EGFR, Erlova can be used  safely instead of  other tyrosine-kinase inhibitors.

T790M and Acquired Resistance of Epidermal Growth Factor Receptor to Tyrosine Kinase Inhibitors in Patients with Lung Adenocarcinoma.

Background: Activating mutations in the epidermal growth factor receptor (EGFR) are initially responsive to tyrosine kinase inhibitors (TKIs), but responses to TKIs is not permanent and drug resistance eventually happens for almost all patients. Subsequent studies found different resistance mechanisms, among which (EGFR) T790M mutation is the most important mechanism of TKI treatment failure. Using cell-free DNA (cfDNA) is a new way for diagnosing resistance mutations in EGFR. The aim of present study is to determine cfDNA-identified recurrence mutation rate and their association with clinical outcome in lung Adenocarcinoma patients. Materials and Methods: Patients who were diagnosed with metastatic adenocarcinoma of the lung and acquired resistance to TKIs were enrolled. The incidence of T790M positivity, overall survival (OS) and median duration of TKI treatment before progression was calculated. Polymerase chain reaction (PCR) and sequencing were used to identify the T790M mutation in cfDNA. Results: The incidence of T790M mutations was higher in men, younger cases (<59 years), in patients with L858R primary mutation and never smokers although they were not significantly different (P-values= 041, 0.316, 0.316 and 0.158, respectively). There was significant longer OS in the Del19 subgroup than the L858R subgroup (p = 0.014). In multivariable analysis, significant longer OS was associated with younger age (<59 years) and primary EGFR mutation exon 19 (P-values= 0.028 and 0.050, respectively). Conclusion: T790M mutations frequency may differ by ethnicity, genetic factors and EGFR primary mutations. Detecting T790M mutations in plasma is considered as an indicator of treatment with third generation EGFR-TKIs.

The Frequency of Epidermal Growth Factor Receptor (EGFR) Mutation in Patients with Lung Adenocarcinoma Referred to a Lung Diseases Hospital; A Cross-Sectional Study from Iran.

Background & Objective: Various studies showed the use of epidermal growth factor receptors (EGFRs) gene mutations in the therapeutic plan of patients with advanced lung cancer. This study aimed to investigate the frequency and types of EGFR gene mutations among Iranian patients with lung adenocarcinoma referred to a specialized lung diseases hospital from 2014 to 2019. Methods: The data of all patients with lung adenocarcinoma referred to the Molecular Department of Masih Daneshvari Hospital Laboratory (National Research Institute of Tuberculosis and Lung Diseases) from 2014 to 2019 for EGFR mutation tests were collected. Patients' characteristics data and information on the frequency and types of EGFR gene mutations were obtained from the hospital information system (HIS). The collected data were analyzed using SPSS 25. Results: A total of 570 individuals (Mean age of 58.74, 51.6% Male) were included in the study; 113 out of 570 patients (19.8%) were diagnosed with gene mutation. In terms of the type of mutation, 65 participants (57%) showed deletion, 48 patients (42.1%) were diagnosed with replacement, and one (0.9%) case demonstrated both. Notably, the mutation rate detected among the female patients was significantly higher than the male ones (P=0.001); in particular, deletion type of mutation was found more among women, although both genders were the same in terms of the replacement frequency. However, the age had no effect on the mutation in this study (P=0.05). Conclusion: Among Iranian patients with lung adenocarcinoma, 19.8% harbored EGFR gene mutation. This mutation was found in association with lung cancer and could affect the patient's therapeutic plan.

The miR-196a SNP Rs11614913 but not the miR-499 rs37464444 SNP is a Risk Factor for Non-small Cell Lung Cancer in an Iranian Population.

Background: Globally, lung cancer represents a major cause of cancer-related deaths. The regulation of gene expression is modulated by small noncoding RNAs called miRNAs that can act as both tumor suppressors and oncogenes. The maturation, expression and binding to target mRNAs is affected by single nucleotide polymorphisms (SNPs) in miRNA genomic regions thereby contributing to cancer susceptibility. SNPs Rs11614913 in miR196a and Rs3746444 in miR-499 are implicated in the development of cancers such as non-small cell lung cancer (NSCLC) in non-Arabic subjects. Materials and Methods: A small cohort of 204 participants including 104 lung cancer patients and 100 non-cancer controls subjects were enrolled into the study. The allele frequencies were determined by Polymerase Chain Reaction- Restriction Fragment Length Polymorphism (PCR-RFLP) and their correlation with lung cancer risk was determined. Results: The miR-196a rs11614913 polymorphism increased the risk of NSCLC (CC vs. TT+TC: OR= 2.26, 95%CI= 1.28 - 3.98, P= 0.0046) in a dominant genetic model. No statistically significant association was found between the miR-499 rs37464444 polymorphism and NSCLC. Conclusion: The rs11614913 polymorphism in miR-196a, but not the miR-499 rs37464444 polymorphism, increased the risk of NSCLC. Further studies with larger sample sizes in correlation with functional outcomes at the cellular level should be undertaken.

National Research Institute of Tuberculosis and Lung Disease (NRITLD) Protocol for the Treatment of Patients with COVID-19.

More than a year after the onset of the coronavirus disease pandemic in 2019, the disease remains a major global health issue. During this time, health organizations worldwide have tried to provide integrated treatment guidelines to control coronavirus disease 2019 (COVID-19) at different levels. However, due to the novel nature of the disease and the emergence of new variants, medical teams' updating medical information and drug prescribing guidelines should be given special attention. This version is an updated instruction of the National Research Institute of Tuberculosis and Lung Disease (NRITLD) in collaboration with a group of specialists from Masih Daneshvari Hospital in Tehran, Iran, which is provided to update the information of caring clinicians for the treatment and care of COVID-19 hospitalized patients.

An Overview on the Upper and Lower Airway Microbiome in Cystic Fibrosis Patients.

BACKGROUND: In cystic fibrosis patients, the mucus is an excellent place for opportunistic bacteria and pathogens to cover. Chronic infections of upper and lower airways play a critical role in the mortality of cystic fibrosis. This study aimed to introduce the microbiota profiles in patients with cystic fibrosis. MATERIALS AND METHODS: In this study, a comprehensive literature search was done for studies on upper and lower airway microbiota in cystic fibrosis patients. International and national databases were searched for the following MeSH words: microbiota, microbiome, upper airway, lower airway, cystic fibrosis, cystic fibrosis, upper airway microbiome, lower airway microbiome, microbiome pattern in cystic fibrosis, microbiome pattern in cystic fibrosis, upper airway microbiota, lower airway microbiota, and microbiota pattern. RESULTS: Streptococcus spp. are in significantly higher relative abundance in infants and children with cystic fibrosis; however, Pseudomonas spp. are in higher relative abundance in adults with cystic fibrosis. Molecular diagnostic techniques can be remarkably accurate in detecting microbial strains. CONCLUSION: For the detection and isolation of most bacterial species, independent-culture methods in addition to the standard culture method are recommended, and sampling should include both upper and lower airways.

The effect of CHRNA3 rs1051730 C>T and ABCB1 rs3842 A>G polymorphisms on non-small cell lung cancer and nicotine dependence in Iranian population.

AIMS: Lung cancer is still the leading cause of cancer mortality in all over the world. Nicotine and its derivatives are the most well-known carcinogens that participate in both etiology and progression of lung cancer. The objective of the current study was to investigate whether single nucleotide polymorphisms (SNPs) rs1051730C > T in CHRNA3 and rs3842A > G in ABCB1, two genes contributing in the mechanism of disposition and metabolism of nicotine and its derivatives, could modify the risk of developing lung cancer, as well as nicotine dependence in Iranian. MAIN METHODS: The genotyping analysis for these two SNPs was conducted in a case-control study of 108 lung cancer cases and 120 healthy controls using ARMS-PCR and Tetra-primer ARMS-PCR techniques. The correlation between studied SNPs and lung cancer was assessed by the regression analysis. KEY FINDINGS: We observed a significant association between lung cancer and rs1051730C > T by using four genetic models: allele (OR:1.83; 95% CI:1.24-2.6; p = 0.002), dominant (OR: 2.19; 95% CI:1.27-3.78; p = 0.005), recessive (OR: 2.25; 95% CI: 1.02-4.95; p = 0.043) and additive (TT vs CC: OR:3.25; 95% CI:1.38-7.60; p = 0.007, CT vs CC: OR:1.96; 95% CI:1.10-3.48; p = 0.021). Furthermore, a significant association between this variant and nicotine dependence (OR: 2.27; 95% CI: 1.52-3.39; p = 0.00005) was reported. However, no association was found for rs3842A > G. SIGNIFICANCE: The results suggested that the CHRNA3 rs1051730C > T via a smoking-dependent manner could modify susceptibility to lung cancer among Iranian population.

Favipiravir Effects on the Control of Clinical Symptoms of Hospitalized COVID-19 Cases: An Experience with Iranian Formulated Dosage Form.

Coronavirus disease -19 (COVID-19) pandemic, caused by SARS-CoV-2, has gradually spread worldwide, becoming a major public health event. This situation requires designing a novel antiviral agent against the SARS-CoV-2; however, this is time-consuming and the use of repurposed medicines may be promising. One such medicine is favipiravir, primarily introduced as an anti-influenza agent in east world. The aim of this study was to evaluate the efficacy and safety of favipiravir in comparison with lopinavir-ritonavir in SARS-CoV-2 infection. In this randomized clinical trial, 62 patients were recruited. These patients had bilateral pulmonary infiltration with peripheral oxygen saturation lower than 93%. The median time from symptoms onset to intervention initiation was seven days. Favipiravir was not available in the Iranian pharmaceutical market, and it was decided to formulate it at the research laboratory of School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. The patients received favipiravir tablet at a dose of 1600 mg orally twice a day for day one and then 600 mg orally twice a day for days 2 to 6. In the second group, the patients received lopinavir-ritonavir combination tablet at a dose of 200/50 mg twice a day for seven days. Fever, cough, and dyspnea were improved significantly in favipiravir group in comparison with lopinavir-ritonavir group on days four and five. Mortality rate and ICU stay in both groups were similar, and there was no significant difference in this regard (P = 0.463 and P = 0.286, respectively). Chest X-ray improvement also was not significantly different between the two groups. Adverse drug reactions occurred in both groups, and impaired liver enzymes were the most frequent adverse effect. In conclusion, early administration of oral favipiravir may reduce the duration of clinical signs and symptoms in patients with COVID-19 and hospitalization period. The mortality rate also should be investigated in future clinical trials.

Sleep Disorders and Mental Health in Menopausal Women in Tehran.

BACKGROUND: Sleep complaints are common problems in the general population and insomnia and sleep disorders place significant economic and social burdens on the community. Postmenopausal women are 2.6 to 3.5 times more likely to develop obstructive sleep apnea (OSA) compared to non-menopausal women. In this study, we evaluated sleep disorders and mental health in postmenopausal women. MATERIALS AND METHODS: This study was a descriptive cross-sectional study and the samples were selected from postmenopausal women above 50 years who had participated in a survey entitled, "Evaluation of Sleep Disorders among Adults in Tehran" in 2017. Cluster sampling method was applied with proportional allocation. A total of 4021 samples were collected, 2075 of which belonged to women. In addition, 174 out of 2075 samples were related to postmenopausal women over the age of 50. The data were analyzed using the statistical package IBM SPSS version 22.0. P-values less than 0.05 were considered significant. RESULTS: In this study, 118 (67.8%) women had insomnia for less than three months, and 23 (13.2%) women had insomnia for more than three months. The prevalence of STOPBANG parameters in this group of postmenopausal women was 37% and significantly related to Body mass index (BMI) and neck circumference at P < 0.001 and 0.006, respectively. There was no significant relationship between social dysfunction and insomnia. However, anxiety in General Health Questionnaire (GHQ) was significantly associated with insomnia, sleepiness, sadness, and irritability. CONCLUSION: Our results indicate that the impact of insomnia symptoms, OSA comorbidity and mental disorders could extend far beyond. The use of urgent health care and quality of life issues is essential for long-term mental and physical well-being; if there is no treatment in the menopause population, there will be serious mental and physical complications.

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

BACKGROUND: The clinical presentation of SARS-CoV-2 infection ranges from mild symptoms to severe complications, including acute respiratory distress syndrome. In this syndrome, inflammatory cytokines are released after activation of the inflammatory cascade, with the predominant role of interleukin (IL)-6. The aim of this study was to evaluate the effects of tocilizumab, as an IL-6 antagonist, in patients with severe or critical SARS-CoV-2 infection. METHODS: In this prospective clinical trial, 76 patients with severe or critical SARS-CoV-2 infection were evaluated for eligibility, and ultimately, 42 patients were included. Tocilizumab was administered at a dose of 400 mg as a single dose via intravenous infusion. Primary outcomes included changes in oxygenation support, need for invasive mechanical ventilation, and death. Secondary outcomes included radiological changes in the lungs, IL-6 plasma levels, C-reactive protein levels, and adverse drug reactions. The data were analyzed using SPSS software. RESULTS: Of the 42 included patients, 20 (48%) patients presented the severe infection stage and 22 (52%) were in the critical stage. The median age of patients was 56 years, and the median IL-6 level was 28.55 pg/mL. After tocilizumab administration, only 6 patients (14%) required invasive ventilation. Additionally, 35 patients (83.33%) showed clinical improvement. By day 28, a total of 7 patients died (6 patients in the critical stage and 1 patient in the severe stage). Neurological adverse effects were observed in 3 patients. CONCLUSIONS: Based on the current results, tocilizumab may be a promising agent for patients with severe or critical SARS-CoV-2 infection, if promptly initiated during the severe stage.

COVID19 Prevention & Care; A Cancer Specific Guideline.

On March 11th 2020, the coronavirus outbreak was declared a pandemic by the WHO. One of the groups that is considered high risk in this pandemic are cancer patients as they are treated with a variety of immune system suppressor treatment modalities and this puts them in a great risk for infectious disease (including COVID-19). Therefore, cancer patients require higher level measures for preventing and treating infectious diseases. furthermore, cancer patients may bear additional risk due to the restriction of access to the routine diagnostic and therapeutic services during such epidemic. Since most of the attention of health systems is towards patients affected with COVID-19, the need for structured and unified approaches to COVID-19 prevention and care specific to cancer patients and cancer centers is felt more than ever. This article provides the recommendations and possible actions that should be considered by patients, their caregivers and families, physician, nurses, managers and staff of medical centers involved in cancer diagnosis and treatment. We pursued two major goals in our recommendations: first, limiting the exposure of cancer patients to medical environments and second, modifying the treatment modalities in a manner that reduces the probability of myelosuppression such as delaying elective diagnostic and therapeutic services, shortening the treatment course, or prolonging the interval between treatment courses.