Antineoplastic agents associated with neutropenic enterocolitis in patients with malignancy: A quantitative safety signal analysis.

BACKGROUND: The use of certain chemotherapy agents is associated with the development of a condition called "chemotherapy-associated neutropenic enterocolitis" (CANE). OBJECTIVE: To determine the risk of CANE associated with the use of each antineoplastic agent. METHODS: The FDA FAERS database of spontaneous adverse reactions was searched for the occurrence of the MedDRA preferred term "neutropenic colitis." RESULTS: The search resulted in 1134 records of patients (535 [47.3%] females, 479 [42.2%] males, sex not specified in 120 [10.6%]) with neutropenic colitis receiving immunosuppressive chemotherapy. The mean age of patients was 47 (SD 22). 22 antineoplastic agents were found to have a strong association (reported odds ratio [ROR] > 100) with the occurrence of CANE; 9 had ROR < 2. CONCLUSION: Drug databases have several limitations in providing updated information about newly approved pharmaceutical adverse events. Signal detection is a diagnostic method recognized as practical in pharmacovigilance. It may be utilized in the FDA's adverse event reporting database and has demonstrated a reasonable predictive performance in signaling adverse events. Our study emphasized the substantial knowledge gap between what we know about the potential risk of CANE caused by antineoplastic agents and the reports of the FDA on their new approved products.

Intranasal Topical Application of Tranexamic Acid in Atraumatic Anterior Epistaxis: A Double-Blind Randomized Clinical Trial.

STUDY OBJECTIVE: To determine the effectiveness of intranasal topical application of tranexamic acid in reducing the need for anterior nasal packing and determine the number of episodes of rebleeding in adult patients presenting with spontaneous atraumatic anterior epistaxis. METHODS: This study was a double-blind randomized trial conducted from September to November 2021 in the ears, nose, and throat (ENT) emergency department (ED), Khalili Hospital, Shiraz, Iran. Cotton pledgets soaked in either phenylephrine and lidocaine (control group) or tranexamic acid with phenylephrine and lidocaine (intervention group) were inserted into the patients' nostrils for 15 minutes. The primary outcome was the need for anterior nasal packing. The secondary outcomes were staying in the ED for more than 2 hours, needing electrical cauterization, and rebleeding within 24 hours and 1 to 7 days of the first referral to the ED. The trial was registered with the Iranian Registry of Clinical Trials (IRCT20210403050815N1). RESULTS: A total of 240 patients (120 in each group) were enrolled in this study. Tranexamic acid was associated with a lower rate of need for anterior nasal packing (50.0% versus 64.2%; odds ratio [OR], 0.56; 95% confidence interval [CI], 0.33 to 0.94). There were no significant differences between the 2 groups in terms of the need for electrical cauterization and the rate of rebleeding within 1 to 7 days. Tranexamic acid was associated with a lower rate of stay in the ED for more than 2 hours (9.2% versus 20.8%; OR, 0.38; 95% CI, 0.18 to 0.82) and rebleeding in 24 hours (15.0% versus 30%; OR, 0.41; 95% CI, 0.22 to 0.78) compared with the rates in the control group. CONCLUSION: Intranasal topical application of tranexamic acid is associated with a lower rate of need for anterior nasal packing and a shortened stay in the ED; it may be considered a part of the treatment for atraumatic anterior epistaxis.

Bloodstream infections in adult patients with malignancy, epidemiology, microbiology, and risk factors associated with mortality and multi-drug resistance.

BACKGROUND: This study aimed to investigate the epidemiology, microbiology, and risk factors associated with mortality and multi-drug resistance bacterial bloodstream infections (BSIs) among adult cancer patients in Shiraz, Iran. We also report a four-year trend of antimicrobial resistance patterns of BSIs. METHODS: We conducted a retrospective study at a referral oncology hospital from July 2015 to August 2019, which included all adults with confirmed BSI. RESULTS: 2393 blood cultures tested during the four-year study period; 414 positive cultures were included. The mean age of our patients was 47.57 ± 17.46 years old. Central Line-Associated BSI (CLABSI) was more common in solid tumors than patients with hematological malignancies. Gram-negative (GN) bacteria were more detected (63.3%, 262) than gram-positive bacteria (36.7%, 152). Escherichia coli was the most common gram-negative organism (123/262, 47%), followed by Pseudomonas spp. (82/262, 31%) and Klebsiella pneumoniae (38/262, 14.5%). Coagulase-negative staphylococci (CoNS) was the most frequently isolated pathogen among gram-positive bacteria (83/152, 54.6%). Acinetobacter spp., Pseudomonas spp., E. coli, and K. pneumoniae were the most common Extended-Spectrum Beta-Lactamase (ESBL) producers (100, 96.2, 66.7%, and 60.7, respectively). Acinetobacter spp., Pseudomonas spp., Enterobacter spp., E. coli, and K. pneumoniae were the most common carbapenem-resistant (CR) isolates (77.8, 70.7, 33.3, 24.4, and 13.2%, respectively). Out of 257 Enterobacterales and non-fermenter gram-negative BSIs, 39.3% (101/257) were carbapenem-resistant. Although the incidence of multi-drug resistance (MDR) gram-negative BSI increased annually during 2015-2018, the mortality rate of gram-negative BSI remains unchanged at about 20% (p-value = 0.55); however, the mortality rate was significantly greater (35.4%) in those with resistant gram-positive BSI (p-value = 0.001). The overall mortality rate was 21.5%. Early (7-day mortality) and late mortality rate (30-day mortality) were 10 and 3.4%, respectively. CONCLUSIONS: The emergence of MDR gram-negative BSI is a significant healthcare problem in oncology centers. The high proportion of the most frequently isolated pathogens were CR and ESBL-producing Enterobacterales and Pseudomonas spp. We have few effective choices against MDRGN BSI, especially in high-risk cancer patients, which necessitate newer treatment options.

Family dermatology life quality index in patients with pemphigus vulgaris: A cross-sectional study.

BACKGROUND AND AIMS: Pemphigus vulgaris is a rare autoimmune intraepidermal vesiculobullous disease involving the skin and mucosa. It impacts the quality of life of both patients and their families. METHODS: A total of 70 patients with pemphigus vulgaris (either outpatient or hospitalized) were enrolled using the simple sampling method between 2016 and 2017 from the dermatology clinic at Faghihi Hospital, Shiraz, Iran. A validated Persian version of the Family Dermatology Life Quality Index (FLDQI) questionnaire was filled by a family caregiver. The questionnaire contained 10 items assessing the quality of life of the family. Demographic variables were recorded in a separate form. RESULTS: The mean age of the patients was 51 ± 11.3 years and that of the family caregivers was 32 ± 8.8 years. The FLDQI score was higher (poorer quality of life) if the patient was male, older, had shorter disease duration or had fewer disease recurrences (P = 0.046, 0.01, 0.001 and >0.001, respectively). Higher scores were also obtained in the less-educated caregivers (P = 0.026) but there was no association with either gender or age (P = 0.399, 0.1). CONCLUSION: Pemphigus vulgaris significantly affects the Family Dermatology Life Quality Index. Education and counseling of family caregivers by various support groups such as Pemphigus Family Associations could be effective in improving the quality of life of the caregivers. LIMITATIONS: This study did not assess the effect of comprising domain analysis, severity of disease, patients' Dermatology Life Quality Index (DLQI), mucosal involvement, response to treatment, outpatient or admitted status, socioeconomic status, or the quality of life among the various family members.

A novel frame shift mutation in STIM1 gene causing primary immunodeficiency.

Immunodeficiency 10 is an autosomal recessive disorder presenting with iris hypoplasia, muscular hypotonia and nonprogressive myopathy, recurrent bacterial infections, autoimmune hemolytic anemia, hypohidrosis and nail dysplasia caused by the mutation of stromal interaction molecule 1 gene (STIM1). Herein, we present a new case of STIM1 mediated immunodeficiency, carrying a novel frameshift mutation. Our patient presented with nephrotic syndrome, hypotonia, myopathy, recurrent bacterial infections, thrombocytopenia and autoimmune hemolytic anemia. She is now 23 months old and is on steroid, cyclosporine and monthly IVIG. She has had no recent significant infections and is receiving rehabilitation therapy to improve her motor skills. Rare genetic syndromes should be suspected in patients of consanguineous parents, who present with a set of different manifestations. Gathering all the patient's manifestations together and looking them as one disease should be encouraged.