A cross sectional analysis of medical device associated adverse events with radiotherapy devices - A materiovigilance study.

BACKGROUND: Materiovigilance is a method for tracking, documenting, and analyzing the causal factors of adverse outcomes or complications associated with the use of medical devices. In addition, it recommends that the Indian regulatory authority takes necessary steps with the aim of enhancing patient safety. The present study was taken up as there are hardly any studies available in the public domain on adverse events due to radiotherapy. OBJECTIVE: The objective of the study is to analyze the pattern of adverse events due to medical devices used in the department of radiation oncology. METHODS: It was a cross-sectional study carried out from June to September, 2022. The patients who were treated with the medical devices in radiation oncology at Victoria Hospital affiliated with Bangalore Medical College and Research Institute, Bengaluru, were included. The medical device used on the patients causes adverse events. The data were collected from the patient's health records available in the department of radiotherapy. RESULTS: Total 40 adverse events collected as per inclusion and exclusion criteria were analyzed. All the adverse events associated with medical devices were filled in the medical device adverse event reporting form and submitted to materiovigilance program, which also included the causality assessment. All the adverse events were caused due to external beam radiotherapy/teletherapy device. Dermatitis was the most common adverse event found in the reported cases (n = 20, 50%). CONCLUSION: Materiovigilance program is in budding stage. It was observed that the adverse events in patients were due to medical devices used in radiation oncology. Medical devices with skin-sparing effect (radiation is converged onto tumor) should be promoted and more research and engineering are required in designing of advanced medical devices for the treatment of cancer across the globe.

Extent of extravasation: Patients on parenteral plant alkaloids.

BACKGROUND: Plant alkaloids remain an essential part of many chemotherapeutic regimens. Although many adverse effects have been studied with appropriate management guidelines, extravasation (EV) is one adverse event that is yet to be studied at a regional scale to frame population-specific guidelines. METHODOLOGY: A hospital-based observational study was done for 1 year to understand the extent of extravasation among patients on parenteral plant alkaloids. Clinical pharmacists congregated information about patients satisfying the study criteria. The incidence of EV injuries associated with parenteral plant alkaloids was assessed. The severity was scored using the Common Terminology Criteria for Adverse Events (CTCAE) v4.3. The ESMO-EONS guidelines were followed for the classification of chemotherapeutic agents as well as management of the incidents of EV. RESULTS: Among the 80 patients recruited into the study, 26.25% of patients experienced EV injuries, of which 66.67% were grade 2 and 33.33% were grade 3. Females were prevalent at 62% among the injured group. Patients in the age group 31-50 years and 51-60 years sustained 28.57% of the injuries each. In 76.19% of injured patients, ambulation status was positive during the infusion. ESMO-EONS drug classification showed that 54.84% of the drugs prescribed were vesicants. Paclitaxel was seen in 33.33% of prescriptions in the injured group, among other plant alkaloids. CONCLUSION: Our study saw a trend of vesicant-induced extravasation injury among patients prescribed parenteral chemotherapeutic regimens with a combination of plant alkaloids, indicating the significant risk they may pose.

Antioxidant potential and optimization of production of extracellular polysaccharide by Acinetobacter indicus M6.

BACKGROUND: Extracellular polysaccharides (ECPs) produced by biofilm-producing marine bacterium have great applications in biotechnology, pharmaceutical, food engineering, bioremediation, and bio-hydrometallurgy industries. The ECP-producing strain was identified as Acinetobacter indicus M6 species by 16S rDNA analysis. The polymer produced by the isolate was quantified and purified and chemically analyzed, and antioxidant activities have been studied. The face-centered central composite design (FCCCD) was used to design the model. RESULTS: The results have clearly shown that the ECP was found to be endowed with significant antioxidative activities. The ECP showed 59% of hydroxyl radical scavenging activity at a concentration of 500 µg/mL, superoxide radical scavenging activity (72.4%) at a concentration of 300 µg/mL, and DPPH˙ radical scavenging activity (72.2%) at a concentration of 500 µg/mL, respectively. Further, HPLC and GC-MS results showed that the isolated ECP was a heteropolymer composed of glucose as a major monomer, and mannose and glucosamine were minor monomers. Furthermore, the production of ECP by Acinetobacter indicus M6 was increased through optimization of nutritional variables, namely, glucose, yeast extract, and MgSO4 by "Response Surface Methodology". Moreover the production of ECP reached to 2.21 g/L after the optimization of nutritional variables. The designed model is statistically significant and is indicated by the R2 value of 0.99. The optimized medium improved the production of ECP and is two folds higher in comparison with the basal medium. CONCLUSIONS: Acinetobacter indicus M6 bacterium produces a novel and unique extracellular heteropolysaccharide with highly efficient antioxidant activity. GC-MS analyses elucidated the presence of quite uncommon (1→4)-linked glucose, (1→4)-linked mannose, and (→4)-GlcN-(1→) glycosidic linkages in the backbone. The optimized medium improved the production of ECP and is two folds higher in comparison with the basal medium. The newly optimized medium could be used as a promising alternative for the overproduction of ECP.

A Rare Case of Genital Malformation with Omphalocele, Exstrophy of Bladder, Imperforate Anus and Spinal Defect Complex-Autopsy Findings.

Omphalocele, Exstrophy of cloaca, Imperforate anus and Spinal defects (OEIS) is a severe manifestation of exstrophy-epispadias sequence with a combination of defects including OEIS. It results from improper closure of anterior abdominal wall and defective development of cloaca and urogenital septum due to defect in blastogenesis during the 4th week of gestation. Identification of this complex is important through foetal autopsy as this condition can recur in siblings. Prenatal diagnosis also helps to prevent foetal death with appropriate management in the less severe cases. In severe cases, termination of pregnancy is considered. A primigravida with 28 weeks of gestation had delivered a live baby with multiple congenital anomalies; baby died after 10 minutes. These anomalies were grouped under OEIS complex.

Non Diphtheritic Corynebacteria: An Emerging Nosocomial Pathogen in Skin and Soft Tissue Infection.

INTRODUCTION: Non-diphtheritic corynebacteria are normal inhabitants of skin and mucous membrane. When isolated from clinical specimens they are often considered as contaminants. Recent reports suggest their role as emerging nosocomial pathogens. AIM: To speciate non-diphtheritic corynebacteria isolated from wound specimens, to correlate their clinical significance and to determine their invitro antimicrobial susceptibilities to 9 antimicrobial agents. MATERIALS AND METHODS: Twenty five non-diphtheritic corynebacteria from skin and soft tissue infections were selected for study. Isolates were identified by battery of tests and minimum inhibitory concentration (MIC) was detected by Clinical & Laboratory Standards Institute (CLSI) described broth microdilution method. MIC was interpreted according CLSI and British Society for Antimicrobial Chemotherapy (BSAC) guidelines. RESULTS: C. amycolatum was the predominant species (20%) followed by C. striatum (16%). Penicillin was least effective invitro followed by clindamycin and ciprofloxacin. Excellent activities were shown by vancomycin, linezolid and imipenem. Multidrug resistance was found in all the species. CONCLUSION: Non-diphtheritic corynebacteria are potential nosocomial pathogens among acute/chronic complicated skin and soft tissue infection. Vancomycin or linezolid can be used empirically to treat such infections until the invitro susceptibility results are available.

Clinical evaluation of the efficacy of Khadiradi yoga avachoornana in Kachchu with special reference to genitoinguinal intertrigo.

Kachchu is a simple localized dermatological infection of the genitoinguinal region, which occurs because of unhygienic observance, and manifests in the form of inflammation followed by secondary bacterial or fungal infections that can be best correlated to genitoinguinal intertrigo. Even though it rarely causes systemic manifestations, its mere presence itself is disturbing because of intractable itching and pain. It may delay the proper healing of the episiotomy wound and may cause difficulty in walking because of severe pain. Candida powder is the highest selling medicine for the intertrigo, as the incidence of intertrigo is as high as 40% in some particular seasons. In the Ayurveda fraternity, there is no established preparation that can be preserved safely in all the epochs of life in females and which is easy to apply. After understanding the disease in the perspective of the ayurvedic and modern medicinal systems, Khadiradi yoga choorna - a new ayurvedic formulation - was prepared on the basis of stringent ayurvedic principles. Hence, an attempt has been made to study the efficacy of the khadiradi yoga avachurnana(1) in Kachchu, with special reference to genitoinguinal intertrigo in females.

Adenosine 5'-triphosphate-sensitive potassium channel-mediated blood-brain tumor barrier permeability increase in a rat brain tumor model.

Brain tumor microvessels/capillaries limit drug delivery to tumors by forming a blood-brain tumor barrier (BTB). The BTB overexpresses ATP-sensitive potassium (K(ATP)) channels that are barely detectable in normal brain capillaries, and which were targeted for BTB permeability modulation. In a rat brain tumor model, we infused minoxidil sulfate (MS), a selective K(ATP) channel activator, to obtain sustained, enhanced, and selective drug delivery, including various sized molecules, across the BTB to brain tumors. Glibenclamide, a selective K(ATP) channel inhibitor, significantly attenuated the MS-induced BTB permeability increase. Immunocytochemistry and glibenclamide binding studies showed increased K(ATP) channel density distribution on tumor cells and tumor capillary endothelium, which was confirmed by K(ATP) channel potentiometric assay in tumor cells and brain endothelial cells cocultured with brain tumor cells. MS infusion in rats with brain tumors significantly increased transport vesicle density in tumor capillary endothelial and tumor cells. MS facilitated increased delivery of macromolecules, including Her-2 antibody, adenoviral-green fluorescent protein, and carboplatin, to brain tumors, with carboplatin significantly increasing survival in brain tumor-bearing rats. K(ATP) channel-mediated BTB permeability increase was also demonstrated in a human, brain tumor xenograft model. We conclude that K(ATP) channels are a potential target for biochemical modulation of BTB permeability to increase antineoplastic drug delivery selectively to brain tumors.