Efficacy and safety of ferric carboxymaltose in Indian pregnant women with iron deficiency anemia

Background: Iron deficiency anemia (IDA) is a significant problem worldwide particularly in women. The aim of the study was to evaluate the effectiveness of intravenous ferric carboxymaltose (FCM) in in Indian pregnant women with anemia.Method: This was a single centre, prospective, observational, open label, clinical study at real life scenario with 4 weeks follow up. Fifty pregnant women with IDA and visiting to the Radhakrishna multispecialty hospital, Bangalore, for antenatal care were enrolled for the study. IV FCM was given as per the standard protocol. Change in the laboratory parameters such as hemoglobin, mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), packed cell volume (PCV) level at baseline and after 4 weeks of completion of parenteral iron therapy was recorded and fatigue score was assessed. The pregnant women were monitored for the adverse events. Results: All pregnant women received a single IV infusion of FCM 1000 mg. A significant increase in the hemoglobin of 2.37±0.51 g/dl (p<0.001) was noted at 4 weeks, MCV rise of 19.89±21.94 (p<0.001) was noted at 4 weeks, MCHC rise was of 2.56±5.65 and PCV rise was of 4.45±2.67 (p<0.011) at over 4 weeks. Significant improvement in fatigue score was observed at 4 weeks after single FCM infusion. No adverse effects were observed in any pregnant woman throughout the duration of the study.Conclusions: This real-life observational study highlights IV FCM is effective in management of IDA in pregnant women and well tolerated. Trial registration number: CTRI/2021/02/030874

Prospective study of treatment of extraarticular fractures of distal end radius by cross K wire fixation and cast immobilisation and its comparison with Kapandji’s method of intrafocal pinning anatomically and functionally

Background: Distal radius fractures account for 17% of all fractures in adults. The fracture of the lower end of radius crushes the mechanical foundation of man’s most elegant tool, the hand. No other fracture has a greater potential to devastate hand function. Extra-articular fractures (type A in the AO classification) require avoidance of malunion with angulation and shortening. Malalignment results in limitation of movement, changes in load distribution, midcarpal instability and an increased risk of osteoarthritis of the radiocarpal joint. Aims and objectives: Treatment of extraarticular fractures of distal end radius by cross K wire fixation and cast immobilisation and its comparison with Kapandji’s method of intrafocal pinning anatomically and functionally.Methods: Total 50 cases were included in the study. First 25 cases were treated by Kapandji’s method and next 25 cases were treated by cross K wire fixation and all cases were given below elbow cast after internal fixation. Patients were followed up at regular intervals and Anatomical and functional outcomes were evaluated in all the patients.Results: In our study anatomical end results were satisfactory in 96% and unsatisfactory in 4% of the subjects treated with cross K wire fixation and 72% and 28% in cases treated by Kapandji’s method whereas Functional end results were excellent in 28% cases, good in 68% cases, fair in 4% case and poor in 0% cases treated with cross k wire fixation and 12%, 60%, 24% and 4% in cases treated by Kapandji’s method.Conclusion: Cross K wire method proved to be better than Kapandji’s method of intrafocal K wire fixation both functionally and anatomically.

Assessment of safety and effectiveness of desoximetasone emollient cream 0.25% in comparison to mometasone cream 0.1% in Indian patients with eczema

Background: Topical corticosteroids have become indispensable in the treatment of eczema. The current study was conducted to assess the safety and effectiveness of Desoximetasone emollient cream 0.25% (DESO) compared to Mometasone cream 0.1% (MOM) in patients with eczema.Methods: This was a prospective, observational, open label, multicentre post marketing study at real-life scenario. Newly diagnosed, treatment naïve patients with clinical diagnosis of eczema were enrolled. All patients received either DESO or MOM for 3 weeks. Primary end point was proportion of patients developing adverse events. Secondary endpoints comprised of change in visual analog scale for perception of improvement in intensity of pruritus at day 14 and day 21 from baseline, change in eczema area and severity index (EASI) score at day 0 and day 21.Results: 45 patients in DESO group and 43 patients in MOM group completed study. DESO and MOM were well tolerated. Severity of pruritus was significantly reduced in 54.59% patients in DESO group compared to 45.60% patients in MOM group on day 14 (p=0.023). Severity of pruritus was reduced in 69.16% patients in DESO group as compared to 66.97 % patients in MOM group on day 21 (p=NS). There was a statistically significant reduction (p<0.001) in EASI score at day 21 and as compared to baseline within the study groups, but without any difference between the groups.Conclusions: Desoximetasone 0.25% emollient cream was well tolerated in the treatment of eczema with earlier reduction in pruritus as compared to Mometasone furoate 1% cream

Ferric carboxymaltose in the management of anemia due to non-obstetric conditions in women: a sub-group analysis of a large multi-center real-world study/PROMISE from India

Background: Real-world data on the efficacy and safety of intravenous ferric carboxymaltose (FCM) for treating iron deficiency anemia (IDA) in Indian women is limited. Methods: This was a sub-group analysis of the real-world PROMISE study, which analyzed data of women who received FCM for the management of IDA due to non-obstetric causes. Hematological parameters were retrieved from the charts at baseline and at 4±1 week and analyzed for the whole sub-group and by the severity of anemia. Results: In 442 women with anemia, Hb and serum ferritin improved by 2.77 gm/dl and 62.07 µg/l, respectively (p&lt;0.001 for both) at 4 weeks. There was a significant increase in red blood cell (RBC) count, hematocrit, mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) (p&lt;0.001 for all). In 192 subjects with severe anemia, there was a significant increase in Hb by 3.19 gm/dl, serum ferritin by 61.67 µg/l, RBC count, hematocrit, and MCV (p&lt;0.001 for all); and MCH (p=0.002). In 226 subjects with moderate anemia, there was a significant increase in Hb by 2.41 gm/dl, serum ferritin by 62.75 µg/l, and MCV (p&lt;0.001 for all); and MCH (p=0.003). No subject had mild anemia. No new safety signals or serious adverse events were reported. Physicians rated the efficacy and safety of FCM as very good to good in 94.1 and 94.2% of subjects, respectively. Conclusions: In Indian women, FCM effectively and safely corrects IDA due to non-obstetric causes, in a short span of 4 weeks.

Infectious Complications Are Associated With Alterations in the Gut Microbiome in Pediatric Patients With Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia is the most common pediatric cancer. Fortunately, survival rates exceed 90%, however, infectious complications remain a significant issue that can cause reductions in the quality of life and prognosis of patients. Recently, numerous studies have linked shifts in the gut microbiome composition to infection events in various hematological malignances including acute lymphoblastic leukemia (ALL). These studies have been limited to observing broad taxonomic changes using 16S rRNA gene profiling, while missing possible differences within microbial functions encoded by individual species. In this study we present the first combined 16S rRNA gene and metagenomic shotgun sequencing study on the gut microbiome of an independent pediatric ALL cohort during treatment. In this study we found distinctive differences in alpha diversity and beta diversity in samples from patients with infectious complications in the first 6 months of therapy. We were also able to find specific species and functional pathways that were significantly different in relative abundance between samples that came from patients with infectious complications. Finally, machine learning models based on patient metadata and bacterial species were able to classify samples with high accuracy (84.09%), with bacterial species being the most important classifying features. This study strengthens our understanding of the association between infection and pediatric acute lymphoblastic leukemia treatment and warrants further investigation in the future

Antibiotic and antifungal use in pediatric leukemia and lymphoma patients are associated with increasing opportunistic pathogens and decreasing bacteria responsible for activities that enhance colonic defense

Due to decreased immunity, both antibiotics and antifungals are regularly used in pediatric hematologic-cancer patients as a means to prevent severe infections and febrile neutropenia. The general effect of antibiotics on the human gut microbiome is profound, yielding decreased diversity and changes in community structure. However, the specific effect on pediatric oncology patients is not well-studied. The effect of antifungal use is even less understood, having been studied only in mouse models. Because the composition of the gut microbiome is associated with regulation of hematopoiesis, immune function and gastrointestinal integrity, changes within the patient gut can have implications for the clinical management of hematologic malignancies. The pediatric population is particularly challenging because the composition of the microbiome is age dependent, with some of the most pronounced changes occurring in the first three years of life. We investigated how antibiotic and antifungal use shapes the taxonomic composition of the stool microbiome in pediatric patients with leukemia and lymphoma, as inferred from both 16S rRNA and metagenome data. Associations with age, antibiotic use and antifungal use were investigated using multiple analysis methods. In addition, multivariable differential abundance was used to identify and assess specific taxa that were associated with multiple variables. Both antibiotics and antifungals were linked to a general decline in diversity in stool samples, which included a decrease in relative abundance in butyrate producers that play a critical role in host gut physiology (e.g., Faecalibacterium, Anaerostipes, Dorea, Blautia),. Furthermore, antifungal use was associated with a significant increase in relative abundance of opportunistic pathogens. Collectively, these findings have important implications for the treatment of leukemia and lymphoma patients. Butyrate is important for gastrointestinal integrity; it inhibits inflammation, reinforces colonic defense, mucosal immunity. and decreases oxidative stress. The routine use of broad-spectrum anti-infectives in pediatric oncology patients could simultaneously contribute to a decline in gastrointestinal integrity and colonic defense while promoting increases in opportunistic pathogens within the patient gut. Because the gut microbiome has been linked to both short-term clinical outcomes, and longer-lasting health effects, systematic characterization of the gut microbiome in pediatric patients during, and beyond, treatment is warranted