Real-world clinical experience of extended half-life recombinant factor VIII Fc fusion protein (rFVIIIFc) in comparison to conventional factor products in patients with severe hemophilia A

Introduction: The recombinant factor FVIII Fc fusion protein (rFVIIIFc) is a first-in-class extended half-life FVIII product to treat patients with hemophilia A. The safety, efficacy and prolonged half-life of rFVIIIFc was demonstrated in the phase 3 studies A-LONG, Kids A-LONG and the extension study ASPIRE. Despite robust efficacy and safety data of rFVIIIFc therapy from clinical trials, evidence on the effectiveness of rFVIIIFc use in real-world remains scarce. Our analysis aimed at investigating the effectiveness of prophylactic rFVIIIFc treatment in routine clinical use in Germany. Material and Methods: Twenty-seven patients with severe hemophilia A, who switched from prophylaxis with conventional recombinant factor VIII (rFVIII) products to rFVIIIFc, were included. Annualized bleeding rates, factor consumption, number of injections and adherence to prophylaxis were compared. The retrospective period prior switching to rFVIIIFc was three years, while the mean follow-up period after switching to rFVIIIFc was 24.9 months. Results: Switching to rFVIIIFc led to a 33.7% reduction in mean annualized number of injections and a 18.3% reduction in mean annualized factor consumption while maintaining low bleeding rates. The mean annualized bleeding rate (ABR) was 2.5 and 1.7 for rFVIII and rFVIIIFc, respectively. The adherence improved from 87% to 94%. During the follow-up period eleven surgeries were performed; all with a hemostatic response rated as excellent. No FVIII inhibitor formation after switching to rFVIIIFc has been detected. Conclusion: Real-world treatment with rFVIIIFc was associated with substantial reductions in consumption and injection frequenies while maintaining low bleeding rates supporting safety and efficacy data from clinical trials.

Convalescent Plasma to Limit Coronavirus Associated Complications: A Proof of Concept Phase-2 Clinical Study at a designated COVID-19 hospital in Mumbai city

Objective: With few treatment options available to manage coronavirus disease 2019 (COVID-19), health systems devised strategies to manage covid-19 using repurposed drugs and revisiting older strategies, such as convalescent plasma. This study was planned to evaluate safety and efficacy of Anti-SARS-CoV-2 convalescent plasma in hospitalized subjects with COVID-19. Method: An open label, single centre, two arm, prospective, randomised, controlled exploratory phase 2 study was conducted at a covid-19 designated center. 20 subjects (≥18 years) were admitted to hospital (screened 15 June to 27 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen (PaO2/FiO2) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 10 subjects were assigned to convalescent plasma with standard treatment (test arm) and 10 subjects to standard treatment only (control arm). Subjects in the test arm received either single or two doses of convalescent plasma 24 hours apart based on their clinical condition as per investigator’s discretion. Results: Subjects in test arm showed earlier resolution of symptoms of fever, shortness of breath and cough and the mean duration for RT-PCR test turning negative was better in the test arm. One subject in the control arm progressed to severe ARDS, while none in test arm progressed to severe ARDS. There was no difference in the use of respiratory support (invasive and non-invasive ventilation) between the 2 arms. There was no mortality observed in the study and no serious adverse reaction observed with the transfusion of convalescent plasma in the study. Conclusion: This was an exploratory proof of concept study to explore the effectiveness of convalescent plasma in COVID-19 subjects and sample size was not large enough to detect a statistically significant difference however subjects in test arm of this study showed better outcomes in few of the efficacy parameters as compared to subjects in control arm. The use of convalescent plasma transfusion was also observed to be safe.

Understanding the “Conflict of Interest

According to Wikipedia, ‘Çonflict of interest’ is a set of circumstances that creates a risk that professional judgement or actions regarding a primary interest will be unduly influenced by a secondary interest' [1]. It may be broadly described as conditions which may influence one’s judgement in a situation (primary interest) for some other gain (secondary interest), this may be financial or non-financial . It is of importance to understand that having a secondary gain is not wrong but these gains should not be illegal. This pertains to delivery of patient care, teaching and research in the medical profession.

Child Abuse and Neglect: An Overview

Child abuse and neglect are serious global problems and can be in the form of physical, sexual, emotional or just neglect in providing for the child's needs. These factors can leave the child with serious, long-lasting psychological damage. Child maltreatment is a complex life experience occurs when a parent or caregiver does an intentional or potential damage to a child, including acts of commission and omission. Child abuse is not an uncommon event, but it is not always recognized. Identifying the real number of maltreated children is a challenge because of the large variability in reported prevalence data across studies. It is associated with important economic and social costs (such as physical and mental health, productivity losses, child welfare, criminal justice and special education costs) due to its high prevalence and its long-term and short-term consequences.

Oncotherapeutics: A General Overview

Experimental oncotherapeutics programs have been in place at major academic centres for over four decades. The emergence of molecular targeting agents and the recent introduction of immuno-oncology drugs have expanded the scope and eligibility for first-in-human trials. Improved understanding of tumor biology coupled with the ability to screen for tumor associated targets, as well as, genetic alterations have heralded the era of personalized (personalized or precision) cancer treatment. Molecular targeting agents with their improved tolerability and sustained responses compared to conventional cytotoxic chemotherapy have contributed to remarkable improvements in clinical outcomes Dramatic phase 1 observations of anti-tumor activity of novel molecules in the relapsed or refractory setting have ofen led to their investigation as monotherapy or in combinatorial strategies early in the course of cancer treatment. Studies have thus evolved from the traditional role of dose and toxicity-fnding studies to innovative enrichment study designs which match patients with study agents, thus increasing the potential of clinical efcacy, even in the early dose escalation setting.

Interactions- Readdressing the issue

Broadly drugs include all the chemical substances excluding food that affect the bodily processes. The drug is considered to be a medicine if it benefits the body. Whereas, if the drug is injurious to the body, it’s considered as a poison. Therefore, the same chemical can be a boon or curse with respect to the situation, condition of use, dosage and the individual using it. In this contemporary healthcare era, a huge number of medications are formulated each year and new interactions between drugs are reported every now and then. As a result, it is no more practical for doctors to be dependent on the memory alone to avoid possible drug interactions. Changes in absorption, distribution, metabolism or elimination of drugs are referred to as pharmacokinetic interactions, resulting in alteration in the level of drugs and its metabolites. The effect of drug changes from person to person than expected because it causes different reaction when a drug reacts with the food or dietary supplements they take (drug -food interaction). So, the effect of the drug is altered by means of increasing, decreasing, or producing a new effect which cannot be produced on its own the effect caused by food or dietary supplements. These interactions may occur due to accidental misuse or due to other factors such as lack of knowledge about it. This review provides a comprehensive literature review on various drug interaction. Generally, drug food interactions are neglected and not well defined but it can cause mild to serious effects. However, all clinicians, pharmacists and nurses should be aware of drug interaction to avoid the consequences caused by drug interactions.

A Study To Determine The Effect Of Egg Albumin Dressing On Peristomal Wound Healing of the Colostomy Patients In A Selected Hospital, Kolkata, West Bengal

The researcher conducted a quasi experimental study to evaluate the effect of egg albumin dressing on peristomal wound healing in a selected hospital, Kolkata, with the objectives to assess the peristomal skin condition of colostomy patients before treatment, to evaluate the effect of egg albumin dressing on healing of peristomal area and reduction of pain, to find out the association between the peristomal wound healing and selected variables. The final study was conducted at Curzon ward, Victoria ward of SSKM hospital, Kolkata. Ethical permission was sought out from Ethical Committee of SSKM hospital, Kolkata. Informed consent was taken from all respondents. The sample was selected according to their selected criteria. The sample selection was done by purposive sampling. They were randomly assigned into two groups (experimental and control group) in 1:1 ratio. The study concluded with its limitations, implications and recommendations for conducting a study may be conducted for a longer duration of observation with the treatment.

Peripheral Nerve Blockade and Botox Treatment in Chronic Migraine: A Comparative Study

Migraine is the most commonly encountered disabling headache. Chronic migraine significantly affects the quality of life and reduces the ability to attend work and social events, and consequently becomes an increasing economic burden.In recent years, peripheral nerve block with botulinum toxin A (botox) and local analgesics has been included in alternative treatment regimens.In cases of chronic migraine, botox is injected into the facial area, maxillary and mandibular nerve, and the head and neck muscles.Recent methods such as great occipital nerve (GON), and lesser occipital nerve, supra orbital nerve (SON), sphenopalatine ganglion blockade and trigeminal ganglion blockade have been applied using local analgesics. GON and SON blockade are the most frequently used of these methods. Studies related to these methods have shown a decrease in the frequency and severity of migraine pain.The results of this study showed that both GON and SON blockade and long-term application of BTX-A treatment were highly effective in the treatment of chronic migraine and both treatment methods had a similar level of effectiveness.That the follow-up period of this study was longer than in previous research can be considered a strong aspect of the study.

Rosuvastatin and Fenofibrate Combination in The Treatment of Mixed Hyperlipidemia: A Narrative Review

Introduction: Patients with mixed dyslipidemia are presented with high levels of low-density lipid cholesterol (LDL-C), triglycerides (TG), and reduced high-density lipid cholesterol (HDL-C). Though useful in lowering LDL-C, therapy with rosuvastatin is insufficient in optimizing the overall lipid profile, thus putting the patient at risk of residual cardiovascular risk. A combination of statin with other lipid-modifying agents has been used with more efficient lipid control and cardiovascular risk prevention. Of these, fenofibric acid is the most frequently used, along with rosuvastatin. Methods: Authors conducted a literature search of published literature to assess the use of rosuvastatin and fenofibrate combination in the management of mixed hyperlipidaemia. Results and discussion: The authors selected a total of 46 articles to be included in the review. Due to the small number of articles and heterogeneity on the combination of rosuvastatin and fenofibrate combination in mixed hyperlipidemia, the findings herein are presented using narrative summaries. Based on the thorough assessment of the selected literature, the essential themes that emerged from the review include safety and efficacy of rosuvastatin and fenofibrate combination, place of therapy of rosuvastatin, and fenofibrate combination, and potential cardiovascular risk reduction with rosuvastatin and fenofibrate combination. Conclusion: Based on the review, the authors suggested that the combination therapy with fenofibric acid was beneficial, well-tolerated with a similar safety profile compared with statin monotherapy. The combination therapy of moderate dose rosuvastatin and fenofibric acid led to a reduction of cardiovascular risk factors via several pathways.

Comparative study between H. Pylori induced and NSAIDs induced peptic ulcer

The use of Non-steroidal anti-inflammatory drugs as well as the infecting agent H Pylori has been attributed as the prominent common etiological factor for peptic ulcers in patients. Distinguishing proof of Helicobacter pylori as the essential etiologic factor in the improvement of peptic ulcer illness and the perception that the frequency of H. pylori increments with age have brought up the issue of a potential synergistic connection between the presence of H. pylori contamination and NSAID use in the improvement of treatment in gastroenterology. Both H.Pylori and NSAIDs have, nevertheless, been appeared to affect the creation rate and the nature of gastric cyclic AMP, the bodily fluid layer, mucosal prostaglandins, blood stream, and platelet-activating factor. Therefore, it is necessary to determine the risk factors such as age and history of peptic ulcers of the patient prior to prescribing. A co-prescription may be important to reduce the risk of peptic ulcers in patients of high risk. Since H.Pylori infection remains the world's most common chronic bacterial infection, it has been suggested that the establishment of a synergistic or additive effect of H.Pylori infection and NSAID use in the development of peptic ulcer is of great clinical importance as eradication of the bacterium is likely to reduce the risk of upper gastrointestinal complications in infected NSAID users. The prevention and overcoming of NSAIDS induced peptic ulcer and H Pylori induced peptic ulcer is embedded in the thorough understanding and assessment of pathophysiology and other underlying causes in each individual patient. There are wide range of studies that emphasize on the various methods of overcoming these conditions as well as understanding the co factors for the risk of ulcer. The main aim of the treatment is to protect the gastric mucosal layer from further eroding away and heal the mucosal ulcer as soon as possible to avoid further complications.