Apremilast Add-On Benefits Over Conventional Drugs (ABCD) in Unstable Non-segmental Vitiligo: A 12-Week Single-Center Randomized Controlled Trial.

Background Apremilast is an oral phosphodiesterase-4 enzyme inhibitor that modulates the immune system by increasing intracellular cyclic adenosine monophosphate levels and inhibiting inflammatory cytokines synthesis. We aimed to compare the efficacy and safety of add-on apremilast in combination therapy with standard treatment in patients with unstable, non-segmental vitiligo. Methods The study was a 12-week randomized, controlled, parallel-group, open-labeled trial. The control group received standard treatment (n=15), and the intervention group received 30 mg apremilast twice daily in addition to standard treatment (n= 16). Time to the first sign of re-pigmentation, halt in progression, and change in vitiligo area scoring index (VASI) score is the primary outcomes. Normality was assessed, and appropriate parametric and nonparametric tests were undertaken. Results Thirty-seven participants were randomized into two groups, and analysis was done on thirty-one participants. Over the treatment duration of 12 weeks, the median time to observe the first sign of re-pigmentation was four weeks in the add-on apremilast group compared to seven weeks in the control group (p=0.018). The halt in progression was observed more in the add-on Apremilast group (93.75%) compared to the control group (66.66%) (p=0.08). The VASI score decreased by 1.24 in the add-on apremilast group and 0.05 in the control group (p= 0.754). Parameters including body surface area, dermatology life quality index, and body mass index reduced significantly, while the visual analog scale increased significantly in the add-on apremilast group. However, results were comparable between groups. Conclusions Treatment with add-on apremilast accelerated clinical improvement. It also reduced disease progression and improved the disease index among participants. However, add-on apremilast had a lower tolerability profile than the control group.

Shoulder Injury Related to Vaccine Administration (SIRVA) with COVID-19 vaccination - A case report.

The case report evaluates shoulder injury related to COVID-19 vaccine administration. A 26-year-old female patient presented with shoulder pain, which increased on extension and overhead abduction in routine work. Magnetic resonance imaging (MRI) was done based on which, a diagnosis of shoulder injury related to vaccine administration (SIRVA) was reported. Significant improvement was seen after Non-steroidal anti-inflammatory drugs (NSAIDs), topical diclofenac ointment, and serratiopeptidase tablets. Physical muscle strengthening exercises were advised. Based on Naranjo and World Health Organization (WHO) casualty assessments, the adverse drug reaction (ADR) was categorized under probable. Preventability, Hartwig's scales for severity was assessed, which showed preventability and moderate grade in severity. The total cost (direct and indirect) for management was found to be rupees 7021 and 41,781 in government and private hospital respectively. Thus ADRs not only add to patient suffering but also increase the economic burden. Health care professionals (HCPs) need to be made aware of potentially fatal ADRs associated with the administration of vaccines and should be keen to report such ADRs to drug safety authorities.

Renal Histopathological Changes in Coronavirus Disease 2019 Patients: A Systematic Review and Meta-analysis of Individual Patient Data.

The major targets of coronavirus disease 2019 (COVID-19) are the respiratory and immune systems. However, a significant proportion of hospitalized patients had kidney dysfunction. The histopathological surveys have principally focused on respiratory, hematopoietic, and immune systems, whereas histopathologic data of kidney injury are lacking. Our study aimed to summarize the renal histopathological findings in COVID-19 from the published case report and case series. We conducted a systematic searching of databases such as MEDLINE, EMBASE, and Cochrane Library for published reports of COVID-19 patients with renal histopathological changes from autopsy studies and from "for cause" indication biopsies. Included in our study are case reports and case series with extractable quantitative data on patient demographics such as age, sex, ethnicity, as well as data on renal function tests, their comorbidities, and biopsy to study the histopathological changes. Data were analyzed with Microsoft Excel. To evaluate the methodological quality, we chose the framework for appraisal, synthesis, and application of evidence suggested by Murad et al. Systematic searches of literature found 31 studies that fulfilled the eligibility criteria. These studies included a total of 139 cases, where individual case details including clinical and histopathological findings were available. The median age of the cases was 62 years with a male:female ratio of 2.5:1. Associated comorbidities were noted in 78.4% of cases. The majority of the cases had renal dysfunction with proteinuria which was documented in more than two-thirds of the cases. The histopathological findings observed the frequent tubular involvement manifested by acute tubular injury. Regarding glomerular pathology, collapsing glomerulopathy emerged as a distinct lesion in these patients and was noted among 46.8% of cases with glomerular lesions. A small subset of cases (4.3%) had thrombotic microangiopathy. Collapsing glomerulopathy emerged as a hallmark of glomerular changes among COVID-19 patients. Tubular damage is common and is linked to multiple factors including ischemia, sepsis among others. In the form of thrombotic microangiopathy seen in a subset of patients, vascular damage hints toward the hyper-coagulable state associated with the infection. The demonstration of viral particles in renal tissue remains debatable and requires further study.

Demand of COVID-19 medicines without prescription among community pharmacies in Jodhpur, India: Findings and implications.

Background: COVID-19 pandemic led to increased self-medication of antimicrobials, vitamins, and immune boosters among the common people and consuming without prescription can lead to adverse consequences including antimicrobial resistance. Methods: A cross-sectional study was conducted on community pharmacies in Jodhpur, India. They were inquired regarding the prescription and increased sales (<25%, 25-50%, 50--75%, or 75--100%) of various medicines (Hydroxychloroquine, Azithromycin, Ivermectin, and Vitamin C) during the COVID-19 pandemic. Logistic regression analysis was conducted to assess the relationship between requests for certain COVID-19 medications and an increase in their sale. Results: A total of 204 pharmacies took part, and 88.23% reported patients to approach them without prescriptions. Most of the pharmacies revealed that <25% of patients came without prescription. The majority came for azithromycin (68%) and vitamin C (92%). Increased sales of the four targeted medications were seen by 85.92% of pharmacies compared to last year. A majority (51.5%) reported <25% increased sales of azithromycin, but no change in the sale of hydroxychloroquine and ivermectin. However, 39.6% reported >75% increase in vitamin C sales. Conclusion: There was an increase in the demand for COVID-19 medications without prescription. This study was unable to detect a significant increase in sales of antimicrobials, which is encouraging.

Analysis of Neurological Adverse Events Reported in VigiBase From COVID-19 Vaccines.

BACKGROUND: Fifteen COVID-19 vaccines have been granted emergency approval before the completion of conventional phases of clinical trials. The present study aimed to analyze the neurological adverse events (AEs) post-COVID-19 vaccination and focuses on determining the association of AEs with the vaccine. METHODOLOGY: The neurological AEs reported for COVID-19 vaccines in the WHO pharmacovigilance database (VigiBase) were extracted from the System Organ Classes - neurological disorders and investigations. Descriptive statistics are reported as percentage and frequency and the disproportionality analysis was also conducted. RESULTS:  For the neurological system, 19,529 AEs were reported. Of these, 15,638 events were reported from BNT162b2 vaccine, 2,751 from AZD1222 vaccine, 1,075 from mRNA-1273 vaccine, eight from Vero vaccine, two from Covaxin, and for 55 AEs, vaccine name was not mentioned. The reason for more AEs reported with BNT162b2 can be maximum vaccination with BNT162b2 vaccine in the study period. According to the disproportionality analysis based on IC025 value, ageusia, anosmia, burning sensation, dizziness, facial paralysis, headache, hypoaesthesia, lethargy, migraine, neuralgia, paresis, parosmia, poor sleep quality, seizure, transient ischemic attack, and tremor are some of the AEs that can be associated with the administration of the vaccine. CONCLUSION: The vaccines should be monitored for these AEs till the causality of these AEs with COVID-19 vaccines is established through further long-term follow-up studies. These neurological AEs reported in VigiBase should not be taken as conclusive and mass vaccination should be carried out to control the pandemic until a definite link of these adverse effects is established.

Tocilizumab in COVID-19: a study of adverse drug events reported in the WHO database.

BACKGROUND: Elevated inflammatory cytokines in Coronavirus disease 2019 (COVID-19) affect the lungs leading to pneumonitis with a poor prognosis. Tocilizumab, a type of humanized monoclonal antibody antagonizing interleukin-6 receptors, is currently utilized to treat COVID-19. The present study reviews tocilizumab adverse drug events (ADEs) reported in the World Health Organization (WHO) pharmacovigilance database. RESEARCH DESIGN AND METHODS: All suspected ADEs associated with tocilizumab between April to August 2020 were analyzed based on COVID-19 patients' demographic and clinical variables, and severity of involvement of organ system. RESULTS: A total of 1005 ADEs were reported among 513 recipients. The majority of the ADEs (46.26%) were reported from 18-64 years, were males and reported spontaneously. Around 80%, 20%, and 64% were serious, fatal, and administered intravenously, respectively. 'Injury, Poisoning, and Procedural Complications' remain as highest (35%) among categorized ADEs. Neutropenia, hypofibrinogenemia were common hematological ADEs. The above 64 years was found to have significantly lower odds than of below 45 years. In comparison, those in the European Region have substantially higher odds compared to the Region of Americas. CONCLUSION: Neutropenia, superinfections, reactivation of latent infections, hepatitis, and cardiac abnormalities were common ADEs observed that necessitate proper monitoring and reporting.

The Satisfaction Level of Undergraduate Medical and Nursing Students Regarding Distant Preclinical and Clinical Teaching Amidst COVID-19 Across India.

BACKGROUND: The COVID-19 pandemic has disrupted the educational system and led to a drastic shift of professional undergraduate teaching for medical and nursing students into online mode. METHODS: This was a cross-sectional, observational questionnaire-based study to assess the satisfaction level of the students. The questionnaire had 25 items of which 23 were questions with responses on the Likert scale and two items on views and suggestions were open-ended. The online questionnaire was shared through various messaging/mailing platforms. Overall satisfaction was assessed, and a satisfaction index was calculated for each item. Data are presented in frequencies and percentages, and SPSS was used to analyze the data. RESULTS: A total of 1068 students participated in the study. The majority were from the age group 21-23 years (54%) and there was almost the same number of participants from both genders. The majority of the students were medical undergraduates (n=919), were in their second year (n=669), belonged to a government institution (n=897) and used a mobile phone for their online classes (n = 871). The majority of the students were dissatisfied (42%) with no significant difference between medical and nursing students (p = 0.192). First-year students were significantly dissatisfied compared with other senior students (p = 0.005). The maximum satisfaction index (78.23%) was observed with faculties being supportive and responsive in resolving the queries and the minimum (46.39%) was observed with issues related to communication and discussion with peer students. There were 662 responses as views which mostly contained negative comments regarding interaction and focus, practical learning, teaching content, and technological/infrastructural flaws. There was major dissatisfaction regarding the practical and clinical learning. CONCLUSION: Online learning is essential at current times but is not an effective alternative for medical and nursing education. Face-to-face classes and practical sessions along with online learning can be a viable option.