Background: Reference set choice can influence automated disproportionality analysis of spontaneous reporting data. Active comparators may reduce confounding by indication but can increase susceptibility to masking and reporting differences. This study examined comparator effects under different clinical and reporting conditions. Methods: A controlled simulation separately modelled event generation, reporting, and analysis. Full-data, active-comparator, and class-exclusion reference sets were compared across nine prespecified scenarios involving confounding by indication, masking, differential reporting, and their combinations. Each scenario included 5,000 Monte Carlo replicates. The primary outcome was the pairwise difference in mean log-ROR. Sensitivity analyses examined comparator similarity, while exploratory analyses assessed masking intensity and consistency using PRR and BCPNN. A published FAERS analysis provided an illustrative external comparison. Results: Under masking, mean RORs were 1.481, 0.759, and 1.933 for full-data, active, and class-exclusion comparators, respectively. The active versus full difference in mean log ROR was −0.670. Under combined confounding and masking, corresponding RORs were 1.543, 0.771, and 2.331, with a difference of −0.696. With confounding alone (true OR=1.0), the active comparator reduced mean ROR from 1.126 to 1.008. Findings were consistent across comparator similarity levels and with PRR and BCPNN. Conclusions: Comparator effects depended on the underlying conditions. Active comparators reduced distortion from confounding by indication but could lower disproportionality estimates when masking occurred. Comparator selection should therefore consider the clinical and reporting factors that shape spontaneous reporting data rather than assume active comparators are always preferable.
Toxic erythema of chemotherapy (TEC) refers to a variety of skin eruptions secondary to the use of antineoplastic drugs. We report a case of 49-year-old female, diagnosed case of right- side Ca breast, on chemotherapy for 3 months after MRM, who presented with gradually progressive skin rash on bilateral dorsa of hands, forearms, neck folds, bilateral axilla, groins, perianal area and buttocks with pain and burning sensation on lesions. Sloughed skin, denudation, and ruptured bullae generate a broad range of differential diagnoses, including toxic epidermal necrolysis (TEN), PNP and acute GVHD. Topical corticosteroids applied two to three times daily for several weeks can be beneficial in treating affected areas in TEC along with dose reduction of offending agent, extending the interval between treatment cycles, or discontinuing the offending chemotherapeutic agent.
Background: Dengue fever, a globally significant mosquito borne viral infection, exhibits a wide spectrum of clinical manifestations, yet gender specific variations in its presentation and outcomes remain underexplored. We conducted a prospective observational study at Jaipur National University Institute for Medical Sciences and Research Centre, enrolling 50 confirmed dengue patients to evaluate demographic, clinical, and serological differences between genders. Methods: The cohort comprised 62% females and 38% males, with fever (90%), generalized weakness (54%), and myalgia (44%) as the most common symptoms. Hematological involvement was predominant (92%), followed by hepatic (54%) and respiratory (28%) systems. Serological analysis revealed IgM as the most detected marker (50%), while thrombocytopenia (92%) and hepatomegaly (34%) were frequent comorbidities. Results: Notably, gender-based differences emerged, with females exhibiting significantly higher IgG seropositivity (p=0.026) and lower hemoglobin levels (p=0.011) compared to males. Treatment regimens were largely supportive, including pantoprazole (98%), paracetamol (84%), and ondansetron (66%). Our findings highlight the critical role of early hematological and serological monitoring in identifying severe cases, while underscoring the need for gender specific considerations in dengue management. Conclusions: The study provides novel insights into the interplay between gender and disease manifestations, offering actionable evidence to refine clinical protocols and public health strategies in endemic regions. These results emphasize the importance of tailored interventions to mitigate complications and improve patient outcomes.
Liposomal salicylic acid represents a significant advancement in the formulation of topical dermatological therapies. Salicylic acid, an established beta-hydroxy acid, is highly effective for its keratolytic and comedolytic properties; however, its traditional formulations are often limited by poor aqueous solubility and the potential for significant cutaneous irritation. To address these challenges, liposomal delivery systems, such as Lipoedge™ have been developed to encapsulate the active ingredient within phospholipid bilayers, facilitating a controlled and sustained release mechanism. This review examines the various preparation techniques, including thin-film hydration and reverse-phase evaporation, and analyses the physicochemical characterization essential for stable delivery, such as particle size and entrapment efficiency. Furthermore, the article explores the clinical efficacy of liposomal salicylic acid in managing acne vulgaris, post-inflammatory hyperpigmentation, and other hyperkeratotic conditions like psoriasis. By reinforcing the skin barrier and reducing trans-epidermal water loss, these next-generation formulations not only enhance therapeutic outcomes but also significantly improve safety profiles and patient compliance compared to conventional free-acid treatments.
Background: Amylotropic Lateral Sclerosis (ALS) is a neurodegenerative progressive disorder affecting the motor neurons with a prevalence of 5 per 100000 population in India. Riluzole, a presynaptic glutamate receptor blocker, was the only treatment available for last 20 yrs. Recently Edaravone, a free radical scavenger, was approved in 2017 by FDA for its neuroprotective behaviour in ALS and is being used as an add-on drug. This study was undertaken to analyse the add-on beneficial effects of Edaravone with Riluzole in ALS patients and compare it with patients on Riluzole alone. Methods: A prospective, analytical, hospital-based study of 2 years in duration was conducted in the Department of Pharmacology and Neurology, S.C.B. MCH, Cuttack. All adult patients diagnosed with ALS (based on neurogenic pattern with spontaneous activity in EMG) were included in the study. One study group received Riluzole orally alone while the other group received Edaravone IV infusion along with Riluzole. Efficacy was assessed using ALSFRS-R score, evaluated at baseline and at the end of each month till 6 months. Causality assessment was done by using the WHO-UMC Causality assessment scale and severity assessment was done using Modified Hartwig and Seigel severity scale. Cost effective analysis was done by calculating ICER (Increamental cost effective ratio). Results: Each group had 70 study subjects with similar baseline characters. There was no significant difference observed studying the baseline characteristics. The ALSFRS-R scores were assessed for 6 months which showed deterioration. Mean ALSFRS-R score significantly decreased by – 5.12 and – 8.87 in Gr A and B respectively at the end of 6 months. A total of 80 ADRs were recorded in the study subjects which were of mild severity. Conclusions: Edaravone add-on significantly improved functions in ALS patients in comparison to Riluzole alone therefore, it may be prescribed to ALS patients to reduce the disease progression.
