International Journal of

Pharmaceutical Quality Assurance

e-ISSN: 0975 9506

p-ISSN: 2961-6093

Peer Review Journal

Impact Score 3.213

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1. Correlations of Hypothyroidism and Prolactin Level in Female Infertility Patients
Ashwini S. Hambarde, Youraj A. Kokate, Sandeep Hambarde
Abstract
Introduction: Both thyroid and prolactin hormones play key role in fertility among women. Disturbances in these hormones leads to infertility by causing menstrual irregularities and anovlatory cycles. Early detectation of these hormonal imbalances can help in better outcome in patients of infertility. This study showed correlations of Prolactin level and Hypothyroidism in female infertility patients. Materials and Methods: In this study, we studied the thyroid profile and prolactin levels in 60 infertile women who visited the obstetrics and gynecology department or in vitro fertilization center of a tertiary care hospital. The frequency of hypo and hyperthyroidism along with hyperprolactinemia was studied, and the association between thyroid dysfunction and levels of serum prolactin was analyzed. Results: The majority of the infertile women were having normal thyroid function tests and normal serum prolactin level. Thyroid dysfunction was noted in 41.66% of infertile women, with 8.33% showing hyperthyroidism and 33.33% showing hypothyroidism. Hyperprolactinemia was observed in 31.66% of infertile females. Hypothyroidism was found to be positively associated with hyperprolactinemia. Conclusion: Thyroid function test and prolactin level is important routine workup in female infertility patients so that appropriate measures can be taken to improve results.

2. A Clinical Comparison between Dexmedetomidine and Fentanyl as an Adjuvant with Bupivacaine Lignocaine Combination in USG Guided Brachial Plexus Block By Supraclavicular Approach
Himanshu Kumar, Amit Kumar, Sandhya B. K., Kuldeep Singh
Abstract
Background: Regional anaesthesia technique is mostly preferred for upper limb surgeries due to superior analgesia and reduced systemic complications. The addition of adjuvants to local anaesthetics influences both block characteristics and cardiovascular stability. Dexmedetomidine and fentanyl are commonly used adjuvants; however, comparative evidence remains limited. Objective: To compare the onset & duration of sensory and motor block, hemodynamic effects and analgesic efficacy of dexmedetomidine versus fentanyl when used as adjuvants to a bupivacaine–lignocaine combination in ultrasound-guided supraclavicular brachial plexus block. Materials and Methods: A Prospective randomized comparative study including 105 patients (ASA I–II) undergoing unilateral upper limb surgeries below the shoulder were randomly allocated into three groups (n=35 each): Inj. Bupivacaine–lignocaine (Group A), Inj. Bupivacaine–lignocaine with dexmedetomidine 1 µg/kg (Group B), and Inj. Bupivacaine–lignocaine with fentanyl 1 µg/kg (Group C) ; Onset and duration of sensory and motor block, duration of postoperative analgesia and adverse effects were recorded. Results: Dexmedetomidine significantly reduced onset time and prolonged duration of sensory and motor blockade compared to Group A and Group C. Similarly, it demonstrated significantly lower heart rate and blood pressure compared to Groups A and C (p<0.05), without clinically significant hypotension. Duration of analgesia was significantly prolonged in Group B compared to Group C and Group A (p<0.001). Mild bradycardia was observed in the dexmedetomidine group but required no intervention. Conclusion: Dexmedetomidine provides superior hemodynamic stability and prolonged postoperative analgesia compared to fentanyl when used as an adjuvant in supraclavicular brachial plexus block.

3. Comparative Histopathological Analysis of HER2/neu Overexpression in Gastrointestinal Adenocarcinomas across Different Sites
R. Kalpana, V. Jayanthi, B. Arulvaruni
Abstract
Background: Gastrointestinal adenocarcinomas (GIAs) constitute a major proportion of global cancer incidence and mortality. Among their diverse biological behaviours, molecular heterogeneity significantly influences prognosis and therapy. HER2/neu (human epidermal growth factor receptor-2) is a proto-oncogene encoding a tyrosine kinase receptor involved in cell growth and differentiation. Its overexpression has diagnostic and therapeutic relevance in several malignancies, notably breast and gastric cancers. This study aimed to do comparative analysis of HER2/neu overexpression in gastrointestinal adenocarcinomas across different sites. Materials and Methods: A total of 50 cases of histopathologically proven gastric and colorectal adenocarcinomas were evaluated retrospectively and prospectively at a tertiary care teaching hospital for a extended period of two years. Immunohistochemistry (IHC) for HER2/neu was performed on formalin-fixed, paraffin-embedded sections using the Hoffmann et al. scoring system. Expression patterns were correlated with histological subtype, grade, and demographic parameters. Statistical analysis was carried out using SPSS v26 with p < 0.05 considered significant. Results: HER2/neu positivity (3+) was detected in 12 (24%) of 50 cases—7 (25%) gastric and 5 (22.7%) colorectal carcinomas. Overexpression was most frequent in well-differentiated intestinal-type adenocarcinomas, while poorly differentiated tumors were uniformly negative (p = 0.003). No significant correlation was observed with patient age or sex. Conclusion: HER2/neu expression correlates strongly with histological differentiation in gastrointestinal adenocarcinomas. Its assessment provides valuable adjunctive information to routine histopathology, assisting in prognostication and therapeutic stratification, especially for anti-HER2 targeted treatment.

4. Prevalence and Association of Obesity Markers with Glycaemic Status and Early Peripheral Neuropathy among Individuals Undergoing Screening for Type 2 Diabetes Mellitus in a Tertiary Care Hospital in South India: A Hospital-Based Cross-Sectional Study
Gowri T., Reka R., Harikrishnan
Abstract
Background: Type 2 diabetes mellitus (T2DM) and obesity represent major public health challenges in India, with a large proportion of individuals remaining undiagnosed. Central obesity has been shown to be more strongly associated with dysglycemia than generalized obesity. Emerging evidence suggests that early peripheral neuropathy may occur even in prediabetes. However, limited data from South India simultaneously examine obesity markers, glycemic status, and early peripheral neuropathy in screening populations. Our objective is to estimate the prevalence of obesity, dysglycemia, and early peripheral neuropathy among adults undergoing screening for T2DM, and to assess the association of obesity markers with glycemic status and early peripheral neuropathy. Materials and Methods: This hospital-based cross-sectional study was conducted among 360 adults attending a tertiary care non-communicable disease clinic in South India. Anthropometric measurements (BMI, waist circumference, waist–hip ratio), glycemic status (OGTT and HbA1c), and early peripheral neuropathy (Diabetic Neuropathy Symptom score and 128-Hz tuning fork test) were assessed. Associations were analyzed using chi-square tests and multivariable logistic regression. Results: Overweight/obesity was prevalent in a majority of participants, with central obesity being more common than generalized obesity. Dysglycemia was detected in a substantial proportion of the screened population. Early peripheral neuropathy was present not only in newly diagnosed diabetes but also in individuals with prediabetes. Waist circumference and waist–hip ratio showed stronger associations with dysglycemia and early neuropathy than BMI. Conclusion: Simple anthropometric markers, particularly measures of central obesity, are strongly associated with dysglycemia and early peripheral neuropathy. Incorporating these low-cost measures into routine diabetes screening may enhance early risk stratification and prevention strategies.

5. Association between Digital Device Use and Speech Delay among Preschool Children Aged 2–5 Years: A Cross-Sectional Study
Nirmal Jyoti Jyotsana, Kanishk, Akriti Kumari, Kunal
Abstract
Background: The rapid expansion of digital technology has led to increased exposure of young children to smartphones, tablets, and television. Early childhood is a critical period for speech and language development, and excessive screen exposure may interfere with parent–child interaction and verbal stimulation. Objective: To assess the association between digital device use and speech delay among preschool children aged 2–5 years. Methods: A cross-sectional study was conducted among 200 preschool children aged 2–5 years attending the pediatric OPD. Data regarding digital device exposure, duration of screen time, age of first exposure, and parental interaction were collected using a structured questionnaire. Speech development was assessed using age-appropriate developmental milestone checklists based on standard pediatric developmental guidelines. Children who failed to achieve expected speech milestones for their age were categorised as having speech delay. Statistical analysis was performed using chi-square tests and logistic regression. Results: Among the 200 children studied, 62% used digital devices daily. Speech delay was observed in 28% of participants. Children exposed to screens for more than two hours per day had significantly higher rates of speech delay compared with those exposed for less than one hour per day (p < 0.001). Early exposure before the age of two years was also associated with increased risk of speech delay. Conclusion: Excessive digital device use is significantly associated with speech delay among preschool children. Limiting screen exposure and promoting interactive communication between parents and children may help support optimal language development.

6. Biomarker Insights for Early Screening for Gestational Diabetes Mellitus: Serum Leptin, Adiponectin, and Leptin–Adiponectin Ratio in Pregnant Women
Vibha Khare, Teena Gupta, Sapna Singh
Abstract
Background: It is still difficult for clinicians to diagnose gestational diabetes mellitus (GDM) early. Pregnancy-related metabolic regulation and insulin resistance are profoundly affected by adipokines, especially leptin and adiponectin. Objective: To analyze pregnant women’s first-trimester serum leptin, adiponectin, and leptin–adiponectin ratio (LAR) profiles and determine their potential as early GDM biomarkers. Methods: 180 pregnant women between weeks 11 and 13 were included in a prospective cohort study. ELISA was used to measure serum levels of adiponectin and leptin. The IADPSG criteria were used to diagnose GDM at 24–28 weeks. Analysis was done using receiver operating characteristic (ROC), correlation, and comparison. Results: In the first trimester, women with GDM (n=42) had significantly higher levels of leptin and significantly lower levels of adiponectin and LAR than normoglycemic controls (p<0.001). LAR had the best predictive value, with an AUC of 0.86.  Conclusion: These findings suggest that gestational diabetes mellitus (GDM) is associated with altered adipokine profiles during early pregnancy. The leptin–adiponectin ratio (LAR) shows promising potential as a screening biomarker for early risk stratification.

7. Persistent Inflammation Predicts Hospitalization After CPAP: A 12-Month Cohort Study in Obstructive Sleep Apnea
Lokendra Dave, Parag Sharma, Vishwas Gupta, Vinod Kumar Kurmi, Pravin Gulab Dandekar, Vikas Kumar Mishra
Abstract
Background: Obstructive sleep apnea (OSA) is associated with systemic inflammation and increased cardiopulmonary morbidity. Although continuous positive airway pressure (CPAP) is the standard therapy, its impact on inflammatory biomarkers and their relationship with clinical outcomes such as hospitalization remains incompletely understood. Aim and Objectives: This study evaluated changes in C-reactive protein (CRP) and body mass index (BMI) over 12 months of CPAP therapy and examined whether baseline or persistent inflammation predicts dyspnea-related hospitalization. Materials and Methods: In this prospective cohort study, 166 adults with polysomnography-confirmed OSA initiating CPAP were enrolled. After exclusion of deaths and 76 participants lost to follow-up or non-adherent to CPAP, 90 patients completed 12-month evaluation. Baseline demographics, comorbidities, CRP, and BMI were recorded and reassessed at 12 months. The primary outcome was change in CRP; secondary outcomes included BMI change and time to first hospitalization for dyspnea. Analyses included paired tests, Chi-square tests, Cox proportional hazards models, Kaplan–Meier curves, and Fine-Gray competing-risk regression. Results: CRP decreased significantly after 12 months of CPAP (median 4.1 to 2.6 mg/L, p < 0.001), whereas BMI showed no significant change (31.6 to 31.5 kg/m², p = 0.12). Forty-one patients (45.6%) required dyspnea-related hospitalization, with 78% of events occurring after 8 months. Hospitalized patients had higher baseline CRP, higher 12-month CRP, and worsening CRP over time. In univariate Cox analysis, age, smoking, drinking, hypertension, baseline CRP, post-therapy CRP, and persistently high CRP were associated with increased hospitalization risk. In multivariate analysis, baseline CRP (HR 1.18), post-therapy CRP (HR 1.23), and persistently elevated CRP (HR 1.92) remained independent predictors, along with age, drinking history, and hypertension. Fine-Gray competing-risk models confirmed that CRP—but not BMI—was consistently associated with higher subdistribution hazard for dyspnea-related hospitalization. Conclusions: Twelve months of CPAP therapy significantly reduced systemic inflammation but did not alter BMI. Persistently elevated or rising CRP was strongly associated with increased risk of dyspnea-related hospitalization, while BMI showed limited prognostic value. These findings support CRP as a clinically relevant biomarker for risk stratification in CPAP-treated OSA and highlight the need for continued monitoring of inflammatory status and comorbid conditions to identify patients at elevated risk of clinical deterioration.

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