Introduction: Thalassaemia Major patients require frequent blood transfusion leading to iron overload. Excessive iron gets deposited in vital organs and leads to dysfunction of the heart, liver, anterior pituitary, pancreas, and joints. Our body has limited mechanism to excrete iron, so patients with iron overload and its complications need safe and effective iron chelation therapy. Aim:To assess the efficacy of Deferasirox (DFX) as an iron chelator, with specific reference to reduction in serum ferritin level. Materials and Methods:This is a prospective; observational study done in 45 multitransfused Thalassaemia Major Children receiving DFX therapy at registered Thalassaemia society Raipur Chhattisgarh. DFX was given in an initial dose of 20 mg/kg/day and according to response increased to a maximum of 40 mg/kg/ day. Serum ferritin level was estimated at time of registration and at every three monthly intervals (four times during study period). The primary end point of the study was change in serum ferritin level after 12 months of DFX therapy. Results:The mean serum ferritin before DFX therapy of all cases was 3727.02 ng/mL. After 12 months of mean dose of 38 mg/kg/ day of DFX, the mean decline in serum ferritin was 1207.11 ng/ mL (drop by 32.38%, p-value <0.001).Conclusion: DFX monotherapy has a good safety profile and effectively chelates total body iron in Thalassaemia major patients.Shikha Jaiswal et al., Efficacy of Deferasirox as an Oral Iron Chelator in Paediatric Thalassaemia Patients www.jcdr.net
BACKGROUND:India is a developing country and adverse drug reactions (ADRs) influence most of the diseases in our population, and monitoring is required due to the paucity of ADRs. The present study was done to analyze the ADRs at the ADR monitoring center (AMC) of tertiary care hospital in Raipur during 1 year.MATERIALS AND METHODS:Study of ADR monitoring of outpatient and inpatient was a prospective and observational study carried out between September 2015 and August 2016. The ADRs in the form of Individual Case Safety Report (ICSR) was sent to the Indian database (Vigiflow®).RESULTS:Total ICSRs reported to Vigiflow® were 232 during 1 year. Among them, 63.79% were found to be nonserious and 36.21% were serious. Nearly 45% of ADRs were implicated only due to antimicrobials, which is highest among all other groups of drugs. A maximum number of ADRs were observed in 31–60 years of age group (52.15%). In causality assessment, the probable cases had a higher incidence (67.24%), followed by possible (27.58%) and certain (4.74%). The frequency of ADR reporting at our AMC was low (0.043%) compared to national average. Our AMC shared 0.35% of total ICSRs, which is insignificant (P < 0.001) compared to the JSS, Mysore and PGIMER, Chandigarh, AMCs, which have shared most of the ICSRs in Vigiflow®.CONCLUSIONS:The frequencies of ADRs reporting in our study are less compared to those reported with other similar studies. Underreporting is a very serious concern in Raipur, and Pharmacovigilance Programme of India must intercede to pick up ADRs across the country.
Background: Pharmacovigilance has evolved as an important tool for dealing with Adverse Drug Reactions (ADRs) both in pre-marketing and post-marketing scenario. Underreporting of ADRs at our Adverse drug reaction Monitoring Centre (AMC) led us to conduct this study to assess Knowledge, Attitude and Practice (KAP) of the practicing clinicians at our tertiary care Pt. J.N.M. Medical College associated Dr. B.R.A.M. Hospital, Raipur, Chhattisgarh, India, towards ADRs reporting.Methods: This was a cross-sectional study using pretested questionnaires consisting of 29 questions related to KAP of the practicing clinicians at Pt. J.N.M. Medical College associated Dr. B.R.A.M. Hospital, Raipur towards ADRs reporting. The percentage of responders for each question was calculated. All statistical analysis was performed in Microsoft Office Excel 2007.Results: Out of 135 questionnaires distributed only 100 were considered for analysis, so the overall response rate was 74.07%. We calculated the result from the 100 responders. Overall 77% responders were aware of existence of ADR monitoring system in India, while only 40% were aware of its existence at their hospital. Only 8% responders had reported ADRs to the National Pharmacovigilance Centre and 10% to the Adverse drug reaction Monitoring Centre (AMC) at their hospital. Lack of knowledge about where, how and whom to report ADRs, lack of time, inability to decide what to report (known or unknown ADRs) and unavailability of ADR reporting form were the important factors discouraging them reporting ADRs.Conclusions: Creating awareness regarding ADR reporting through CMEs among practicing clinicians and early sensitization at medical undergraduate level for medical students may improve the current ADR reporting rate.
Background: Rheumatoid arthritis (RA) is an autoimmune disease characterized by polyarticular inflammation with systemic symptoms like malaise, fatigue and fever. Various groups of drugs have been used along with supportive therapies (physical and occupational) for the treatment of rheumatoid arthritis. Non-steroidal anti-inflammatory drugs (NSAIDs) and disease modifying agents in rheumatoid disease (DMARDs) are the two major classes among them. However, none of these medications have proved to be successful enough to be accepted universally as the standard therapy for RA.Aims and Objective: To compare the clinical efficacy of nimesulide as a standalone therapy with combination therapy of nimesulide plus methotrexate and nimesulide plus hydroxychloroquine.Materials and Methods: The study comprised of three groups of rheumatoid arthritis patients. Each group consists of 32 study subjects. Group 1, 2 and 3 consisted of patients taking nimesulide alone, nimesulide plus hydroxycholoroquine and nimesulide plus methotrexate respectively for the disease. The cases were followed up to a period of six months and based upon subjective & objective (Radiological and serological examination) criteria, results have been evaluated.Results: Observations have revealed that nimesulide plus hydroxycholoroquine combination produced significant improvement in the patients in mild, moderate and severe cases of rheumatoid arthritis as compared to nimesulide plus methotrexate. The improvement observed was least in the patients who received nimesulide as standalone therapy. No significant adverse drug reaction was seen in any of the study groups.Conclusion: The study concludes that nimesulide plus hydroxychloroquine combination can be used in cases of rheumatoid arthritis as disease modifying drugs without noticeable toxicity in doses used in this study in patients who have no renal and hepatic insufficiency.Asian Journal of Medical Sciences Vol.9(1) 2018 61-64
Background: Sickle cell disease hemoglobinopathy gets inherited in autosomal recessive pattern. In sickle cell disease substitution of amino acid valine for glutamic acid at the sixth position on beta globin chain takes place resulting in sickled hemoglobin which is a hemoglobin tetramer.Methods: A prospective observational study was conducted in the Sickle Cell Institute, Raipur, India, and Department of Pharmacology in collaboration with Department of Biochemistry, Pt. J.N.M. Medical College, Raipur, Chhattisgarh, India, from February 2018 to June 2018. Patients included were in the steady state for a long period of time without any symptoms related to sickle cell disease or any other diseases which could affect hematological parameters. Subjects transfused in the last three months were excluded. Student t test and Pearson Correlation Coefficient test was done on stat pages and socscistatistics calculators. P-value<0.05 was considered as statistically significant.Results: A total of 50 subjects of sickle cell disease homozygous (SS) were studied for hematological parameters. The mean age±SD of 50 subjects were 13.3±9.24 years. Out of 50 subjects, 35 were males and 15 were females. Total RBC count, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC) was low in present study. Significant inverse correlation was found in females between HbA2 and HbF, p=0.01, while it was insignificant and negatively correlated in males being 0.23.Conclusions: Sickle cell disease homozygous is a common and challenging health problem of Chhattisgarh population.
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