A prospective pharmacovigilance study to evaluate adverse effect profile of first line anti-tubercular drugs in newly diagnosed sputum positive patients

Background: Tuberculosis (TB) continues to remain one of the most pressing health problems in India with highest TB burden country in the world. Anti-tubercular therapy (ATT) induced organ toxicities are potentially serious ADRs of first line ATT regimen. The underlying mechanism of ATT-induced ADRs especially hepatotoxicity and the factors predisposing to its incidence which is significantly high in Indians are not clearly understood. It's vital to emphasize on ATT induced ADRs as it has direct influence on therapeutic outcome; result in high dropout rate and potential to develop MDR/XDR cases. ADR monitoring help us to revise the treatment protocol thereby improve treatment adherence and therapeutic outcome. Objective of this study is therefore designed to explore and monitor ADRs of first line anti-TB drugs.Methods: In this prospective observational study 60 TB patients (18-70 yrs) of either sex, newly sputum positive with normal parameters were included. Patients were followed up for six months aiming primarily to assess rate of ADRs and to identify preventable and potentially serious ADRs of anti-TB drugs. The ADRs of ATT on various organ systems (heart, kidney and liver), biochemical and haematological parameters were assessed and compared after 2 and 6 months; gender and age specific adverse events were also studied. Data obtained was analysed using student’s t-test of OpenEpi statistical software.Results: Study clearly revealed that ATT exhibit significant increase in toxicity markers viz. liver enzymes (p<0.01), urea and creatinine (p<0.01), ESR (p<0.05) and PTINR (p<0.01), wherein decrease in Hb% (p<0.01) when compared to baseline.Conclusions: ATT related ADRs is the major cause of dropouts and development of MDR/XDR cases. It's crucial to develop strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely. The data obtained from present study may be helpful in developing these effective strategies.

Management of Methicillin Resistant Staphylococcus aureus Infection of Endogenous Origin in an Electrical Burns Patient - A Case Report.

Methicillin Resistant Staphylococcus aureus (MRSA) poses a major problem and plays a vital role in nosocomial infections. Management of MRSA infection becomes cumbersome in healthcare settings due to its extension of resistance towards much class of antibiotics and it is purely based on antibiotic susceptibility. Nasal carriage of MRSA is a recognized risk factor for subsequent endogenous infection. We hereby report a case of MRSA infection in burns patient of endogenous origin and recovered by antibiotic therapy with 2% mupirocin. MRSA is frequent confront in the burn’s ward where the patients have more colonized and infected than other group of patients. Disturbances in the skin barrier and immunological variations are recorded among burn patients. Surveillance of microbial entities, its epidemiology and following the strict infection control practices lessen the frequency of such infection but very dangerous to control the outbreak situations.

Seroprevalence of hepatitis B virus among patients at a rural tertiary health care centre in South India: a four year study.

Background: Infection with the Hepatitis B Virus (HBV) is a global health problem. Epidemiological studies worldwide show wide variations in the prevalence patterns of the Hepatitis B infections. Early detection can contribute substantially to the timely diagnosis of the patients with acute illnesses and to an early treatment and hence, it can limit the transmission of the infection. Aim: To provide a baseline data on the prevalence of Hepatitis B among the patients who were attending Chennai Medical College Hospital and Research Centre, Trichy, Tamilnadu, over a period of 4 years (2010-2013). Methods: This was a retrospective study which was carried out among 19,513 patients who were attending the rural tertiary care teaching hospital, Trichy, over a period of 4 years (January 2010 – December 2013). The sera were screened for the presence of Hepatitis B surface antigen (HBsAg) by HEPACARD. Those found positive on screening test were confirmed by Enzyme linked Immuno-sorbent Assay (ELISA) test. Results: Out of 19,513 sera which were studied, 315 (1.61%) were sero-positive cases. Among the positive cases (315), the seroprevalence in males and females were 73% (230) and 27% (85) respectively and the frequency of HBV among age groups 0-20, 21-40, 41-60, >60 was 5.07% (16), 45.07% (142), 35.9% (113),11425% (36) respectively. Among the positive cases, a majority were in the age group of 21 to 40 years, with a male preponderance (p<0.05). Conclusion: The overall prevalence for this HBsAg marker among the patients who attended the rural tertiary teaching hospital in this study was comparatively similar to that which was reported by other studies from India.

Study of effects of antiepileptic therapy on various biochemical and hematological parameters patients suffering of epilepsy.

Background: Low therapeutic index of established antiepileptic drugs (AEDs) coupled with better understanding of the pathophysiology of seizure has encouraged the development of several novel AEDs. The conventional antiepileptics like phenytoin, phenobarbitone, valproate and carbamazepine and newer antiepileptics like levetiracetam, lamotrigine and topiramate etc. are used for epilepsy. AEDs induce potentially toxic effects over a period of time which remains undetermined over very long time. Earlier studies in this regard, states uneven results about biochemical (i.e. blood sugar level, lipid profile) and hematological (Hb%, blood cell count etc.) toxicity of AEDs. Aims: To unveil the toxic effects of AEDs when given singly or as combinations. Methods: Adult epileptics of either sex taking antiepileptic monotherapy or combination therapy for ≥ six months were enrolled. Biochemical and hematological parameters studied were compared with their age and sex matched controls, baseline and amongst groups. Statistical Analysis Used: Student’s ‘t’-test & One way ANOVA followed by posthoc Tukey HSD test for pair wise comparison; p<0.05 was considered significant. Results: Conventional antiepileptic combination therapy was found more toxic; p<0.01 for lipid profile. Combination groups showed significant reduction in Hb% (p<0.05) with no significant difference among them (p>0.05). Monotherapy and conventional combination therapy caused significant reduction in platelet count (p<0.01), but conventional combination therapy was found more toxic in this regard (p<0.05). Conclusions: Monotherapy found less toxic with no significant effects on lipid profile, Hb%, RBC count and O2 carrying capacity and less impact on platelets while combination therapy did not show any advantage over monotherapy and its use must be reserved only for refractory cases.

In vivo antimalarial activity of leaves of Plectranthus amboinicus (lour) spreng on Plasmodium berghei yoelii.

An invivo study of aqueous extract of the leaves of Plectranthus amboinicus on Plasmodium berghei yoelii was conducted on laboratory infected albino mice and compared with standard drug chloroquine. Reduction of parasitemia at 250 mg/kg and 500 mg/kg of aqueous extract for 24 hrs, 48 hrs, 72 hrs and 96 hrs were determined. The reduction of parasitemia after 96 hrs was 100%, 67.9% and 76.2% for standard, 250 mg/kg and 500 mg/kg of aqueous extract respectively. The isolation of active principle responsible for the reduction of parasitemia may give a promising drug molecule.