Causality assessment and pattern of adverse drug reactions in a tertiary care hospital

Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management. Hence, this study was planned to evaluate causality and pattern of ADRs in a tertiary care hospital.Methods: The present study was undertaken in a tertiary care teaching hospital. A total of 200 ADRs reports collected in the ADR monitoring centre were analysed. The WHO definition of an ADR was adopted as well as WHO scale for causality assessment was used. Evaluation of the data was done for various parameters which included drug groups causing ADRs, body systems affected in ADRs, reporters and seriousness of reactions.Results: Overall occurrence of ADRs was slightly more in males (58%). Skin (72%) was the most commonly affected organ system. Antimicrobials (47%) were the drug group most commonly involved in ADRs. The causative drug was withdrawn for the management of the ADR in the majority (86%) of the patients. Upon causality assessment, majority of the ADRs were rated as probable (83.5%). Almost all of the reports were contributed by clinicians (99%).Conclusions: The causality assessment and pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere, although there are few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use

Prophylactic levofloxacin in cancer chemotherapy: a randomized controlled study

Background: The patients on cancer chemotherapy are at substantial risk of developing febrile episodes, bacteremia and infection related mortalities, yet the prophylactic use of antimicrobials continues to be a controversial issue. Hence, this study was designed to study the effect of antimicrobial prophylaxis in cancer chemotherapy.Methods: The patients receiving the cancer chemotherapy were randomly divided into two groups. Group A patients received cancer chemotherapy and no prophylactic antimicrobials. Group B patients were given prophylactic levofloxacin with each cancer chemotherapy cycle. Patients were evaluated for febrile episodes, documented infections and hospitalizations. The Eastern Cooperative Oncology Group (ECOG) performance grade and culture sensitivity reports were also recorded.Results: Demographic profile of patients was comparable in both groups. Absolute neutrophil count at 6 weeks was significantly higher with levofloxacin prophylaxis. Levofloxacin prophylaxis led to 92% reduction in risk of having neutropenia in first cycle, 78% reduction in clinically documented febrile episodes during the first chemotherapy cycle (36 % vs 8%, 95% confidence interval 0.08 to 0.56, p<0.001), 88% reduction in risk of developing infections, 63% reduction in risk of hospitalization and 30% decrease in average cost of treatment per patient per day (₹1269.80±220.32 vs. ₹372.21±99.23, p<0.01) as compared to control group. All documented infections were from gram negative bacteria, E. coli being the commonest.Conclusions: Antimicrobial prophylaxis with levofloxacin is beneficial to patients receiving cancer chemotherapy as it decreases the morbidity, in terms of febrile episodes, neutropenia, infections, hospitalizations and it also reduces the cost of overall treatment

TO COMPARE THE EFFICACY AND SAFETY OF RAMIPRIL VERSUS LOSARTAN IN POST-MYOCARDIAL INFARCTION PATIENTS

Objective: Renin–angiotensin–aldosterone system (RAAS) plays an important role in regulating post-myocardial infarction (post-MI) events. Ramipril and losartan act mainly by inhibiting RAAS. This study was designed to compare the efficacy and safety of ramipril against losartan in post-MI patients. Methods: A total of 100 enrolled patients were divided into two groups A and B of 50 each by computer-generated random numbers. Group A (n=50) patients were given ramipril 1.25–2.5 mg once a day and Group B (n=50) patients were given losartan 25–50 mg once a day. The patients were followed after 0, 1, and 3 months and at 6 months (optional). Efficacy was compared based on the left ventricular ejection fraction (LVEF%) and New York Heart Association class improvement. Safety was compared by considering ADRs, mortality, and biochemical test profile. Data were analyzed using unpaired t-test and Chi-square test. p&lt;0.05 was considered to be statistically significant. Results: The mean LVEF% at 0 month for Group A was 40.6 ± 4.48 and for Group B was 39.6 ± 4.02 (p=0.212). The mean LVEF% at 6 months for Group A was 45.12 ± 4.6 and for Group B was 43.57 ± 4.03 (p=0.11). The most common side effects were headache in Group A and hypotension in Group B. Conclusion: Both ramipril and losartan are equally efficacious; however, losartan has a better safety profile than ramipril

EFFICACY AND SAFETY OF SEVELAMER CARBONATE VERSUS CALCIUM ACETATE IN PATIENTS WITH CHRONIC RENAL DISEASE ON DIALYSIS

Purpose: Powdered sevelamer carbonate is a new phosphate binder with unproven therapeutic benefit in Indian population. Hence, we aimed to compare its efficacy and safety with calcium acetate in patients with Chronic Renal Disease on hemodialysis. Methods: This was a randomized, prospective, cross over and open labeled study, conducted in the Department of Nephrology, Christian Medical College and Hospital, Ludhiana. Fifty patients were included in data analysis and were randomization into two groups, A &amp; B. Group A patients first received powdered sevelamer carbonate for  4 weeks (n= 25) followed by 1 week of washout and calcium acetate for the next 4 weeks (n=25). Group B: vice-versa.  Serum phosphorus, calcium, C-reactive protein (CRP), total cholesterol, triglycerides (TGs) and low density lipoprotein (LDL) levels were performed before and after each drug was administered. Results: Mean baseline serum phosphorus and calcium phosphorus product in group A, reduced from 6.59 ± 0.31mg/dl &amp; 53.18 ± 2.5mg2/dl2 to 5.26± 0.33mg/dl &amp; 44.76mg2/dl2 respectively. In group B these reduced from 6.42±0.33 mg/dl &amp; 52.06±2.5 mg2/dl2 to 5.44±0.3 mg/dl &amp; 44.5mg2/dl2 respectively. The reduction in these values in both groups was statistically significant (p&lt;0.05). Reductions in serum CRP, total cholesterol, triglycerides and low density lipoprotein (LDL) levels were not statistically significant in either group. Conclusion: Powdered sevelamer carbonate and calcium acetate are equally efficacious with no serious adverse effects. Both the drugs were well tolerated. Hence, powdered sevelamer carbonate can be a useful alternate to calcium based binders in Indian patients. Keywords: powdered sevelamer carbonate, calcium acetat

A High Energy X-Ray and Neutron Scattering Study of Iron Phosphate Glasses Containing Uranium

The atomic structure of iron phosphate glasses containing uranium has been studied by complementary neutron and x-ray scattering techniques. by combining x-ray and neutron structure factors, detailed information about different pair interactions has been obtained. Most of the basic structural features such as coordination numbers and O-O and P-O distances in uranium containing glasses are the same as those in the base glass of batch composition 40Fe2O3-60P2O5 (mol %). However, the Fe-O distances change slightly with the addition of uranium. The observed structural parameters support a structural model in which the waste elements occupy voids in the Fe-O-P network, hence, not altering the basic structure of the parent iron phosphate glass

Interferometry of Direct Photons in Central 280Pb+208Pb Collisions at 158A GeV

Two-particle correlations of direct photons were measured in central 208Pb+208Pb collisions at 158 AGeV. The invariant interferometric radii were extracted for 100<K_T<300 MeV/c and compared to radii extracted from charged pion correlations. The yield of soft direct photons, K_T<300 MeV/c, was extracted from the correlation strength and compared to theoretical calculations.Comment: 5 pages, 4 figure

Systematics of Inclusive Photon Production in 158 AGeV Pb Induced Reactions on Ni, Nb, and Pb Targets

The multiplicity of inclusive photons has been measured on an event-by-event basis for 158 AGeV Pb induced reactions on Ni, Nb, and Pb targets. The systematics of the pseudorapidity densities at midrapidity (rho_max) and the width of the pseudorapidity distributions have been studied for varying centralities for these collisions. A power law fit to the photon yield as a function of the number of participating nucleons gives a value of 1.13+-0.03 for the exponent. The mean transverse momentum, , of photons determined from the ratio of the measured electromagnetic transverse energy and photon multiplicity, remains almost constant with increasing rho_max. Results are compared with model predictions.Comment: 16 pages including 4 figure

Event-by-Event Fluctuations in Particle Multiplicities and Transverse Energy Produced in 158.A GeV Pb+Pb collisions

Event-by-event fluctuations in the multiplicities of charged particles and photons, and the total transverse energy in 158$\cdot A$ GeV Pb+Pb collisions are studied for a wide range of centralities. For narrow centrality bins the multiplicity and transverse energy distributions are found to be near perfect Gaussians. The effect of detector acceptance on the multiplicity fluctuations has been studied and demonstrated to follow statistical considerations. The centrality dependence of the charged particle multiplicity fluctuations in the measured data has been found to agree reasonably well with those obtained from a participant model. However for photons the multiplicity fluctuations has been found to be lower compared to those obtained from a participant model. The multiplicity and transverse energy fluctuations have also been compared to those obtained from the VENUS event generator.Comment: To appear in Physical Review C; changes : more detailed discussion on errors and few figures modifie

Centrality Dependence of Neutral Pion Production in 158 A GeV Pb + Pb Collisions

The production of neutral pions in 158AGeV Pb+Pb collisions has been studied in the WA98 experiment at the CERN SPS. Transverse momentum spectra are studied for the range 0.3 GeV/c < mT-m0 < 4.0 GeV/c. The results for central collisions are compared to various models. The centrality dependence of the neutral pion spectral shape and yield is investigated. An invariance of the spectral shape and a simple scaling of the yield with the number of participating nucleons is observed for centralities with greater than about 30 participating nucleons which is most naturally explained by assuming an equilibrated system.Comment: 5 pages, Latex, including 3 eps figures, submitted to Phys.Rev.Lett; updated pQCD comparison due to new input from the author, updated references, corrected plotting error in figure

Scaling of Particle and Transverse Energy Production in 208Pb+208Pb collisions at 158 A GeV

Transverse energy, charged particle pseudorapidity distributions and photon transverse momentum spectra have been studied as a function of the number of participants (N_{part}) and the number of binary nucleon-nucleon collisions (N_{coll}) in 158 A GeV Pb+Pb collisions over a wide impact parameter range. A scaling of the transverse energy pseudorapidity density at midrapidity as N_{part}^{1.08 \pm 0.06} and N_{coll}^{0.83 \pm 0.05} is observed. For the charged particle pseudorapidity density at midrapidity we find a scaling as N_{part}^{1.07 \pm 0.04} and N_{coll}^{0.82 \pm 0.03}. This faster than linear scaling with N_{part} indicates a violation of the naive Wounded Nucleon Model.Comment: 13 pages, 16 figures, submitted to European Physical Journal C (revised results for scaling exponents