A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India

Background: In terms of morbidity and death, adverse drug reactions (ADR) have been highlighted as a worldwide burden. Determining the origin of ADRs remains a tough issue and no one approach for determining causation has been adopted as the gold standard throughout the world. Aim and Objectives: The objectives of the present study were (1) to evaluate the causality of ADRs using World Health Organization-Uppsala Monitoring Center (WHO-UMC) and Naranjo Algorithm ADRs causality assessment tools and (2) to evaluate the agreement and correlation between two universally used approaches for causality assessment of ADRs viz. WHO-UMC system and Naranjo algorithm. The secondary objective was to assess the reported ADRs in a tertiary care hospital in Northern India. Materials and Methods: The present study was a retrospective cross-sectional study. A total of 180 patients of ADRs from different departments of tertiary care hospital which were reported by Pharmacovigilance unit over a period of April 2018 to May 2019 were assessed. The causality assessment for these reported ADRs were done by WHO-UMC system and Naranjo algorithm. The agreement between these two methods calculated by Cohen’s kappa (?) statistics and Spearman’s correlation was used to evaluate the correlation between these two methods. Results: According to WHO-UMC criteria, 55.5% of adverse event instances were of the probable type, 34.4% were possible, 9.4% of cases were improbable, and 0.5% of cases were definite. According to the Naranjo methodology, 80.5% of adverse outcomes were likely, while 19.4% were feasible. The WHO and Naranjo causality comparisons had a positive and fair agreement (= 0.29), according to Cohen’s kappa test. Between the WHO-UMC scale and the Naranjo algorithm, the Spearman’s correlation coefficient was determined to be 0.409. Conclusion: “Probable” was the most common causality category observed by the WHO-UMC scale and the Naranjo algorithm. The WHO-UMC scale and the Naranjo algorithm have a good and reasonable agreement.

Protective effect of eucalyptus globulus extract on glufosinate ammonium -induced hepatotoxicity in wistar rats

The present study aims to investigate the hepatoprotective effect of Eucalyptus globulus extract against pesticide liver damage in comparison to silymarin, a classical antioxidant liver medicine. Liver damage was induced by oral administration of toxicant i.e. Glufosinate ammonium. The extent of damage was studied by assessing biochemical parameters and histopathological evaluations. The aqueous extracts of Eucalyptus globulus were administered respectively to the animals pretreated with pesticide and its effects on biochemical parameters were compared with standard drug silymarin (100mg/kg b.wt). Eucalyptus globules showed significant reduction of serum enzymes AST, ALT, ALP & Bilirubin (Aspartate Transminase, Alanine Transminase, Alkaline Phosphatase & Total bilirubin) when compared to control counterparts. The hepatoprotective effect of Eucalyptus globules was comparable with the standard drug silymarin and it was confirmed by histopathological findings. Moreover, these effects presented in a dose-dependent manner.The present study showed that aqueous extract of Eucalyptus globulus at the dosage level of 500 mg/kgb.wt may play a protective role against pesticideinduced hepatotoxicity

Prophylactic effect of coconut water (Cocos nucifera L.) on ethylene glycol induced nephrocalcinosis in male wistar rat

Purpose Many medicinal plants have been employed during ages to treat urinary stones though the rationale behind their use is not well established. Thus, the present study was proposed to evaluate the effect of coconut water as a prophylactic agent in experimentally induced nephrolithiasis in a rat model. Materials and Methods The male Wistar rats were divided randomly into three groups. Animals of group I (control) were fed standard rat diet. In group II, the animals were administrated 0.75% ethylene glycol in drinking water for the induction of nephrolithiasis. Group III animals were administrated coconut water in addition to ethylene glycol. All the treatments were continued for a total duration of seven weeks. Results and Conclusion Treatment with coconut water inhibited crystal deposition in renal tissue as well as reduced the number of crystals in urine. Furthermore, coconut water also protected against impaired renal function and development of oxidative stress in the kidneys. The results indicate that coconut water could be a potential candidate for phytotherapy against urolithiasis. .

Merits of performing coronary artery by-pass grafts on the beating heart.

A retrospective study of 1006 patients was undertaken to evaluate the benefit of a change of strategy in performing coronary artery by-pass grafting surgery. Group A consisted of 500 patients who were consecutively operated on cardiopulmonary by-pass and group B consisted of 506 patients who were consecutively operated on using "off pump" techniques. Pre-operative risk profile in both groups were similar as was as in the operating time. There was distinct benefit in amount of homologous transfusion, period of ICU stay, increased usage of radial artery conduit and improvement in transoesophageal echocardiography assessment of ischaemic mitral incompetence immediately after revascularisation in off pump (group B). Though there was a lower mortality in group B ie, 3/506 vis-a-vis 10/500 in group A this is not of statistical significance. Improvement in left ventricular ejection fraction >5.0% occurred more frequently in one month follow-up visits of group B patients. Period of return to active life was also shorter (28 versus 56 days). Based on observations, we conclude that there is a distinct benefit in avoiding cardiopulmonary by-pass while performing coronary artery by-pass grafting.

Aortoarteritis presenting with hypoparathyroidism.

Clinical manifestations of aortoarteritis (Takayasu's arteritis) are varied, depending on the involved segment of the aorta and its branches. A case of a young Indian woman with aortoarteritis presenting primarily with hypoparathyroidism is reported. Aortogram showed total occlusion of the arch arteries. To the best of our knowledge, the occurrence of hypoparathyroidism in aortoarteritis has not been reported. Possible mechanisms of such an involvement are discussed.

Askin tumor: a malignant small cell tumor.

Malignant tumours of the chest wall are rare in the pediatric age group. Askin tumour, a primitive neuroectodermal tumour with aggressive nature, is extremely rare. Clinico-pathological features make it quite distinct from Ewing's sarcoma. Aggressive nature of the tumour results in short clinical presentation of the patient. Diagnosis of Askin tumour is mainly by histo-pathology. Imaging modalities play only a complimentary role. We present a case diagnosed to have this rare malignant tumour in the thoraco-pulmonary area in a child.

Malignant peritoneal mesothelioma in an inguinal hernial sac: an unusual presentation.

Malignant peritoneal mesothelioma, which is a rare neoplasm, usually presents with abdominal complaints. Though such tumours have been reported from tunica vaginalis testis presenting as para-testicular mass, there is only one documented case of the tumour arising from the inguinal hernial sac. In this paper, we are reporting a rare presentation of this tumour.

Intrapericardial benign teratoma with unusual presentation.

Benign teratoma, also referred as dermoid cyst, do occur in the mediastinum. However, their intrapericardial location has been reported very occasionally. This case of intrapericardial benign solid teratoma is being presented because of its rarity and its unusual presentation as a case of empyema, with features of cardiac compression and pericardial effusion.

Conjunctival impression cytology in xerophthalmia among rural children.

The advent of Conjunctival Impression Cytology (CIC) has opened a new chapter in the detection of Vitamin A deficiency as it is a simplified field technique. The need for such a technique was of paramount importance in India where as estimated 5 to 7 percent children suffer from eye signs of Vitamin A deficiency. In the present study the results of clinical evaluation of apparently healthy children and those having clinical sings and symptoms of Vitamin A deficiency have been compared with CIC results. Serum Vitamin A levels have also been estimated wherever possible. The findings indicate that CIC results are superior to the clinical assessment and it is suggested that CIC can be used as screening tool for children of school going age (and earlier) for early detection and correction of Vitamin A deficiency.

Urinary calcium creatinine ratio and hypercalciuria.

Random urine samples of 352 children in the age group of 5-12 yrs were studied for urinary calcium-creatinine ratio (Uca/Ucr mg/mg). None had any predisposing factor for secondary hypercalciuria. Calcium and creatinine both were estimated by colorimetric method. We observed that Uca/Ucr in the general pediatric population was skewed, the pattern was similar to that described in western children and it was independent of age and sex. The mean and standard deviation (SD) of Uca/Ucr was 0.10 +/- 0.094. Considering mean +2SD as the upper limit of normal, which was 0.29 in this series, the prevalence of hypercalciuria was 6.5%.