Background: NSAIDS are associated with side effects and research should continue for developing safer drugs. This study aims to evaluate newer thiazolidine-4-ones for their anti-inflammatory and ulcerogenic activities in wister rats.Methods: Five groups of wister rats, 6 in each were used. Anti-inflammatory and ulcerogenic activities of diclofenac (30mg/kg), nimesulide (50mg/kg), thia-1 (50mg/kg) and thia-2 (50mg/kg) are compared with control group (4% Gum Acacia). Carrageenin-induced paw edema, formaline induced acute peritonitis and cotton pellet-induced granulomatous tissue formation models were used for evaluating anti-inflammatory activity. After removing cotton pellets with granuloma on 8th day gastric ulcerogenicity was assessed by using macroscopic and microscopic scoring of ulcers.Results: Diclofenac, nimesulide and thia 2 reduced both paw edema and peritoneal exudate volume significantly (p <0.01). Wet weight of cotton pellets reduced significantly (p <0.01) by diclofenac, nimesulide and thia 2. Diclofenac (p <0.01) and thia 2 (p <0.05) reduced dry weight of cotton pellets significantly. nimesulide and thia-1 reduced it by 19.14% and 2.68% respectively and was considered statistically not significant (p>0.05). Nimesulide, thia-1 and thia-2 did not increase gastric ulcer score significantly (p >0.05). Diclofenac increased ulcer score significantly (p <0.01).Conclusions: Thia-2 demonstrated significant anti-inflammatory activity in acute and chronic models. In addition to inhibition of cyclooxygenase pathway, PPAR agonistic activity may be involved in its anti-inflammatory activity. No significant ulcerogenicity was observed on comparing with nimesulide and control. Further in-vitro and in-vivo studies are recommended to confirm the results of this study.
Background: Drug safety information about children is scarcely available. This study aims to describe the ADRs in hospitalized paediatric patients under 12 years of age in paediatrics wards of DM WIMS Hospital, Wayanad, Kerala, a tertiary care center in southern part of India.Methods: A retrospective study based on data collected as per the ongoing pharmacovigilance program of India (PvPI) was conducted for twelve months period in order to study the ADRs in hospitalized paediatric patients under 12 years of age with at least one medication prescribed. The study was conducted in paediatrics wards of DM WIMS Hospital, Wayanad. WHO-UMC scale and Naranjo´s Algorithm was used to evaluate causality, the modified Hartwig and Siegel assessment scale was used to establish severity and the Schumock and Thornton criteria was used to determine preventability.Results: Forty-two children (42) who experienced 55 ADRs were included in the study. The frequency was higher in children under 1 year of age (47.62%). Emergence of ADRs was higher in male patients (59.52%), in those used three or more medicines together (71.43%) and in those with systemic antibiotics (58.18%).Conclusions: Being the first study from Kerala in paediatric patients, it is an important contribution to drug safety profile in children from this region of India. ADRs frequency and other descriptive characteristics are provided for the enrolled children under 12 years of age. ADRs are an additional burden of morbidity and risk, particularly in those who used several medicines, including antibiotics.
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