ABSTRACT
Background: Post-operative nausea and vomiting continues to be a common side effect of surgery and anaesthesia, affecting the economics of medical care, as well as the degree of patients’ satisfaction, comfort and quality of life.The objective of the present study were to compare the efficacy and safety of palonosetron versus placebo for prophylaxis of early onset (within 24 hours post-surgery) and late onset (24-72 hours post-surgery) post-operative nausea or vomiting in patients undergoing elective major surgery under general anaesthesia.Methods: A prospective, randomized, parallel group, two arm, double blind placebo controlled trial was conducted on n=100 indoor patients undergoing elective major surgeries were enrolled into the present study.Results: The patients showing complete response were 32 (64%) in palonosetron group and 19 (38%) in the placebo group (p<0.05) in the 0-24 hour time interval. The patients receiving palonosetron showed higher complete response rates in the 0-24 hour and 0-72 hour time intervals. 42 patients (84%) on palonosetron and 30 (60%) on placebo showed complete control of vomiting in 0-24 hour period. Adverse events related to the drug were reported in 5 patients (10%) in palonosetron group as compared to 3 patients (6%) in placebo group.Conclusions: A single prophylactic 0.075 mg IV dose of palonosetron effectively reduced the occurrence and severity of nausea and vomiting and delayed the time to emesis and treatment failure in the early as well as the overall postoperative period of 72 hours.
ABSTRACT
Background: First line Anti-TB therapy with rifampicin, isoniazid, pyrazinamide, and ethambutol / streptomycin is very effective. However, major adverse reactions to antituberculous drugs can cause significant morbidity and mortality. One of the main reasons for non?adherence to anti?TB therapy (ATT) is ADRs, even under DOTS. Present study was carried out in tertiary care hospital. The objective of the study was to evaluate types and frequency of ADRs in intensive and continuation phase of category I and II Anti-TB medication.Methods: A prospective observational study conducted in Department of TB- Chest and Medicine, Govt. Medical College, Aurangabad, Maharashtra, India. All the TB patients reporting at DOTS Center of institute were enrolled and monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire.Results: Total, n = 241 tuberculosis patients on DOTS therapy were enrolled for the study. Out of 241 patients, 17 were dropouts so 224 patients assessed for ADRs. 127 (56.69%) developed adverse drug reactions. The higher numbers of ADRs were observed in age group 31-40 yrs followed by 21-30 yrs, ADRs were more common in men. Pulmonary TB (73.66%) cases were more common than extra pulmonary TB. Majority of adverse drug reactions were Gastrointestinal (GI) problems (30.92%), followed by Liver dysfunction and Hepatotoxicity (20.39%) and skin problems (17.10%). The causality of ADRs, in majority cases were found to be Probable (56.57%). Around 19 patients require treatment interruption and most of the patients were managed with supportive medication without removing anti tubercular drug from regimen.Conclusions: ADRs are major limiting factor for completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.
ABSTRACT
Background: The emergence of drug resistant mycobacteria has become a significant public health problem world over creating an obstacle to effective TB control. ADRs are common in patients of MDR-TB on DOTs-Plus drug regimen. Present study was carried out in tertiary care hospital. Identification of types and frequency of adverse drug reactions in Intensive and continuation phase of MDR-TB Patients.Methods: It was a prospective observational study conducted in Department of TB- Chest and Medicine, Govt. Medical College, Aurangabad, Maharashtra, India. All the MDR-TB patients admitted at the directly observed treatment, short course plus (DOTS plus) Center at Medical College Hospital were enrolled and were monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire, respectively.Results: A total of 121 tuberculosis patients of MDR-TB on DOTS therapy were enrolled for the study. Out of 121 patients, 13 were dropouts, 6 died, 7 defaulted so 108 patients assessed for ADRs, 48 patients developed 61 (56.48%) adverse drug reactions. The higher numbers of ADRs were observed in age group 31-40yrs followed by 21-30yrs which were more common in men. Majority of adverse drug reactions were Gastrointestinal (GI) problems 32 (52.45%), followed by Ototoxicity 7 (11.48%) and Psychiatric Manifestations 6 (9.84%) and skin problems 3 (4.92%). On evaluation of the causality of ADRs, majority were found to be Possible (59.02%). The severity assessment showed that most of the patients ADRs were of moderate level (50.82%).Some patients required treatment withdrawal and replacement with other drug and most of the patients were managed with supportive medication without removing anti-tubercular drug from their treatment regimen.Conclusions: ADRs are major factor limiting completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.
ABSTRACT
Neuroactive steroids are the certain steroids that alter neuronal excitability via the cell surface through interaction with certain neurotransmitter receptors. Neuroactive steroids regulate physiological functions of the central nervous system and have possible therapeutic potential in neurological diseases. They have been shown to affect neuronal excitability via their interaction with the ligand-gated ion channel family, such as the GABAA receptor by acting genomically as well as nongenomically. Positive modulators of GABAA receptor have anticonvulsant action as they enhance GABAergic transmission thereby increasing the seizure threshold. By virtue of these properties, neurosteroids appear to be relevant to pathophysiology and pharmacological treatment of many neurological diseases including catamenial epilepsy, stress induced epilepsy, temporal lobe epilepsy, alcohol withdrawal seizures, infantile spasm and status epilepticus. So far, only synthetic neurosteroid, ganaxolone has been tried in treatment of epilepsy and has shown good efficacy and tolerability. But, human data of trials are limited and hence, large double-blinded, placebo-controlled, randomized clinical trials are required before their use. The paper reviews the biosynthesis and GABAA receptor modulation of neurosteroids and their potential role in epilepsy.
ABSTRACT
Postoperative care of cardiac surgical patients have shown important changes parallel to the surgical improvements in recent years. The post-operative approach to these patients is best directed by dividing their problems into the systems like cardiovascular care, Bleeding-Thrombosis and Transfusion Strategies, CNS care, Respiratory & renal care, Postoperative pain and sedation management and lastly managing complications if any. The present article explains the drugs as therapeutic agents used in management of post-operative bypass surgery.