Assessment of Prescribing Pattern and Safety Profile of Drugs Used in Intranasal Route in Paediatric Age Group of Patients in a Tertiary Care Hospital.

Background Recently there has been an increased preference for intranasal delivery of drugs due to highly vascular nasal mucosa, bypassing first pass metabolism and the blood brain barrier (BBB) lead in quick drug absorption to the systemic circulation and direct access to brain from olfactory region. For pediatric patients this route offers significant benefits over injections or oral routes, like increased compliance, easy administration, and minimal side effects. Objective Assessment of prescription pattern of drugs and safety profile of drugs used by intranasal route in paediatric age group. Method Our study was a prospective observational study paediatric age group of patients conducted in the departments of Pharmacology, Paediatrics and Otorhinolaryngology of Burdwan Medical College and Hospital, Burdwan. Data were collected in CRF and frequency distribution of collected data done. Microsoft Excel 2010 was used for analysis. Result Common age group was infants. Males were more in number. Most common indication was epistaxis. Intranasal drugs per prescription were 1.05. Most commonly prescribed intranasal drug was nasal saline. Nasal decongestant was the most common prescribed medication. Nasal drops were the most common dose formulation. Conclusion Intranasal drug prescribing in our study was mainly aimed for treating local problems, very few being for systemic action. Some prescribing indicators like prescribing by generic name and prescribing from national essential drug lists were acceptable with scope for improvement. Average number of drugs per prescription and antibiotic use was high. Adverse events after intranasal drug use were primarily local and nose related.

An Open Label Prospective Study on Evaluation of Safety and Efficacy of Cilnidipine Over Amlodipine in Stage 1 Hypertensive Patients.

Background Calcium channel blockers are considered the first line drug over renin-angiotensinaldosterone system inhibitor in black population and with renin-angiotensinaldosterone system inhibitor in non-black population with Hypertension. Amlodipine has longer biological half life and lower potential to stimulate SNS. But, is associated with reflex tachycardia and pedal oedema. Cilnidipine has potent inhibitory both on voltage gated L-type and N-type calcium channels with better anti-proteinuric effect and good tolerability. Hence, our study compared the efficacy, safety and compliance of cilnidipine over amlodipine in Stage 1 hypertensive subjects. Objective To find out antihypertensive and renoprotective effect of cilnidipine. Method The study was open-label, single centre, prospective, parallel design, randomized controlled was done in Outdoor Patient Department (OPD) of Medicine and Department of Pharmacology in Burdwan Medical College and Hospital (BMCH). Patients with stage 1 HTN received cilnidipine while the other group received amlodipine. There were 4 follow-up visits for each participant consisting of baseline, 1 week, 6 weeks and after 12 weeks. Clinical parameters including pulse rate, blood pressure and ankle oedema noted also laboratory investigations were done. Safety parameters with adverse events and compliance by traditional pill count method. Result Blood pressure was effectively decreased by both amlodipine and cilnidipine. Cilnidipine significantly decreased Pulse Rate while amlodipine increased it and the difference in Pulse Rate comparing both the groups was statistically significant. None of the ADRs were statistically significant except pedal oedema. Pedal oedema was noted only in amlodipine arm and was statistically significant. Compliance to both the drugs was excellent. Total cost of therapy was higher with cilnidipine. Conclusion Though amlodipine is preferred drug, cilnidipine should be a better alternative when we consider subjects with sympathetic over activity, proteinuria or pedal oedema.

Has Oxidative Stress any Role on Mechanisms of Aminophylline-Induced Seizures? An Animal Study.

BACKGROUND: Aminophylline can trigger seizures in patients without known underlying epilepsy or added risk factor for seizure exacerbation in epilepsy. Most of these seizures are difficult to control and are underappreciated compared to other drug toxicities. Despite a long clinical history of aminophylline-induced seizures, relatively little is known about the underlying molecular mechanisms that contribute to methylxanthine-induced seizure generation. OBJECTIVE: The present study evaluated the possible involvement of free radicals in aminophylline induced seizures in rat. METHOD: The rats were divided into two groups. The first group graded single doses of aminophylline from 100 to 300 mg/kg were administered intraperitoneally. On the basis of the results Aminophylline, a dose (300 mg/kg) producing tonic-clonic seizures and mortality in 100% animals was selected as control in the study. The second group were subjected to single antioxidant (Vitamin E or Vitamin C) or in combination for 45 days then single doses of aminophylline 300 mg/kg administered intraperitoneally to rats. RESULT: Aminophylline induced convulsions in rats in a dose-dependent manner, and both incidence of seizure and mortality were maximum at 300 mg/kg and there was significant increase of free radical generation. But though pre-treatment with antioxidants showed differential attenuating effects on aminophylline induced free radical generation as we all known but they were very much ineffective in antagonizing aminophylline induced seizures and post-seizure mortality by any appreciable extent. CONCLUSION: Though Aminophylline induces oxidative stress the results are suggestive that at least free radicals is not only cause of convulsiogenic effects and post-seizure mortality of aminophylline.

Stem cell transplant: An experience from eastern India.

BACKGROUND: Hematopoietic stem cell transplant using human leukocyte antigen (HLA)-matched sibling or unrelated bone marrow, or related or unrelated cord blood has been performed successfully to treat patients with different types of hematological malignancies, genetic disorders and hereditary immune deficiencies. Since 1983, stem cell transplantation has been carried out in different institutes of India. But, till then, no transplantation was performed in eastern India. MATERIALS AND METHODS: Our present study is reporting for the first time stem cell transplantation in eastern India. From August 2000 to June 2011 (with a 3-year gap for up-gradation), we have performed a total of 22 transplants. Thirteen patients (M:F:9:4) with indications of aplastic anemia, thalassaemia, acute myeloid leukemia and chronic myeloid leukemia underwent allogenic transplant, whereas autologous transplant was performed for nine patients (M:F:2:1) of multiple myeloma, Hodgkin's and non-Hodgkin's lymphoma and neuroblastoma. The median age of the patients was 19.6 years, with a range of 5 years 8 months to 52 years. Fourteen patients received myeloablative conditioning regime whereas eight patients received immunosuppressive and less myeloablative protocol. Sources of stem cells in case of allogenic transplant are bone marrow and related or unrelated umbilical cord blood and in case of autologous transplant, these are peripheral blood stem cells or self-bone marrow. Standard prophylactic medication was followed prior to transplants. RESULTS: A disease-free survival of 68.18% and overall survival of 86.3% were seen at the median follow-up period of 4.6 years. Common post-transplant complications were mucositis, infection, venoocclusive disease, graft versus host disease, hemorrhagic cystitis, etc. CONCLUSION: The use of cord blood as a source of stem cells has been proved inferior as compared with the bone marrow stem cell source in cases of thalassaemia in our institute and thus is not recommended for thalassaemia. But, it has been proved to be a very useful and effective stem cell source (both related and unrelated cord blood) in cases of aplastic anemia and other immunological disorders.

Imatinib mesylate therapy in patients of chronic myeloid leukemia with Philadelphia chromosome positive: an experience from eastern India.

Imatinib inhibits constitutively active BCR-ABL tyrosine kinase of chronic myeloid leukemia (CML). In a long term study it was found superior to interferon alfa plus cytarabine for newly diagnosed CML in the chronic phase. However, till date there is no major study to evaluate eastern Indian CML patients treated with imatinib mesylate. The aim of our study was to see the efficacy, tolerability, toxicity and safety of imatinib in eastern Indian subset of CML population. The present study enrolled 831 patients with CML out of which 197 were excluded due to various reasons of noncompliance, death and not being fit to receive the drug. The rest, 634 (76% of total enrolled) were selected for the evaluation. In the beginning of the study, 603 patients were in chronic phase, 27 in accelerated phase and 4 patients in blast crisis phase. Among 634 patients, 280 patients (44%) received previously either interferon alpha or hydroxyurea and other 354 patients (56%) were previously untreated. Complete hematological remission and major cytogenetic response were 91 and 67%, respectively after 1 year of treatment. Complete molecular remission was 35% after 1 year of treatment. Sixty-four patients (10.1%) were resistant to imatinib mesylate in 5 years. The disease free and overall survival at 60 months were 72.2 and 76.1% respectively. After 60 months of follow up, continuous treatment of chronic phase CML with imatinib as initial therapy was found to be safe and able to induce durable responses in a high proportion of patients.

A study of use of low dose aspirin in prevention of pregnancy induced hypertension.

Forty-six nulliparous women in third trimester of pregnancy with a raised blood pressure of 30 mm Hg (systolic) or/and 15 mm Hg (diastolic) or both, over baseline values were treated with 75 mg of aspirin per day. The results are compared with another 48 age, height, weight, and gestational period matched nulliparaous women with similar condition for trial selection, who were treated as control. There is considerable more number of cases in the control group than in aspirin treated group showing subsequent rise of BP, appearance of proteinuria, and severe pre-eclamptic toxaemia. The aspirin treated group showed increased mean gestational age at termination 39.4 +/- 2.6 weeks as against 38.2 +/- 3.4, increased foetal weight 2860 +/- 552 g as against 2540 +/- 720 g. No case of neonatal haemorrhagic manifestations or congenital malformations were seen. However not much result is obtained with aspirin therapy in cases with established pregnancy induced hypertension or with proteinuria. Hence it is concluded that aspirin therapy should be given to prevent pregnancy induced hypertension. As predictability of other screening tests are not unequivocal, criterion used in this series for screening may be used.

Use of calcium antagonist (nifedipine) in premature labour.

Effectiveness of nifedipine in suppressing premature uterine activity was studied on 20 normal pregnant women who received, depending on the frequency of uterine contractions and degree of cervical dilatation, 5-10 mg nifedipine orally 8 hourly till the uterine contractions were abolished followed by 5 mg 12 hourly up to 38 weeks of gestation. Another 20 age, gravida and gestational period matched normal pregnant women received 10 mg isoxsuprine hydrochloride orally 8 hourly till the uterine contractions were abolished, followed by 10 mg 12 hourly up to 38 weeks of gestation. Successful tocolysis was observed in 85% of cases receiving nifedipine in contrast to 40% of women receiving isoxsuprine hydrochloride. The mean time from presentation to delivery and mean birth weight were 21.8 days and 2510 g respectively in isoxsuprine hydrochloride treated cases and 34.2 days and 2750 g respectively in cases treated with nifedipine. In either group there were no serious untoward effects on mother, labour and baby.

Long-term survival after chemotherapy with cisplatinum, adriamycin and cyclophosphamide for carcinoma of the ovary.

Forty six patients with FIGO Stage II, III, and IV ovarian cancer received treatment with cisplatinum, adriamycin and cyclophosphamide. After a minimum follow-up time of 60 months 13 patients remain free of recurrence. The overall 5-year survival is 39% and the median survival is 39 months. The 5-year survival for Stages II, III, and IV is 64%, 40% and 0% respectively. The 5-year actuarial survival for those who had less than 2 cm residual disease (including those with complete debulking) is 72%, while for those who had greater than 2 cm residual disease (including those who had biopsy only) is 15%. None of the patients have developed any second neoplasm.