Safety profile of G-CSF in chemotherapy-induced neutropenia: A prospective observational study in Eastern India.

Background: Granulocyte-colony stimulating factor (G-CSF) is used in cancer patients to treat chemotherapy-induced neutropenia (CIN). However, G-CSF poses few risks. Despite the regular use of G-CSF in CIN management, there is a paucity of published data on its safety profile in the management of CIN in India. Hence, the present study was designed to demonstrate the safety profile of G-CSF in patients with CIN. Methods: A prospective observational study was conducted over a period of 5 months enrolling 100 cancer patients aged from 18 years to 70 years. Patients with a diagnosis of CIN who received G-CSF were included. Patients were followed up for 15 days. Adverse events (AEs) were graded according to US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The system organ class and preferred term of Medical Dictionary for Regulatory Activities (MedDRA) were used for reporting the AEs. Causality assessment was done by using the WHO-Uppsala Monitoring Centre scale. Results: The most frequently reported AEs were musculoskeletal and connective tissue disorders which included bone pain, myalgia, arthralgia, and pain in the extremity. Other AEs reported were general disorders and administration site conditions, and gastrointestinal disorders. The highest grade of toxicity reported was of grade 3 among all AEs. The majority of AEs had a "probable" type of causality relationship with G-CSF. Conclusion: ">G-CSF has a safety profile consistent with previous G-CSF studies.

Pretomanid: The latest USFDA-approved anti-tuberculosis drug.

Pretomanid is a nitroimidazooxazine drug which inhibits synthesis of mycolic acid. This leads to defective cell wall formation, ultimately causing bacterial cell death. It is active against both replicating and non-replicating M. tuberculosis. Following promising result in a phase III trial, pretomanid was approved by United States Food and Drug Administration in August 2019. This orally active drug has been approved as part of a combination regimen of bedaquiline, pretomanid and linezolid (BPaL regimen) to treat adults with pulmonary extensive drug resistant tuberculosis (TB) or treatment-intolerant or non-responsive multidrug resistant TB. Peripheral neuropathy and increased liver enzymes are some of the reported adverse events associated with pretomanid. However, more studies are required to confirm the role of pretomanid in paediatric, geriatric and HIV co-infection cases.

Low-dose olanzapine, sedation and chemotherapy-induced nausea and vomiting: a prospective randomized controlled study.

Aims: Comparison of efficacy, safety and sedation between two doses of olanzapine in the control of chemotherapy-induced nausea and vomiting (CINV). Patients & methods: A prospective, randomized, double-blind, controlled study was conducted, enrolling 68 patients receiving a single-day cycle of high and moderately emetogenic chemotherapy. Patients received either of olanzapine 5 mg or 10 mg from day 1 through 3 in addition to ondansetron and dexamethasone. Control of CINV, nausea, sedation, quality of life (QoL) and adverse events were compared. Results: Nausea, emesis control and improvement of QoL were similar in both groups. Sedation severity was 133% higher with 10 mg olanzapine. Conclusions: Lower dose olanzapine is effective to control CINV with significantly reduced sedation.

Lay abstract Methods to prevent chemotherapy-induced nausea and vomiting (CINV) are often not sufficient for patients. Olanzapine, along with other similar drugs (antiemetics), improved control but is often sedating. In this study, a lower dose of olanzapine was compared with the conventional dose. Patients on cancer chemotherapy, which has high occurrence of nausea and vomiting, were given either the low dose or the conventional dose of olanzapine for 3 days, in addition to some other antiemetic agents. Control of nausea and vomiting was reasonably achieved with both doses of olanzapine. The lower dose was significantly less sedating. There were no serious side effects with either doses.

Efficacy and safety of modafinil versus dexamethasone in cancer-related fatigue: a prospective randomized controlled study.

The aim of this study was to compare the efficacy and safety of modafinil and dexamethasone in the management of cancer-related fatigue and their effects on quality of life (QoL). A prospective randomized controlled study was conducted, enrolling 80 cancer patients experiencing moderate or severe fatigue following at least three cycles of chemotherapy or a course of palliative/curative radiotherapy. Patients received either oral modafinil 100 mg or dexamethasone 4 mg daily for 14 days. Levels of fatigue, QoL and symptom severity were compared after 14-21 days. Both drugs were efficacious and safe in the management of fatigue and QoL. However, modafinil performed marginally better. Although modafinil demonstrated marginal superiority, both modafinil and dexamethasone can improve fatigue and QoL in cancer patients. Clinical trials registry of India: CTRI/2018/05/014046 (www.ctri.nic.in).

Lay abstract Cancer-related fatigue is a common and nagging problem that needs best evidence-based management. Modafinil, a brain stimulant, and dexamethasone, a corticosteroid, have been shown in separate studies to provide benefit, but there are little data regarding which one is superior. The present study compared modafinil with dexamethasone in a randomized controlled trial. Modafinil was found to be marginally superior in treating cancer-related fatigue and several domains of quality of life, though dexamethasone also demonstrated significant improvement of fatigue. This study provides a valuable guide for future larger studies for implementation of the findings in the form of better patient care.

A Randomized Controlled Trial to Compare the Efficacy, Safety and Tolerability of Asenapine versus Olanzapine in Management of Schizophrenia.

OBJECTIVE: : Schizophrenia is a serious disease characterized by impairment in the perception or expression of reality, leading to occupational and social dysfunction. The use of antipsychotic medication is now universal in the first-line treatment of schizophrenia. This study was undertaken to compare the efficacy of asenapine with a standard atypical antipsychotic, olanzapine in treating this disease. METHODS: It was designed as a single blind, randomized, controlled, parallel group, single centre Phase IV trial of a newer atypical antipsychotic, asenapine versus existing standard atypical antipsychotic, olanzapine. Total 80 subjects were enrolled as per eligibility criteria.Each recruited subject received daily treatment with the trial medication (Olanzapine 10 mg or Asenapine 10 mg daily) for duration of 12 weeks. BPRS, CGI-S, CGI-I, Laboratory parameters and compliance was assessed and analyzed. Continuous variables were compared by t test and non-parametric data was analyzed by Mann-Whitney U test and Wilcoxon signed rank test. Likely categorical variables were analyzed by chi-square test or Fisher's exact test, as appropriate. RESULTS: The duration of schizophrenia at presentation was comparable in both the treatment groups. There was significant reduction of BPRS score between any two visits of each treatment groups. The decline in CGI-S and CGI-I scores was statistically significant (p < 0.001) when compared between visits of any of the both treatment arms. Adherence to treatment was excellent for all patients. CONCLUSION: Newer atypical antipsychotic asenapine is more effective than standard olanzapine in reducing the symptoms of schizophrenia in this study and further larger studies are to be done.

Comparative evaluation of aqueous and plasma concentration of topical moxifloxacin alone and with flurbiprofen in patients of cataract surgery.

OBJECTIVES: To determine the aqueous and plasma concentrations of moxifloxacin administered topically alone and with flurbiprofen in patients undergoing cataract surgery. MATERIALS AND METHODS: A total of 50 subjects scheduled for routine cataract surgery were randomly allocated to two groups (n = 25 each). Group-1 patients were treated with topical moxifloxacin alone: One drop 6 times/day for 3 days before surgery and one drop 4 times on the day of surgery: Group-2 patients were treated with topical moxifloxacin as in Group-1 and with topical flurbiprofen: One drop 4 times/day for 3 days before and on the day of surgery. The interval between two drugs was 30 min for last 3 days and 15 min on the day of surgery. Last dose was administered 1 h before aqueous humor and blood sampling for both the groups. The antibiotic concentration in aqueous humor and plasma were determined by using high performance liquid chromatography. RESULTS: The mean concentration of moxifloxacin in aqueous humor was 1.71 ± 0.82 mg/ml in Group-1 and 2.39 ± 1.34 mg/ml in Group-2. Concentrations of moxifloxacin in aqueous humor were significantly higher in Group-2 than that of Group-1. CONCLUSION: Flurbiprofen may increase the concentration of moxifloxacin in aqueous humor.

Corneal ulcer with Scopulariopsis brevicaulis and Staphylococcus aureus--a rare case report.

Scopulariopsis brevicaulis is a saprophytic fungus, found in soil. It causes human nail infection. Corneal ulcer with this organism is unusual. Here a case of a 36-year-old farmer is reported who developed a paracentral corneal ulcer in the right eye. The ulcer was caused by mixed infection with Staphylococcus aureus and Scopulariopsis brevicaulis. It was treated with topical natamycin 5% and moxifloxacin 0.5% drops. This is a unique case of corneal ulcer with mixed infection of Staphylococcus aureus and Scopulariopsis brevicaulis without any history of trauma, which was treated successfully, resulting in a minimal corneal opacity.

Effect of dacryocystorhinostomy on systemic adverse effects of topical timolol maleate.

PURPOSE: To evaluate whether transformation of the naso-lacrimal passage as happens after dacryocystorhinostomy (DCR) operation has any effect on the systemic adverse effects of topically administered timolol maleate. MATERIALS AND METHODS: Fifty otherwise healthy adult patients without any prior history of cardiac or pulmonary problems scheduled for elective DCR surgery received a drop of timolol maleate 0.5% on the healthy eye. This eye served as a control. Six weeks after successful DCR surgery, the operated eye received the same medication. Parameters compared included intraocular pressure (IOP), pulse rate, blood pressure and forced expiratory volume in the first second (FEV1) findings. OBSERVATIONS: Post DCR patients showed an increased incidence of reduced pulse rate and FEV1. CONCLUSION: Timolol maleate ophthalmic preparation should be used with caution in post-DCR patients.

Impact of increased rate of caesarean section on perinatal outcome: sociolegal evaluation.

Sharp rise in the caesarean section rate, over the past years has been causing lot of concerns. It is to be evaluated whether the decrease in perinatal mortality rate is due to the rising rate of caesarean section. Five hundred consecutive patients were selected on whom caesarean section had been performed. Both mother and baby were followed till they are discharged from the hospital. Foetal distress was the commonest indication in primigravidae who underwent caesarean section. The other indications of caesarean section in this study were breech, severe pre-eclampsia, eclampsia, cord prolapse, elderly primi, postdated, premature rupture of membrane, twin, compound presentation, meconium stained liquor. The occurrence of perinatal morbidity in caesarean section was 10% compared to 12% in vaginal delivery. Common causes of perinatal morbidity were asphyxia, prematurity, diarrhoea, septicaemia, jaundice, conjunctivitis and scalp injury. The occurrence of perinatal mortality in caesarean section was 3.8% compared to 3% in vaginal delivery. Causes of perinatal mortality were stillbirth, meconium aspiration syndrome, hypoxic ischaemic encephalopathy, prematurity and congenital malformation. In spite of safety of vaginal birth after caesarean section it continues to be underutilised. Good perinatal care proper screening and use of newer effective pharmacological agents improve the maternal progress as well as perinatal outcome without increasing the caesarean section rate.

Trends to access internet among medical students of a government medical college in West Bengal.

The use of computer and information technology is on an escalation. The internet, one of the key developments in this field, provides instant access to latest medical information. The present study was conducted (i) to estimate the extent and purpose of internet usage among undergraduate (UG) and postgraduate (PG) medical students, (ii) to identify factors that encourage the students to use internet for medical information, (iii) to assess the need for incorporating computer education in medical curriculum. A prospective, cross-sectional, questionnaire-based study was conducted on 150 students of Burdwan Medical College and Hospital between June 2009 and December 2009. Majority of the students accessed internet from their home PC (42% UGs and 52% PGs).Common search engines browsed commonly by both UGs and PGs include Google and yahoo. Regarding principles of telemedicine and evidence-based medicine, majority of the PGs are well versed while UGs are not (p-value 0.0001). Almost all students agreed to incorporate computer education in medical curriculum. Primary source of medical information was textbook for UGs (62%) and internet for the PGs (48%). Majority of UGs (48%) used internet as a ready source of information thus saving time while PGs (68%) primarily relied on internet for recent advances in their disciplines. The primary purposes of internet use are educational for both UGs and PGs. The data obtained indicates that majority of the medical students participating in the present study embrace and use internet to access medical information. It also justifies the need to incorporate internet and associated information technology into existing medical curriculum.

Pharmaco-epidcemiology of drugs utilised for cataract surgery in a government medical college and hospital.

Prescription audit is a powerful tool for rational prescription. To evaluate pharmaco-epidemiology of drugs utilised for cataract surgery, a retrospective study was conducted in the department of pharmacology, RG Kar Medical College, Kolkata. Data from bed head tickets of one year, available in medical record section, were collected in case report forms and analysed. Utilisation pattern of drugs like dosage form, dose, route and frequency of administration and duration of therapy were audited. Drug prescription versus therapeutic indication was also evaluated. Price of the prescribed drugs was evaluated for rationality towards cost-effective prescription. For 848 cases of cataract surgery, drugs were prescribed pre-, per- and post-operatively. Different fluoroquinolone antibiotics, anti-inflammatory and mydriatic-cycloplegic agents were prescribed. High or low cost drugs were prescribed both in generic (52%) and brand (48%) names. Few Latin abbreviations were used in directions. Different parameters and study results were discussed from various aspects to explore their social impacts. Though prescription pattern was almost rational, some parts need improvement. Healthcare provider should be aware of cost-effectiveness of the prescribed drugs for the benefit of patients to provide a rational prescription.

Study of victims of organophosphorus compound poisoning: evaluation after medicolegal autopsy.

Indiscriminate use of organophosphorus compounds (OPC) increases the potential threat of self-poisoning and death. To make a conclusive diagnosis on academic interest a retrospective record-based study was undertaken. Postautopsy studies were carried out on 100 victims of OPC poisoning by collecting data from following 3 sources: Medicolegal autopsy reports, inquest reports, and inpatient case sheets. Mode of ingestion of OPC was to commit suicide. Incidence was more in 20 to 30 years age group, in females and in urban area. Diagnosis was confirmed by history of poison exposure, clinically well-defined cholinergic effects, and characteristic autopsy findings. Early and correct identification of the cause of poisoning enables specific treatment. Restrictions on access of very toxic pesticides through national policies and enforcement, public education on storage and safe use, early recognition of poisoning, and appropriate medical management may reduce the incidence of poisoning and death.

Comparative evaluation of the efficacy of four topical medications individually or in combination to treat grade I acne vulgaris.

A randomised study was carried out to evaluate the efficacy of four topical medications individually and in combination to treat grade I acne vulgaris which is characterised by mild lesions (< 10 in one side of face) consisting of predominantly comedones with occasional pustules in oily skin. Maintaining the inclusion and exclusion criteria 100 patients were selected and divided into 5 groups to receive different topical drugs at random basis in the dermatology OPD. Topical medication given to them is mentioned below against each group: Group I--retinonic acid, group II--benzoyl peroxide, group III--clindamycin, group IV--cleanser and group V--all the four medications. The patients were observed for reduction in number of comedones, suppression of papulopustules with healing rate, effects on facial skin, and rate of recurrence. Results were observed according to the groups. In group I old acne was reduced in size and gradually cleared off (80%). Recurrence was few with appearance of new microcomedones which were cleared off within short time. Skin became smoother and fresh. Texture became lighter in colour. In group II whiteheads were reduced at about 70% in number. Rate of recurrence was normal. Skin became rough and dry. In group III pustular acne healed better and faster. In group IV acne of oily skin healed better and faster. Rate of recurrence was normal. Skin became fresh and oil-free. In group V reduction of lesions was very much significant (90%) with quick healing rate of the comedones. Recurrence was normal but delayed. Skin became smoother, finer and fresher. So, combination therapy is better. Cleanser is always helpful even without medications.

Conjunctival intra-epithelial neoplasia in a young Indian male with human immunodeficiency virus (HIV) infection.

Conjunctival intra-epithelial neoplasia is a disease of the elderly but recently this ocular surface tumour has been observed in younger age group specially who are serologically human immunodeficiency virus (HIV)-positive. Here a case of conjunctival intra-epithelial neoplasia of a 38-year-old male who was HIV-positive from Kolkata is reported. The patient presented with a growth at limbus in his left eye. Excision of the mass under local anaesthesia was done. Biopsy report confirmed conjunctival intra-epithelial neoplasia. The serological tests for HIV were found positive.

Review of ocular leprosy.

Leprosy, a chronic infectious disease caused by Mycobacterium leprae, affects peripheral nerves and skin. Eye is also frequently affected, partial or total loss of vision is especially tragic in leprosy. But ocular leprosy is still neglected by the leprosy workers due to lack of knowledge, and is also often overlooked even by the ophthalmologists. Here, an update review of ocular leprosy has been attempted regarding its epidemiology, clinical features, pathology, management and prevention under one umbrella.