ABSTRACT
Background: Inhalers containing corticosteroid and a long acting ?2 agonist (LABA) are widely used in asthma treatment. This study assessed the patient sensory perception and satisfaction of budesonide/formoterol fixed dose combination by pressurized metered dose inhalers (pMDI) with spacer and dry powder inhalers (DPI) in patients of moderate persistent asthma.Methods: This was a 6 week prospective, randomized, open label, comparative, parallel group clinical study. All patients had a forced expiratory volume in 1 second (FEV1) of 60-80% predicted normal. The patients were assessed for sensory perception and satisfaction in group I (pMDIs with spacers) and group II (DPIs) using patient evaluation questionnaire (PEQ) and patient satisfaction and preference questionnaire (PASAPQ) at the end of 6th week.Results: In PEQ, statistical analysis of the mean attribute ratings showed that both the devices were easy to use by patients. More medication was felt reaching throat using DPIs. Patients on DPI liked the taste and felt it to be less strong than patients on pMDIs. The overall liking was statistically comparable in two groups. In PASAPQ, the patients on DPI group were very satisfied with the treatment than pMDI (p<0.05).Conclusion: Overall liking of both DPIs and pMDIs was comparable and patients on DPI were satisfied more with the treatment device. Patient sensory perception and satisfaction may be taken into account in selecting device to improve compliance to treatment.
ABSTRACT
Ovulatory dysfunction is one of the leading causes of female infertility. Clomiphene citrate has emerged as a boon in the induction of ovulation in the human female. Clomiphene results in many adverse effects some of which are documented, and some reported spontaneously. Clomiphene citrate is a non-racemic mixture of two isomers, zuclomiphene and enclomiphene, having individual and opposite biological actions. It is accepted that cis isomer (zuclomiphene) is estrogenic and trans isomer (enclomiphene) is anti-estrogenic. Zuclomiphene does not have any ovulation-induction propertybut gets accumulated for a longer time in the human body and it has more agonistic activity than enclomiphene. Thus, Zuclomiphene may be responsible for the adverse effects by clomiphene citrate. Enclomiphene is being explored for its potential use in male as well as female infertility. Trails are underway to explore its effectiveness and safety in various disorders. This article highlights the pharmacology of Clomiphene with respect to its isomers and the potential uses of enclomiphene based on evidences available.
ABSTRACT
Background: Adverse drug reactions (ADRs) are among top 10 causes of mortality in patients. Pharmacovigilance programme of India (PvPI) is a step towards participation in the WHO programme for International Drug Safety Monitoring. The present article is an evaluation of the incidence and the patterns of ADRs from the reports collected from various clinical departments of this hospital. Methods: A total of 859 suspected ADR reports submitted to the pharmacovigilance unit at Department of Pharmacology under PvPI were evaluated for 6 months with respect to demographics, causative drug, organ system involvement, severity and seriousness of ADRs. The causality assessment was carried out by using WHO assessment method and Naranjo’s scale. Results: Males experienced more (66.33%) ADRs. The highest percentage (45.83%) of ADRs was seen in the age group of 46-60 years (35.33%), followed by 16-30 years (25.5%). The most common drug group causing ADRs was antimicrobials (43.37%), followed by anticancer and immunosuppressive agents (29.02%). The gastrointestinal system (31.43%) was most prone system, followed by generalized body reactions (22.93%) and cutaneous reactions (17.11%). 662 (77%) ADRs were non-serious, 197 (22.9%) were serious. On severity scale, 682 (79.39%) were mild, 168 (19.65%) moderate and only 9 (1.05%) ADRs were severe out of which three were fatal. As per WHO assessment method 66.94% ADRs were probable and 33.06% possible. The probability was comparable with Naranjo’s scale. Conclusion: ADRs to drugs happen commonly, and their reporting is important for the early recognition and prevention of ADRs and will also help in generating signals. ADR monitoring not only acts as an alerting mechanism for physicians, but helps the regulatory authorities in making the policy decision.