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1.
J Clin Pharmacol ; 58(11): 1406-1417, 2018 11.
Article in English | MEDLINE | ID: mdl-29799622

ABSTRACT

This observational, prospective, single-center study was conducted to evaluate the efficacy and safety of commonly prescribed drugs for zoster-associated pain and their impact on quality of sleep at a tertiary care hospital in western India. Patients ≥18 years of age, newly diagnosed with zoster-associated pain were evaluated on days 0, 7, 14, 30, 60, 90, 120, 150, and 180 or until resolution of pain, whichever was earlier, using the Wong Baker FACES Pain Rating Scale, Neuropathic Pain Scale, and Insomnia Severity Index for intensity of pain, quality of pain, and quality of sleep, respectively. A total of 78 patients (46.0 [16.3] years) completed the study. They received nonsteroidal anti-inflammatory drugs (65), gabapentin (30), amitriptyline (27), and amitriptyline + gabapentin (21) for mean durations of 7.7 (3.0), 89.2 (7.2), 107.6 (46.3), and 104.5 (46) days, respectively. Improvement in the Wong Baker FACES Pain Rating Scale and Neuropathic Pain Scale score was similar among treatment groups except for a greater fall in Wong Baker FACES Pain Rating Scale score at days 7 and 120 and that in deep pain score at day 7 in combination treatment group vs the amitriptyline group. Clinically significant insomnia was detected in 35 patients at baseline and demonstrated progressive and similar improvement among groups. Treatment modification was required in 20 patients. Zoster-associated pain resolved in 69 patients. Nine adverse drug reactions, mostly mild, nonserious, and nonpreventable, were reported. To conclude, drugs commonly used for zoster-associated pain are effective and well tolerated. These have a similar effect on pain and quality of sleep, except for a possible greater effect of combination treatment in the early phase of intense and deep pain.


Subject(s)
Amitriptyline/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Gabapentin/therapeutic use , Neuralgia/drug therapy , Adolescent , Adult , Aged , Aged, 80 and over , Amitriptyline/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Drug Therapy, Combination , Female , Gabapentin/adverse effects , Herpes Zoster/complications , Humans , India , Male , Middle Aged , Pain Measurement , Prospective Studies , Sleep , Treatment Outcome
2.
Asian J Transfus Sci ; 11(2): 180-187, 2017.
Article in English | MEDLINE | ID: mdl-28970688

ABSTRACT

BACKGROUND: Use of blood and its components is lifesaving. However, their use is often associated with adverse events. OBJECTIVE: To analyze the pattern of adverse reactions associated with transfusion of blood and its components in pediatric and surgical patients at a tertiary care teaching hospital. MATERIALS AND METHODS: Patients receiving transfusion of blood or its components in a randomly selected unit each from Departments of Pediatrics, including thalassemia OPD and surgery, were monitored intensively for a period of 6 months. Clinical course, management, outcome, causality, severity, seriousness, and preventability of observed transfusion reactions (TRs) were analyzed. RESULTS: A total of 411 pediatric and 433 surgical patients received 594 and 745 transfusions respectively during the study period. Of these, TRs were observed in 69 (11.6%) children and 63 (8.4%) surgical patients. Majority of reactions in children (48, 69.5%) and surgical patients (51, 80.9%) were acute, developing within 24 h of transfusion. TRs were observed with packed cells (13.2%), cryoprecipitate (10%), platelet concentrate (14.3%) and fresh frozen plasma (1.3%) in pediatric patients and with packed cells (7.2%), whole blood (25%) and platelet concentrate (62.5%) in surgical patients. Most common TRs included febrile nonhemolytic TRs (FNHTRs) and allergic reactions. Reactions were more frequent in patients with a previous history of transfusion or those receiving more than one transfusion and in children, when transfusion was initiated after 30 min of issue of blood component. Majority of reactions were managed with symptomatic treatment, were nonserious, moderately severe, probably preventable and probably associated with the suspect blood component in both populations. CONCLUSION: Transfusion reactions in children and surgical patients are commonly observed with cellular blood components. Majority of reactions are acute and nonserious. FNHTRs and allergic reactions are the most common transfusion reactions. Risk of transfusion reactions is more in patients receiving multiple transfusions.

3.
Indian J Med Paediatr Oncol ; 38(2): 103-110, 2017.
Article in English | MEDLINE | ID: mdl-28900315

ABSTRACT

OBJECTIVE: To evaluate efficacy, safety and utilization pattern of deferasirox in paediatric patients of transfusion dependant ß Thalassemia Major at a tertiary care teaching hospital in Gujarat. MATERIALS AND METHODS: This observational, prospective-retrospective, single centre, continuous study was conducted in a tertiary care teaching hospital among paediatric patients of transfusion dependent ß Thalassemia Major. Patients treated with deferasirox for not more than 12 weeks were enrolled. Details of blood transfusions, relevant investigations performed every 3 weeks and 3 months and drugs used were recorded in a pretested case record form. Parents were provided with a diary to record the details of ADRs. Data were analyzed for demographic characteristics, number and mean volume of blood transfusions, changes in serum ferritin and iron levels, number and types of ADRs and progression, causality, severity and preventability of ADRs. RESULTS: Of the 60 patients enrolled, one patient was lost to follow up and four withdrew their consent. Of the remaining 55 patients, 36 were boys and 19 were girls (mean age: 6 ± 3.14 years), including patients of 1-3 years (11), 4-6 years (24), 7-10 years (12) and 11-12 years (8). Thirty six patients were born of consanguineous marriages. Adherence to blood transfusion guidelines and deferasirox prescribing and administration guidelines was observed. A serial and significant decrease in mean serum ferritin and serum iron at 3 weeks and 3 months with deferasirox treatment was observed in all age groups except that of 11-12 years. A total of 117 ADRs were observed in 52 patients from 19498 doses, most common being diarrhea (24), raised serum creatinine (15), raised hepatic enzymes (14), abdominal pain (14) and rashes (14). A reduction in dose was required in 32 cases, while a temporary stoppage was indicated in 41 cases. Deferasirox was the possible and probable cause of 65 and 51 ADRs respectively as assessed by WHO-UMC scale. Majority of ADRs were definitely preventable and mild in nature. CONCLUSION: ß Thalassemia Major is more common in males. A rational prescribing of deferasirox was observed. Deferasirox effectively reduced serum ferritin and serum iron levels in these patients.

4.
J Basic Clin Pharm ; 8(1): 4-7, 2016 Dec.
Article in English | MEDLINE | ID: mdl-28104967

ABSTRACT

OBJECTIVES: To evaluate the knowledge, attitude and practice of consumers in India about disposal of unused medicines. MATERIALS AND METHODS: A questionnaire comprising 11 questions evaluating the Knowledge (2), Attitude (3) and Practice (6) of unused medicines was prepared and pre validated before administering to 200 consumers of medicines attending the outpatient department of Civil Hospital Ahmedabad, a tertiary care teaching hospital in Western India. Requisite permissions from Institutional Ethics Committee and informed consent were obtained prior to recruiting them for the study. Responses were recorded, in Microsoft Excel® spreadsheet and evaluated for percentage response. RESULTS: Majority of the respondents (136, 68%) stored unused medicines at home. Analgesics (26.5%) were the most common unused medicine stored. Safe disposal of medicine was considered necessary by majority respondents (160, 80%) for different reasons like prevention of illegal/unintended use (84, 42%), prevention of environmental pollution (32, 16%) or possible ADR caused by old drugs (54, 27%). Only 78 (39%) respondents were aware of appropriate methods of disposal. Disposal in household trash (61, 30.5%) was the most common method used. Majority of respondents felt the need for a facility or programme to collect unused medicines (152, 76%) and an increased awareness among consumers regarding hazards and methods of disposal of unused medicines (154, 77%). CONCLUSION: Majority of consumers are aware about the need for safe disposal of unused medicines. But the right attitude for and practice of safe disposal of medicines is lacking. A need for increased awareness regarding safe disposal of medicines is acknowledged by majority of consumers.

5.
Indian J Pharmacol ; 45(5): 447-52, 2013.
Article in English | MEDLINE | ID: mdl-24130377

ABSTRACT

OBJECTIVES: To assess the efficacy and safety of anti-tuberculosis drugs in HIV-positive patients at a tertiary care teaching hospital. MATERIALS AND METHODS: As a part of an ongoing study of opportunistic infections (OIs) in HIV-positive patients, drug treatment in patients suffering from tuberculosis was assessed to determine its efficacy and safety. Based on prevalence data for last three years, a purposive sampling of study population was carried out in this observational, prospective, single centre study. Tuberculosis (TB) was the most common OI observed. The selected patients were followed up for a period of one year to evaluate the clinical course and outcome of OIs, and the efficacy and safety of drugs used was checked. RESULTS: Tuberculosis was observed in 89 out of 134 enrolled patients. These included 79 adults and 10 children. Males (66.2%) were commonly affected. Extra pulmonary TB (73%) was the most common manifestation with abdominal TB observed in 55 (61.7%) patients. All patients were treated in accordance with the Revised National Tuberculosis Control Programme (RNTCP) guidelines as recommended by National AIDS Control Organization (NACO), India. Outcome of TB was assessable in 70 patients. Majority (82.8%) of the patients were cured, while 12 patients (17.1%) died during the course of treatment. A total of 149 ADRs were observed in 67 (75.2%) patients. Majority of ADRs (n = 147) were non-serious and did not warrant a change in therapy. Discoloration of urine was the most common ADR observed. CONCLUSION: TB is the most common opportunistic infection in HIV-positive patients with abdominal TB being the most common manifestation. RNTCP and NACO guidelines are adhered to in these patients. Anti-tuberculosis drugs are well tolerated and effective in majority of the patients.


Subject(s)
AIDS-Related Opportunistic Infections/drug therapy , Antitubercular Agents/therapeutic use , Tuberculosis/drug therapy , Adult , Child , Female , Humans , Male , Prospective Studies
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