Cases Of Adverse Drug Reactions Research Articles

Time to development of adverse drug reactions and associated factors among adult HIV positive patients on antiretroviral treatment in Bahir Dar City, Northwest Ethiopia.

BackgroundAdverse drug reactions (ADRs) are harmful and unintended reactions to medicines given at standard doses. Although the antiretroviral treatment (ART) changed the global HIV epidemic significantly, it’s associated adverse events is huge. Therefore, investigating the rate and development of ADRs of ART provides vital information for monitoring risks.MethodsRetrospective study was conducted among patients on ART from July1/2011—June 30/2016 at Felege Hiwot referral hospital. Data were collected using checklist and document review. The p-value and hazard ratio with its confidence interval was used to show presence and strength of association.ResultsA total of 602 subjects were studied. The rate of occurrence of major ADRs was 4.3/100PY. Patients with no formal and completed primary education were at higher risk of developing ADRs compared to those with higher level education [AHR = 8, 95% CI: 2.53–25.20, AHR = 4.9, 95% CI: 1.65–14.44]. The risks of ADRs among patients working in NGOs were more than four times compared to those in governmental organizations [AHR = 4.3, 95% CI: 1.42–13.31]. The risks of ADRs in WHO clinical stage II, III and IV were much higher than in stage I [AHR = 4, 95% CI: 1.33–11.93, AHR = 5.3, 95% CI: 2.02–13.79 and AHR = 7, 95% CI: 2.51–20.10] respectively. Moreover, patients didn’t receive OI prophylaxis were more three times at risk of ADRs compared to those received [AHR = 3.2, 95% CI: 1.47–7.08].ConclusionsMost of the ADRs cases were occurred within a year after initiation of ART. Educational status, occupation, advanced clinical stage and OI prophylaxis therapy were predictors ADRs. Continuous counseling for non-educated patients and clients in clinical stage II and above, and patients didn’t take OI prophylaxis need to get close follow up to prevent the associated ADRs by the concerned parties.

Retrospective analysis of adverse drug reactions in stomatology hospital from 2014 to 2016

This study aims to investigate the characteristics and general rules of adverse drug reactions (ADR) in a 3A-grade stomatology hospital for safe and rational drug use in clinical stomatology. We retrospectively analyzed 52 ADR cases (1∶1.36, males∶females) reported in the West China Hospital of Stomatology of Sichuan University from 2014 to 2016 in terms of gender and age distributions, drug categories, and clinical manifestations. Eight kinds of drugs and antibiotics were predominately used [24 cases, 46.15% (24/52)], followed by nutrition drugs and antitumor drugs. Cephalosporin was the leading antibiotic drug associated with ADR [20 cases, 83.33% (20/24)]. Intravenous infusion was the most common route of drug administration [49 cases, 94.23% (49/52)]. The most common manifestations of the ADR were damages of the skin and its appendages and lesions of the digestive and nervous systems. Strengthening the ADR monitoring system and further management should be implemented to alleviate ADR in stomatology hospitals.

Causality assessment and the severity of the adverse drug reactions in tertiary care hospital: a pharmacovigilance study

Background: Adverse drug reactions (ADRs) constitute a major clinical problem in terms of human suffering and increased health care costs. To study the adverse drug reactions reported in a tertiary care hospital and study of causality assessment and severity of adverse drug reaction (ADR) cases reported.Methods: A prospective observational study was conducted as part of pharmacovigilance program over 12months between September 2015 and August 2016. Adverse drug reactions reported from hospital were filled into Suspected ADR - CDSCO forms and submitted to pharmacovigilance unit. Causal relationship was assessed and categorized by Naranjo’s algorithm and WHO - UMC causality scale. The severity of each ADR was assessed using Modified Hartwig and Siegel scale.Results: Total 120 cases were reported over 12 months. Among them, 66% were in males and 55% were in females. The majority of ADRs were due to antimicrobial agents (40.78%) followed by haematinics (12%) and anti-epileptics (10%). Maximum number of patients (30.25%) reported with dermatological manifestations. Highest number of ADRs was reported from the department of medicine (45%). As per Naranjo’s scale, 54% reports were assessed as probable and 46% classified as possible. Majority of cases were mild to moderate in severity.Conclusions: The pattern of ADRs reported in our hospital is similar with the pattern of studies conducted in other hospitals elsewhere. This study provides a database of ADRs due to commonly used drugs in our hospital, which will help clinicians for their optimum and safe use. Hence effective pharmacovigilance is required for the use of these drugs and their safety assessment.

Проблема взаимозаменяемости противоэпилептических лекарственных препаратов

Обсуждаются проблемы взаимозаменяемости противоэпилептических лекарственных препаратов, имеющих 1 международное непатентованное наименование. Проведен анализ 2562 спонтанных сообщений российской базы данных за период 2009 по 2015 гг. c целью выявления информации о нежелательных реакциях, возникавших при замене указанных препаратов. Преобладали сообщения о нежелательных реакциях при замене препаратов вальпроевой кислоты (21,4 % от всех сообщений на данный препарат в базе данных), ламотриджина (20,0 %), топирамата (18,6 %). Для всех лекарственных препаратов превалировали случаи неэффективности при замене, которые проявлялись учащением судорожных припадков. Преимущественно референтный лекарственный препарат переносился хорошо, а замена на воспроизведенный препарат приводила к снижению эффективности или развитию нежелательных реакций. Результаты исследования показывают, что данные спонтанных сообщений возможно и необходимо использовать при оценке взаимозаменяемости противоэпилептических лекарственных препаратов и для проведения пострегистрационного контроля за лекарственными препаратами, которые уже признаны взаимозаменяемыми.

Adverse drug reactions reported to the drug and poison information center of Tehran, Iran.

BackgroundBurden of adverse drug reactions (ADRs), in home-environment and domestic settings, is unknown.ObjectiveTo discuss the epidemiology of reported ADRs to 13-Aban drug and poison information center (DPIC) and to discuss the burden of hospitalization caused by these ADRs from commonly implicated therapeutic groups.MethodsA retrospective analysis of the yellow card schemes of suspected ADRs reported to the 13-Aban DPIC was conducted from 21 March 2013 to 21 November 2016 inclusive.Main outcome measuresCharacteristics of the ADRs, such as the sex and age of the patient, the therapeutic group involved, and the medical outcome of the exposure, were examined. ADR Hospitalization (ADRH) index was calculated for each drug group by dividing the number of ADR-related hospitalizations with total number of reported ADR cases (n = 748), and then multiplying by 100.ResultsADRs were reported for 748 patients representing 5 cases per 1000 enquiries to the 13-Aban DPIC over almost 4-years of the study period. Public were responsible for reporting every 4 out of 5 ADR cases (n = 651, 87%) and the remaining 1 out of 5 ADR cases was reported by the health care professionals (n = 97, 13%). Most of the ADRs had a medical outcome documented as having a minor effect or were minimally bothersome to the patients (n = 509, 68%), and less than 4.9% (n = 37) were documented as having a major effect or were life-threatening. Overall, 7.4% (n = 55) of ADRs were resulted in hospitalization. Antibacterials for systemic use represented the therapeutic group with the highest hospitalization index (1.7%).ConclusionsThe study concluded that ADRs to antibiotics are common and some of them resulted in hospitalization.

O-24 Adrin 1 methodology study: adverse drug reactions in neonates: what are the best ways to evaluate suspected adverse drug reactions in neonates?

Background There are 90 000 babies admitted to neo-natal care units in the UK annually, and many of these require medications.1 Use of unlicensed and off-label medications is common in neonatal units, with accounting for up to 90% medicines.2 The incidence of adverse drug reactions (ADRs) in children is estimated to range between 0.6% and 16.8%, but the data specifically for neonates is limited.3 A number of tools exist to help clinicians to assess the causality of ADRs, but few have been validated in neonatal settings. This study aims to compare three existing methods for assessing causality of ADRs in a neonatal setting and to compare the outcomes be-tween tests and raters. Methods Following ethical approval, data were col-lected prospectively on suspected ADRs occurring in a tertiary neonatal care unit in the north of England over a five week period. Summaries of these cases were pre-sented to two investigators who undertook three sepa-rate causality assessments of each case using the Karch and Lasagna algorithm(KL), the Liverpool ADR Causality Assessment Tool (LCAT), and the New Adverse Drug Re-actions Algorithm for Infants in Neonatal Intensive Care Units(NAINICU).4,5,6 Inter-rater and inter-test statisti-cal analyses were performed. Results Causality assessments have been undertaken on 21 ADR cases reported from the unit to date. The KL algorithm rated 14.3% of cases as definite/likely, NAINICU 42.9% definite and LCAT 0% definite. Inter-rater reliability Kappa scores were 0.131, 0.136 and 0.294 for the 3 tools respectively. Inter-test reliability was greatest between the KL algorithm and the LCAT (Kappa 0.211) and least between NAINICU and LCAT (Kappa −0.149). Conclusion These three tools produced varied causali-ty assessment outcomes when used on neonatal ADRs. Marked inter-test and inter-rater variability was noted. The study is continuing to collect cases to help determine the optimal way to assess causaility in this popualtion.

Importance of Publishing Adverse Drug Reaction Case Reports: Promoting Public Health and Advancing Pharmacology and Therapeutics

This article, which encourages physicians to publish case reports of adverse drug reactions (ADRs), is a review of how well-documented published case reports have contributed to promoting public safety and health and thus served to advance basic pharmacology. The origin of a number of regulatory guidelines can ultimately be traced to safety concerns triggered by such reports. It illustrates how case reports of ADRs, when coupled with simultaneous monitoring of drug pharmacokinetics, have also led to further investigations resulting in major advances in pharmacology, especially pharmacogenetics, mechanisms of drug–drug interactions and modulation of drug metabolism during inflammatory co-morbidities. Published case reports differ significantly from spontaneous case reports since they enjoy quality-compliant peer review and an immediate wider visibility among the readership, triggering others to report similar cases, and ultimately leading to prescribing restrictions on or withdrawals of the drug from the market depending on the risk. Therefore, the reporter should not be discouraged by (a) the unusual or bizarre nature of the reaction; (b) the interval, however long, from commencing drug administration to the onset of the suspected reaction; (c) however well-known the drug or the period for which it has been on the market; and (d) any pressure not to publish. Case reports should be published in reputable journals that are searchable through databases such as PubMed.

Cost effectiveness analysis of HLA-B*58:01 genotyping prior to initiation of allopurinol for gout.

To determine whether prospective testing for HLA-B*58:01, as a strategy to prevent serious adverse reactions to allopurinol in patients with gout, is cost-effective from the perspective of the National Health Service in the UK. A systematic review and meta-analysis for the association of HLA-B*58:01 with cutaneous and hypersensitivity adverse drug reactions informed a decision analytic and Markov model to estimate lifetime costs and outcomes associated with testing vs standard care (with febuxostat prescribed for patients who test positive). Scenario analyses assessed alternative treatment assumptions and patient populations. The number of patients needed to test to prevent one case of adverse drug reaction was 11 286 (95% central range (CR): 2573, 53 594). Cost and quality-adjusted life-year (QALY) gains were small, £103 (95% CR: £98, £106) and 0.0023 (95% CR: -0.0006, 0.0055), respectively, resulting in an incremental cost-effectiveness ratio (ICER) of £44 954 per QALY gained. The probability of testing being cost-effective at a threshold of £30 000 per QALY was 0.25. Reduced costs of testing or febuxostat resulted in an ICER below £30 000 per QALY gained. The ICER for patients with chronic renal insufficiency was £38 478 per QALY gained. Routine testing for HLA-B*58:01 in order to reduce the incidence of adverse drug reactions in patients being prescribed allopurinol for gout is unlikely to be cost-effective in the UK; however testing is expected to become cost-effective with reductions in the cost of genotyping, and with the future availability of cheaper, generic febuxostat.

A demographic study on gender related differences in adverse drug reactions of a tertiary care teaching hospital

Background: As a part of pharmacovigilance program of India (PvPI) adverse drug reactions (ADRs) are cause of mortality and morbidity in patients unnoticed, which is a part of WHO program for International Drug Safety Monitoring across world. ADRs are considered to be among top 10 causes for mortality. The reason for sex difference in medication response is multi factorial with wide range of aspects like steroid hormones, organ physiology to psychology and socio-cultural factors. The aim was to study on gender related differences in adverse drug reactions in patients attending tertiary care teaching hospital at Nandyal.Methods: ADR cases were collected from multicenter health care units from tertiary care teaching hospital. ADRs were reported in ADR notification forms or yellow form, CDSCO forms are used to report ADR to Regional pharmacovigilance center. Causality assessment of the ADRs was done based on WHO-UMC causality assessment scale using modified Hartwig and Seigel scale.Results: In the 30 ADR reports collected 21 reports (70%) are of female patients and 9 reports (30%) are of male patients. According to WHO-UMC scale 20 (70%) of Adverse drug reactions were falling into PROBABLE, while 10 (30%) ADR’s are CERTAIN. In 21 females, ADR reports were due to 15(76.43%) Antibiotics, 2 (9.52%) NSAID’s, 2 (9.52%) proton pump inhibitors, 2 (9.52%) anti-convulsants. In 9 males, ADR reports were due to 5 (55.5%) Antibiotics, 2 (22.22%) NSAID’s, 2 (22.22%) anti-convulsants.Conclusions: ADRs are the common occurrences but ADR monitoring helps in prevention of morbidity and mortality in patients. The most commonly affected gender is among female patients, as they are more exposed to drugs starting their journey right from the childhood, pregnancy till their adult menopausal stage.

Dermatitis medicamentosa- a rare case of adverse drug reaction due to sitagliptin

Dermatitis medicamentosa- a rare case of adverse drug reaction due to sitagliptin

The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis.

IntroductionClinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients.ObjectiveThe aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional.MethodsA retrospective analysis of all ADR reports on the same case, i.e., cases with a report from both the patient and the patient’s healthcare professional, selected from the database of the Dutch Pharmacovigilance Center Lareb, was conducted. The extent to which relevant clinical information was reported was assessed by trained pharmacovigilance assessors, using a structured tool. The following four domains were assessed: ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as poorly (≤45%), moderately (from 46 to 74%) or well (≥75%) reported. Data were analyzed using a paired sample t test and Wilcoxon signed rank test.ResultsA total of 197 cases were included. In 107 cases (54.3%), patients and healthcare professionals reported a similar level of clinical information. Statistical analysis demonstrated no overall differences between the groups (p = 0.126).ConclusionsIn a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report.

Retrospective analysis of non-laboratory-based adverse drug reactions induced by intravenous radiocontrast agents in a Joint Commission International-accredited academic medical center hospital in China.

The authors retrospectively analyzed the pattern and characteristics of non-laboratory-based adverse drug reactions (ADRs) induced by intravenous radiocontrast agents in a large-scale hospital in China during 2014–2015. There were 314 ADR cases among 118,208 patients receiving enhanced CT or MRI examinations. The frequency of moderate/severe ADRs defined by Chinese Society of Radiology (ie, severe vomiting, systematic urticaria, facial swelling, dyspnea, vasovagal reaction, laryngeal edema, seizure, trembling, convulsions, unconsciousness, shock, death, and other unexpected adverse reactions) was rare (0.0431%), whereas the mild ADRs were uncommon (0.2225%) and accounted for 83.76% of ADRs. Frequency of ADRs induced by iodinated contrast agents was related with examination site, sex, and type of patient settings (P<0.01) and was higher compared with gadolinium contrast agents (0.3676% vs 0.0504%, P<0.01). From 2014 to 2015, frequencies of total and moderate/severe ADRs induced by iodinated contrast agents decreased significantly (0.4410% vs 0.2947%, P<0.01; 0.0960% vs 0.0282%, P<0.01, respectively). Frequency of ADRs differed among different iodinated contrast and gadolinium contrast (P<0.05) agents. Iopromide’s ADR frequency in 2014 was significantly higher compared with iopamidol, ioversol, or iohexol (P<0.01). Frequency of moderate/severe ADRs induced by iodixanol was 4.1–5.4 times that of iohexol, iopromide, or iopamidol. Rash was the predominant ADR subtype (84.39%) and occurred more frequently with iodixanol compared with iohexol, iopamidol, or ioversol (P<0.01). Overall, 21.97% of ADR cases had allergy history or atopy traits, and these cases experienced ADRs earlier than the negative ones (17.19 min vs 85.34 min, P<0.01). The mean time to onset of ADRs was increased in patients receiving iodixanol compared with other iodinated contrast agents (323.77 min vs 42.36 min, P<0.01). Overall, 37.26% of ADRs occurred within 5 min and 84.08% of ADRs occurred within 30 min. Efficient quality improvement in decreasing ADRs induced by radiocontrast agents has been achieved by multidisciplinary collaboration.

El uso de la corifolitropina alfa en donantes de óvulos obtiene la misma eficiencia reproductiva y efectividad que la FSH recombinante, con una mayor comodidad para la donante

IntroductionConventional ovarian stimulation with daily injections of FSH for oocyte donors, besides the discomfort of the medication, involves a great demand of time. Treatments need to be simplified without losing effectiveness and safety. Corifollitropin alpha (Elonva) enables the first 7injections of FSH to be replaced with one single injection. ObjectiveTo compare the effectiveness and convenience of corifollitropin alpha (Elonva) compared to daily recombinant FSH (rFSH) in the ovarian stimulation of oocyte donors. Materials and methodsAn analysis was performed on 90 cycles of Elonva and 96 cycles of rFSH. The statistical analysis included the Student t-test for means and the chi-squared test for percentages. Effectiveness has been evaluated through reproductive effectiveness defined as the total number of live births in relation to the total number of mature eggs. An analysis was also performed on variables, such as number of mature oocytes, percentage of viable embryos, implantation rate, and clinical pregnancy rate per embryo transfer. Comfort has been evaluated by the number of visits to the clinic for medication administration. ResultsSignificant differences were only found in the number of injections administered to donors (3.20 Elonva vs. 8.55 rFSH, P<.005). Reproductive effectiveness was 5.61 vs. 5.49, with implantation rate 44.44 vs. 44.34, and clinical pregnancy 56.25 vs. 58.73. There no significant differences in any of variables analysed, including the mean cost. No cases of OHSS or adverse drug reactions were observed. ConclusionsThe use of corifollitropin alpha in oocyte donors offers the same reproductive effectiveness and is more convenient for the donor compared to stimulation with daily rFSH.

Imputation of adverse drug reactions: Causality assessment in hospitals.

Background & objectivesDifferent algorithms have been developed to standardize the causality assessment of adverse drug reactions (ADR). Although most share common characteristics, the results of the causality assessment are variable depending on the algorithm used. Therefore, using 10 different algorithms, the study aimed to compare inter-rater and multi-rater agreement for ADR causality assessment and identify the most consistent to hospitals.MethodsUsing ten causality algorithms, four judges independently assessed the first 44 cases of ADRs reported during the first year of implementation of a risk management service in a medium complexity hospital in the state of Sao Paulo (Brazil). Owing to variations in the terminology used for causality, the equivalent imputation terms were grouped into four categories: definite, probable, possible and unlikely. Inter-rater and multi-rater agreement analysis was performed by calculating the Cohen´s and Light´s kappa coefficients, respectively.ResultsNone of the algorithms showed 100% reproducibility in the causal imputation. Fair inter-rater and multi-rater agreement was found. Emanuele (1984) and WHO-UMC (2010) algorithms showed a fair rate of agreement between the judges (k = 0.36).Interpretation & conclusionsAlthough the ADR causality assessment algorithms were poorly reproducible, our data suggest that WHO-UMC algorithm is the most consistent for imputation in hospitals, since it allows evaluating the quality of the report. However, to improve the ability of assessing the causality using algorithms, it is necessary to include criteria for the evaluation of drug-related problems, which may be related to confounding variables that underestimate the causal association.

STUDI FARMAKOVIGILANS PENGOBATAN ASMA PADA PASIEN RAWAT INAP DI SUATU RUMAH SAKIT DI BOJONEGORO

Background: Asthma is a respiratory disease with a large enough number of prevalence in the world. Asthma treatmentin hospital needs serious monitoring because of the risk to patient safety and increase the cost of treatment. One attempt to reduce the incidence of unwanted is the pharmacovigilance studies to improve patient safety.Purpose: to determine safety in terms of adverse drug reactions (ADR) and drug interactions of the treatment of inpatient asthmatic patients in a hospital.Methods: This is a non-experimental study with sampling using purposive sampling. Then the data were obtained from medical records were analyzed ADRs and drug interactions that occur using the library and shown descriptively.Results: The study sample as many as 43 people. The results showed there were 56 cases of ADRs on asthma medications, especially the use of nebulized salbutamol (57.14%). While the incidence of asthma therapy drug interactions there were 10 cases and the highest is aminophylline with salbutamol (14.29%).Conclusion: Treatment of asthma need to get to the ADR incidence and risk of drug interactions. Incidence of ADRs and drug interactions at most of the use of salbutamol which is relatively safe preference. This still needs to be done further research.

Characterization of adverse drug reactions causing admission to an intensive care unit.

This study aimed to determine the occurrence of adverse drug reactions (ADRs) that caused admission to the intensive care unit (ICU) of a university hospital. Clinical records were reviewed for patients meeting the inclusion criteria who were admitted to the ICU between September and December 2012. Suspected cases of ADRs were documented. Nine researchers later evaluated causality using the Naranjo Algorithm, preventability using the Schumock and Thornton criteria, and clinical classification based on the dose-time-susceptibility system. In total, 96 patients presented 108 cases of ADR (13.8%, 95% confidence interval 11.2-16.4%) as the cause of admission. The most frequent ADRs were bradyarrhythmias and upper gastrointestinal bleeding (12%). Therapeutic failure accounted for 20%. The most commonly associated medications were acetylsalicylic acid (16%) and losartan (10%). Forty-six cases were categorized as possible, and only one as definite. According to the dose-time-susceptibility classification, in 82% of the cases, the dosage was collateral (within the therapeutic range), and 90% were independent of time; the factors most associated with susceptibility to ADRs were comorbidities (42%) and age (49%). Forty-four percent of the ADRs were considered possibly preventable. ADRs contribute significantly to ICU admissions, and a significant number of ADRs are preventable. National studies are needed to assess their incidence and to establish classification standards to reduce their clinical impact.

Development of the Liverpool Adverse Drug Reaction Avoidability Assessment Tool.

AimTo develop and test a new tool to assess the avoidability of adverse drug reactions that is suitable for use in paediatrics but which is also applicable to a variety of other settings.MethodsThe study involved multiple phases. Preliminary work involved using the Hallas scale and a modification of the existing Hallas scale, to assess two different sets of adverse drug reaction (ADR) case reports. Phase 1 defined, modified and refined a new tool using multidisciplinary teams. Phase 2 involved the assessment of 50 ADR case reports from a prospective study of paediatric inpatients by individual assessors. Phase 3 compared assessments with the new tool for individuals and groups in comparison to the ‘gold standard’ (the avoidability outcome set by a panel of senior investigators: an experienced clinical pharmacologist, paediatrician and pharmacist).Main Outcome MeasuresInter-rater reliability (IRR), measure of disagreement and utilization of avoidability categories.ResultsPreliminary work—Pilot phase: results for the original Hallas cases were fair and pairwise kappa scores ranged from 0.21 to 0.36. Results for the modified Hallas cases were poor, pairwise kappa scores ranged from 0.06 to 0.16.Phase 1: on initial use of the new tool, agreement between the two multidisciplinary groups was found on 13/20 cases with a kappa score of 0.29 (95% CI -0.04 to 0.62).Phase 2: the assessment of 50 ADR case reports by six individual reviewers yielded pairwise kappa scores ranging from poor to good 0.12 to 0.75 and percentage exact agreement (%EA) ranged from 52–90%.Phase 3: Percentage exact agreement ranged from 35–70%. Overall, individuals had better agreement with the ‘gold standard’.ConclusionAvoidability assessment is feasible but needs careful attention to methods. The Liverpool ADR avoidability assessment tool showed mixed IRR. We have developed and validated a method for assessing the avoidability of ADRs that is transparent, more objective than previous methods and that can be used by individuals or groups.

Results of a prospective multicenter non-interventional study in adult outpatients with acute sinusitis treated with Flemoclav Solutab® in routine clinical practice in Russia (FlemENT)

Background. According to Russian clinical guidelines, amoxicillin/clavulanic acid is an antibiotic of the 1st choice in treatment of adult outpatients with acute sinusitis with suspected or confirmed bacterial etiology. The growth of bacterial resistance causes reasonable concern of otorhinolaryngologists about the efficacy of commonly used antibiotics in the routine clinical practice. Objective. The objective of this study was to evaluate the clinical success rate and tolerability of acute sinusitis treatment with Flemoclav Solutab® as initial antibiotic treatment in adult outpatients with acute sinusitis in routine clinical practice. Methods. A prospective multi-center study. The study covered adult outpatients with acute sinusitis with suspected or confirmed bacterial etiology treated with Flemoclav Solutab® and included the assessment of effectiveness and tolerability of Flemoclav Solutab® in the patients with acute sinusitis. Besides, the clinical effectiveness of treatment with this antibiotic in the subgroups of patients aged 65 years or older, smokers and non-smokers was assessed. Clinical success was determined as the complete resolution of all the symptoms and clinical signs of acute bacterial sinusitis that did not require supplementary of alternative antimicrobial therapy. In period of October 2015 to February 2016 eighty otorhinolaryngologists from various regions of Russia examined 893 adult outpatients (346 men and 547 women) with acute sinusitis treated with the antibiotic Flemoclav Solutab®. Clinical recovery confirmed by the data of all the examinations was achieved in 97.2% [(868/893), 95% CI 96.1 – 98.3%]. In the subgroup of patients aged 65 years or older the clinical success rate was 98.5% [(128/130), 95% CI 96.3 – 100%], in the subgroup of non-smokers clinical success was 97.3% [(690/709), 95% CI 96.1 – 98.5], in the subgroup of smokers clinical success was 96.7% [(178/186), 95% CI 94.2–99.3%]. Twenty five cases of adverse drug reactions (ADR) were recorded in 20 (2.2%) patients, of them 22 non-serious ADRs were in 17 (1.9%) patients and 3 serious ADRs were in 3 (0.3%) patients. Conclusion. The study proved high clinical success of acute sinusitis treatment with Flemoclav Solutab® in adult outpatients, including the patients aged 65 years or older, smokers and non-smokers. Antimicrobial treatment with Flemoclav Solutab® was well tolerated.

C 型肝炎治療薬ダクラタスビルおよびアスナプレビルの投与後に生じた皮膚障害の1例

C 型肝炎治療薬ダクラタスビルおよびアスナプレビルの投与後に生じた皮膚障害の1例

Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis centre: A four year retrospective study.

Background:Treatment of multidrug-resistant tuberculosis (MDR-TB) requires the use of expensive and toxic second-line anti-tubercular drugs which are given for a longer duration. Adverse drug reactions (ADRs) of second-line antitubercular drugs affect compliance and thereby treatment outcome. We set out to analyze ADRs and treatment outcome of MDR-TB patients receiving directly observed treatments plus therapy.Materials and Methods:A retrospective study of registered MDR-TB cases at district tuberculosis center during 2010–2014 was performed. Data regarding sociodemographic profile, diagnosis, and treatment as well as ADRs were recorded and evaluated. ADRs were evaluated for causality, severity assessment, management aspects, and impact on treatment outcome.Results:In total 147 ADRs were reported among 72 cases. Most commonly observed ADRs were gastrointestinal (24.5%) followed by self reported weakness (21.23%), psychological (14.38%), joint pain (14.38%), and respiratory symptoms. Discontinuation of the drugs due to ADRs was required in 36 (24.48%) events. ADRs were significantly associated with nontreatment adherence and defaulter outcome. Cure rate was higher in MDR-TB cases with ADRs (59.72%) than MDR-TB cases without ADRs (30.18%).Conclusion:Attention needs to be paid for timely recognition and treatment of ADR with minimum modification of treatment regimen. Equal attention should be paid to MDR-TB without ADR cases to raise over all cure rate.