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- Singh, K. P., et al.
(author)
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Clinical standards for the management of adverse effects during treatment for TB
- 2023
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In: The International Journal of Tuberculosis and Lung Disease. - : International Union Against Tuberculosis and Lung Disease. - 1027-3719 .- 1815-7920. ; 27:7, s. 506-519
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Journal article (peer-reviewed)abstract
- BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE.METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards.RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitiv-ity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research.CONCLUSION: These standards provide a person -centred, consensus-based approach to minimise the impact of AE TB treatment.
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- Batista, N, et al.
(author)
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Phase II study of capecitabine in combination with paclitaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer.
- 2004
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In: Br J Cancer. - 0007-0920. ; 90:9, s. 1740-6
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Journal article (peer-reviewed)abstract
- The addition of oral capecitabine to docetaxel improves response rate, time to progression (TTP) and overall survival in anthracycline-pretreated metastatic breast cancer (MBC). This phase II study evaluates the efficacy and safety of a 21-day cycle of oral capecitabine (1000 mg m(-2) twice daily, days 1-14) plus i.v. paclitaxel (175 mg m(-2), day 1) in anthracycline-pretreated advanced/MBC. In all, 73 patients were enrolled at 13 Swedish and Spanish centres. The objective response rate was 52% (95% confidence interval (CI): 40-63%) in the intent-to-treat population, including complete responses in 11%. Disease was stabilised in a further 29%. The median time to disease progression (TTP) was 8.1 months and the median overall survival was 16.5 months. The combination was generally well tolerated with a predictable safety profile. The most common treatment-related nonhaematological adverse events were hand-foot syndrome (42%), alopecia (30%) and diarrhoea (26%). The only treatment-related Grade 3/4 adverse events occurring in >5% of patients were alopecia (22%) and hand-foot syndrome (11%). Grade 3/4 neutropenia and lymphocytopenia were reported in 12 and 14% of patients, respectively. Capecitabine plus paclitaxel is highly active with a favourable safety profile in anthracycline-pretreated MBC.
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- Borisov, S, et al.
(author)
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Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report
- 2019
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In: The European respiratory journal. - : European Respiratory Society (ERS). - 1399-3003 .- 0903-1936. ; 54:6
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Journal article (peer-reviewed)abstract
- The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1–2) and 57 (11.3%) as serious (grade 3–5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.
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- Pramanik, P., et al.
(author)
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Cationic distribution, exchange interactions, and relaxation dynamics in Zn-diluted MnCo2O4 nanostructures
- 2019
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In: Journal of Applied Physics. - : AMER INST PHYSICS. - 0021-8979 .- 1089-7550. ; 125:12
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Journal article (peer-reviewed)abstract
- We report an experimental investigation of the electronic structure and magnetic properties of bulk and nanosized MnCo2O4 diluted with Zn. The cationic distribution for tetrahedral A-site dilution is (Co1-yA2+ZnyA2+)(A)[Mn3+Co3+](B)O-4 +/-delta, whereas B-site dilution results in (Co2+)(A)[Mn1-xB3+ZnxB2+Co3+](B)O4-delta. The strength of exchange interaction J(ij) between the magnetic ions in a bulk spinel lattice decreases by similar to 15% for A-site dilution relative to the undiluted compound; however, B-site dilution results in an enhancement in J(ij) by 17%. The frequency and temperature dependence of dynamic-susceptibility [chi(ac)(f, T)] studies of nanostructured compounds reveals the existence of spin-glass like behavior below the freezing temperature T-F similar to 125.7 K (for x(B) = 0.2) and 154.3 K (y(A) = 0.1). Relaxation time tau follows the Power-Law variation with a dynamical critical exponent zv = 6.17 and microscopic spin relaxation time tau(o) = 4.4 x 10(-15) s for x(B) = 0.2 (for y(A) = 0.1, zv = 5.2 and tau(o) = 5.4 x 10(-13) s). The amplitude and peak position in chi(ac)(T) decreases with an increase in the DC bias field, which indicates that the spin-glass phase can survive in the presence of low fields forming a critical line with an exponent 2/3. This behavior is similar to the de Almeida-Thouless (AT-line) analysis in the T-H phase diagram which supports the existence of spin-glass like behavior below T-F in these Zn diluted spinels.
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