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Comparison of Therapeutic Results with/without Additional Hyperbaric Oxygen Therapy in Idiopathic Sudden Sensorineural Hearing Loss: A Randomized Prospective Study.
Tong, B, Niu, K, Ku, W, Xie, W, Dai, Q, Hellström, S, Duan, M
Audiology & neuro-otology. 2021;(1):11-16
Abstract
OBJECTIVE To assess the efficacy of the combination of hyperbaric oxygen (HBO) and pharmacological treatment in patients with idiopathic sudden sensorineural hearing loss (ISSNHL) and define patients amenable for HBO therapy. METHODS Prospective, randomized, trial involving 136 cases with unilateral ISSNHL that were randomly divided into 2 groups: the pharmacological treatment (P) group and HBO + pharmacological treatment (HBO+P) group, which received additional HBO for 14 days besides the pharmacological treatments. Pure tone audiometry gain larger than 15 dBHL was defined as success, and the success rate of each group was calculated. RESULTS The overall success rate of the HBO+P group and the P group is 60.6% (40/66) and 42.9% (30/70), respectively (p < 0.05). Furthermore, patients with mild-moderate baseline hearing loss, aged ≤50 years, receiving treatment in ≤14 days, or without accompanied dizziness/vertigo in the HBO+P group had higher success rate than the P group (p < 0.05). CONCLUSIONS HBO combined with pharmacological treatments leads to better hearing recovery than pharmacological treatments alone.
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Markers of neutrophil extracellular traps predict adverse outcome in community-acquired pneumonia: secondary analysis of a randomised controlled trial.
Ebrahimi, F, Giaglis, S, Hahn, S, Blum, CA, Baumgartner, C, Kutz, A, van Breda, SV, Mueller, B, Schuetz, P, Christ-Crain, M, et al
The European respiratory journal. 2018;(4)
Abstract
Neutrophil extracellular traps (NETs) are a hallmark of the immune response in inflammatory diseases. However, the role of NETs in community-acquired pneumonia (CAP) is unknown. This study aims to characterise the impact of NETs on clinical outcomes in pneumonia.This is a secondary analysis of a randomised controlled, multicentre trial. Patients with CAP were randomly assigned to either 50 mg prednisone or placebo for 7 days. The primary end-point was time to clinical stability; main secondary end-points were length of hospital stay and mortality.In total, 310 patients were included in the analysis. Levels of cell-free nucleosomes as surrogate markers of NETosis were significantly increased at admission and declined over 7 days. NETs were significantly associated with reduced hazards of clinical stability and hospital discharge in multivariate adjusted analyses. Moreover, NETs were associated with a 3.8-fold increased adjusted odds ratio of 30-day mortality. Prednisone treatment modified circulatory NET levels and was associated with beneficial outcome.CAP is accompanied by pronounced NET formation. Patients with elevated serum NET markers were at higher risk for clinical instability, prolonged length of hospital stay and 30-day all-cause mortality. NETs represent a novel marker for outcome and a possible target for adjunct treatments of pneumonia.
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Testicular vs adrenal sources of hydroxy-androgens in prostate cancer.
Zang, T, Taplin, ME, Tamae, D, Xie, W, Mesaros, C, Zhang, Z, Bubley, G, Montgomery, B, Balk, SP, Mostaghel, EA, et al
Endocrine-related cancer. 2017;(8):393-404
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Abstract
Neoadjuvant androgen deprivation therapy (NADT) is one strategy for the treatment of early-stage prostate cancer; however, the long-term outcomes of NADT with radical prostatectomy including biochemical failure-free survival are not promising. One proposed mechanism is incomplete androgen ablation. In this study, we aimed to evaluate the efficiency of serum hydroxy-androgen suppression in patients with localized high-risk prostate cancer under NADT (leuprolide acetate plus abiraterone acetate and prednisone) and interrogate the primary sources of circulating hydroxy-androgens using our recently described stable isotope dilution liquid chromatography mass spectrometric method. For the first time, three androgen diols including 5-androstene-3β,17β-diol (5-adiol), 5α-androstane-3α,17β-diol (3α-adiol), 5α-androstane-3β,17β-diol (3β-adiol), the glucuronide or sulfate conjugate of 5-adiol and 3α-adiol were measured and observed to be dramatically reduced after NADT. By comparing patients that took leuprolide acetate alone vs leuprolide acetate plus abiraterone acetate and prednisone, we were able to distinguish the primary sources of these androgens and their conjugates as being of either testicular or adrenal in origin. We find that testosterone, 5α-dihydrotestosterone (DHT), 3α-adiol and 3β-adiol were predominately of testicular origin. By contrast, dehydroepiandrosterone (DHEA), epi-androsterone (epi-AST) and their conjugates, 5-adiol sulfate and glucuronide were predominately of adrenal origin. Our findings also show that NADT failed to completely suppress DHEA-sulfate levels and that two unappreciated sources of intratumoral androgens that were not suppressed by leuprolide acetate alone were 5-adiol-sulfate and epi-AST-sulfate of adrenal origin.
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Daily prednisone treatment in Duchenne muscular dystrophy in southwest China.
Hu, J, Ye, Y, Kong, M, Hong, S, Cheng, L, Wang, Q, Qin, J, Zou, L, Jiang, L
Muscle & nerve. 2015;(6):1001-7
Abstract
INTRODUCTION In this study we aimed to determine the influence of daily prednisone treatment in Duchenne muscular dystrophy (DMD) by performing a prospective, randomized, placebo-controlled trial in southwestern China. METHODS Sixty-six children with DMD (4-12 years of age) were divided randomly into prednisone and placebo groups. Efficacy and safety of daily prednisone at 0.75 mg/kg/day were evaluated over 12 months by muscle strength and function, quality of life (QoL), quantitative muscle ultrasound (QMUS), and side effects. RESULTS Significant improvements in muscle strength and function, QoL, and QMUS were observed in the prednisone group compared with the placebo-treated group (P < 0.05). Changes in body weight, height, body mass index, and diastolic blood pressure were similar in both groups (P > 0.05). CONCLUSIONS This pilot study in southwestern China found that daily prednisone at 0.75 mg/kg/day is suitable for children with DMD. It slowed disease progression and improved QoL and QMUS. Moderate side effects were generally well tolerated.
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[Steroids in addition to antibiotics improve outcome in patients with "community acquired" pneumonia].
Steurer, J
Praxis. 2015;(13):705-6
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Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial.
Blum, CA, Nigro, N, Briel, M, Schuetz, P, Ullmer, E, Suter-Widmer, I, Winzeler, B, Bingisser, R, Elsaesser, H, Drozdov, D, et al
Lancet (London, England). 2015;(9977):1511-8
Abstract
BACKGROUND Clinical trials yielded conflicting data about the benefit of adding systemic corticosteroids for treatment of community-acquired pneumonia. We assessed whether short-term corticosteroid treatment reduces time to clinical stability in patients admitted to hospital for community-acquired pneumonia. METHODS In this double-blind, multicentre, randomised, placebo-controlled trial, we recruited patients aged 18 years or older with community-acquired pneumonia from seven tertiary care hospitals in Switzerland within 24 h of presentation. Patients were randomly assigned (1:1 ratio) to receive either prednisone 50 mg daily for 7 days or placebo. The computer-generated randomisation was done with variable block sizes of four to six and stratified by study centre. The primary endpoint was time to clinical stability defined as time (days) until stable vital signs for at least 24 h, and analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00973154. FINDINGS From Dec 1, 2009, to May 21, 2014, of 2911 patients assessed for eligibility, 785 patients were randomly assigned to either the prednisone group (n=392) or the placebo group (n=393). Median time to clinical stability was shorter in the prednisone group (3·0 days, IQR 2·5-3·4) than in the placebo group (4·4 days, 4·0-5·0; hazard ratio [HR] 1·33, 95% CI 1·15-1·50, p<0·0001). Pneumonia-associated complications until day 30 did not differ between groups (11 [3%] in the prednisone group and 22 [6%] in the placebo group; odds ratio [OR] 0·49 [95% CI 0·23-1·02]; p=0·056). The prednisone group had a higher incidence of in-hospital hyperglycaemia needing insulin treatment (76 [19%] vs 43 [11%]; OR 1·96, 95% CI 1·31-2·93, p=0·0010). Other adverse events compatible with corticosteroid use were rare and similar in both groups. INTERPRETATION Prednisone treatment for 7 days in patients with community-acquired pneumonia admitted to hospital shortens time to clinical stability without an increase in complications. This finding is relevant from a patient perspective and an important determinant of hospital costs and efficiency. FUNDING Swiss National Science Foundation, Viollier AG, Nora van Meeuwen Haefliger Stiftung, Julia und Gottfried Bangerter-Rhyner Stiftung.
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A randomised phase 2 study combining LY2181308 sodium (survivin antisense oligonucleotide) with first-line docetaxel/prednisone in patients with castration-resistant prostate cancer.
Wiechno, P, Somer, BG, Mellado, B, Chłosta, PL, Cervera Grau, JM, Castellano, D, Reuter, C, Stöckle, M, Kamradt, J, Pikiel, J, et al
European urology. 2014;(3):516-20
Abstract
Castration-resistant prostate cancer (CRPC) is partially characterised by overexpression of antiapoptotic proteins, such as survivin. In this phase 2 study, patients with metastatic CRPC (n=154) were randomly assigned (1:2 ratio) to receive standard first-line docetaxel/prednisone (control arm) or the combination of LY2181308 with docetaxel/prednisone (experimental arm). The primary objective was to estimate progression-free survival (PFS) for LY2181308 plus docetaxel. Secondary efficacy measures included overall survival (OS), several predefined prostate-specific antigen (PSA)-derived end points, and Brief Pain Inventory (BPI) and Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores. The median PFS of treated patients for the experimental arm (n=98) was 8.64 mo (90% confidence interval [CI], 7.39-10.45) versus 9.00 mo (90% CI, 7.00-10.09) in the control arm (n=51; p=0.755). The median OS for the experimental arm was 27.04 mo (90% CI, 19.94-33.41) compared with 29.04 mo (90% CI, 20.11-39.26; p=0.838). The PSA responses (≥ 50% PSA reduction), BPI, and FACT-P scores were similar in both arms. In the experimental arm, patients had a numerically higher incidence of grades 3-4 neutropenia, anaemia, thrombocytopenia, and sensory neuropathy. In conclusion, this study failed to detect a difference in efficacy between the two treatment groups.
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Zinc supplement in reduction of relapses in children with steroid sensitive nephrotic syndrome.
Sherali, AR, Moorani, KN, Chishty, SH, Khan, SI
Journal of the College of Physicians and Surgeons--Pakistan : JCPSP. 2014;(2):110-3
Abstract
OBJECTIVE To determine whether Zinc supplementation could reduce relapse rate in children with nephrotic syndrome. STUDY DESIGN Randomized-controlled trial. PLACE AND DURATION OF STUDY National Institute of Child-Health and The Kidney Centre, Karachi, from January 2008 to June 2009. METHODOLOGY Sixty nephrotic children aged 2 - 15 years were selected. Baseline data including age, number of infections and relapses during pre and post study one year were recorded. Randomization was done to divide into Zinc group (Zg) to receive Zinc versus placebo (Pg) for 6 months. Relapses and infections were treated with standard therapy. T-test and chi-square tests were used to compare the mean values and proportions respectively with significance at p < 0.05. RESULTS Among 60 children, 54 completed trial (Zg = 25, Pg = 29). Forty (74%) were males and 14 (26%) females. Mean age, pre study relapses and Zinc level in the two groups were similar. Overall, infections and relapses were observed in 43 (79.62%) and 17 cases (31.48%) respectively. There was no significant difference in frequency of infections and mean infection rate in Zg (20, 80% and 1.92 ± 1.47) compared to Pg (23, 79.3% and 2 ± 1.53, p = 0.950). Relapses occurred in 7 (28%) in Zg compared to 10 (34%) in Pg which was not significant (p = 0.609). Mean infection and relapse rate per patient per year (PPPY) in Zg was 1.92 ± 1.47and 1.14 ± 0.37 compared to 2 ± 1.53 and1.3 ± 0.48 in Pg respectively (p=0.846, 0.464). Pre study relapses in two groups were similar (Zg vs. Pg = 96 vs. 96.6%) whereas post study relapses in Zg were lower (7, 28%) compared to Pg (10, 34.5%). Post study mean relapse rate in Zg was 1.14 ± 0.37 PPPY compared to 2.71 ± 1.11 in pre study (p = 0.005). In Pg, post study mean relapse rate PPPY was 1.30 ± 0.48 compared to 1.70 ± 0.48 in pre study period (p = 0.037). Relapse rate reduction was 43% after Zinc supplementation compared to 27% reduction in placebo. Metallic taste was observed in 10% of cases. CONCLUSION Zinc supplementation was helpful in reducing relapses in nephrotic syndrome.
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Treatment with metadoxine and its impact on early mortality in patients with severe alcoholic hepatitis.
Higuera-de la Tijera, F, Servín-Caamaño, AI, Cruz-Herrera, J, Serralde-Zúñiga, AE, Abdo-Francis, JM, Gutiérrez-Reyes, G, Pérez-Hernández, JL
Annals of hepatology. 2014;(3):343-52
Abstract
BACKGROUND & AIM: Despite treatment with glucocorticoids, mortality remains high in patients with severe alcoholic hepatitis. Oxidative stress and depletion of mitochondrial glutathione are implicated factors in liver injury. The aim of this study was to evaluate the impact of the addition of metadoxine, a drug which possesses a multifactorial mechanism of action, including antioxidant properties, to standard treatment with glucocorticoids in patients with severe alcoholic hepatitis. MATERIAL AND METHODS This randomized open label clinical trial was performed in Mexico's General Hospital (Registry Key DIC/10/107/03/043). We randomized 70 patients with severe alcoholic hepatitis. The first group received prednisone (40 mg/day), and the second group received prednisone (40 mg/day) plus metadoxine tablets (500 mg three times daily). The duration of treatment in both groups was 30 days. Survival at 30 and 90 days, development of complications, adverse events and response to treatment (Lille model) were assessed. RESULTS In the group receiving metadoxine, significant improvements were observed, as follows: survival at 30 days (74.3 vs. 45.7%, P = 0.02); survival at 90 days (68.6 vs. 20.0%, P = 0.0001). There was less development or progression of encephalopathy (28.6 vs. 60.0%, P = 0.008) and hepatorenal syndrome (31.4 vs. 54.3%, P = 0.05), and the response to treatment (Lille model) was higher in the metadoxine group (0.38 vs. 0.63, P = 0.001; 95% CI 0.11 to 0.40). There were no differences between groups regarding the development or progression of variceal hemorrhage or infection. The incidence of adverse events, mainly gastrointestinal, was similar in both groups. CONCLUSIONS Addition of metadoxine to glucocorticoid treatment improves the short-term survival of patients with severe alcoholic hepatitis and diminishes the development or progression of encephalopathy and hepatorenal syndrome.
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Head and neck manifestation and prognosis of Langerhans' cell histiocytosis in children.
Nicollas, R, Rome, A, Belaïch, H, Roman, S, Volk, M, Gentet, JC, Michel, G, Triglia, JM
International journal of pediatric otorhinolaryngology. 2010;(6):669-73
Abstract
OBJECTIVE To appreciate the several head and neck manifestations of Langherans' cell histiocytosis (LCH) in children and their multidisciplinary management and outcome. STUDY DESIGN Retrospective study. PATIENTS AND METHODS Clinical reports of 42 patients with LCH treated in the Departments of Paediatric Haematology, Paediatric Oncology and Paediatric Otorhinolaryngology of a tertiary care center were analyzed. Only cases where the disease was localized to the head and neck were considered. The age at diagnosis, gender, clinical presentation, extension of disease as well as response to treatment and outcome were recorded from the charts of each of these patients. RESULTS Of the 42 patient charts reviewed, 31 (73.8%) presented with head and neck localization. 10 of these had an exclusive head and neck presentation. Multisystem LCH was mostly found in infants under 3-year-old (mean age: 2-year-old), and bony manifestations in older. All treatments delivered to patients were well-tolerated and the evolution good. DISCUSSION AND CONCLUSION Head and neck involvement is known to be very frequent in LCH. There is no consensus about treatment but authors highlight that all teams in charge of patients presenting with LCH agree to remain as conservative as possible. For solitary large lesions looking like a tumor which resection could result in functional or cosmetic morbidity, it would be important to get first a biopsy. For multisystemic LHC, therapeutic trials with chemotherapy agents still in process should increase the rate of success.