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Efficacy and safety of standardized Ginkgo biloba L. leaves extract as an adjuvant therapy for sudden sensorineural hearing loss: A systematic review and meta-analysis.
Si, X, Yu, Z, Ren, X, Huang, L, Feng, Y
Journal of ethnopharmacology. 2022;:114587
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Ginkgo biloba L. has been used for medical purposes in China for centuries. Standardized Ginkgo biloba L. leaves extract (GBE) is a widely used botanical drug which displays a variety of pharmacological effects against sudden sensorineural hearing loss (SSNHL). AIM OF THE STUDY To evaluate the efficacy and safety of GBE as an adjuvant therapy, administered with corticosteroids, for the initial management of patients with SSNHL. MATERIALS AND METHODS We searched seven databases for randomized clinical trials (RCTs) comparing GBE plus corticosteroids with corticosteroids alone for SSNHL treatment. Data analysis was carried out by Review Manager 5.4 and Stata 16.0 software. The study was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. We subsequently evaluated the certainty of evidence using the GRADE (Grading of Recommendation Assessment, Development and Evaluation) approach. RESULTS A total of 11 RCTs involving 1069 patients were included. Meta-analysis indicated that the clinical cure rate (RR = 1.33, 95% CI = 1.12 to 1.58, P = 0.001) and total effective rate (RR = 1.24, 95%CI = 1.17 to 1.31, P < 0.001) in SSNHL patients receiving GBE plus corticosteroids was superior to patients receiving corticosteroids alone. After treatment, pure tone average (PTA) improvement of observation group was better than that in the control group (WMD = 10.33, 95%CI = 6.46 to 14.21, P < 0.001). The levels of whole blood high shear viscosity (WMD = 0.93, 95%CI = 0.28 to 1.59, P = 0.005), whole blood medium shear viscosity (WMD = 0.53, 95%CI = 0.11 to 0.95, P = 0.01), whole blood low shear viscosity (WMD = 1.26, 95%CI = 0.80 to 1.72, P < 0.001), plasma viscosity (WMD = 0.19, 95%CI = 0.09 to 0.30, P < 0.001) and fibrinogen (WMD = 0.80, 95%CI = 0.25 to 1.35, P = 0.004) were lower than those in the control group. There was no significant difference in the change of hematokrit between two groups (WMD = 4.23, 95%CI = -0.54 to 8.99, P = 0.08). GBE was generally well tolerated, and there was no significant difference in the incidence of adverse reactions between two groups (RR = 1.01, 95%CI = 0.57 to 1.79, P = 0.97). CONCLUSION The results of the current study suggested that GBE might be effective and promising as an adjuvant to corticosteroids in the initial treatment of moderate to profound SSNHL. However, the GRADE assessment indicated that the overall strength of evidence was not high. Further studies with high methodological quality and low risk of bias are needed to confirm the positive results. PROSPERO registration No. CRD 42020190113.
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IL-6 antagonists to replace systemic corticosteroids as the preferred anti-inflammatory therapy in patients with COVID-19?
Kow, CS, Zaihan, AF, Ramachandram, DS, Hasan, SS
Cytokine. 2022;:155730
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Early short-course corticosteroids and furosemide combination to treat non-critically ill COVID-19 patients: An observational cohort study.
Kevorkian, JP, Riveline, JP, Vandiedonck, C, Girard, D, Galland, J, Féron, F, Gautier, JF, Mégarbane, B
The Journal of infection. 2021;(1):e22-e24
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Vitamin D can safely reduce asthma exacerbations among corticosteroid-using children and adults with asthma: a systematic review and meta-analysis of randomized controlled trials.
Chen, Z, Peng, C, Mei, J, Zhu, L, Kong, H
Nutrition research (New York, N.Y.). 2021;:49-61
Abstract
Previous studies have failed to draw a consistent conclusion over the effect of vitamin D administration on asthma. We hypothesized that vitamin D supplementation could improve the clinical efficacy of corticosteroids in patients with asthma as measured by exacerbations, Asthma Control Test (ACT) score, and lung function in order to maintain asthma control. We searched Web of Science, PubMed, the Cochrane Library, and ScienceDirect up through January 20, 2021 for randomized controlled trials analyzing the effect of vitamin D supplementation on asthma exacerbation. Studies were limited to patients with moderate to severe asthma who were treated with corticosteroids. We identified 12 studies involving 1,543 participants in this meta-analysis. Vitamin D supplementation significantly reduced the risk of asthma exacerbation (pooled risk ratio (RR) 0.70, 95% confidence interval (CI), 0.59, 0.83; P < .05). The pooled RR of the ACT score was 0.04 (95% CI, -0.19, 0.27; P > .05). The pooled standardized mean difference in vitamin D levels was 1.07 (95% CI, 0.77, 1.38; P < .05), and in the percentage of forced expiratory volume in one second was -0.02 (95% CI, -0.13, 0.09; P > .05). The pooled RR of adverse events was 1.06 (95% CI, 0.89, 1.25; P > .05). We performed subgroup analysis and meta-regression of serum vitamin D levels but found no source of heterogeneity. Vitamin D supplementation safely reduced the rate of asthma exacerbation but did not improve ACT score or lung function among patients with asthma treated with corticosteroids.
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Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial.
Reich, K, Teixeira, HD, de Bruin-Weller, M, Bieber, T, Soong, W, Kabashima, K, Werfel, T, Zeng, J, Huang, X, Hu, X, et al
Lancet (London, England). 2021;(10290):2169-2181
Abstract
BACKGROUND Systemic therapies are typically combined with topical corticosteroids for the management of moderate-to-severe atopic dermatitis. Upadacitinib is an oral Janus kinase (JAK) inhibitor with greater inhibitory potency for JAK1 than JAK2, JAK3, or tyrosine kinase 2 that is being tested for atopic dermatitis. We aimed to assess the efficacy and safety of upadacitinib plus topical corticosteroids compared with placebo for the treatment of moderate-to-severe atopic dermatitis. METHODS In this randomised, double-blind, placebo-controlled, phase 3 trial (AD Up) adults (aged 18-75 years) and adolescents (aged 12-17 years) with chronic atopic dermatitis that was moderate to severe (≥10% of body surface area affected, Eczema Area and Severity Index [EASI] score of ≥16, validated Investigator's Global Assessment for atopic dermatitis [vIGA-AD] score of ≥3, and weekly average Worst Pruritus Numerical Rating Scale score of ≥4 at baseline) were enrolled at 171 clinical centres across 22 countries in the Asia-Pacific region, Europe, the Middle East, North America, and Oceania. Patients were randomly assigned (1:1:1) to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily, all in combination with topical corticosteroids for 16 weeks. Randomisation was done using an interactive response technology system, stratified by baseline disease severity, geographical region, and age. Study investigators, study site personnel, and patients were masked to study treatment. The coprimary endpoints were the proportion of patients who had achieved at least a 75% reduction in EASI score from baseline (EASI-75) and the proportion of patients who had achieved a vIGA-AD response (defined as a vIGA-AD score of 0 [clear] or 1 [almost clear] with ≥2 grades of improvement from baseline) at week 16. Efficacy was analysed in the intention-to-treat population and safety was analysed in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT03568318, and is active, but not recruiting. FINDINGS Between Aug 9, 2018, and Dec 20, 2019, 901 patients were randomly assigned to receive upadacitinib 15 mg plus topical corticosteroids (n=300), upadacitinib 30 mg plus topical corticosteroids (n=297), or placebo plus topical corticosteroids (n=304). At week 16, the proportion of patients who had achieved EASI-75 was significantly higher in the upadacitinib 15 mg plus topical corticosteroid group (194 [65%] of 300 patients) and the upadacitinib 30 mg plus topical corticosteroids group (229 [77%] of 297 patients) than the placebo group (80 [26%] of 304 patients; adjusted difference in EASI-75 response rate vs placebo, 38·1% [95% CI 30·8-45·4] for the upadacitinib 15 mg group and 50·6% [43·8-57·4] for the upadacitinib 30 mg group; p<0·0001 for both doses). The proportion of patients who had achieved a vIGA-AD response at week 16 was significantly higher in the upadacitinib 15 mg plus topical corticosteroid group (119 [40%] patients) and upadacitinib 30 mg plus topical corticosteroid group (174 [59%] patients) than the placebo group (33 [11%] patients; adjusted difference in vIGA-AD response vs placebo, 28·5% [22·1-34·9] for the upadacitinib 15 mg group and 47·6% [41·1-54·0] for the upadacitinib 30 mg group; p<0·0001 for both doses). During the double-blind period, upadacitinib 15 and 30 mg were well tolerated in combination with topical corticosteroids. The most frequently reported treatment-emergent adverse events (≥5% in any treatment group) were acne, nasopharyngitis, upper respiratory tract infection, oral herpes, elevation of blood creatine phosphokinase levels, headache, and atopic dermatitis. The incidence of acne was higher in the upadacitinib 15 mg (30 [10%] of 300 patients) and upadacitinib 30 mg (41 [14%] of 297 patients) groups than the placebo group (six [2%] of 304 patients). The incidence of adverse events leading to discontinuation of study drug (four [1%] patients in the upadacitinib 15 mg plus topical corticosteroids group, four [1%] patients in the upadacitinib 30 mg plus topical corticosteroids group, and seven [2%] patients in the placebo plus topical corticosteroids group) and serious adverse events (seven [2%] patients, four [1%] patients, and nine [3%] patients) were similar among treatment groups. No deaths were reported in any treatment group. INTERPRETATION Upadacitinib plus topical corticosteroids was well tolerated and superior to placebo plus topical corticosteroids. Upadacitinib as combination therapy had a positive benefit-risk profile in adults and adolescents with moderate-to-severe atopic dermatitis. FUNDING AbbVie.
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Intraoperative Applications of Topical Corticosteroid Therapy for Chronic Rhinosinusitis.
Lelegren, MJ, Bloch, RA, Lam, KK
Ear, nose, & throat journal. 2021;(5):320-328
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Abstract
OBJECTIVES To provide an overview of recent techniques and technologies for the application of topical corticosteroid therapy immediately following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). METHODS A comprehensive search in the PubMed and Google Scholar databases was conducted to identify publications between January 2000 and December 2019 detailing clinical trials that have evaluated the efficacy and safety of intraoperative applications of topical corticosteroids for CRS. RESULTS A total of 21 articles, all of which highlight a variety of corticosteroid-infused products, including Propel corticosteroid-eluting stents, NasoPore, Merocel, SinuBand, calcium alginate, and bioresorbable gel-type products, are included for review. Propel stents are the only devices that have achieved level 1A evidence in terms of efficacy and have data to support their safety. The remaining products have shown mixed results in terms of efficacy and safety. CONCLUSION A wide range of techniques and technologies have been introduced to enhance the topical delivery of corticosteroids into the neosinuses after ESS for CRS. Regarding efficacy, there is level 1A evidence to support the use of Propel stents. Most of the remaining strategies show some degree of efficacy. Direct comparisons across the different strategies are limited owing to the varied uses of delivery vectors, corticosteroid choices, and doses of corticosteroids. Propel stents and SinuBand have sufficient data to support systemic and ocular safety, whereas the remaining products have limited data to support their safety.
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Management of acute food protein-induced enterocolitis syndrome emergencies at home and in a medical facility.
Leonard, SA, Miceli Sopo, S, Baker, MG, Fiocchi, A, Wood, RA, Nowak-Węgrzyn, A
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology. 2021;(5):482-488.e1
Abstract
OBJECTIVE Acute food protein-induced enterocolitis syndrome (FPIES) is characterized by delayed repetitive vomiting after ingestion of a trigger food, and severe reactions may lead to dehydration, hypotension, and shock. We provide recommendations on management of FPIES emergencies in a medical facility and at home. DATA SOURCES This review summarizes the literature on clinical context, pathophysiology, presentation, and treatment of FPIES emergencies. STUDY SELECTIONS We referred to the 2017 International Consensus Guidelines for the Diagnosis and Management of FPIES and performed a literature search identifying relevant recent primary articles and review articles on clinical management. RESULTS Management of FPIES emergencies in a medical facility is based on severity of symptoms and involves rehydration, ondansetron, and corticosteroids. A proactive approach for reactions occurring at home involves prescribing oral ondansetron and providing an individualized treatment plan based on the evolution of symptoms and severity of past reactions. A better understanding of the pathophysiology of FPIES and randomized trials on ondansedron and cocorticosteroid use could lead to more targeted treatments. CONCLUSION Children with FPIES are at risk for severe symptoms constituting a medical emergency. Management of FPIES emergencies is largely supportive, with treatment tailored to the symptoms, severity of the patient's condition, location of reaction, and reaction history.
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Autoimmune encephalitis: proposed best practice recommendations for diagnosis and acute management.
Abboud, H, Probasco, JC, Irani, S, Ances, B, Benavides, DR, Bradshaw, M, Christo, PP, Dale, RC, Fernandez-Fournier, M, Flanagan, EP, et al
Journal of neurology, neurosurgery, and psychiatry. 2021;(7):757-768
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Abstract
The objective of this paper is to evaluate available evidence for each step in autoimmune encephalitis management and provide expert opinion when evidence is lacking. The paper approaches autoimmune encephalitis as a broad category rather than focusing on individual antibody syndromes. Core authors from the Autoimmune Encephalitis Alliance Clinicians Network reviewed literature and developed the first draft. Where evidence was lacking or controversial, an electronic survey was distributed to all members to solicit individual responses. Sixty-eight members from 17 countries answered the survey. Corticosteroids alone or combined with other agents (intravenous IG or plasmapheresis) were selected as a first-line therapy by 84% of responders for patients with a general presentation, 74% for patients presenting with faciobrachial dystonic seizures, 63% for NMDAR-IgG encephalitis and 48.5% for classical paraneoplastic encephalitis. Half the responders indicated they would add a second-line agent only if there was no response to more than one first-line agent, 32% indicated adding a second-line agent if there was no response to one first-line agent, while only 15% indicated using a second-line agent in all patients. As for the preferred second-line agent, 80% of responders chose rituximab while only 10% chose cyclophosphamide in a clinical scenario with unknown antibodies. Detailed survey results are presented in the manuscript and a summary of the diagnostic and therapeutic recommendations is presented at the conclusion.
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Efficacy and safety of pharmacological cachexia interventions: systematic review and network meta-analysis.
Saeteaw, M, Sanguanboonyaphong, P, Yoodee, J, Craft, K, Sawangjit, R, Ngamphaiboon, N, Shantavasinkul, PC, Subongkot, S, Chaiyakunapruk, N
BMJ supportive & palliative care. 2021;(1):75-85
Abstract
AIMS: Randomised controlled trials (RCTs) demonstrated benefits of pharmacological interventions for cachexia in improving weight and appetite. However, comparative efficacy and safety are not available. We conducted a systematic review and network meta-analysis (NMA) to evaluate the relative efficacy and safety of pharmacological interventions for cachexia. METHODS PubMed, EmBase, Cochrane, and ClinicalTrials.gov were searched for RCTs until October 2019. Key outcomes were total body weight (TBW) improvement, appetite (APP) score and serious adverse events. Two reviewers independently extracted data and assessed risk of bias. NMA was performed to estimate weight gain and APP score increase at 8 weeks, presented as mean difference (MD) or standardised MD with 95% CI. RESULTS 80 RCTs (10 579 patients) with 12 treatments were included. Majority is patients with cancer (7220). Compared with placebo, corticosteroids, high-dose megestrol acetate combination (Megace_H_Com) (≥400 mg/day), medroxyprogesterone, high-dose megestrol acetate (Megace_H) (≥400 mg/day), ghrelin mimetic and androgen analogues (Androgen) were significantly associated with MD of TBW of 6.45 (95% CI 2.45 to 10.45), 4.29 (95% CI 2.23 to 6.35), 3.18 (95% CI 0.94 to 5.41), 2.66 (95% CI 1.47 to 3.85), 1.73 (95% CI 0.27 to 3.20) and 1.50 (95% CI 0.56 to 2.44) kg. For appetite improvement, Megace_H_Com, Megace_H and Androgen significantly improved standardised APP score, compared with placebo. There is no significant difference in serious adverse events from all interventions compared with placebo. CONCLUSIONS Our findings suggest that several pharmacological interventions have potential to offer benefits in treatment of cachexia especially Megace_H and short-term use corticosteroids. Nonetheless, high-quality comparative studies to compare safety and efficacy are warranted for better management of cachexia.
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AIRE Gene Mutation Presenting at Age 2 Years With Autoimmune Retinopathy and Steroid-Responsive Acute Liver Failure: A Case Report and Literature Review.
Sakaguchi, H, Mizuochi, T, Haruta, M, Takase, R, Yoshida, S, Yamashita, Y, Nishikomori, R
Frontiers in immunology. 2021;:687280
Abstract
Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy (APECED) is a rare monogenic autosomal recessive disorder caused by mutation in the autoimmune regulator (AIRE) gene. Patients usually are diagnosed at ages between 5 and 15 years when they show 3 or more manifestations, most typically mucocutaneous candidiasis, Addison's disease, and hypoparathyroidism. APECED-associated hepatitis (APAH) develops in only 10% to 40% of patients, with severity varying from subclinical chronic active hepatitis to potentially fatal acute liver failure (ALF). Ocular abnormalities are fairly common, most often keratopathy but sometimes retinopathy. Here we report a 2-year-old Japanese girl with an AIRE gene mutation who developed APAH with ALF, preceded by autoimmune retinopathy associated with anti-recoverin antibody before major symptoms suggested a diagnosis of APECED. Intravenous pulse methylprednisolone therapy followed by a corticosteroid combined with azathioprine treatment resolved ALF and achieved control of APAH. To our knowledge, our patient is the youngest reported to have ALF resulting from an AIRE gene mutation. Pulse methylprednisolone induction therapy followed by treatment with corticosteroid plus azathioprine may well be effective in other children with APAH and AIRE gene mutations.