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Extracorporeal photopheresis vs standard therapies for steroid-refractory chronic graft-vs-host disease: Pharmacoeconomic assessment of hospital resource use in Spain.
Boluda, B, Solana-Altabella, A, Cano, I, Acuña-Cruz, E, Rodríguez-Veiga, R, Ballesta-López, O, Megías-Vericat, JE, Martínez-Cuadrón, D, Gómez, I, Solves, P, et al
Journal of clinical apheresis. 2021;(4):612-620
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Abstract
BACKGROUND This study assessed pharmacoeconomic costs associated with extracorporeal photopheresis (ECP) compared with other available second-line therapies for chronic graft-vs-host disease (cGvHD) in a tertiary Spanish institution. METHODS Patients (≥18 years) diagnosed with steroid-refractory cGvHD were eligible. Data were collected retrospectively from index date until 1 year or relapse. Patients were distributed in two cohorts (ECP vs non-ECP), matched by age (≤ or > 40), hematopoietic stem cell transplant (HLA-identical sibling donor or other) and number of previous immunosuppressive lines (1, 2, or ≥ 3). Costs were assigned using the 2016 diagnosis-related group (DRG) system: DRG 579 (€22 383) overnight stay due to major complication (ie, sepsis, pneumonia, parenteral nutrition, or respiratory failure), and DRG 875 (€5154) if no major complication. The primary endpoint was healthcare resource utilization per patient. RESULTS Forty patients (n = 20 per cohort) were included. Median age was 49, and 37.5% were female. Mean total cost per patient was €25 319 (95% CI: €17 049-€33 590) across the two cohorts, with a slightly lower mean cost per ECP-treated patient (€23 120) compared with the non-ECP cohort (€27 519; P = .597). Twenty-seven inpatient hospitalizations occurred among ECP-treated patients, vs 33 in the non-ECP cohort. Day hospital and external consultations were more frequent in the ECP cohort. However, fewer inpatient admissions included DRG 579 compared with the non-ECP cohort (44% vs 58%). Inpatient length of stay was slightly shorter in the ECP cohort (30 vs 49 days; P = .298). CONCLUSIONS ECP treatment may yield economic savings in Spain through resource savings and moving costs toward outpatient care.
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Effects of lisdexamfetamine on plasma steroid concentrations compared with d-amphetamine in healthy subjects: A randomized, double-blind, placebo-controlled study.
Strajhar, P, Vizeli, P, Patt, M, Dolder, PC, Kratschmar, DV, Liechti, ME, Odermatt, A
The Journal of steroid biochemistry and molecular biology. 2019;:212-225
Abstract
The novel d-amphetamine prodrug lisdexamfetamine is applied to treat attention-deficit/hyperactivity disorder (ADHD). d-Amphetamine releases dopamine and norepinephrine and stimulates the hypothalamic-pituitary-adrenal (HPA) axis, which may contribute to its reinforcing effects and risk of abuse. However, no data is currently available on the effects of lisdexamfetamine on circulating steroids. This randomized, double-blind, placebo-controlled, cross-over study evaluated the effects of equimolar doses of d-amphetamine (40 mg) and lisdexamfetamine (100 mg) and placebo on circulating steroids in 24 healthy subjects. Plasma steroid and d-amphetamine levels were determined up to 24 h. Delayed increase and peak levels of plasma d-amphetamine concentrations were observed following lisdexamfetamine treatment compared with d-amphetamine administration, however the maximal concentrations and total exposure (area under the curve [AUC]) were similar. Lisdexamfetamine and d-amphetamine significantly enhanced plasma levels of adrenocorticotropic hormone, glucocorticoids (cortisol, cortisone, corticosterone, 11-dehydrocorticosterone, and 11-deoxycortisol), androgens (dehydroepiandrosterone, dehydroepiandrosterone sulfate, and Δ4-androstene-3,17-dione [androstenedione]), and progesterone (only in men) compared with placebo. Steroid concentration-time curves were shifted to later time points due to a non-significantly later onset following lisdexamfetamine administration than after d-amphetamine, however maximal plasma steroid concentrations and AUCs did not differ between the active treatments. None of the active treatments altered plasma levels of the mineralocorticoids aldosterone and 11-deoxycorticosterone or the androgen testosterone compared with placebo. The effects of the amphetamines on glucocorticoid production were similar to those that were previously reported for methylphenidate (60 mg) but weaker than those for the serotonin releaser 3,4-methylenedioxymethamphetamine (MDMA; 125 mg) or direct serotonin receptor agonist lysergic acid diethylamide (LSD; 0.2 mg). Lisdexamfetamine produced comparable HPA axis activation and had similar pharmacokinetics than d-amphetamine, except for a delayed time of onset. Thus, serotonin (MDMA, LSD) may more effectively stimulate the HPA axis than dopamine and norepinephrine (D-amphetamine).
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A randomized nutrition counseling intervention in pediatric leukemia patients receiving steroids results in reduced caloric intake.
Li, R, Donnella, H, Knouse, P, Raber, M, Crawford, K, Swartz, MC, Wu, J, Liu, D, Chandra, J
Pediatric blood & cancer. 2017;(2):374-380
Abstract
BACKGROUND Quality of life in survivors of pediatric acute lymphocytic leukemia (ALL) can be compromised by chronic diseases including increased risk of second cancers, cardiovascular disease, and diabetes. Overweight or obesity further increases these risks. Steroids are a component of chemotherapy for ALL, and weight gain is a common side effect. To impact behaviors associated with weight gain, we conducted a randomized nutrition counseling intervention in ALL patients on treatment. PROCEDURE ALL patients on a steroid-based treatment regimen at the MD Anderson Children's Cancer Hospital were recruited and randomized into control or intervention groups. The control group received standard care and nutrition education materials. The intervention group received monthly one-on-one nutrition counseling sessions, consisting of a baseline and 12 follow-up visits. Anthropometrics, dietary intake (3-day 24-hr dietary recalls) and oxidative stress measures were collected at baseline, 6 months, and postintervention. Dietary recall data were analyzed using the Nutrition Data System for Research. RESULTS Twenty-two patients (median age 11.5 years), all in the maintenance phase of treatment, were recruited. The intervention group (n = 12) reported significantly lower calorie intake from baseline to 12-month follow-up and significant changes in glutamic acid and selenium intake (P < 0.05). Waist circumference was significantly associated with calorie, vitamin E, glutamic acid, and selenium intake. CONCLUSIONS A year-long dietary intervention was effective at reducing caloric intake in pediatric ALL patients receiving steroid-based chemotherapy, indicating that this is a modality that can be built upon for obesity prevention and management.
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Steroid vs. Platelet-Rich Plasma in Ultrasound-Guided Sacroiliac Joint Injection for Chronic Low Back Pain.
Singla, V, Batra, YK, Bharti, N, Goni, VG, Marwaha, N
Pain practice : the official journal of World Institute of Pain. 2017;(6):782-791
Abstract
BACKGROUND Despite widespread use of steroids to treat sacroiliac joint (SIJ) pain, their duration of pain reduction is short. Platelet-rich plasma (PRP) can potentially enhance tissue healing and may have a longer-lasting effect on pain. OBJECTIVES To assess the efficacy and safety of PRP compared with methylprednisolone in ultrasound-guided SIJ injection for low back pain. STUDY DESIGN Prospective randomized open blinded end point (PROBE) study. METHODS Forty patients with chronic low back pain diagnosed with SIJ pathology were randomly allocated into 2 groups. Group S received 1.5 mL of methylprednisolone (40 mg/mL) and 1.5 mL of 2% lidocaine with 0.5 mL of saline, while Group P received 3 mL of leukocyte-free PRP with 0.5 mL of calcium chloride into ultrasound-guided SIJ injection. Visual analog scale (VAS) scores, Modified Oswestry Disability Questionnaire (MODQ) scores, Short Form (SF-12) Health Survey scores, and complications (if any) were evaluated at 2 weeks, 4 weeks, 6 weeks, and 3 months. RESULTS Intensity of pain was significantly lower in Group P at 6 weeks (median [interquartile range (IQR)] = 1 [1 to 1] vs. 3.5 [2 to 5]; P = 0.0004) and 3 months (Median [IQR] = 1 [1 to 3] vs. 5 [3 to 5]; P = 0.0002) as compared to Group S. The efficacy of steroid injection was reduced to only 25% at 3 months in Group S, while it was 90% in Group P. A strong association was observed in patients receiving PRP and showing a reduction of VAS ≥ 50% from baseline when other factors were controlled. The MODQ and SF-12 scores were improved initially for up to 4 weeks but deteriorated further at 3 months in Group S, while both the scores improved gradually for up to 3 months in Group P. CONCLUSION The intra-articular PRP injection is an effective treatment modality in low back pain involving SIJ.
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"Coffee plus honey" versus "topical steroid" in the treatment of chemotherapy-induced oral mucositis: a randomised controlled trial.
Raeessi, MA, Raeessi, N, Panahi, Y, Gharaie, H, Davoudi, SM, Saadat, A, Karimi Zarchi, AA, Raeessi, F, Ahmadi, SM, Jalalian, H
BMC complementary and alternative medicine. 2014;:293
Abstract
BACKGROUND Oral mucositis is one of the common complications of cancer chemotherapy and about 40% of the patients who take chemotherapy protocols, experience this irritating problem. The purpose of this study was to draw comparison between the therapeutic effects of our treatment modalities (topical steroid, honey, honey plus coffee) in patients suffering from oral mucositis. METHODS This was a double blinded randomised clinical trial of a total of 75 eligible adult participants which they randomly fell into three treatment groups. For all the participants a syrup-like solution was prepared. Each 600 grams of the product consisted of "20 eight-mg Betamethasone solution ampoules" in the Steroid (S) group, "300 grams of honey plus 20 grams of instant coffee" in the Honey plus Coffee (HC) group, and "300 grams of honey" for the Honey (H) group. The participants were told to sip 10 ml of the prescribed product, and then swallow it every three hours for one week. Severity of lesions was clinically evaluated before the treatment and also one week after the initiation of the intervention. This study adhered to the principles of the Declaration of Helsinki and guidelines of Good Clinical Practice. RESULTS This study showed that all three treatment regimens reduce the severity of lesions. The best reduction in severity was achieved in HC group. H group and S group took the second and third places. In other words, honey plus coffee regimen was the most effective modality for the treatment of oral mucositis. CONCLUSION Oral mucositis can be successfully treated by a combination of honey and coffee as an alternative medicine in a short time. Further investigations are warranted in this field. TRIAL REGISTRATION Iranian Registry of Clinical Trials IRCT 201104074737N3, (9 May 2011).
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[Comparison of the mechanisms of intralesional steroid, interferon or verapamil injection in the treatment of proliferative scars].
Xu, SJ, Teng, JY, Xie, J, Shen, MQ, Chen, DM
Zhonghua zheng xing wai ke za zhi = Zhonghua zhengxing waike zazhi = Chinese journal of plastic surgery. 2009;(1):37-40
Abstract
OBJECTIVE To investigate the effects of intralesional steroid, interferon alpha-2b or verapamil injection on proliferation, apoptosis and TGF-beta1 expression in keloid and hypertrophic scar in vivo. METHODS 6 patients with keloids and 6 patients with hypertrophic scar were treated with intralesional injection of triamcinolone acetonide (40 mg/ml) or IFN alpha-2b (15 x 10(5) U/ml) or verapamil (2.5 mg/ml). Samples were collected on the 7th day after intralesional injection. Samples of untreated keloid and hypertrophic scar and normal skin were used as control. Expression of PCNA and TGF-beta1 was detected in situ by immunohistochemical staining, and apoptosis was detected in situ by terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin nick end labeling (TUNEL). RESULTS 1) Triamcinolone acetonide could prohibit proliferative scars through inhibiting cell proliferation and TGF-beta1 expression, as well as inducing apoptosis. 2) IFN alpha-2b could prohibit proliferative scars through inhibiting cell proliferation and TGF-beta1 expression, but not inducing apoptosis; 3) Verapamil could also prohibit proliferative scars through inhibiting proliferation and TGF-beta1 expression in fibroblasts, as well as inducing apoptosis. While the effect of inducing apoptosis was stronger than that of triamcinolone acetonide, the effect of inhibiting TGF-beta1 expression was weaker than those of triamcinolone acetonide and IFN alpha-2b. CONCLUSIONS Although intraleional injection of steroid, interferon alpha-2b or verapamil were all effective in the treatment of keloid and hypertrophic scar, their mechanisms are not similar.
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Molecular docking simulations of steroid substrates into human cytosolic hydroxysteroid dehydrogenases (AKR1C1 and AKR1C2): insights into positional and stereochemical preferences.
Jin, Y, Penning, TM
Steroids. 2006;(5):380-91
Abstract
AKR1C1 and AKR1C2 are human cytosolic hydroxysteroid dehydrogenases, which play pivotal roles in the metabolism and action of natural and synthetic steroid hormones. The two enzymes are highly homologous, and have distinct positional and stereochemical preferences with various substrates. We performed molecular docking simulations of three steroid substrates, including an androgen (5alpha-dihydrotestosterone, DHT), a progestin (progesterone, PRO), and a synthetic hormone ([7alpha,17alpha]-17-hydroxy-7-methyl-19-norpregn-5(10)-en-20-yn-3-one or tibolone, TIB), into the active sites of the two enzymes. For each substrate and enzyme pair, the activity inferred by the "productive" docking models (in which the spatial arrangement of the steroid and the cofactor would permit a reaction) matched the experimentally observed positional and stereochemical outcome. These productive conformations were energetically and statistically favored except for TIB and PRO with AKR1C2, where experimentally strong substrate inhibition and low activity were observed, respectively. Results showed that (i) a 3-ketosteroid (DHT) and a 20-ketosteroid (PRO) were reduced by AKR1C1 since the carbonyl groups could occupy the same position by "backwards" binding of steroids; (ii) 3alpha-reduced (DHT) and 3beta-reduced (TIB) products were formed by AKR1C2 since the angular methyl groups of the steroids were inverted by "upside-down" binding of steroids; and (iii) the 3beta- and 3alpha-reduction of DHT by AKR1C1 and AKR1C2, respectively occurred since the steroids employed a "swinging" motion to present opposite faces to the cofactor. Favorable nonproductive modes were observed with all substrates in both enzymes in which the steroid was bound at a "near-entry" position and/or an "in-middle" position, which may influence the reaction coordinate.
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Perioperative steroids in tonsillectomy using electrocautery and sharp dissection techniques.
Hanasono, MM, Lalakea, ML, Mikulec, AA, Shepard, KG, Wellis, V, Messner, AH
Archives of otolaryngology--head & neck surgery. 2004;(8):917-21
Abstract
OBJECTIVE To determine the effect of preoperative dexamethasone sodium phosphate administration on posttonsillectomy morbidity for electrocautery ("hot") and sharp ("cold") dissection techniques. DESIGN Prospective, randomized, double-blind study. SETTING University pediatric hospital and county teaching hospital. Subjects A total of 219 children, aged 9 months to 12 years, undergoing tonsillectomy. Intervention Participants who underwent tonsillectomy were randomly assigned to receive either intravenous dexamethasone sodium phosphate (1 mg/kg) or placebo. OUTCOME MEASURES Pain scores, oral intake, and emesis on postoperative day (POD) 1. RESULTS A total of 106 subjects (62 undergoing hot and 44 cold tonsillectomies) received preoperative steroids, and 113 (56 hot and 57 cold tonsillectomies) received placebo. On POD 1, pain scores reported by patients (P =.02), parents (P =.002), and physicians (P<.001) were significantly lower in subjects receiving steroids than in those receiving placebo. Emesis was reduced from a mean of 2.1 (placebo group) to 1.2 episodes (steroid group) (P =.02). Oral intake improved from 24.5% of normal diet (placebo) to 31.7% (steroid group) (P =.004). When all 4 groups were compared (cold placebo, cold steroid, hot placebo, and hot steroid), pain scores reported by physicians and parents were significantly lower in the cold steroid group than in the other groups. CONCLUSIONS Perioperative dexamethasone use reduces posttonsillectomy morbidity in pediatric patients in the early postoperative period after hot or cold tonsillectomy. The combination of steroid and cold dissection technique provided the greatest advantage in reducing posttonsillectomy subjective pain levels.
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Efficacy of interventions for bronchiolitis in critically ill infants: a systematic review and meta-analysis.
Davison, C, Ventre, KM, Luchetti, M, Randolph, AG
Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies. 2004;(5):482-9
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Abstract
BACKGROUND Viral bronchiolitis is the leading cause of respiratory failure among infants in the United States. Currently, the mainstay of treatment is supportive care. The effectiveness of treatments used for mechanically ventilated infants with bronchiolitis is unclear. OBJECTIVE To evaluate the strength of the evidence supporting the use of currently available treatments for critically ill infants with bronchiolitis. DATA SOURCE We searched PubMed, citations of relevant articles, personal files, and conference proceedings, and we contacted experts in the field. STUDY SELECTION Randomized, controlled trials evaluating any therapy for bronchiolitis that included children in an intensive care unit. DATA EXTRACTION Two reviewers independently extracted data and assessed methodologic quality. DATA SYNTHESIS A total of 2,319 citations were screened, and 16 randomized, controlled trials were included. There were three trials of surfactant, three of ribavirin, three of immune globulin, three of systemic corticosteroids, and one each of vitamin A, interferon, erythropoietin, and heliox. A meta-analysis of the three surfactant studies showed a strong trend toward a decrease in duration of mechanical ventilation of 2.58 days (95% confidence interval, -5.34 to 0.18 days; p =.07) and a significant decrease of 3.3 intensive care unit days (95% confidence interval, -6.38 to -0.23 days; p =.04). A meta-analysis of the three systemic corticosteroid studies showed no overall effect on duration of mechanical ventilation when all three trials were combined (-0.62 day; 95% confidence interval, -2.78 to 1.53 days; p =.57). We identified one published meta-analysis of three ribavirin studies showing a significant decrease in ventilator days with ribavirin (-1.2 days; 95% confidence interval, -0.2 to -3.4 days; p =.2). CONCLUSIONS Currently, there are no clearly effective interventions available to improve the outcome of critically ill infants with bronchiolitis. Surfactant seems to be a promising intervention, and corticosteroids or ribavirin may also be beneficial.
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Validity of methods for analyzing urinary steroid data to detect ovulation in athletes.
McConnell, HJ, O'Connor, KA, Brindle, E, Williams, NI
Medicine and science in sports and exercise. 2002;(11):1836-44
Abstract
PURPOSE The purpose of this study was to determine whether the accuracy of ovulation detection algorithms is compromised when applied to menstrual cycles exhibiting subclinical hormonal abnormalities, which are particularly prevalent in female athletes. METHODS The validity of five ovulation detection algorithms was compared between 25 regularly exercising women and 15 sedentary controls. Subjects collected daily urine samples for an entire menstrual cycle for analysis of estrone-3-glucuronide (E1G), pregnanediol-3-glucuronide (PDG), and luteinizing hormone (LH). The algorithms were applied to determine their sensitivity (% of true ovulatory cycles), specificity (% of true anovulatory cycles), and the deviation from the reference day of ovulation (difference scores). RESULTS The sensitivity was > 80% in all algorithms except Baird's E1G/PDG ratio algorithm (74%) and Kassam's PDG ratio algorithm (78%). All algorithms, except Kassam's PDG ratio algorithm (80%), were found to exhibit specificities < 70%. Baird's E1G/PDG ratio algorithm was the most accurate in estimating the day of ovulation by deviating only -0.2 +/- 0.3 d from the reference day in the exercising female cycles and -0.5 +/- 0.3 d in the controls. No statistical differences in the sensitivities of the algorithms were found between the exercising and control cycles. When comparing the deviation from the reference day of ovulation between subject groups, no statistical difference was found. CONCLUSION The algorithms display similar validity in determining the presence and day of ovulation between subject groups, and thus may be applied to cycles exhibiting subclinical hormonal abnormalities as commonly observed in exercising women.