Safety and clinical efficacy of bilastine in reduction of pruritus in patients with chronic spontaneous urticaria

2021 ◽  
pp. 28-32
Author(s):  
A.Ye. Bogomolov
Keyword(s):  
Standard Deviation ◽  
Clinical Efficacy ◽  
Activity Index ◽  
Randomized Study ◽  
Initial Therapy ◽  
Chronic Spontaneous Urticaria ◽  
Double Dose ◽  
Analog Scale ◽  
The Mean ◽  
Urticaria Activity Score

Objective — to evaluate the efficacy/safety of bilastine in relieving pruritus in patients with chronic spontaneous urticaria. Materials and methods. This prospective randomized study included 50 adult patients aged 18 to 59 years with chronic spontaneous urticaria and pruritus with an intensity of more than 4 points by the visual analog scale of pruritus assessment in the last 3 days and more than 16 points by the Urticaria activity score 7 (UAS7) which assessed chronic urticaria intensity for the last week.Patients received bilastine orally at a dose of 20 mg once a day for 8 weeks. Patients who did not respond to therapy within the first 2 weeks subsequently received bilastine at a dose of 40 mg per day (two 20 mg tablets) till the end of the study (for 6 weeks). Results and discussion. The mean age of patients was 39.61 years with standard deviation (SD) of 12.33 years. In the group of patients who responded positively to the initial therapy, within 8 weeks, the pruritus intensity scoring level decreased significantly to 0.46 (95 % CI: 0.14—0.78) points (p < 0.05). The patients who received a double dose of bilastine also revealed a decrease in the intensity of pruritus and on average on the 8th week of treatment had 0.48 (95 % CI: 0.26—0.70) points (p < 0.05).The study reported 14 adverse events (AE) that occurred during bilastine treatment in 10 (23.8 %) patients. All of them were classified as mild and the most common was headache, registered in 12 (85.7 %) cases. No moderate or severe AEs were reported during the study. Conclusions. 8 week treatment with bilastine has demonstrated proven clinical efficacy both in reducing the urticaria activity index according to UAS7 and in reducing the intensity of pruritus in the absence of moderate and severe AEs. Patients who did not respond to starting therapy after doubling the bilastine dose also significantly decreased the urticaria activity index according to UAS7 and reduced the intensity of pruritus. At the same time, increasing the dose of the drug did not lead to an increase in the frequency of AEs.

What Is the Price and Claimed Efficacy of Platelet-Rich Plasma Injections for the Treatment of Knee Osteoarthritis in the United States?

2018 ◽  
Vol 32 (09) ◽  
pp. 879-885 ◽  
Author(s):  
Nicolas S. Piuzzi ◽  
Mitchell Ng ◽  
Ariel Kantor ◽  
Kenneth Ng ◽  
Stephanie Kha ◽  
...  
Keyword(s):  
United States ◽  
Standard Deviation ◽  
Knee Osteoarthritis ◽  
Clinical Efficacy ◽  
Health Care Providers ◽  
Platelet Rich Plasma ◽  
The United States ◽  
Care Providers ◽  
Knee Oa ◽  
The Mean

AbstractPlatelet-rich plasma (PRP) injections are often used for the treatment of knee osteoarthritis (OA), despite clinical value and cost-effectiveness not being definitely established. PRP injections are considered as a potential means of reducing pain and improving function in patients with knee OA, in the hope of delaying or avoiding the need for surgical intervention. Centers that offer PRP injections usually charge patients out of pocket and directly market services. Therefore, the purpose of this study was to quantify the current (1) prices and (2) marketed clinical efficacy of autologous PRP injections for knee OA. A prospective cross-sectional study was performed based on 286 centers identified in the United States offering PRP injections for knee OA. A total of 179 (73.4%) centers were successfully contacted via e-mail or phone, using a simulated 52-year-old male patient with knee OA. Scripted questions were asked by the simulated patient to determine the current marketed prices and clinical efficacy, either reported as “good results” or “symptomatic improvement,” claimed by each treating center. The mean price for a single unilateral knee same-day PRP injection was $714 with a standard deviation of $144 (95% confidence interval [CI]: $691–737, n = 153). The mean claim of clinical efficacy was 76% with a standard deviation of 11% (95% CI: 73.5–78.3%, n = 84). Out of the 84 clinics, 10 claimed “90 to 100% efficacy,” 27 claimed “80 to 90%,” 29 claimed “70 to 80%,” 9 claimed “60 to 70%,” 8 claimed “50 to 60%,” and 1 claimed “40 to 60%.” These findings provide a unique perspective on the PRP market for the treatment of knee OA that is valuable to physicians and health care providers in providing better education to patients on the associated costs and purported clinical benefits of PRP injections.

The Real-Life Effectiveness and Safety of Omalizumab Updosing in Patients With Chronic Spontaneous Urticaria

2019 ◽  
Vol 23 (5) ◽  
pp. 496-500 ◽  
Author(s):  
Andac Salman ◽  
Elif Comert
Keyword(s):  
Real Life ◽  
Complete Response ◽  
Response To Therapy ◽  
Chronic Spontaneous Urticaria ◽  
Life Effectiveness ◽  
The Mean ◽  
Group 2 ◽  
Urticaria Activity Score ◽  
Higher Doses ◽  
Group 1

Background: Omalizumab is a third-line treatment for chronic spontaneous urticaria (CSU). Studies investigating the use of higher doses of omalizumab in patients unresponsive to regular doses are limited. Objectives: This study aims to investigate the effectiveness and safety of omalizumab 450 mg in CSU. Methods: A retrospective cohort study was conducted. The response to therapy was evaluated using the Urticaria Activity Score over 7 days (UAS7) and the Urticaria Control Test (UCT). Patients showing complete response (CR) (UAS7: 0-1) to omalizumab 300 mg (Group 1) and patients receiving at least 3 doses of omalizumab 450 mg (Group 2) between 2016 and 2018 were included. Results: A total of 72 patients (Group 1: 59; Group 2: 13) were included. In Group 2, the mean UAS7 score decreased from 18.6 to 5.1 and the mean UCT score increased from 8.6 to 12 after a mean 4.3 courses of 450 mg omalizumab treatment. Of the 13 patients in Group 2, 6 had CR and 3 had good disease control (UAS7: 2-6). The rate of patients with low baseline IgE levels (< 43 IU/mL) was significantly higher in Group 2. Conclusions: Higher doses of omalizumab are effective and safe in patients with CSU that is unresponsive to omalizumab 300 mg. Lower baseline total IgE levels might be used as a predictor of nonresponse to omalizumab and the need for higher doses.

The Stem-Cell Market for the Treatment of Knee Osteoarthritis: A Patient Perspective

2017 ◽  
Vol 31 (06) ◽  
pp. 551-556 ◽  
Author(s):  
Nicolas Piuzzi ◽  
Mitchell Ng ◽  
Morad Chughtai ◽  
Anton Khlopas ◽  
Kenneth Ng ◽  
...  
Keyword(s):  
Stem Cell ◽  
Standard Deviation ◽  
Knee Osteoarthritis ◽  
Clinical Efficacy ◽  
Symptomatic Improvement ◽  
Stem Cell Therapies ◽  
Cell Therapies ◽  
Musculoskeletal Conditions ◽  
Knee Oa ◽  
The Mean

AbstractThe use of stem-cell therapies for the treatment of various musculoskeletal conditions, especially knee osteoarthritis (OA), is rapidly expanding, despite only low-level evidence to support its use. Centers offering these therapies are often marketing and charging patients out-of-pocket costs for such services. Therefore, the purpose of this study was to determine the current marketed: (1) prices and (2) clinical efficacy of stem-cell therapies for knee OA. This was a prospective cross-sectional study which queried 317 U.S. centers that offered direct-to-consumer stem-cell therapies for musculoskeletal conditions. A total of 273 of 317 centers were successfully contacted via phone or e-mail, using a simulated 57-year-old male patient with knee OA. Scripted questions were asked by the simulated patient to determine the marketed prices and clinical efficacy. Centers generally reported the proportion of patients who had “good results” or “symptomatic improvement.” The mean price of a unilateral (same-day) stem-cell knee injection was $5,156 with a standard deviation of $2,446 (95% confidence interval [CI]: $4,550–5,762, n = 65). The mean proportion of claimed clinical efficacy was 82% with a standard deviation of 9.6% (95% CI: 79.0–85.5%, n = 36). Most American stem-cell centers offer therapies for knee OA. The cost of these therapies averages about $5,000 per injection, and centers claim that 80% of the patients had “good results” or “symptomatic improvement,” denoting a gap between what is documented in the published literature and the marketing claims. These findings offer both patients and physicians insight into the current stem-cell market for knee OA. We hope that with this information, providers can more optimally make patients aware of discrepancies between what is being marketed versus the current evidence-based landscape of these therapies for knee OA.

scholarly journals Severity of voice disorders: integration of perceptual and acoustic data in dysphonic patients

CoDAS ◽  
2014 ◽  
Vol 26 (5) ◽  
pp. 382-388 ◽  
Author(s):  
Leonardo Wanderley Lopes ◽  
Débora Pontes Cavalcante ◽  
Priscila Oliveira da Costa
Keyword(s):  
Standard Deviation ◽  
Fundamental Frequency ◽  
Visual Analog Scale ◽  
Voice Disorders ◽  
The Other ◽  
Discriminatory Power ◽  
Analog Scale ◽  
Acoustic Data ◽  
Acoustic Measures ◽  
The Mean

Purpose:To analyze the correlation between acoustic measures and intensity of vocal deviation, and its discriminatory power in detecting the presence of vocal change, classifying the severity of the deviation and differencing the type of predominant voice.Methods:The sample comprised 186 patients with dysphonia. The vocal deviation from the vowel/ε/was evaluated by consensus between three speech language pathologists, using a Visual Analog Scale. We extracted the mean and standard deviation (SD) of the fundamental frequency (F0), jitter, shimmer, and Glottal-to-Noise Excitation Ratio (GNE).Results:Mean F0 was negatively correlated with the degree of roughness and positively with the degree of tension. The F0 SD was positively correlated with the overall, roughness, tension, and instability grades. The jitter and shimmer were positively correlated with all perceptual parameters. Only the GNE distinguished between healthy and dysphonic voices and rated the degree of breathiness. The shimmer separated rough voices from not rough voices. The mean F0 was helpful to determine the degree of phonatory tension and to separate rough voices from breathy and strained voices.Conclusion:There is a correlation between the acoustic and auditory perceptual measures. The shimmer, the GNE, and F0 SD can be used to detect roughness, breathing, and strain, respectively. The GNE and mean F0 are useful to classify the degree of breathiness and strain, respectively. The mean F0 distinguished between rough, breathy, and strained voices, with rough voices more severe compared to the other two.

scholarly journals High-dose levocetirizine for the treatment of refractory chronic spontaneous urticaria and the effect on the serum inositol triphosphate level

2019 ◽  
Vol 47 (9) ◽  
pp. 4374-4379 ◽  
Author(s):  
Xianqiong Huang ◽  
Zhaoyang Li ◽  
Renshan Sun
Keyword(s):  
Serum Concentration ◽  
Cell Types ◽  
Chronic Spontaneous Urticaria ◽  
Inositol Triphosphate ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
High Dose ◽  
Before And After ◽  
The Mean ◽  
Urticaria Activity Score

Objective The second messenger inositol triphosphate (IP3) is involved in signal transduction in multiple cell types. We evaluated the effects of high-dose levocetirizine on chronic spontaneous urticaria (CSU) and examined the significance of serum IP3 level in the pathogenesis of CSU. Methods Fifteen patients with refractory CSU were given oral levocetirizine at a dose of 15 mg once daily for 7 days, and treatment efficacy was determined using the Urticaria Activity Score and by evaluating wheal-and-erythema reactions and itching. The serum concentration of IP3 at specific time points was determined by enzyme-linked immunosorbent assay. Results The mean serum concentration of IP3 was 43.54 ± 41.97 pg/mL prior to treatment, 18.40 ± 17.53 pg/mL after treatment, and 1.31 ± 0.92 pg/mL in a healthy control group. The mean concentration of IP3 was significantly higher before treatment than after treatment, and the level of IP3 in the patient group before and after treatment was significantly higher than that in the control group. Conclusion High-dose levocetirizine was shown to be effective in the treatment of CSU. The level of serum IP3 was positively correlated with CSU activity, indicating that IP3 may play an important role in the pathogenesis of this condition.

scholarly journals Clinical Efficacy and Safety of Leflunomide in Egyptian Patients with Active Rheumatoid Arthritis: CLEAR Interim Results

2018 ◽  
Vol 12 (1) ◽  
pp. 323-331
Author(s):  
Adel El Sayed ◽  
Abd El-Monim Hilal ◽  
Ahmed Abogamal ◽  
Alaa Labeeb ◽  
Amin Abdel Hamid ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Efficacy ◽  
Interim Analysis ◽  
Active Rheumatoid Arthritis ◽  
Activity Index ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
First Line ◽  
Egyptian Patients ◽  
The Mean

Background: Worldwide, leflunomide is a commonly used Disease-Modifying Anti-Rheumatic Drugs (DMARDs). It can be used as a monotherapy or in combination with other DMARDs to inhibit the production of inflammatory cells and accordingly reduce inflammation. Objectives: CLEAR is a multi-centric study that aims to assess the clinical efficacy and safety of leflunomide as first-line and/or add-on therapy to other DMARDs with or without steroids in Egyptian patients with active Rheumatoid Arthritis (RA). Methods: Egyptian patients with active RA for whom leflunomide was prescribed at physicians’ discretion were observed for 12 weeks. Clinical Disease Activity Index (CDAI) score, and Health Assessment Questionnaire Disability Index (HAQ-DI) score were acquired thrice during this period. This study was registered on clinicaltrials.gov (NCT03599986). Results: Interim analysis of the data collected from 337 patients (in 21 centers) showed a statistically significant decrease in the mean total CDAI score throughout the first 12 weeks of treatment (p<0.001); as the mean ±SD score decreased from 36.60 ±14.90 at baseline to reach 16.16 ±9.84 at week 12 (% reduction: 61.16 ±14.36). A statistically significant decrease (p<0.001) was also observed in HAQ-DI, as the mean ±SD score decreased from 1.46 ±0.69 at baseline to reach 0.67 ±0.54 at week 12 (% reduction: 56.11 ±27.59). Conclusion: Results of the interim analysis suggest that treatment of Egyptian patients with active RA with leflunomide (as first-line and/or add-on therapy to other DMARDs with or without steroids) for 12 weeks may be effective in terms of CDAI score and HAQ-DI score reduction and may offer an alternative for patients who experienced resistance, inadequate response or intolerance to other DMARDs.

Rorschach Characteristics in Adolescents with Systemic Lupus Erythematosus

2006 ◽  
Vol 28 (1) ◽  
pp. 100-118 ◽  
Author(s):  
J. Santoantonio ◽  
L. Yazigi ◽  
E. I. Sato
Keyword(s):  
Lupus Erythematosus ◽  
Case Control Study ◽  
Activity Index ◽  
Disease Activity Index ◽  
Female Adolescents ◽  
Control Group ◽  
Intelligence Scale ◽  
The Mean ◽  
Experimental Group ◽  
Control Study

The purpose of this study was to investigate the personality characteristics in adolescents with SLE. The research design is a case-control study by means of the Rorschach Method and the Wechsler Intelligence Scale. Study group: 30 female adolescents with lupus, 12–17 years of age. The SLE Disease Activity Index was administered during the period of psychological evaluation. Control group: 32 nonpatient adolescents were matched for age, sex, and socioeconomic level. In the Wechsler Intelligence Scale the mean IQ of the experimental group was significantly lower than that of the control group (77 and 98, respectively, p < .001). In the Rorschach, the lupus patients showed greater difficulty in interpersonal interactions, although they displayed the resources to process affect and to cope with stressful situations. A positive moderate correlation (p = .069) between the activity index of the disease and the affect constriction proportion of the Rorschach was observed: the higher the SLEDAI score, the lower the capacity to process affect. There is a negative correlation between the activity index of the disease and the IQ (p = .001): with a higher activity index of the disease, less intellectual resources are available.

At Least One Standard Deviation Above the Mean

1969 ◽  
Vol 14 (9) ◽  
pp. 470-471
Author(s):  
M. DAVID MERRILL
Keyword(s):  
Standard Deviation ◽  
The Mean

The Estimation of Blood Platelet Survival

1972 ◽  
Vol 28 (03) ◽  
pp. 447-456 ◽  
Author(s):  
E. A Murphy ◽  
M. E Francis ◽  
J. F Mustard
Keyword(s):  
Standard Deviation ◽  
Least Squares ◽  
Experimental Error ◽  
Blood Platelet ◽  
Least Squares Estimation ◽  
Systematic Relationship ◽  
Platelet Survival ◽  
The Mean ◽  
Normally Distributed

SummaryThe characteristics of experimental error in measurement of platelet radioactivity have been explored by blind replicate determinations on specimens taken on several days on each of three Walker hounds.Analysis suggests that it is not unreasonable to suppose that error for each sample is normally distributed ; and while there is evidence that the variance is heterogeneous, no systematic relationship has been discovered between the mean and the standard deviation of the determinations on individual samples. Thus, since it would be impracticable for investigators to do replicate determinations as a routine, no improvement over simple unweighted least squares estimation on untransformed data suggests itself.

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