scholarly journals Comparison of eight-week and twelve-week corticosteroid treatment regimens in children with idiopathic nephrotic syndrome; A clinical trial

2020 ◽  
Vol 9 (3) ◽  
pp. e25-e25
Author(s):  
Hossein Emad Momtaz ◽  
Amin al Sadat Sharif ◽  
Ali Amri
Keyword(s):  
Clinical Trial ◽  
Nephrotic Syndrome ◽  
Relapse Rate ◽  
Steroid Treatment ◽  
Steroid Resistance ◽  
Treatment Protocols ◽  
Steroid Dependence ◽  
Treatment Groups ◽  
Treatment Regimens ◽  
Frequent Relapse

Introduction: Nephrotic syndrome (NS) is the commonest chronic glomerular disease in children. Idiopathic NS can perfectly be controlled using corticosteroids in most instances, but a significant relapse rate of NS is still a major problem. Several treatment protocols are suggested to decrease relapse rate of NS in children. Objectives: The current clinical trial aimed at comparing the relapse rate between two 8- and 12-week steroid treatment regimens. Patients and Methods: In the current non-randomized, clinical trial, a total of 68 children with primary NS were enrolled. Oral prednisolone was administered to 34 patients for eight weeks (2 mg/kg/d and 1.5 mg/kg/alternate-day/each for four weeks) and other 34 patients for 12 weeks (2 mg/kg/d and 1.5 mg/kg/alternate-day/each for six weeks). A one-year followup was completed for all the patients to evaluate relapse rate, steroid resistance, and steroid dependence. Results: The remission rates were 47.1% and 73.5%, respectively in children of the eight- and 12-week treatment groups because the difference was significant (P=0.026). The frequent relapse rates in the eight- and 12-week treatment groups were respectively 26.5% and 11.8%. Steroid dependence rate was 17.6% and 8.8% in the eight- and 12-week treatment groups respectively. The steroid resistance rates were respectively 8.8% and 5.9% in the eight- and 12-week treatment groups. Conclusion: Twelve-week steroid treatment can significantly decrease the relapse rate in comparison with eight-week treatment because no significant difference in steroid resistance, steroid dependence, and frequent relapse between the two treatment protocols was observed.

scholarly journals Comparative study utilizing different post-breeding treatment regimens in cyclic Arabian mares

2021 ◽  
pp. 2863-2868
Author(s):  
Khalid Mohammed Karam ◽  
Ahmed Saed Alebady ◽  
Haitham O. Alhilfi ◽  
Dhia Hussain Al-Delemi
Keyword(s):  
Treatment Regimen ◽  
Normal Saline ◽  
Prophylactic Treatment ◽  
Treatment Protocols ◽  
Treatment Groups ◽  
Treatment Regimens ◽  
Reproductive Management ◽  
Natural Breeding ◽  
Uterine Lavage ◽  
Age Category

Background and Aim: Post-breeding treatment is the most common practice in the reproductive management of mares. Oxytocin, uterine lavage, and intrauterine (I/U) antibiotic are usually used as prophylactic therapy. This study aimed to determine the most efficient prophylactic treatment regimen among six treatment protocols applied during natural breeding of cyclic Arabian mares. Materials and Methods: The current study was conducted on cyclic Arabian mares that were subdivided into three age categories (n=968): Category I (5-10 years, n=380), Category II (11-15 years, n=361), and Category III (≥16 years, n=227). Six prophylactic treatments were applied after 4 h of breeding. According to the treatment regimen, treated mares (n=483) were divided into six treatment groups: A (n=80), treated with I/U antibiotic (1 g gentamicin); B (n=81), I/U lavage (normal saline 500 mL); C (n=83), intramuscular (I/M) oxytocin (10 IU); D (n=82), I/U antibiotic and I/M oxytocin; E (n=78), I/U lavage and I/M oxytocin; and F (n=79), I/U lavage with I/U antibiotic and I/M oxytocin. Non-treated mares were classified as controls (n=485). Ultrasonography was performed to monitor pregnant mares 30 and 60 days after mating, and mares were followed until foaling. Results: Pregnancy and foaling results reveals that in age Category I, treatment with oxytocin alone or oxytocin with I/U lavage showed the highest pregnancy and foaling rates (p<0.01). In age Category II, the highest pregnancy and foaling rates were observed in lavage treatment (p<0.01), whereas, in age Category III, the good pregnancy and foaling rates were monitored in treatment with oxytocin and I/U lavage (p<0.01). Conclusion: Treatment with systemic I/M oxytocin is ideal in early age group mares (5-10 years of age). However, irrespective of the age categories, all mares exhibited high pregnancy and foaling rates after treatment with systemic I/M oxytocin and I/U lavage with normal saline (0.9%) 4 h post-breeding.

scholarly journals Rituximab versus cyclophosphamide for the treatment of children with steroid resistance nephrotic syndrome; a clinical trial study

2019 ◽  
Vol 5 (2) ◽  
pp. e15-e15
Author(s):  
Mohsen Akhavan Sepahi ◽  
Najmeh Farahani ◽  
Mohammad Reza Razavi ◽  
Hossein Heydari ◽  
Shahram Arsang-Jang
Keyword(s):  
Clinical Trial ◽  
Nephrotic Syndrome ◽  
Intervention Group ◽  
T Test ◽  
Steroid Resistance ◽  
Control Group ◽  
Steroid Resistant ◽  
Steroid Administration ◽  
Frequent Relapses ◽  
The Mean

Introduction: The most common complications of the nephrotic syndrome (NS) are the frequent relapses, steroid resistance, and long-term steroid administration. Objectives: This study aimed to compare the therapeutic effect of rituximab versus cyclophosphamide in the prevention of relapses and the complications of treatment in children with steroid-resistant NS. Patients and Methods: This clinical trial study was performed on 50 patients with resistant steroidal NS referred to Masoumeh hospital in Qom, Iran. Patients were randomly divided into the two groups including intervention (n=20) and control groups (n=30). In addition to the prednisolone, the intervention group received 375 mg/m2/weekly rituximab intravenously for 4 weeks. The control group received oral doses of cyclophosphamide 2 mg/kg/d for 3 months. During treatment, the frequency of relapses, the mean dose of steroid and the complications of treatment were compared with a paired t-test, independent t-test, and chi-square test. Results: A significant decrease in the mean dose of steroids and the mean number of relapses were seen in patients after administration of rituximab and cyclophosphamide (P<0.001). However, rituximab reduced the dose of steroid administration by 12.25 mg/d, while cyclophosphamide reduced only 2.83 mg/d (P<0.001). Rituximab reduced the relapse rate two times on average, while cyclophosphamide reduced only 0.5 times (P<0.001). The incidence of complications in the cyclophosphamide group was found to be more severe than the rituximab group. Conclusion: To compare rituximab versus cyclophosphamide regarding lower the frequency of recurrence after treatment, we found rituximab is a more suitable drug for the treatment of steroid-resistant NS than cyclophosphamide.

scholarly journals Prediction of steroid resistance and steroid dependence in nephrotic syndrome children

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Katarzyna Zaorska ◽  
Piotr Zawierucha ◽  
Monika Świerczewska ◽  
Danuta Ostalska-Nowicka ◽  
Jacek Zachwieja ◽  
...  
Keyword(s):  
Nephrotic Syndrome ◽  
Multiple Logistic Regression Analysis ◽  
Kidney Injury ◽  
Steroid Resistance ◽  
Neural Network Approach ◽  
Steroid Resistant ◽  
Steroid Dependence ◽  
Steroid Dependent ◽  
Stage Renal Disease ◽  
End Stage

Abstract Background Steroid resistant (SR) nephrotic syndrome (NS) affects up to 30% of children and is responsible for fast progression to end stage renal disease. Currently there is no early prognostic marker of SR and studied candidate variants and parameters differ highly between distinct ethnic cohorts. Methods Here, we analyzed 11polymorphic variants, 6 mutations, SOCS3 promoter methylation and biochemical parameters as prognostic markers in a group of 124 Polish NS children (53 steroid resistant, 71 steroid sensitive including 31 steroid dependent) and 55 controls. We used single marker and multiple logistic regression analysis, accompanied by prediction modeling using neural network approach. Results We achieved 92% (AUC = 0.778) SR prediction for binomial and 63% for multinomial calculations, with the strongest predictors ABCB1 rs1922240, rs1045642 and rs2235048, CD73 rs9444348 and rs4431401, serum creatinine and unmethylated SOCS3 promoter region. Next, we achieved 80% (AUC = 0.720) in binomial and 63% in multinomial prediction of SD, with the strongest predictors ABCB1 rs1045642 and rs2235048. Haplotype analysis revealed CD73_AG to be associated with SR while ABCB1_AGT was associated with SR, SD and membranoproliferative pattern of kidney injury regardless the steroid response. Conclusions We achieved prediction of steroid resistance and, as a novelty, steroid dependence, based on early markers in NS children. Such predictions, prior to drug administration, could facilitate decision on a proper treatment and avoid diverse effects of high steroid doses.

scholarly journals Therapies for Glomerular Diseases in Children

2018 ◽  
Vol 54 (01) ◽  
pp. 043-053
Author(s):  
Arvind Bagga
Keyword(s):  
Nephrotic Syndrome ◽  
Immunosuppressive Agents ◽  
Calcineurin Inhibitors ◽  
Steroid Resistance ◽  
Glomerular Diseases ◽  
Steroid Resistant ◽  
Steroid Resistant Nephrotic Syndrome ◽  
Steroid Dependence ◽  
Frequent Relapses ◽  
Steroid Sensitive

AbstractNephrotic syndrome is an important chronic disease of childhood, with a steroid sensitive course in most patients. Research on pathogenesis has emphasized the importance of T-lymphocyte dysregulation and vascular permeability factors that alter podocyte function and glomerular permselectivity. Mutations in genes that encode important podocyte proteins and therapeutic targets within podocytes have been identified. A hypothesis unifying available evidence on pathogenesis is yet to be proposed. An important proportion of patients have difficult disease course, characterized by frequent relapses, steroid dependence or steroid resistance, requiring therapy with alternative immunosuppressive agents. Clinical studies support the use of levamisole, cyclophosphamide, mycophenolate mofetil, calcineurin inhibitors (CNIs) and rituximab in patients with frequent relapses or steroid dependence. The management of steroid-resistant nephrotic syndrome is difficult and patients failing to achieve remission show progressive renal damage. Prospective studies in patients with steroid sensitive and steroid resistant nephrotic syndrome are the basis of current guidelines while ongoing studies will help identify and formulate effective and safe therapies.

scholarly journals Dental Fluorosis Treatment Can Improve the Individuals’ OHRQoL? Results from a Randomized Clinical Trial

2018 ◽  
Vol 29 (2) ◽  
pp. 109-116 ◽  
Author(s):  
Sônia Saeger Meireles ◽  
Marilia Leão Goettems ◽  
Kaline Silva Castro ◽  
Fábio Correia Sampaio ◽  
Flávio Fernando Demarco
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Endemic Area ◽  
Dental Fluorosis ◽  
Tooth Bleaching ◽  
Treatment Protocols ◽  
Treatment Groups ◽  
Anterior Teeth ◽  
Related Quality ◽  
At Home

Abstract This study aimed to evaluate the effect on oral health-related quality of life (OHRQoL) of two treatment protocols for dental fluorosis in individuals enrolled in a randomized clinical trial. Seventy volunteers, who lived in a fluorosis endemic area in Brazil, and had at least four maxillary anterior teeth showing fluorosis with a Thylstrup and Fejerskov index from 1 to 7, were randomized into two treatment groups (n= 35): GI- enamel microabrasion; or GII- microabrasion associated with at-home bleaching. Microabrasion was performed using 37% phosphoric acid and pumice, and at-home tooth bleaching with 10% carbamide peroxide in a tray. Volunteers completed a questionnaire at baseline and 1-month post treatment to assess changes in OHRQoL, using the Oral Impact on Daily Performance (OIDP). Differences in overall impact scores between and within treatment groups were analyzed with Wilcoxon (within) and Mann-Whitney (between) tests. Changes in performance scores were analyzed using Wilcoxon tests (a< 0.05). One month after treatment, subjects reported improvement in OHRQoL. Both groups showed lower OIDP scores (p< 0.001), but there was no difference between them. Eating, cleaning teeth, smiling and emotional state performance scores were lower after treatment for the whole sample. In conclusion, the treatment with microabrasion improved the OHRQoL in this sample of individuals living in a fluorosis endemic area regardless of the addition of at-home bleaching.

Comparative clinical trial of granisetron and ondansetron in the prophylaxis of cisplatin-induced emesis. The Granisetron Study Group.

1995 ◽  
Vol 13 (5) ◽  
pp. 1242-1248 ◽  
Author(s):  
R Navari ◽  
D Gandara ◽  
P Hesketh ◽  
S Hall ◽  
J Mailliard ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Single Dose ◽  
Demographic Characteristics ◽  
Study Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Comparative Clinical Trial ◽  
Treatment Groups ◽  
Treatment Regimens ◽  
Parallel Group

PURPOSE To compare the efficacy and safety of granisetron and ondansetron, serotonin (5-HT3) receptor antagonists shown to be effective in the prevention of chemotherapy-induced emesis. PATIENTS AND METHODS In a double-blind, randomized, stratified, parallel-group study, the efficacy and safety of granisetron and ondansetron were compared in 987 chemotherapy-naive patients who received cisplatin in doses > or = 60 mg/m2. Granisetron was administered as a single dose of 10 or 40 micrograms/kg before the start of chemotherapy. Ondansetron was administered in doses of 0.15 mg/kg before and 4 and 8 hours after the start of chemotherapy. The three treatment groups were well-matched with respect to demographic characteristics and the dose of cisplatin administered. RESULTS For all evaluations, single doses of granisetron 10 or 40 micrograms/kg were as effective as three 0.15-mg/kg doses of ondansetron. Total control (no vomiting, no retching, no nausea, and no use of rescue) was attained by 38%, 41%, and 39% of all patients who received granisetron 10 microgram/kg, granisetron 40 micrograms/kg, and ondansetron, respectively. No vomiting or retching and no use of rescue antiemetics were reported in 47%, 48%, and 51% of patients who received granisetron 10 micrograms/kg, granisetron 40 micrograms/kg, and ondansetron, respectively; no nausea and no use of rescue antiemetics were reported in 39%, 42%, and 40% of patients, respectively. CONCLUSION All three treatment regimens were well-tolerated. The results of this study indicate that a single dose of granisetron 10 or 40 micrograms/kg is as effective as three doses of ondansetron 0.15 mg/kg in the prevention of nausea and vomiting induced by cisplatin chemotherapy.

Telemedicine for Patients with Inflammatory Bowel Disease (TELE-IBD) Clinical Trial: Qualitative Assessment of Participants’ Perceptions of the TELE-IBD Intervention (Preprint)

2019 ◽  
Author(s):  
Charlene C Quinn ◽  
Sarah Chard ◽  
Erin G Roth ◽  
J. Kevin Eckert ◽  
Katharine M Russman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Disease Activity ◽  
Remote Monitoring ◽  
Standard Care ◽  
Disease Process ◽  
The United States ◽  
Qualitative Assessment ◽  
Structured Interviews ◽  
Treatment Groups ◽  
Inflammatory Bowel

BACKGROUND Inflammatory bowel diseases (IBD), comprising Crohn’s disease and ulcerative colitis, affects 1 to 3 million people in the United States. Telemedicine has shown promise in IBD. The objective of the parent study, TELE-IBD, was to compare disease activity and quality of life (QoL) in a one-year randomized clinical trial of IBD patients receiving telemedicine versus standard care. Treatment groups experienced improvements in disease activity and QoL but there was not significant differences between groups. Study adherence to the text-based intervention was less than the 80% of the targeted goal. OBJECTIVE To understand adherence to remote monitoring, the goal of this qualitative assessment was to obtain TELE-IBD trial participants’ perceptions of the TELE-IBD system, including their recommendations for future TELE-IBD monitoring. METHODS In the parent study, patients attending three tertiary referral centers with worsening IBD symptoms in the previous two years were eligible for randomization to remote monitoring via texts every other week (EOW), weekly (W) or standard care. Participants (n=348) were evenly enrolled in the treatment groups and 259 (74.4%) completed the study. For this study, a purposive sample of adherent (N=15) and non-adherent (N=14) patients was drawn from the TELE-IBD trial population. Adherence was defined as the completion of 80% or more of the W or EOW self-assessments. Semi-structured interviews conducted by phone surveyed 1) the strengths and benefits of TELE-IBD; 2) challenges associated with using TELE-IBD; and 3) how to improve the TELE-IBD intervention. Interviews were recorded, professionally transcribed, and coded based on a priori concepts and emergent themes with the aid of ATLAS.ti qualitative data analysis software. RESULTS Participants' discussions centered on three elements of the intervention: 1) self-assessment questions, 2) action plans, and 3) educational messages. Participants also commented on: text-based platform, depression and adherence, TELE-IBD system in place of office visit, and their recommendations for future TELE-IBD systems. Adherent and non-adherent participants prefer a flexible system that is personalized, including targeted education messages, and they perceive TELE-IBD as effective in facilitating IBD self-management. CONCLUSIONS Participants identified clear benefits to the TELE-IBD system, including obtaining a better understanding of the disease process, monitoring their symptoms, and feeling connected to their health care provider. Participants' perceptions obtained in this qualitative study will assist in improving the TELE-IBD system to be more responsive to patients with IBD. CLINICALTRIAL NCT01692743

scholarly journals Steroid treatment for the first episode of childhood nephrotic syndrome: comparison of the 8 and 12 weeks regimen using an individual patient data meta-analysis

2021 ◽  
Author(s):  
Anne M. Schijvens ◽  
Nynke Teeninga ◽  
Eiske M. Dorresteijn ◽  
Steven Teerenstra ◽  
Nicholas J. Webb ◽  
...  
Keyword(s):  
Nephrotic Syndrome ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Steroid Treatment ◽  
First Episode ◽  
Childhood Nephrotic Syndrome ◽  
Steroid Sensitive Nephrotic Syndrome ◽  
Steroid Sensitive ◽  
First Relapse ◽  
Steroid Regimen

AbstractSteroids are the cornerstone of the treatment of childhood nephrotic syndrome. The optimal duration for the first episode remains a matter of debate. The aim of this study is to determine whether the 8 weeks International Study of Kidney Disease in Children (ISKDC) regimen is equally effective as the 12 weeks steroid regimen from the German society of pediatric nephrology (Arbeitsgemeinschaft für Pädiatrische Nephrologie [APN]). An individual patient data (IPD) meta-analysis of randomized controlled trials reporting on prednisolone treatment for a first episode of childhood nephrotic syndrome was conducted. European trials aimed at investigating the ISKDC and/or APN steroid regimen were selected. The lead investigators of the selected trials were requested to provide the IPD of the specific treatment groups. Four trials included European cohorts using dosing schedules according to the regimens studied. IPD of two trials were available. A significant difference was found in time to first relapse after cessation of steroid treatment between the 8 and 12 weeks treatment group with a median time to relapse of 29 and 63 days, respectively. Moreover, relapse rate ratios during total follow-up were 51% higher for the 8 weeks regimen. Finally, younger children have a significantly lower time to first relapse and frequently relapsing nephrotic syndrome.Conclusions: The results of this IPD meta-analysis suggest that the 8 weeks steroid regimen for a first episode of steroid-sensitive nephrotic syndrome may not be equally effective as the 12 weeks steroid regimen. Moreover, this study highlights the importance of using uniform definitions to enable accurate comparison and interpretation of trial results.Trial registration: Registration number: CRD42020199244, date of registration 16-08-2020 What is Known:• Steroids are the cornerstone of the treatment of childhood nephrotic syndrome, however the optimal duration for the first episode remains a matter of debate.• Currently, the 8 weeks ISKDC protocol and 12 weeks APN protocol are among the most frequently used protocols in Europe. What is New:• The 8 weeks steroid regimen for a first episode of steroid-sensitive nephrotic syndrome may not be equally effective as the 12 weeks steroid regimen for the treatment of a first episode of nephrotic syndrome.• Younger children have a significantly shorter time to first relapse and time to frequent relapsing nephrotic syndrome.

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