Effect of Lisinopril and Verapamil on Angiopoietin 2 and Endostatin in Hypertensive Diabetic Patients with Nephropathy: A Randomized Trial

2021 ◽  
Vol 53 (07) ◽  
pp. 470-477
Author(s):  
Al-Aliaa M. Sallam ◽  
Mohamed Salem ◽  
Eman Abdel-Aleem ◽  
Hala O. El-Mesallamy
Keyword(s):  
Early Stage ◽  
Controlled Trial ◽  
Fasting Blood Glucose ◽  
Diabetic Patients ◽  
Converting Enzyme Inhibitors ◽  
Angiogenic Proteins ◽  
Group 2 ◽  
Angiopoietin 2 ◽  
Group 1

AbstractAngiogenesis is a multistep process implicated in the pathophysiology and progression of diabetic nephropathy (DN). Angiotensin-converting enzyme inhibitors (ACEI) and calcium channel blockers (CCB) have an important role in DN. We performed a randomized-controlled trial of lisinopril alone (an ACEI) or in combination with verapamil (a CCB) as a therapy for DN in type 2 diabetes mellitus (T2DM) patients with hypertension (HTN) and urinary albumin creatinine ratio (UACR) (30–300 mg/g) also to evaluate their effect on UACR, the angiogenic proteins: Angiopoietin 2 (Ang-2) and Endostatin (EST). Forty T2DM patients with microalbuminuria, aged 45–65 years were included. Patients were randomly assigned into group 1 receiving oral lisinopril and group 2 receiving oral lisinopril and verapamil once daily. After 3 months follow-up fasting blood glucose (FPG), HbA1c, lipid profile, UACR, serum urea and creatinine levels were assessed. EST and Ang-2 were measured using ELISA technique. Baseline Ang-2 and EST levels were elevated in both groups compared with controls (p<0.001). After follow-up, group 2 had significantly decreased FPG, HbA1c, UACR, EST and Ang-2 compared with their baseline levels (p<0.001 for all comparisons) and with group 1 (p<0.001). No adverse reactions were reported. Baseline EST and Ang-2 were positively correlated to UACR (r=0.753, p<0.001) (r=0.685, p<0.001). Lisinopril/verapamil combination enhanced glycemic control and kidney function via diminishing EST and Ang-2. This combination can be considered as a safe and effective approach for early stage nephropathy therapy in T2DM.

scholarly journals EFFICACY OF CATHETER ABLATION FOR PERSISTENT ATRIAL FIBRILLATION IN PATIENTS WITH DIABETES MELLITUS PRESENT WITH TACHY-BRADY SYNDROME

2018 ◽  
Vol 7 (3) ◽  
pp. 24-32
Author(s):  
E. A. Archakov ◽  
R. E. Batalov ◽  
S. Yu. Usenkov ◽  
M. S. Khlynin ◽  
A. V. Smorgon ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Catheter Ablation ◽  
Antiarrhythmic Drug ◽  
Pacemaker Implantation ◽  
Diabetic Patients ◽  
Antiarrhythmic Drug Therapy ◽  
Ventricular Stimulation ◽  
Group 2 ◽  
Group 1

Aim. To estimate the efficacy of catheter ablation in patients with type 2 diabetes mellitus (T2D) present with atrial fibrillation and sick sinus syndrome (SSS) undergoing permanent pacemaker implantation.Methods. 56 patients (34 females) with persistent AF and SSS were enrolled in the study. The mean age of patients was 67.7±10.7 years. Dual chamber cardiac pacemaker with remote monitoring function were implanted in all patients. All the patients were assigned to two groups: Group 1 comprised 31 patients aged 67.3±9.6 years, and Group 2 comprised 25 patients aged 72.6±9.9 years, including 22 (39.2%) diabetic patients. 2-3 days after pacemaker implantation, group 1 patients underwent intracardiac electrophysiology study and RFA of the pulmonary vein ostia, mitral isthmus and the left atrial posterior wall. Group 2 patients received antiarrhythmic drug therapy. Results. 3 patients (9%) in Group 1 had recurrent AF within the 6-month follow-up. The efficacy of the RFA for AF was 55% (n = 17) 1 year after the indexed hospitalization. 8 patients had short paroxysmal attacks which gradually lessened and stopped after. 5 patients (21%) in Group 2 did not have any AF paroxysms within the 1-year follow-up (Х2 = 5.52, р = 0.02). All these patients received amiodarone as antiarrhythmic drug therapy, whereas the others had paroxysmal attacks. Frequent attacks in 10 patients (40%) led to a change in antiarrhythmic drug use. Hospital readmission rates for AF were 16% and 52%, respectively (Х2 = 4.15, р = 0.04). The impact of atrial and ventricular stimulation on the development of recurrent AF was statistically insignificant (atrial stimulation – X2 = 0.01, cc = 1, p = 0.90; ventricular stimulation – X2 = 0.15, cc = 1, p = 0.69). None paroxysmal attacks were recorded in 10 diabetic patients (45%) after the RFA within the 1-year follow-up.Conclusion. Catheter ablation for persistent AF and SSS treated with permanent pacemakers is highly effective and safe method. In addition, it is superior to pharmacological approach. The presence of T2D likely did not significantly affect the efficacy of RFA for persistent form of AF. 

scholarly journals THU0338 THE CIRCULATING CD19-POSITIVE LYMPHOCYTES IN PATIENTS WITH SYSTEMIC SCLEROSIS: MODULATION WITHIN A YEAR AFTER THE INITIATION OF RITUXIMAB THERAPY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 400.1-400
Author(s):  
L. P. Ananyeva ◽  
L. Garzanova ◽  
O. Koneva ◽  
M. Starovoytova ◽  
O. Desinova ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
B Lymphocytes ◽  
Cumulative Dose ◽  
Negative Correlation ◽  
Early Stage ◽  
Absolute Number ◽  
Short Disease Duration ◽  
Group 2 ◽  
Group 1

Background:Significant disorders of B-cell homeostasis have been detected in systemic sclerosis (SSc) [1,2]. The improvement of the disease with anti-CD20 monoclonal antibody rituximab (RTM) has been shown in SSc [3]. There are limited data on change in circulating B lymphocytes count after RTM treatment in patients with SSc.Objectives:to investigate the modulations in absolute and relative numbers of circulating CD19-positive B lymphocytes (B-lymph) in patients with SSc within a year after the initiation of RTM therapy.Methods:71 pts with SSc were included in the prospective study. Mean age was 46±13 yrs., 83% were women, 59% had diffuse subset. Duration of SSC from the first non-Raynaud`s symptom was 5.6 ± 4.4 yrs. All pts received low doses of glucocorticoids and 45% -immunosuppressive medications. The average follow-up of patients was 13.2 ± 2.0 (11-18) months. The mean dose of RTM for the period of follow up was 1.43 ± 0.60 grams, 48 patients received < 2 g of RTM (group 1, mean of 1.1 ± 0.1 g) and 23 patients received ≥ 2 grams of RTM (group 2, mean dose of 2.2 ± 0.6 g). Peripheral blood CD19-positive cell count was obtained by flow cytometry in patients and in 20 healthy persons, comparable in sex and age. Data are presented as the percentage (P %) and absolute number (AN) of B-lymph per ml of blood. In patients, the number of B-lymph was determined before (n=67 pts), within first month after the first introduction of RTM (n=66), 6 months later (n=34) and at the end of the study (n=71)Results:At baseline, the AN and P% of B-lymph in pts did not differ from the healthy control. In pts with short disease duration (≤ 3 yrs.) the number of B-lymph before treatment with RTM was the higher (compared with longer duration > 3 yrs) those who was ill ≥3 yrs.) and there was negative correlation between B-lymph count and duration of the disease (R - 0.36, p=0.003 for AN and R - 0.48, p=0.001 for P %). The number of B-lymph was significantly lower in patients receiving cyclophosphamide (Cyc) before being started with RTM. There was a negative correlation between the AN of B-lymph and the cumulative dose of Cyc (R -0.293, p=0.016). In 1 month after the initiation of RTM a complete depletion of B-lymph was observed in all pts and in six months it persisted in 79% of cases, the rest began to repopulate (15%) or reached a normal levels (6%). At the end of the follow up the number of B-lymph was significantly lower than before treatment and a complete (n=41 pts) or partial (n=23) depletion of B-lymph remained, and only in 7 (10%) pts the count of this cells was normalized. We revealed a negative correlation between the AN of B-lymph and the cumulative dose of RTM (R-0.237, p=0.048). Higher doses of RTM in group 2 induced a more significant depletion than in group 1. Change in forced vital capacity and diffusing capacity of the lung (% predicted) during follow up were less pronounced for pts in group 1 compared with group 2 (ΔFVC 2,4% and 7,5% p=0,01; ΔDLCO -0,35% and 5,05%, p=0,001, respectively).Conclusion:RTM may be more effective at the early stage of the disease, when the level of B-lymph is the highest. In SSc, the repopulation of B-lymph after depletion with RTM develops slowly. There were a more significant depletion of B-lymph and a more pronounced improvement in pulmonary function with the higher dose of RTM to compare with the lower one. This results indicate the option of a flexible dosing regimen of RTM.References:[1]Sanges S. et al. La Revue de médecine interne 38 (2017) 113–124[2]Forestier A. et al. Autoimmunity Reviews 17 (2018) 244–255[3]Jordan S, et al. Ann Rheum Dis 2015;74:1188–1194.doi:10.1136/annrheumdis-2013-204522Disclosure of Interests:None declared

scholarly journals Spectral-Domain Optical Coherence Tomography and Multifocal Electroretinography Results in the Long-Term Follow-Up of Glaucoma Patients

2020 ◽  
pp. 22-32
Author(s):  
Ersan Cetınkaya ◽  
Sibel Inan ◽  
Kenan Yıgıt ◽  
Mehmet Cem Sabaner ◽  
Ümit Übeyt Inan
Keyword(s):  
Primary Open Angle Glaucoma ◽  
Early Stage ◽  
Open Angle Glaucoma ◽  
Implicit Time ◽  
Significant Difference ◽  
Long Term Follow Up ◽  
Group 2 ◽  
Group 1

Objective: To investigate the changes in macular retinal layers and panretinal neuroretinal functions in the long-term follow-up of patients with primary open-angle glaucoma. Materials and Methods: Forty-one patients diagnosed with primary open-angle glaucoma were followed up for 12 months. According to their mean deviation (MD) values), the patients were put into two groups as Group 1 with early stage glaucoma (MD≥-6) and Group 2 with middle-advanced stage glaucoma (MD<-6). Optical coherence tomography (OCT) and multifocal electroretinography (mfERG) were performed at the baseline and at the sixth- and 12th-month evaluations. The OCT, retinal layer and mfERG findings were compared between the two groups. Results: There was no statistically significant difference between the groups in terms of gender and age In Group 2, the mean baseline macula Retina Nerve Fiber Layer, Ganglion Cell Layer and Inner Pleksiform Layer measurements were lower in each quadrant compared to Group 1. Concerning progression in OCT measurements, there was no significant difference between the two groups. However, it was noteworthy that in Group 2, there was a decrease especially in the first and second ring amplitudes of the P1 and N2 waves and prolongation of the implicit time. At the 12-month evaluation, there was prolongation of the implicit time of the N1 wave and a decrease in the P1 wave amplitude in Group 1. Conclusion: Retinal layers are affected in patients with intermediate and advanced stage glaucoma. In the follow-up of early stage glaucoma patients, mfERG measurements can show damage that may occur.

scholarly journals P1001RENAL DAMAGE ASSOCIATED WITH INTRAVITREAL ADMINISTRATION OF ANTI-VEGF DRUGS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Maria Fernandez-Vidal ◽  
Candela Moliz ◽  
Beatriz Redondo ◽  
Teresa Bada Bosch ◽  
Lucia Aubert ◽  
...  
Keyword(s):  
Renal Function ◽  
Diabetic Patients ◽  
Vascular Endothelial ◽  
Median Dose ◽  
Anti Vegf ◽  
Group 2 ◽  
Endothelial Growth Factor ◽  
Group 1

Abstract Background and Aims Vascular endothelial growth factor inhibitors (anti-VEGF) have been shown to be effective in the treatment of macular degeneration and diabetic macular edema. It is known that systemic administration of these drugs can produce adverse renal effects, such as decreased glomerular filtration rate (eFGR), proteinuria, hypertension or thrombotic microangiopathy. However, there is little information about it when the administration is intravitreal. The aim of this study was analyzed the effect of anti-VEGF drugs on renal function and proteinuria. Method Observational and prospective study on diabetic patients, which were divided into two groups: non-cronic kidney disease (CKD) (group 1) and CKD (group 2). We analyzed clinical and analytical variables during follow-up. Results We included 45 diabetic patients (55.6% males) with a median age of 75 (50-91) years. Forty one patients (91.1%) were hypertensive and thirty three (73.3%) were CKD patients. Twenty six (57.8%) received bevazicumab, while the rest (42.2%) received ranibizumab, with a median dose of 6 (1-22). The median follow-up was 25 (9-94) months. The evolution of eFGR and albuminuria are described in Figure 1, where it stands out the increase in albuminuria in group 2. Regarding the drug type, there were no differences. Within the CKD group, one patient presented two episodes of decompensation of heart failure after the administration of an anti-VEGF drug, and two required the initiation of renal replacement therapy. Conclusion Based on the results of our cohort, we believe that it would be advisable to establish a closer monitoring in diabetic patients who are administered an intravitreal anti-VEGF drug, with determination of renal function as well as albuminuria to establish an early diagnosis of possible complications.

scholarly journals Effect of Pentoxifylline on Microalbuminuria in Diabetic Patients: A Randomized Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Shahrzad Shahidi ◽  
Marziyeh Hoseinbalam ◽  
Bijan Iraj ◽  
Mojtaba Akbari
Keyword(s):  
Early Stage ◽  
Controlled Trial ◽  
Randomized Study ◽  
Phosphodiesterase Inhibitor ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Double Blind ◽  
Glomerular Diseases

Background. Pentoxifylline is a nonspecific phosphodiesterase inhibitor with anti-inflammatory properties. Human studies have proved its antiproteinuric effect in patients with glomerular diseases, but this study was designed to assess the effects of add-on pentoxifylline to available treatment on reduction of microalbuminuria in diabetic patients without glomerular diseases.Methods. In a double-blind placebo-controlled, randomized study we evaluated the influence of pentoxifylline on microalbuminuria in type 2 diabetic patients. 40 diabetic patients with estimated glomerular filtration rate (eGFR) of more than 60 mL/min/1.73 m2in eight weeks and microalbuminuria were randomized to two groups which will receive pentoxifylline 1200 mg/day or placebo added to regular medications for 6 months. albuminuria; eGFR was evaluated at three- and six-month follow-up period.Results. Baseline characteristics were similar between the two groups. At six months, the mean estimated GFR and albuminuria were not different between two groups at 3- and 6-month follow-up. Trend of albumin to creatinine ratio, systolic and diastolic blood pressure, and eGFR in both groups were decreased, but no significant differences were noted between two groups (Pvalue > 0.05).Conclusion. Pentoxifylline has not a significant additive antimicroalbuminuric effect compared with placebo in patients with type 2 diabetes with early stage of kidney disease; however, further clinical investigations are necessary to be done.

Rotator Cuff Calcific Tendinitis: Ultrasound-Guided Needling and Lavage Versus Subacromial Corticosteroids: Five-Year Outcomes of a Randomized Controlled Trial

2017 ◽  
Vol 45 (14) ◽  
pp. 3305-3314 ◽  
Author(s):  
Pieter Bas de Witte ◽  
Arjen Kolk ◽  
Ferdinand Overes ◽  
Rob G.H.H. Nelissen ◽  
Monique Reijnierse
Keyword(s):  
Randomized Controlled Trial ◽  
Rotator Cuff ◽  
Repeated Measures ◽  
Mixed Model ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Background: Barbotage (needling and lavage) is often applied in the treatment of calcific tendinitis of the rotator cuff (RCCT). In a previously published randomized controlled trial, we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa (SAIC) compared with an isolated SAIC. There are no trials with a midterm or long-term follow-up of barbotage available. Purpose: To compare the 5-year results of 2 regularly applied treatments of RCCT: ultrasound (US)–guided barbotage combined with a SAIC (group 1) versus an isolated US-guided SAIC (group 2). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were randomly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score (CS), the Western Ontario Rotator Cuff Index (WORC), and the Disabilities of the Arm, Shoulder and Hand (DASH). The calcification location and size and Gärtner classification were assessed on radiographs. The rotator cuff condition was evaluated with US. Results were analyzed using t tests, linear regression, and a mixed model for repeated measures. Results: Forty-eight patients were included (mean age, 52.0 ± 7.3 years; 25 [52%] female) with a mean baseline CS of 68.7 ± 11.9. After a mean follow-up of 5.1 ± 0.5 years, the mean CS was 90 (95% CI, 83.0-95.9) in group 1 versus 87 (95% CI, 80.5-93.5) in group 2 ( P = .58). The mean improvement in the CS in group 1 was 18 (95% CI, 12.3-23.0) versus 21 (95% CI, 16.2-26.2) in group 2 ( P = .32). There was total resorption in 62% of group 1 and 73% of group 2 ( P = .45). The US evaluation of the rotator cuff condition showed no significant differences between the groups. With the mixed model for repeated measures, taking into account the baseline CS and Gärtner classification, the mean treatment effect for barbotage was 6 (95% CI, –8.9 to 21.5), but without statistical significance. Follow-up scores were significantly associated with baseline scores and the duration of follow-up. Results for the DASH and WORC were similar. There were no significant complications, but 4 patients in group 1 and 16 in group 2 underwent additional treatment during the follow-up period ( P < .001). Conclusion: No more significant differences were found in the clinical and radiological outcomes between barbotage combined with a SAIC versus an isolated SAIC after 5 years of follow-up. Registration: NTR2282 (Dutch Trial Registry).

P5663Impact of proteinuria on cardiovascular outcomes in Japanese diabetic patients with atrial fibrillation: the Fushimi AF Registry

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Ikeda ◽  
M Iguchi ◽  
H Ogawa ◽  
K Ishigami ◽  
Y Aono ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Dysfunction ◽  
Clinical Outcomes ◽  
Cardiovascular Death ◽  
Diabetic Patients ◽  
Group 4 ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Previous studies have suggested that proteinuria is independently associated with clinical outcomes in diabetic patients, irrespective of the presence of renal dysfunction. However, data regarding the impact of proteinuria on clinical outcomes in diabetic patients with atrial fibrillation (AF) are limited. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in our city in Japan. Follow-up data were available in 4,454 patients, and 634 diabetic patients with available data of proteinuria and estimated glomerular filtration rate (eGFR) were examined. We compared the clinical background and outcomes between patients with proteinuria (n=251) and those without (n=383). Then, we divided the patients into 4 subgroups according to the presence of proteinuria and renal dysfunction, and compared the clinical outcomes between groups; group 1 (without proteinuria, eGFR ≥60 ml/min/1.73 m2; n=203), group 2 (with proteinuria, eGFR ≥60; n=96), group 3 (without proteinuria, eGFR <60; n=180), group 4 (with proteinuria, eGFR <60; n=155). Results Age was comparable between patients with or without proteinuria. Patients with proteinuria had higher prevalences of previous heart failure (HF), stroke/systemic embolism, hypertension and renal dysfunction. The prevalences of previous myocardial infarction, and major bleeding were similar between two groups. During the median follow-up of 1,505 days, the incidence rates of HF hospitalization (4.1/100 person-years vs. 2.5/100 person-years; p<0.01) and cardiovascular death (1.8/100 person-years vs. 0.4/100 person-years; p<0.01) were higher in patients with proteinuria. When we divided patients into 4 subgroups, the incidences of HF hospitalization (group 1: 1.8/100 person-years vs. group 2: 3.4/100 person-years vs. group 3: 3.8/100 person-years vs. group 4: 4.9/100 person-years; p<0.01) and cardiovascular death (group 1: 0.3/100 person-years vs. group 2: 1.8/100 person-years vs. group 3: 0.5/100 person-years vs. group 4: 2.2/100 person-years; p<0.01) tended to be higher in not only group 3 and group 4 but also group 2 than group 1 (Figure). Multivariate Cox proportional hazards regression analysis including female gender, age (≥75 years), hypertension, pre-existing HF, renal dysfunction (eGFR <60),low left ventricular ejection fraction (<40%) and proteinuria revealed that proteinuria was an independent determinant of both of HF hospitalization (adjusted hazard ratio [HR]: 1.57, 95% confidence interval [CI]: 1.05–2.34) and cardiovascular death (HR: 3.76, 95% CI: 1.59–8.88). Figure 1 Conclusion In Japanese diabetic patients with AF, proteinuria was associated with higher incidences of HF hospitalization and cardiovascular death, irrespective of the presence of renal dysfunction.

scholarly journals Comparison of 21 Days Versus 10 Days Bladder Catheterization after Hypospadias Repair

Esculapio ◽  
2021 ◽  
Vol 17 (2) ◽  
pp. 187-190
Author(s):  
Muhammad Abdullah ◽  
Muhammad Saleem ◽  
Ghulam Mujtaba Zafar ◽  
Farrukh Mehmood Sattar ◽  
Imran Hashim ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Wound Dehiscence ◽  
Catheter Removal ◽  
Fistula Formation ◽  
P Value ◽  
Hypospadias Repair ◽  
Bladder Catheterization ◽  
Group 2 ◽  
Group 1

Objectives: To compare 21 days versus 10 days bladder catheterization after hypospadias repair. Methods: After approval from ethical committee, Randomised controlled trial performed, in which 196 male patients were enrolled in the study that was conducted at department of pediatric surgery, Children hospital, Lahore. All patients underwent Snodgrass procedure. Group-1 patients were considered for 10 days bladder catheterization for hypospadias repair and group-2 patients were catheterized for 21 days. Complications were documented on follow-up visits in group 1 at 1 week (17 days), 3 weeks (34 days), and 6 weeks (51 days) after catheter removal. In group 2 at 1 week (day 28th), 3 weeks (day 42nd), 6 weeks (day 63rd) after catheter removal. Results: The mean age in group-1 and group-2 was 7.25 ± 3.22 years and 6.29±3.02 years. There were significantly less cases of urethrocutaneous fistula in group 2 when compared to group 1. Urethro-cutaneous fistulas (UCF) developed in 13(13.26%) ,11(11.22%) and 10 (10.2%) cases at 1, 3, and 6 weeks post catheter removal follow up in group 1. While in group 2 UCF developed in 4 (4.08%), 3(3.1%) and 2(2.04%) at 1, 3, and 6 weeks follow up. There were 5(5.2%) and 4(4.1%) cases of post-operative wound infection in groups 1 and 2 respectively (p-value = 0.500). Wound dehiscence was seen in 1 (1.02%) case in group 1 and was not seen in group 2(p value =0.500). glans dehiscence was not seen in group 1 while 1 (1.02%) case seen in group 2 (p value 0.500). Conclusion: We conclude that 21 days catheterization after hypospadias repair gives better outcome and fewer complications when compared to 10 days catheterization. Keywords: Bladder catheterization; Hypospadias repair; Fistula formation. How to cite: Abdullah M., Saleem M., Zafar M.G., Sattar M.F., Hasnain I, Wasti R.A. Comparison of 21 Days Versus 10 Days Bladder Catheterization for Hypospadias Repair. Esculapio 2021;17(02):187-190.

scholarly journals Azathioprine weekly pulse versus methotrexate for the treatment of chronic plaque psoriasis: A randomized controlled trial

2021 ◽  
Vol 0 ◽  
pp. 1-6
Author(s):  
Kaushal K. Verma ◽  
Pramod Kumar ◽  
Neetu Bhari ◽  
Somesh Gupta ◽  
M. Kalaivani
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Effects ◽  
Plaque Psoriasis ◽  
Controlled Trial ◽  
Laboratory Evaluation ◽  
Chronic Plaque Psoriasis ◽  
Randomized Controlled ◽  
Group 2 ◽  
Group 1

Background: Methotrexate is the most commonly used drug in the treatment of psoriasis with good efficacy and safety. Recently, weekly azathioprine pulse has been shown to be effective in this disease. Aim: The aim of this study is to compare the effectiveness and safety of weekly pulse doses of azathioprine and methotrexate for the treatment of chronic plaque psoriasis. Methods: In this randomized controlled trial, 80 patients with chronic plaque psoriasis were recruited. After detailed clinical and laboratory evaluation, patients were randomized to 2 groups to receive either weekly 300 mg azathioprine (n = 40) or 15 mg methotrexate every week (n = 40) for 20 weeks, following which the response to treatment and adverse effects were assessed. The patients were then followed up every 4 weeks for 3 months to determine any relapse. Results: Overall, 48 (60%) patients achieved PASI 75, while 36 (45%) and 59 (73.8%) patients achieved PASI 100 and 50, respectively. On intention to treat analysis, PASI ≥ 75 was achieved in 47.5% (19/40) patients in group 1 compared to 85% (34/40) patients in group 2 (p < 0.001). However, on per protocol analysis, PASI ≥ 75 was achieved in 86% (19/22) patients in group 1 and 92% (34/37) patients in group 2 (p = 0.497). Minor clinical and biochemical adverse effects were noted in both the groups, which were comparable. One (7.7%) patient in group 1 and 4 (17.4%) in group 2 relapsed during follow-up. Limitations: Limitation of study include small sample size and short follow-up. Conclusion: Weekly azathioprine pulse appears to be beneficial in the management of chronic plaque psoriasis. However, it is less effective than weekly methotrexate. It can thus be of use as a therapeutic option in patients with contraindication to methotrexate or other similar agents in this disease.

scholarly journals Alcohol assessment and feedback by email for university students: main findings from a randomised controlled trial

2013 ◽  
Vol 203 (5) ◽  
pp. 334-340 ◽  
Author(s):  
Jim McCambridge ◽  
Marcus Bendtsen ◽  
Nadine Karlsson ◽  
Ian R. White ◽  
Per Nilsen ◽  
...  
Keyword(s):  
Alcohol Consumption ◽  
Controlled Trial ◽  
Feedback Group ◽  
Cross Sectional ◽  
Significant Difference ◽  
Group 3 ◽  
Group 2 ◽  
Alcohol Assessment ◽  
Group 1

BackgroundBrief interventions can be efficacious in changing alcohol consumption and increasingly take advantage of the internet to reach high-risk populations such as students.AimsTo evaluate the effectiveness of a brief online intervention, controlling for the possible effects of the research process.MethodA three-arm parallel groups design was used to explore the magnitude of the feedback and assessment component effects. The three groups were: alcohol assessment and feedback (group 1); alcohol assessment only without feedback (group 2); and no contact, and thus neither assessment nor feedback (group 3). Outcomes were evaluated after 3 months via an invitation to participate in a brief cross-sectional lifestyle survey. The study was undertaken in two universities randomising the email addresses of all 14910 students (the AMADEUS-1 study, trial registration: ISRCTN28328154).ResultsOverall, 52% (n = 7809) of students completed follow-up, with small differences in attrition between the three groups. For each of the two primary outcomes, there was one statistically significant difference between groups, with group 1 having 3.7% fewer risky drinkers at follow-up than group 3 (P = 0.006) and group 2 scoring 0.16 points lower than group 3 on the three alcohol consumption questions from the Alcohol Use Disorders Identification Test (AUDIT-C) (P = 0.039).ConclusionsThis study provides some evidence of population-level benefit attained through intervening with individual students.

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