scholarly journals Efficacy and Safety of Daflon® in the Treatment of Idiopathic Epistaxis

2018 ◽  
Vol 33 (1) ◽  
pp. 62-68 ◽  
Author(s):  
Tamer M. Attia
Keyword(s):  
Emergency Room ◽  
Study Groups ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label ◽  
Vascular Effects ◽  
Number Of Patients ◽  
Idiopathic Epistaxis

Background Epistaxis is a very common ENT emergency with the idiopathic variety being the commonest type. Daflon® is a mixture of flavonoids with beneficial vascular effects that may help in the treatment of epistaxis. Objective To assess the efficacy and safety of Daflon® in the treatment of idiopathic epistaxis. Methods This is an open-label randomized clinical trial conducted on patients with idiopathic epistaxis comparing 1 group receiving Daflon® for 1 month and a second group receiving Daflon® for 3 months with a control group receiving nothing. The groups were evaluated regarding the number of visits to an emergency room and the number of patients needing cautery as indicators for the control of epistaxis. Also, the severity of epistaxis was assessed using epistaxis severity score (ESS) before and after treatment. We followed the patients for 1 year to determine the long-term effect of both drug protocols. Results The study included 450 patients distributed equally among the 3 study groups. The administration of Daflon® whether for 1 month or 3 months resulted in a significant improvement in our indicators for control of epistaxis including the number of patients visiting an emergency room and those needing cauterization after the failure of light nasal packing when compared with control group. Also, the severity of epistaxis as defined by the ESS was significantly less at the end of each treatment period and at 1-year follow-up when compared with the pretreatment severity. However, the use of Daflon® for 3 months was associated with a significantly more epistaxis control at 1-year follow-up when compared with the 1-month administration. Conclusion Daflon® is a very effective and safe method for controlling idiopathic epistaxis. However, the daily use of Daflon® for 3 months has a more significant long-term beneficial effect than 1 month of use.

scholarly journals Efficacy of Vitamin E in Methotrexate-Induced Hepatotoxicity in Rheumatoid Arthritis: An Open-Label Case-Control Study

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Binit Vaidya ◽  
Manisha Bhochhibhoya ◽  
Shweta Nakarmi
Keyword(s):  
Rheumatoid Arthritis ◽  
Vitamin E ◽  
Treatment Group ◽  
Case Control Study ◽  
Study Groups ◽  
Case Control ◽  
Control Group ◽  
Open Label ◽  
Control Study

Objective. To examine the efficacy of vitamin E in methotrexate- (MTX-) induced transaminitis in patients with rheumatoid arthritis (RA). Methods. A case-control study was conducted at a tertiary rheumatology center for 12 months. Patients with RA on MTX and deranged aminotransferases were included. Patients with previous liver diseases, baseline transaminitis before methotrexate initiation, alcohol intake, muscle diseases, under hepatotoxic drugs, and aminotransferases>3 times the upper normal limit were excluded. The patients were divided into treatment (vitamin E 400 mg bid for 3 months) and control groups (no vitamin E) using a random number table. The dose of MTX was unaltered. Follow-up was done after 3 and 6 months. Independent t-test was done to compare means of two groups. Paired t-test was done to compare differences in mean. Results. Among 230 patients, 86.5% were female with a mean BMI of 25.9±4.5 kg/m2. In the treatment group, SGPT and SGOT at baseline were 73.1±20.4 and 60.2±24.5 IU/L, respectively; at 3-month follow-up 44.6±34.2 and 38.3±20.8 IU/L, respectively; and at 6-month follow-up 40.4±35.7 and 34.2±21.9 IU/L, respectively. In the control group, SGPT and SGOT at baseline were 63.4±15.1 and 46.8±13.7 IU/L, respectively, and at 3-month follow-up 55.8±45.9 and 45.5±30.9 IU/L, respectively. Significant decrease in the level of aminotransferases was seen in the treatment group (p value < 0.001) and not in the control group (p values 0.161 and 0.728, respectively). The change in levels of SGPT and SGOT from baseline to 3 months of follow-up was statistically significant in between two study groups (p values 0.007 and <0.001, respectively). From the control group, 29 patients were crossed over to vitamin E for the next 3 months. SGPT and SGOT decreased from 97.6±44.1 to 46.1±40.9 and 69.3±34.9 to 29.1±11.6 IU/L, respectively (p values 0.031 and 0.017, respectively). Conclusion. Vitamin E significantly attenuates MTX-induced transaminitis.

scholarly journals Efficacy and Safety of Pidotimod in Childhood Wheezing: A Pilot Study 

2020 ◽  
Author(s):  
Sara Manti ◽  
Giuseppe Fabio Parisi ◽  
Maria Papale ◽  
Federico Mollica ◽  
Andrea Giugno ◽  
...  
Keyword(s):  
Clinical Effect ◽  
Pediatric Population ◽  
Efficacy And Safety ◽  
Follow Up Study ◽  
Number Of Patients ◽  
Preventive Efficacy ◽  
Ed Visits ◽  
Concomitant Medications

Abstract Background. Effective therapies for the management of wheezing in pediatric population are needed. We conducted a pilot, mono-centre, prospective, follow-up study to assess the efficacy and the safety of Pidotimod (PDT) in the treatment of wheezing in children. Methods. Globally, 90 children (M:F=58:62, mean age 4.7±1.64 years) with recurrent viral wheezing were enrolled in the study between October-November 2018. At baseline, children were receiving treatment with PDT as 1 vial of 400mg daily for 3 consecutive months. We evaluated the therapeutic efficacy of PDT treatment at the end of 3 (T3) months of therapy as well as the long efficacy and preventive efficacy of PDT treatment during a 3-months follow-up (T6) by using the following outcomes: (i) how many patients showed one or more episodes of viral wheezing, (ii) how many patients were taking concomitant medications (ICS, SABA, antibiotics), (iii) how many patients were requiring ED visits, and (iv) how many patients were requiring hospitalization.Results. A significant decrease in number of patients with at least one or more episodes of wheezing and taking antibiotics was recorded after 3 months of treatment, and a further significant decrease for both outcomes was reported at 3-months follow-up period (p<0.05). Differently, after 3 months of treatment, we found a significant decrease in number of patients taking ICS and SABA, in number of patients requiring ED visits and/or hospitalization (p<0.05); however, for all these outcomes no further significant decrease was reported at follow-up period. Conclusions. We firstly showed that administration of PDT is useful in the management of patients with recurrent viral wheezing because we found a reducing a number of patients requiring ED visits and/or hospitalization as well as number of patients taking drugs during the treatment period. Moreover, firstly to date, we found a long-term clinical effect over three months after treatment suspension counteracting the recurrence of disease.

scholarly journals Maintained Clinical Remission in Ankylosing Spondylitis Patients Switched from Reference Infliximab to Its Biosimilar: An 18-Month Comparative Open-Label Study

2019 ◽  
Vol 8 (7) ◽  
pp. 956 ◽  
Author(s):  
Kaltsonoudis Evripidis ◽  
Pelechas Eleftherios ◽  
Voulgari V. Paraskevi ◽  
Drosos A. Alexandros
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Clinical Remission ◽  
Activity Index ◽  
Disease Activity Index ◽  
Control Group ◽  
Nocebo Effect ◽  
Open Label

Background: Switching from reference infliximab (RI) to biosimilar infliximab (BI) had no detrimental effects on efficacy and safety. However, long-term follow-up data is missing. Objective: To evaluate patients with Ankylosing Spondylitis (AS) in clinical remission who were switching from RI to BI, in terms of the safety and efficacy of this, in a long-term fashion. Methods: One hundred and nine consecutive unselected AS patients were investigated. All were naïve to other biologics and were followed-up at predefined times receiving RI. Patients in clinical remission were asked to switch from RI to BI. Those who switched to BI were compared with a matched control-group receiving continuous RI. During follow-up, several parameters were recorded for at least 18 months. Disease activity was measured using the Bath Ankylosing Spondylitis disease activity index (BASDAI), and the Ankylosing Spondylitis disease activity score (ASDAS), using the C-reactive protein. Remission was defined as BASDAI < 4 and ASDAS < 1.3. Results: Eighty-eight patients were evaluated (21 excluded for different reasons). From those, 45 switched to BI, while 43 continued receiving RI. No differences between groups regarding demographic, clinical and laboratory parameters were observed. All patients were in clinical remission. During follow-up, five patients from the BI-group and three from the maintenance-group discontinued the study (4 patients nocebo effect, 1 loss of efficacy). After 18 months of treatment, all patients in both groups remained in clinical remission. No significant adverse events were noted between groups. Conclusion: BI is equivalent to RI in maintaining AS in clinical remission for at least 18 months.

Long-Term Safety and Efficacy Data on Childhood Venous Thrombosis Treated with Enoxaparin: An Open Label Survey of Once-Daily Versus Twice-Daily Administration.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 549-549
Author(s):  
Ulrike Nowak-Gottl ◽  
Christine During ◽  
Christoph Bidlingmaier ◽  
Nick Merkel ◽  
Rosemarie Schobess
Keyword(s):  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Randomised Study ◽  
Catchment Areas ◽  
Prothrombotic Risk Factors ◽  
The Individual ◽  
A Minor

Abstract Low molecular weight heparin is as effective as unfractionated heparin for treatment of venous thromboembolism (VT) in adults, and it has been recently demonstrated that once-daily (q24h) or twice-daily (q12h) enoxaparin (E) administration had no impact on safety (bleeding rate) of efficacy (re-thrombosis rate) in the treatment of acute VT. However, in this setting it is still unclear for children, if enoxaparin should be administered q24h or q12h. In this open label pilot safety study 75 children &gt; the neonatal period, enrolled from two different catchment areas of Germany were treated with E with a target 2–4 h anti Xa activity between 0.4 – 0.8 IU/ml. After the acute thrombotic onset during which E was administered q12h for a median (range) period of 7 (1–14) days, based on the individual decision of the study centres stratification into the study arms once-daily versus twice daily was performed. Enoxaparin was administered in both study centres regardless of age at DVT-onset, thrombus burden, underlying basic diseases or presence of prothrombotic risk factors. No difference was observed between the stratifications performed in the study centres (p=0.5). Median (range) dose administered q24h (n=50) or q12h (n=25) in children with DVT was 1.2 mg/kg (0.5–3.0) respectively. Median (range) treatment duration was 5 months (1–13). Prospectively defined study endpoints were adverse effects, e.g. re-thrombosis, bleeding, and therapy-related death. Median follow-up time was 24 months. No significant differences were found between the two patient groups treated with respect to anti Xa activities, efficacy and safety. Further statistical analysis performed to evaluate the overall differences between q24h and q12h E administration again revealed no significant differences for the study endpoints: Re-thrombosis occurred in two patients each (p=0.6), and a minor subdural bleeding was diagnosed in one patient treated q12h (p=0.4). During the follow-up no major bleeding or therapy-related death was observed. In conclusion, data presented here give evidence that long-term enoxaparin administration within the reported target anti Xa activity for treatment of childhood VT has a good efficacy and safety profile when administered q24h. These data have to be confirmed in a multicentre randomised study.

scholarly journals Psychopharmacological Medication Has No Influence on Vitamin Status After Bariatric Surgery in Long-term Follow-up

2020 ◽  
Vol 30 (10) ◽  
pp. 3753-3760
Author(s):  
Hannes Beiglböck ◽  
Alexander Kautzky ◽  
Paul Fellinger ◽  
Tamara Ranzenberger-Haider ◽  
Bianca Itariu ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Laboratory Data ◽  
Control Group ◽  
Vitamin Deficiencies ◽  
Vitamin Status ◽  
Number Of Patients ◽  
Long Term Follow Up ◽  
The Impact

Abstract Context A substantial number of patients undergoing bariatric surgery are prescribed psychopharmacological medication. However, the impact of concomitant psychopharmacological medication on the frequency of relevant vitamin deficiencies in postoperative follow-up is not known. Methods Five hundred twenty-four patients with obesity who underwent bariatric surgery (January 2004 to September 2018) with follow-up of at least 12 months, were included in retrospective analysis. Postoperative follow-up visits between January 2015 and September 2019 were analyzed. Anthropometric and laboratory data were analyzed at the first documented follow-up visit after on average 39.5 ± 37.3 months and at every following visit during the observation period. Patients with prescribed psychopharmacological drugs (PD) were compared with patients without (control group, CON). Results Psychopharmacological medication was documented in 25% (132) of patients. In 59 patients documented prescription of more than one psychiatric drug was found, whereas psychopharmacological monotherapy was found in 73 patients. Frequencies of vitamin deficiencies were comparable between PD and CON (vitamin A: p = 0.852; vitamin D: p = 0.622; vitamin E: p = 0.901; folic acid: p = 0.941). Prevalence of vitamin B12 deficiency was rare (6% CON, 1% PD) but was significantly higher in CON (p = 0.023). A comparison of CON and POLY also showed no significant differences between the groups concerning prevalence of vitamin deficiencies. Conclusions Intake of psychopharmacological medication is highly prevalent in patients after bariatric surgery. Patients with psychopharmacological medication, who participate in structured follow-up care after bariatric surgery, are not at higher risk for vitamin deficiencies compared with controls.

scholarly journals Efficacy and Safety of Immunosuppressive Monotherapy Agents for IgA Nephropathy: A Network Meta-Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Shisheng Han ◽  
Tianwen Yao ◽  
Yan Lu ◽  
Min Chen ◽  
Yanqiu Xu ◽  
...  
Keyword(s):  
Serum Creatinine ◽  
Clinical Remission ◽  
Meta Analysis ◽  
Immunosuppressive Agents ◽  
Cochrane Library ◽  
Control Group ◽  
Efficacy And Safety ◽  
Long Term Effects

Background: The efficacy and safety of immunosuppressive monotherapy agents were evaluated for immunoglobulin A nephropathy (IgAN) using a network meta-analysis approach.Methods: Randomized controlled trials (RCTs) published prior to October 1, 2019, using immunosuppressive agents for treating IgAN, were systematically searched in PubMed, Embase, Cochrane Library, and Web of Science databases. Relative risks (RRs) or standard mean differences with 95% confidence intervals (CIs) were estimated using the random-effects model. The primary outcomes were clinical remission, end-stage renal disease (ESRD), and serious adverse events (SAEs). The secondary outcomes were urinary protein excretion and serum creatinine.Results: Twenty-five RCTs with 2,005 participants were deemed eligible. Six medications were evaluated: corticosteroids, mycophenolate mofetil (MMF), tacrolimus (TAC), cyclosporine, leflunomide, and hydroxychloroquine (HCQ). Steroids (RR 1.50, 95% CI 1.17–1.93), MMF (RR 2.05, 95% CI 1.15–3.65), TAC (RR 3.67, 95% CI 1.06–12.63), and HCQ (RR 3.25, 95% CI 1.05–10.09) significantly improved clinical remission rates compared to supportive care alone. Only steroids reduced the risk of ESRD (RR 0.35, 95% CI 0.12–0.98); however, there were significantly more SAEs than in the control group (RR 2.90, 95% CI 1.37–6.13). No significantly different effects in serum creatinine levels were found among the therapies. MMF showed no significant improvement in remission when excluding studies with a follow-up of fewer than 2 years in the sensitivity analysis (RR 1.41, 95% CI 0.40–4.92). The effect of TAC in the decrease of proteinuria was reversed after discontinuing medication for 3 months; the long-term effects of HCQ could not be evaluated due to the short follow-up duration.Conclusion: Corticosteroids might induce remission and increase renal survival in IgAN; however, adverse reactions should be taken into consideration. MMF, TAC, and HCQ might improve the remission of proteinuria when treating IgAN, but showed no superiority compared to steroids, and the long-term effects require further study.

scholarly journals Efficacy and safety of immunosuppressive agent monotherapy for IgA nephropathy: a network meta-analysis

2020 ◽  
Author(s):  
Shisheng Han ◽  
Tianwen Yao ◽  
Yan Lu ◽  
Min Chen ◽  
Yanqiu Xu ◽  
...  
Keyword(s):  
Serum Creatinine ◽  
Clinical Remission ◽  
Meta Analysis ◽  
Immunosuppressive Agent ◽  
Cochrane Library ◽  
Control Group ◽  
Efficacy And Safety ◽  
Long Term Effects

Abstract BackgroundThe efficacy and safety of immunosuppressive agent monotherapy were evaluated for Immunoglobulin A nephropathy (IgAN) using a network meta-analysis approach based on randomised controlled trials (RCTs).MethodsPubMed, Embase, the Cochrane library, and the Web of Science were systematically searched for RCTs published before October 2019 using immunosuppressive agents for treating IgAN. Quality assessments were performed according to the Cochrane Handbook. Pooled relative risks (RRs) or standard mean differences (SMDs) with corresponding 95% confidence intervals (CIs) were calculated for discrete or continuous variables, respectively. The primary outcomes were clinical remission, end-stage renal disease (ESRD), and serious adverse events (SAEs); the secondary outcomes were urinary protein excretion and serum creatinine. Data were synthesised by the random-effects model.ResultsTwenty-five RCTs with 2005 participants were deemed to be eligible, and six medications were evaluated: corticosteroids, mycophenolate mofetil (MMF), tacrolimus (TAC), cyclosporine (CsA), leflunomide (LEF), and hydroxychloroquine (HCQ). Compared to supportive care alone, steroids (RR 1.50, 95% CI 1.17–1.93), MMF (RR 2.05, 95% CI 1.15–3.65), TAC (RR 3.67, 95% CI 1.06–12.63), and HCQ (RR 3.25, 95% CI 1.05–10.09) each significantly improved clinical remission rates; only steroids reduced the risk of ESRD (RR 0.35, 95% CI 0.12–0.98), but the SAEs were significantly higher than those in the control group (RR 2.90, 95% CI 1.37–6.13). Furthermore, steroids, LEF, and HCQ showed lower proteinuria in the pairwise meta-analysis. There was no evidence of different effects of the therapies on serum creatinine levels. The effect of MMF, whereby it induced remission, was reversed when excluding studies with follow-up of fewer than two years in the sensitivity analysis (RR 1.41, 95% CI 0.40–4.92). The anti-proteinuric effect of TAC was reversed three months after discontinuing medication; the long-term effects of HCQ could not be evaluated due to the short follow-up.ConclusionsCorticosteroids might induce remission and increase renal survival in IgAN; however, the adverse reactions should be considered. TAC, LEF, HCQ, and MMF, might improve remission of proteinuria when treating IgAN, but showed no superiority compared to steroids, and the long-term effects require further study.

Efficacy of Pharmacotherapy for Smoking Cessation in Adolescent Smokers: A Meta-analysis of Randomized Controlled Trials

2018 ◽  
Vol 21 (11) ◽  
pp. 1473-1479 ◽  
Author(s):  
Seung-Kwon Myung ◽  
Joo-Young Park
Keyword(s):  
Smoking Cessation ◽  
Meta Analysis ◽  
Abstinence Rate ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Adolescent Smokers ◽  
Meta Analyses

Abstract Introduction This study aimed to evaluate the efficacy of pharmacotherapy for smoking cessation among adolescent smokers by using a meta-analysis of randomized controlled trials (RCTs). Methods PubMed, EMBASE, and Cochrane Library were searched from the inception to January 20, 2018. We included RCTs of pharmacotherapy for smoking cessation among adolescent smokers aged less than 20 years. Data were pooled using a random-effects meta-analysis. The primary outcome measures were a smoking abstinence rate and its relative risk (RR) at the longest follow-up period in each study validated by biochemical markers. Results Among a total of 1035 articles searched, nine RCTs, which involved 1188 adolescent smokers aged 12–20 years with 627 in the intervention group and 561 in the control group, were included in the final analysis. In the random-effects meta-analysis of all the nine trials, pharmacotherapy showed a increased abstinence rate (RR = 1.62; 95% confidence interval [CI] = 1.08 to 2.44, I2 = 0.0%), compared with the control group. Subgroup meta-analyses by follow-up period showed an increased abstinence rate at 4 weeks (RR = 1.87; 95% CI = 1.22 to 2.87; n = 4) and a nonsignificantly increased abstinence rate during the longer term follow-up periods at 8, 12, 24, and 52 weeks. Conclusions The current meta-analysis suggests that pharmacotherapy can be considered as an aid for smoking cessation in the short-term period among adolescent smokers. However, further large RCTs are warranted to determine its long-term efficacy and safety. Implications In this meta-analysis of nine RCTs with 1188 adolescent smokers aged 12–20 years, pharmacotherapy showed an increased abstinence rate, compared with the control group. In the subgroup meta-analyses by follow-up period, it showed the increased abstinence rate at 4 weeks and no efficacy on abstinence during the longer term follow-up periods up to 52 weeks. Further large RCTs are warranted to determine the long-term efficacy and safety of pharmacotherapy in adolescent smokers.

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