scholarly journals Evaluation of Therapeutic Efficacy and Safety of Tranexamic Acid Local Infiltration in Combination with Topical 4% Hydroquinone Cream Compared to Topical 4% Hydroquinone Cream Alone in Patients with Melasma: A Split-Face Study

2018 ◽  
Vol 2018 ◽  
pp. 1-5 ◽  
Author(s):  
Zohreh Tehranchinia ◽  
Bita Saghi ◽  
Hoda Rahimi
Keyword(s):  
Tranexamic Acid ◽  
Efficacy And Safety ◽  
Local Infiltration ◽  
Patient’S Satisfaction ◽  
Treatment Groups ◽  
Exposed Skin ◽  
Therapeutic Outcomes ◽  
Satisfaction With Treatment ◽  
The Difference ◽  
Split Face

Introduction. Melasma is an acquired pigmentary disorder characterized by hyperpigmented macules and/or patches affecting sun-exposed skin. Tranexamic acid (TA) can reduce melanin content of epidermis. Thus, we conducted this study to evaluate the efficacy and safety of tranexamic acid local infiltration in combination with topical 4% hydroquinone cream compared to topical 4% hydroquinone cream alone in patients with melasma.Material and Methods. This study was a prospective assessor- and analyst-blind, randomized split-face clinical trial which was performed on patients with bilateral malar epidermal melasma. A total of 55 patients were enrolled, and each side of their face was randomly allocated to either TA+HQ or HQ alone treatment. The MASI score was applied as an objective measurement to compare two treatment groups. The patient's satisfaction of melasma treatment was evaluated using a four-scale grading, as well.Results. The mean of MASI score in week 16 decreased in both groups significantly (p < 0.01). The therapeutic outcomes were significantly better in TA+HQ group than HQ group (p=0.001). Patients satisfaction with treatment was significantly higher in the TA + HQ group. The difference between the two groups regarding side effect occurrence was not statistically significant.Conclusion. Addition of tranexamic acid injections to conventional hydroquinone therapy can increase the efficacy of topical treatment.This trial is registered withIRCT2015110324865N1.

Efficacy and safety of endostar in the treatment of advanced lung squamous cell carcinoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20574-e20574
Author(s):  
Weiheng Hu ◽  
Jian Fang ◽  
Jun Nie ◽  
Ling Dai ◽  
Jie Zhang ◽  
...  
Keyword(s):  
Group Versus ◽  
Lung Squamous Cell Carcinoma ◽  
Progression Free Survival ◽  
Control Group ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Treatment Groups ◽  
The Difference ◽  
Nsclc Patients

e20574 Background: From the early 2000s, many advances in non-small cell lung cancer (NSCLC) have been made with the emergence of targeted therapies. However, because of safety concerns and a lower prevalence of relevant therapeutic targets, patients with squamous NSCLC have been excluded from many of these breakthroughs. Endostar is a novel inhibitor of tumor angiogenesis that acts specifically on neovascular endothelial cells. This study is to explore the clinical efficacy and safety of endostar in advanced squamous NSCLC patients. Methods: We performed a retrospective analysis of 259 newly diagnosed advanced squamous NSCLC patients who had received platinum-based doublet chemotherapy (PBDC) between September 2009 and March 2016. Of these patients, 116 received Endostar combined with PBDC, and 143 received PBDC only. Clinical tumor responses, progression-free survival (PFS), overall survival (OS), and toxicity profiles were recorded and analyzed. Results: After a median follow-up of 13.5 months, a improvement in PFS was observed in the Endostar group, the median PFS was7.7 months compared with 5.4 months in the control group (HR, 0.745; P= 0.034). The median OS was 19.0 months in the Endostar group versus 14.3 months in the control group, but the difference was not significant (HR, 0.780; P= 0.094). Multivariate analysis demonstrated that in patients with advanced squamous NSCLC, anti-angiogenesis therapy with Endostar, radiotherapy of primary tumor and Ⅲb stage were significant and independent predictors of improved PFS ( P< 0.05). For both arms, hematologic and gastrointestinal toxicities were the most common adverse events. Patients treated with Endostar had slightly higher rates of cardiac disorder and thromboembolic event, as compared with the control patients, but there were no statistically significant differences in toxicities overall between the 2 treatment groups. Conclusions: The current study indicates that Endostar as an anti-angiogenesis therapy combined with PBDC is able to provide further survival benefits with satisfactory toxicity in previously untreated squamous NSCLC patients, which merits further evaluation in randomized trials.

Postoperative Ecchymosis in Upper Blepharoplasty: A Split Face Study of Tranexamic Acid Versus Etamsylate

2021 ◽  
pp. 074880682110590
Author(s):  
Nabil Fakih-Gomez ◽  
Enosh Steward ◽  
Dario Andres Bastidas ◽  
Roshini Manay ◽  
Juan Martin Zarate ◽  
...  
Keyword(s):  
Tranexamic Acid ◽  
Case Studies ◽  
Local Anesthesia ◽  
Aesthetic Surgery ◽  
Acid Versus ◽  
The Difference ◽  
Upper Blepharoplasty ◽  
The Right ◽  
Left Eyelid ◽  
Split Face

Objective: To compare the efficacy of tranexamic acid (TXA) versus etamsylate (ETM) in reducing postoperative ecchymosis in upper blepharoplasty. Introduction: With an increase in demand for shortened recoveries after facial aesthetic surgery, various optional approaches have been sought out. In terms of ecchymosis, TXA and ETM have been most commonly used. Method: A prospective, intrapatient split face study was conducted from January 2020 to January 2021 in 40 patients who underwent upper blepharoplasty under local anesthesia. Two equal anesthetic solutions were prepared; Solution A contained TXA and solution B contained ETM. Solution A was injected in the right eyelid and solution B in the left eyelid. Postoperative ecchymosis was assessed by 2 blinded evaluators, the assisting surgeon (Observer 1) and an external surgeon (Observer 2) at 48 h and on the seventh day using a scale published by Sagiv et al. Results: Postoperative ecchymosis was found to be less at 48 h by both observers with TXA solution. Moreover, at the seventh day, no ecchymosis was found in 32.5% with TXA solution compared to 2.5% with ETM solution. Kappa analysis showed concordance between observers. Conclusion: In our study, TXA solution was a more effective therapy when compared to ETM solution for reducing ecchymosis. Larger case studies are required to prove the difference for validation.

Efficacy and Safety of Oral Ivermectin and Topical Permethrin in the Treatment of Scabies

2020 ◽  
Vol 33 (1) ◽  
pp. 41-47
Author(s):  
Mohsena Akhter ◽  
Ishrat Bhuiyan ◽  
Zulfiqer Hossain Khan ◽  
Mahfuza Akhter ◽  
Gulam Kazem Ali Ahmad ◽  
...  
Keyword(s):  
Skin Diseases ◽  
Close Contact ◽  
Randomized Study ◽  
Sarcoptes Scabiei ◽  
Efficacy And Safety ◽  
Common Skin ◽  
Group A ◽  
The Mean ◽  
The Difference ◽  
Group B

Background: Scabies is one of the most common skin diseases in our country. It is caused by the mite Sarcoptes scabiei var hominis, which is an ecto-parasite infesting the epidermis. Scabies is highly contagious. Prevalence is high in congested or densely populated areas. Individuals with close contact with an affected person should be treated with scabicidal which is available in both oral and topical formulations. The only oral but highly effective scabicidal known to date is Ivermectin. Amongst topical preparations, Permethrin 5 % cream is the treatment of choice. Objective: To evaluate the efficacy & safety of oral Ivermectin compared to topical Permethrin in the treatment of scabies. Methodology: This prospective, non-randomized study was conducted at the out-patient department of Dermatology and Venereology of Shaheed Suhrawardy Medical College & Hospital over a period of 6 months, from August 2016 to January 2017. The study population consisted of one hundred patients having scabies, enrolled according to inclusion criteria. They were divided into two groups. group A was subjected to oral Ivermectin and the group B to Permethrin 5% cream. Patients were followed up on day 7 and 14 for assessment of efficacy and safety. Result: The mean scoring with SD in group A (Ivermectin) and group B (Permethrin) were 8.26 ± 2.22 and 7.59 ± 2.01 respectively at the time of observation. The difference between the mean score of the two group is not significant (p=0.117) the mean scoring with SD in group A and group B were 4.54 ± 2.05 and 1.64 ± 1.84 respectively at 7thdays. The difference between the mean score of the two group is significant (p<0.001). The mean scoring with SD in group A and group B were 2.68± 2.35 and .36± 1.10 respectively at 14th day difference between the mean score of the group is significant (p<0.001). Conclusion: Topical application of permethrin 5% cream is more effective and safer than oral Ivermectin in the treatment of scabies. TAJ 2020; 33(1): 41-47

Effects of an Antihypertensive Combination in Japanese Hypertensive Outpatients Based on the Long-Acting Calcium Channel Blocker Benidipine on Vascular and Renal Events: A Sub-Analysis of the COPE Trial

2020 ◽  
Vol 16 ◽  
Author(s):  
Seiji Umemoto ◽  
Toshio Ogihara ◽  
Masunori Matsuzaki ◽  
Hiromi Rakugi ◽  
Kazuyuki Shimada ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Calcium Channel ◽  
Calcium Channel Blocker ◽  
Channel Blocker ◽  
Rank Test ◽  
Vascular Events ◽  
Treatment Groups ◽  
Β Blocker ◽  
The Difference ◽  
Long Acting

Background: In the trial known as COPE (Combination Therapy of Hypertension to Prevent Cardiovascular Events) three benidipine (a calcium channel blocker; CCB) regimens were compared. Hypertensive Japanese outpatients aged 40–85 years (n=3,293) who did not achieve the target blood pressure of <140/90 mmHg with benidipine 4 mg/day were treated with the diuretic thiazide (n=1,094) or a β-blocker (n=1,089) or an additional angiotensin receptor blocker (ARB; n=1,110). A significantly higher incidence of hard cardiovascular composite endpoints and of fatal or non-fatal strokes was observed in the benidipine-β-blocker group compared to the benidipine-thiazide group. Objective and Methods: We further evaluated the treatment effects of the three benidipine-based regimens on vascular and renal events in a sub-analysis of the COPE patients. Results: A total of 10 vascular events (0.8 per 1,000 person-years) including one aortic dissection (0.1 per 1,000 person-years) and nine cases of peripheral artery disease (0.8 per 1,000 person-years) were documented, as was a total of seven renal events (0.6 per 1,000 person-years). No significant differences in vascular and renal events were revealed among the three treatment groups: vascular events p=0.92 renal events p=0.16 log-rank test. Conclusions: Blood pressure-lowering therapy with benidipine combined with an ARB, β-blocker, or thiazide was similarly effective in the prevention of vascular and renal events in hypertensive outpatients, although there is no enough these events to compare the difference in the three treatment groups.

scholarly journals EXPRESS: Efficacy and Safety of Tadalafil in a Pediatric Population with Pulmonary Arterial Hypertension: Phase 3 randomized, Double Blind Placebo-Controlled Study

2021 ◽  
pp. 204589402110249
Author(s):  
David D Ivy ◽  
Damien Bonnet ◽  
Rolf MF Berger ◽  
Gisela Meyer ◽  
Simin Baygani ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Statistical Significance ◽  
Significance Testing ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Statistical Significance Testing ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Treatment Groups ◽  
Pulmonary Arterial

Objective: This study evaluated the efficacy and safety of tadalafil in pediatric patients with pulmonary arterial hypertension (PAH). Methods: This phase-3, international, randomized, multicenter (24 weeks double-blind placebo controlled period; 2-year, open-labelled extension period), add-on (patient’s current endothelin receptor antagonist therapy) study included pediatric patients aged <18 years with PAH. Patients received tadalafil 20 mg or 40 mg based on their weight (Heavy-weight: ≥40 kg; Middle-weight: ≥25—<40 kg) or placebo orally QD for 24 weeks. Primary endpoint was change from baseline in 6-minute walk (6MW) distance in patients aged ≥6 years at Week 24. Sample size was amended from 134 to ≥34 patients, due to serious recruitment challenges. Therefore, statistical significance testing was not performed between treatment groups. Results: Patient demographics and baseline characteristics (N=35; tadalafil=17; placebo=18) were comparable between treatment groups; median age was 14.2 years (6.2 to 17.9 years) and majority (71.4%, n=25) of patients were in HW cohort. Least square mean (SE) changes from baseline in 6MW distance at Week 24 was numerically greater with tadalafil versus placebo (60.48 [20.41] vs 36.60 [20.78] meters; placebo-adjusted mean difference [SD] 23.88 [29.11]). Safety of tadalafil treatment was as expected without any new safety concerns. During study period 1, two patients (1 in each group) discontinued due to investigator’s reported clinical worsening, and no deaths were reported. Conclusions: The statistical significance testing was not performed between the treatment groups due to low sample size, however, the study results show positive trend in improvement in non invasive measurements, commonly utilized by clinicians to evaluate the disease status for children with PAH. Safety of tadalafil treatment was as expected without any new safety signals.

scholarly journals AB0369 EFFICACY AND SAFETY OF RITUXIMAB ORIGINATOR AND BIOSIMILAR IN PRIMARY SJÖGREN’S SYNDROME IN A REAL-LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1485.3-1485
Author(s):  
F. Carubbi ◽  
A. Alunno ◽  
P. Cipriani ◽  
V. Pavlych ◽  
C. DI Muzio ◽  
...  
Keyword(s):  
Disease Activity ◽  
Real Life ◽  
Primary Sjögren’S Syndrome ◽  
Efficacy And Safety ◽  
Research Support ◽  
Treatment Groups ◽  
Real Life Setting ◽  
Patient Reported ◽  
Time Point

Background:Over the last 2 decades rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren’s syndrome (pSS). Several studies reported that B-lymphocyte depletion with RTX is effective in this disease not only by reducing disease activity but also by affecting the inflammation and the lymphoid organization that occur in target tissues. With the recent release of several RTX biosimilars (bRTX) on the market, the demonstration of their interchangeability with RTX originator (oRTX) is required.Objectives:To compare efficacy and safety of oRTX and bRTX in pSS patients in a real-life setting.Methods:Clinical records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least 2 courses of either oRTX or bRTX (1000 mg IV infusion, repeated after 2 weeks -1 course- and the course repeated after 24 weeks) with complete data at baseline and after 3, 6, 9 and 12 months of treatment were enrolled. Disease activity was assessed with the EULAR SS disease activity index (ESSDAI) and its clinical version without the biological domain (ClinESSDAI). Patient-reported symptoms were assessed with the EULAR SS Patient Reported Index (ESSPRI).Results:Seven patients that received oRTX and 7 patients that received bRTX were enrolled. Baseline clinical features, including ESSDAI and ESSPRI were similar in the 2 treatment groups. Both compounds significantly reduced ESSDAI and ESSPRI as early as 3 months and no difference between the groups was observed at any time point (Figure 1). Of interest, ESSDAI slowly decreased until month 6 when the most pronounced reduction was observed. Conversely, ESSPRI dropped to its lowest values already at month 3. With regard to safety, at 12 months of follow-up no adverse event was observed in any of the treatment groups.Conclusion:At 12 months of follow-up, oRTX and bRTX display similar efficacy and safety profiles. The improvement of patient reported outcomes is faster than the improvement of disease activity with both compounds. Our data support interchangeability of oRTX and bRTX in pSS.References:[1]Carubbi F et al. Arthritis Res Ther. 2013;15(5):R172[2]Carubbi F et al. Lupus. 2014;23(13):1337-49Figure 1 ESSDAI and ESSPRI values at every time point in the 2 treatment groups. Asterisks indicate p values <0.05 compared to the other treatment group at the same time pointDisclosure of Interests:Francesco Carubbi Speakers bureau: Francesco Carubbi received speaker honoraria from Abbvie and Celgene outside this work., Alessia Alunno: None declared, Paola Cipriani Grant/research support from: Actelion, Pfizer, Speakers bureau: Actelion, Pfizer, Viktoriya Pavlych: None declared, claudia di muzio: None declared, Roberto Gerli: None declared, Roberto Giacomelli Grant/research support from: Actelion, Pfizer, Speakers bureau: Abbvie, Roche, Actelion, BMS, MSD, Ely Lilly, SOBI, Pfizer

Efficacy and safety of a novel water‐soluble herbal patch for acne vulgaris treatment: a randomized, assessor‐blinds controlled, intra‐individual split‐face comparative study

2021 ◽  
Author(s):  
Kulwipapat Jaturapisanukul ◽  
Montree Udompataikul ◽  
Silada kanolrungsee ◽  
Salinee Rojhirunsakool ◽  
Nanticha kamanamool ◽  
...  
Keyword(s):  
Comparative Study ◽  
Acne Vulgaris ◽  
Water Soluble ◽  
Efficacy And Safety ◽  
Split Face
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