scholarly journals Prospective Pilot Evaluation of the Efficacy and Safety of Topical Ingenol Mebutate Gel for Localized Patch/Plaque Stage Mycosis Fungoides

2017 ◽  
Vol 11 (1) ◽  
pp. 98-107 ◽  
Author(s):  
Eve Lebas ◽  
Charlotte Castronovo ◽  
Jorge E. Arrese ◽  
Florence Libon ◽  
Nazli Tassoudji ◽  
...  

Background: Mycosis Fungoides (MF) is the most frequent type of the primary cutaneous NK/T-cell lymphomas. Ingenol mebutate (IM) displays in vitro pro-apoptotic properties on neoplastic lymphocytes. Objectives: To evaluate the efficacy and safety of IM gel as topical treatment for MF. Materials and Methods: Ten male patients with longstanding classic type MF (n=9) and follicular MF (FMF; n=1), T2bN0M0B0, stage Ib, resistant to systemic methotrexate or acitretin therapies for at least 3 months, were included in this pilot study. In these patients, 11 target patch/plaque stage lesions with an area ≤ 25 cm2 were selected for IM therapy (0,05%, 2 weekly applications). The primary endpoint was the improvement of the CAILS scores. Biopsies were performed before and after treatment from 10 target lesions. Relapse rates were evaluated at 6 months. Results: The mean CAILS score of treated target lesions was reduced by 58.2%. The mean erythema, scaling and plaque elevation scores were improved by 73.6%, 93.9% and 97.9% (p<0.0001), respectively, while the lesion size remained unchanged (p=0.34). A complete or partial clearance of histological and immunohistochemical features was observed in 6/10 (60%) and 4/10 (40%) of the MF or FMF target lesions, respectively. Monoclonal TCR rearrangement was evidenced in 100% (7/7) of the patients and in 3/7 (43%) after treatment. The relapse rate at 6 months was 18%. All the patients experienced burning sensations, oozing and crusting. Conclusion: IM gel warrants further investigation and development as a potential topical treatment for localized patch/plaque stage MF and FMF.

2021 ◽  
Vol 14 (4) ◽  
pp. 294
Author(s):  
Eric G. Romanowski ◽  
Islam T. M. Hussein ◽  
Steven C. Cardinale ◽  
Michelle M. Butler ◽  
Lucas R. Morin ◽  
...  

Presently, there is no FDA- or EMA-approved antiviral for the treatment of human adenovirus (HAdV) ocular infections. This study determined the antiviral activity of filociclovir (FCV) against ocular HAdV isolates in vitro and in the Ad5/NZW rabbit ocular model. The 50% effective concentrations (EC50) of FCV and cidofovir (CDV) were determined for several ocular HAdV types using standard plaque reduction assays. Rabbits were topically inoculated in both eyes with HAdV5. On day 1, the rabbits were divided into four topical treatment groups: (1) 0.5% FCV 4x/day × 10 d; (2) 0.1% FCV 4x/day × 10 d; (3) 0.5% CDV 2x/day × 7 d; (4) vehicle 4x/day × 10 d. Eyes were cultured for virus on days 0, 1, 3, 4, 5, 7, 9, 11, and 14. The resulting viral eye titers were determined using standard plaque assays. The mean in vitro EC50 for FCV against tested HAdV types ranged from 0.50 to 4.68 µM, whereas those treated with CDV ranged from 0.49 to 30.3 µM. In vivo, compared to vehicle, 0.5% FCV, 0.1% FCV, and 0.5% CDV produced lower eye titers, fewer numbers of positive eye cultures, and shorter durations of eye infection. FCV demonstrated anti-adenovirus activity in vitro and in vivo.


2017 ◽  
Vol 46 (2) ◽  
pp. 802-810 ◽  
Author(s):  
Xiao-Jian Wang ◽  
Feng Chang ◽  
Yun-Xing Su ◽  
Xiao-Chun Wei ◽  
Lei Wei

Objective To evaluate the efficacy and safety of using the Ilizarov invasive distraction technique combined with limited surgical operations in the treatment of relapsed talipes equinovarus in children. Methods This retrospective study analysed the outcomes of paediatric patients with relapsed talipes equinovarus who were treated with the Ilizarov technique with moderate open limited soft tissue or bony operations. The International Clubfoot Study Group (ICFSG) classification system score was used to evaluate the deformities before and after surgery. Results The study evaluated 16 feet in 14 patients (nine boys). The correction time ranged from 6 to 12 weeks. The mean duration of frame application was 5.9 months. The gait was improved significantly in all patients. At final follow-up, the mean ankle dorsiflexion and plantarflexion ranges were 8.3° and 34.6°, respectively. The talocalcaneal angle improved from 10.0° preoperatively to 28.3° postoperatively in the anteroposterior plane; and from 4.1° preoperatively to 42.1° postoperatively in the lateral plane. The differences in the angle of plantarflexion, dorsiflexion, range of motion of the ankle joint and talocalcaneal angles pre- and postoperation were significant. Conclusions These current findings suggest that the Ilizarov technique combined with limited surgery effectively corrects relapsed talipes equinovarus in children.


Zygote ◽  
2008 ◽  
Vol 16 (3) ◽  
pp. 195-202 ◽  
Author(s):  
Z. Reckova ◽  
M. Machatkova ◽  
R. Rybar ◽  
J. Horakova ◽  
P. Hulinska ◽  
...  

SummaryThe efficiency of in vitro embryo production is highly variable amongst individual sires in cattle. To eliminate that this variability is not caused by sperm chromatin damage caused by separation or capacitacion, chromatin integrity was evaluated. Seventeen of AI bulls with good NRRs but variable embryo production efficiency were used. For each bull, motile spermatozoa were separated on a Percoll gradient, resuspended in IVF–TALP medium and capacitated with or incubated without heparin for 6 h. Samples before and after separation and after 3-h and 6-h capacitacion or incubation were evaluated by the Sperm Chromatin Structure Assay (SCSA) and the proportion of sperm with intact chromatin structure was calculated. Based on changes in the non-DFI-sperm proportion, the sires were categorized as DNA-unstable (DNA-us), DNA-stable (DNA-s) and DNA-most stable (DNA-ms) bulls (n = 3, n = 5 and n = 9, respectively). In DNA-us bulls, separation produced a significant increase of the mean non-DFI-sperm proportion (p ≤ 0.01), as compared with the value before separation. Capacitacion produced a significant decrease in the mean non-DFI-sperm proportion in H+ sperm (p ≤ 0.01). In DNA-s bulls, separation significantly increased the mean non-DFI-sperm proportion (p ≤ 0.01) but during capacitacion, the mean non-DFI-sperm proportion remained almost unchanged. In DNA-ms bulls, neither separation nor capacitacion had any effect on the mean non-DFI-sperm proportion. It can be concluded that, although separation and capacitacion may produce some changes in sperm chromatin integrity, these are not associated with different in vitro fertility of the bulls involved.


Author(s):  
Varsha Gajbhiye ◽  
Lamture Yashwant R ◽  
Sadama Quazi

Migraine is a common disorder of the paediatric age group. Propranolol has been used in prophylaxis for migraine.  The use of Sodium valproate in the prophylaxis of migraine is not known. It is postulated that it increases the level of GABA in the brain that will decrease events related to migraine in the cortex. All parents of the patient were advised to keep diaries for noting time, date, severity and duration of headache during the study period, which was for a period of 6 wks. The decreased frequency of headache more than in Group A was 68% and propranolol group was 68.89%. In group A(sodium valproate), patients showed a reduction in headache duration and 52% in Group B. 20% of them headache free in Group A and 18% in Group B. Decrease in the severity of headache in Group A was 52% while 50% in Group B. The mean headache frequency before and after treatment was reduced from 8 to 2.5 attacks per month in group A and from 8.2 to 2.6 in group B. The t-value is 11 for group A. Sodium valproate is more effective and safer in migraine prophylaxis as compared with propranolol.


Kardiologiia ◽  
2018 ◽  
Vol 58 (12) ◽  
pp. 52-58 ◽  
Author(s):  
R. A. Ildarova ◽  
M. A. Shkolnikova ◽  
S. A. Termosesov

Purpose: to assess specificities of course of the long­QT syndrome in children before and after implantation of cardioverter­defibrillator (ICD), and optimization of indications to ICD­therapy.Materials and methods. We included in this study 48 children with long­QT syndrome from 44 unrelated families (28 boys and 20 girls), who underwent ICD implantation at the mean age 11.8±3.8 years. Mean duration of follow­up after implantation was 5.2±2.8 years. Data from these children were compared with those from 59 children of comparable age and gender with long­QT syndrome from 46 unrelated families receiving antiarrhythmic therapy (β­adrenoblockers). We assessed clinical and electrocardiographic characteristics of the disease obtained at initial visit and their dynamics thereafter.Results. Children with long­QT syndrome and ICD were mainly probands with interval QT longer than 500 ms, recurrent syncope and often history of sudden cardiac arrest requiring high doses of β­adrenoblockers for control of ventricular tachyarrhythmias.Conclusion. ICD implantation is an effective and safe method both of primary and secondary prevention of sudden cardiac death in children with long­QT syndrome.


BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhiying Lu ◽  
Yisong Chen ◽  
Xiaojuan Wang ◽  
Junwei Li ◽  
Keqin Hua ◽  
...  

Abstract Background To describe the short-term outcomes of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) for uterosacral ligament suspension (USLS) in patients with severe prolapse. Methods This was a retrospective study of patients with severe prolapse (≥ stage 3) who underwent vNOTES for USLS between May 2019 and July 2020. The Pelvic Organ Prolapse Quantification (POP-Q) score, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12) and Pelvic Floor Inventory-20 (PFDI-20) were used to evaluate physical prolapse and quality of life before and after vNOTES for USLS. Results A total of 35 patients were included. The mean operative duration was 111.7 ± 39.4 min. The mean blood loss was 67.9 ± 35.8 ml. Statistically significant differences were observed between before and after vNOTES USLS in Aa (+ 0.6 ± 1.7 versus − 2.9 ± 0.2), Ba (+ 1.9 ± 2.2 versus − 2.9 ± 0.3), C (+ 1.5 ± 2.2 versus − 6.9 ± 0.9), Ap (− 1.4 ± 1.0 versus − 3.0 ± 0.1) and Bp (− 1.1 ± 1.4 versus − 2.9 ± 0.1) (P < 0.05 for all). The mean pre- and postoperative PFDI-20 score was 19.9 ± 6.7 and 3.2 ± 5.4, respectively, and the mean pre- and postoperative PISQ-12 score was 24.8 ± 2.3 and 38.3 ± 4.1, respectively (P < 0.05 for both). During 1–13 months of follow-up, there were no cases of severe complications or recurrence. Conclusions vNOTES for USLS may be a feasible technique to manage severe prolapse, with promising short-term efficacy and safety. Larger studies with more patients and longer follow-up periods should be performed to evaluate the long-term efficacy and safety profile of vNOTES for USLS.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Hanna Boes ◽  
Sören Brüstle ◽  
Gholamreza Danesh ◽  
Stefan Zimmer ◽  
Mozhgan Bizhang

AbstractPreventing biofilm-related risks such as gingivitis and white spot lesions during orthodontic treatments is very challenging. The cleaning efficiencies of AirFloss Ultra and I-Prox P sulcus brushes were evaluated using an orthodontic phantom model. After attaching brackets onto black-coated maxillary KaVo teeth, a plaque substitute was applied. The evaluated tooth surfaces were divided into two areas. Cleaning was performed with an AirFloss Ultra with two (A-2) or four (A-4) sprays or an I-Prox P for two (I-2) or four (I-4) seconds. Images before and after cleaning were digitally subtracted, and the percentage of fully cleaned surfaces was determined (Adobe Photoshop CS5, ImageJ). Statistical analysis was performed by ANOVA and post hoc tests with Bonferroni correction (SPSS 25, p < 0.05). The mean values of total cleaning efficacy were 26.87% for I-2, 43.73% for I-4, 34.93%, for A-2 and 56.78% for A-4. The efficacy was significantly higher for A-4 than for A-2, I-4, and I-2. There were significant differences between the four groups. Repeated cleaning led to an improved result. Within the study limitations, the AirFloss Ultra with four sprays proved to be more efficient than the sulcus brush I-Prox P for cleaning.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21051-e21051 ◽  
Author(s):  
Henri Montaudié ◽  
Florence Le Duff ◽  
Catherine Butori ◽  
Veronique Hofman ◽  
Eric Fontas ◽  
...  

e21051 Background: Ingenol mebutate gel is indicated for the treatment of actinic keratoses. In vitro, it has been shown that ingenol mebutate can induce the apoptosis of melanoma cells, but robust clinical data are missing with only few case reports reported.The objectives of the current study was to assess the efficacy and safety of ingenol mebutate for the treatment of lentigo maligna (LM). Methods: We conducted a prospective, multicentre, and single-arm phase 2 trial (NCT02723721), from June 2016 to November 2017. This trial was planned according to Simon’s optimal two-stage design for a total sample size of 23 subjects. Adults with LM of the head were included. Ingenol mebutate gel 150 µg/g was applied daily for 3 consecutive days (one cycle). For patients having no remission or only partial remission at 2 months, a second cycle was done. Patients were evaluated 2 months after the (re)treatment and then every 3 months for 36 months if a complete response (CR) was obtained. The primary endpoint was the CR, defined as the complete clearing of the LM evaluated at 2 months clinically and histologically. Results: Twelve patients with a median age of 73 years were recruited. Only 2 achieved a CR; one patient relapsed during the first year following the treatment. Forty-seven adverse events related to ingenol mebutate were declared. Most were grade 3-4 (66%), but all were resolved without any sequelae. The mean maximum local skin reaction score was 12 (min: 3 – max: 22). These results should be interpreted with caution, because this study has limitations, such as the lack of a comparative arm and the heterogeneity of LM (size and localization). Conclusions: To our knowledge, we report the first prospective study evaluating the efficacy and safety of IM in patients with LM of the head. Unfortunately ingenol mebutate is not an effective treatment of LM in this indication at the concentration of 150 µg/g. Its use with a more intense regimen (more cycles and/or highest concentration (500 µg/g)) is also limited by a poor safety profile. Clinical trial information: NCT 02723721.


2019 ◽  
Vol 14 (2) ◽  
pp. 87-92
Author(s):  
Fatema Chowdhury Anny ◽  
Mir Misbahuddin

The aim of this study was to examine the effect of cock’s comb extract in the treatment of moderate palmar arsenical keratosis (n = 35). All the patients were provided cock’s comb extract ointment to apply topically twice daily for 12 weeks. Adherence to the ointment and adverse effects were monitored regularly through the phone call and during the visit of each patient. Photographs of both palms were collected before and after treatment. Clinical improvement was assessed by measuring the arsenical keratotic nodular size of the both palms before starting the treatment and after completion of the treatment. The mean (± SD) sizes of the nodules before the study was 33.6 ± 16.8, which reduced to 5.4 ± 5.2 after completion of the study. This change (84% reduction) was statistically significant. None of the patients reported to any adverse effect during this study period. In conclusion, cock’s comb extract can be used effectively as a topical treatment of the palmar arsenical keratosis.  


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