scholarly journals Topical Estrogen, Testosterone, and Vaginal Dilator in the Prevention of Vaginal Stenosis after Radiotherapy in Women with Cervical Cancer

Author(s):  
Jumara Martins ◽  
Ana Francisca Vaz ◽  
Regina Celia Grion ◽  
Lúcia Costa-Paiva ◽  
Luiz Baccaro

Abstract Background: we aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. Methods: open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18-75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. Results: the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p<0.01), except for the users of vaginal dilator (p=0.37). Conclusions: there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment.Trial registration: Brazilian Registry of Clinical Trials, RBR-23w5fv. Registered 10 January 2017 - Retrospectively registered, https://ensaiosclinicos.gov.br/rg/RBR-23w5fv

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jumara Martins ◽  
Ana Francisca Vaz ◽  
Regina Celia Grion ◽  
Lúcia Costa-Paiva ◽  
Luiz Francisco Baccaro

Abstract Background We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. Methods open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18–75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. Results the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37). Conclusions there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment. Trial registration Brazilian Registry of Clinical Trials, RBR-23w5fv. Registered 10 January 2017 - Retrospectively registered.


Author(s):  
S. Bastianello ◽  
C. Pozzilli ◽  
F. D’Andrea ◽  
E. Millefiorini ◽  
M. Trojano ◽  
...  

Abstract:We present the results of a randomized double-blinded placebo controlled, multicenter trial, of low-dose mitoxantrone (MX), after one year, in 25 patients with relapsing-remitting multiple sclerosis, who had serial enhanced magnetic resonance imaging (MRI). Treatment groups were balanced for age, gender, duration of illness and neurological disability. Five of the 13 MX patients and 10 of the 12 placebo patients had exacerbations during treatment (p < 0.02). The mean change in the extended disability status scale was not significantly different between the MX and placebo treatment groups. Serial Gadolinium-DTPA enhancedMRIdetected no significant difference between the MX treated and placebo groups in the mean total number of new, enlarging, or Gadolinium-DTPA enhancing lesions; there was a trend toward a reduction of new, enlarging and Gadolinium-DTPA enhancing lesions in MX patients. Despite this ameliorating effect, the results indicate that serial Gadolinium-DTPA enhanced MRI, performed over one year in a limited number of patients, could not provide conclusive evidence for a role of MX therapy in relapsing-remitting multiple sclerosis.


Author(s):  
Vagner de Alencar Arnaut de Toledo ◽  
Regina Helena Nogueira-Couto

This experiment was carried out to study the internal temperature regulation of a colony of Africanized honey bees (AFR), compared with hybrid Caucasian (CAU), Italian (ITA), and Carniolan (CAR) bees, during the period of one year and different size hives located in a sub-tropical region. The instant internal temperature, 33.7 ± 1.5° C for the AFR, 33.5 ± 1.4° C for the CAU, 33.7 ± 1.5° C for the ITA and 33.8 ± 1.4° C for the CAR, did not show any significant difference (P>0.05). The maximum temperature (36.1 ± 2.3° C) was statistically different (P<0.05) from the minimum (27.6 ± 5.3° C). There was no difference (P>0.05) in the mean internal temperature, between the nucleus (31.7 ± 6.3° C) and the brood nest (32.1 ± 5.3° C) measured between two and four o'clock in the afternoon.


2021 ◽  
Vol 7 (2) ◽  
pp. 195-199
Author(s):  
Helen Rosita J ◽  
Gnanaselvan J ◽  
Amudhavadivu S ◽  
Anna Kurian Mullasseril

Glaucoma is the leading cause of irreversible blindness, one of the risk factor recognised being high myopia. Intra ocular pressure may be normal in myopic patients, with optic nerve head glaucoma characteristics. Eye ball elongation and optic nerve head tilting may be present in patients with high myopia that will represent field defects mimicking glaucoma. Treating patients with myopia having suspected aspects of glaucoma may be a challenge but even more challenging is the diagnosis of glaucoma in myopic patients.: To evaluate the association of glaucoma features with myopia. To create the awareness regarding the long term follow up.: Patients in the age group of 15 to 45 years who had attended our institution over a period of one year who fulfilled the inclusion and exclusion criteria were subjected for this study. Fifty four patients who were diagnosed to have moderate or high degree myopia were selected for this analytical study. They were subjected to vision, ocular examination, tonometry and results obtained were analysed.: In our study moderate myopes constituted 55.5% and high myopes were 44.5%. The mean Intra ocular pressure and the mean corrected Intra ocular pressure in high myopes were observed to be higher than in moderate myopia. It was observed that higher prevalence of glaucoma was observed in high myopes.: There is a clinically as well as statistically significant difference between mean Intra ocular pressure and mean corrected Intra ocular pressure. So mean corrected Intra ocular pressure should be measured .From our study, there is a clear indication that there is increased prevalence of glaucoma in high myopes.


2020 ◽  
Vol 18 (2) ◽  
pp. 12-17
Author(s):  
Muhammad Tayeb ◽  
Md Hasanuzzaman ◽  
Abul Mansur Md Rezaul Karim ◽  
Mohammad Sanaullah ◽  
Md Ashraful Islam

Background : Migraine is primary headache disorder characterized by recurring attacks of pain and associated symptoms. The management modality is still unsatisfactory due to poor understanding of its cause and pathogenesis. To assess the efficacy and safety of low dose Topiramate vs Propranolol in migraine prophylaxis. Materials and methods : A randomized clinical trial including 130 patients with frequent migraine headache >5 attacks per month was performed in the out patients Department of Medicine and Neurology, CMCH for a period of 12 weeks. The patients were randomly divided into two treatment groups – treated by Topiramate 50mg/day and Propranolol 80mg/day respectively. Topiramate started with 25mg/day for 7 days then increased up to 50mg/day in two divided dose. Propranolol started with 40mg/day for 7 days then increased up to 80mg/day in two divided dose. The patients were assessed at 0, 8 and 12 weeks of the study. Results: The Topiramate group showed a reduction in the mean (±SD) of frequency of migraine attack from 6.95(±2.88) to 1.75(±1.08) episode per month, headache days per month from 7.62(±4.14) to 1.83(±1.10), intensity of headache per attack from 8.98(±1.05) to 6.10(±2.50) based on VAS scale, duration of headache per episode from 11.56(±9.16) to 5.40(±2.97) per hour and MIDAS score from 16.19(±3.91) to 8.14(±3.93). In patient treated with Propranolol, the mean (±SD) of monthly frequency of migraine attack declined from 7.09(±2.87) to 1.92(±0.98) episode per month, headache days per month from 8.17(±4.52) to 1.86(±o.83), intensity of headache per attack from 8.47(±1.10) to 6.03(±2.05) based on VAS scale, duration of headache per episode from 11.16(±8.08) to 5.97(±3.45), MIDAS score from 15.48(±3.55) to7.77(±3.49). Pre- and post-treatment values were significantly different for individual groups but no significant difference observed between groups. Conclusion: This study demonstrated that both low dose Topiramate and propranolol could significantly reduce migraine frequency, intensity and duration. Chatt Maa Shi Hosp Med Coll J; Vol.18 (2); July 2019; Page 12-17


2017 ◽  
Vol 17 (1) ◽  
pp. 124-130
Author(s):  
Ekkasit Tharavichitkul ◽  
Panupat Rugpong ◽  
Nisa Chawapun ◽  
Razvan M. Galalae

AbstractPurposeThis study aims to clarify the influence of overall treatment time (OTT) on the efficiency of combined chemo-radiotherapy in cervical cancer.Material and methodsThis retrospective study enrolled 122 cervical cancer patients who had squamous cell carcinoma and had undergone definitive chemo-radiotherapy from 2009 to 2013. All patients received whole pelvic radiotherapy (WPRT) with the dose of 50 Gy in 25 fractions (with central shielding after 44 Gy) plus intracavitary brachytherapy with the dose of 28 Gy in four fractions. During WPRT, all patients received concurrent chemotherapy with weekly platinum-based regimen. The data of patient characteristics, OTT, treatment results and toxicities were collected and evaluated.ResultsThe mean follow-up time was 36 months. The mean age of patients was 52 years old; 68% of patients were stage IIB related to International Federation of Gynaecology and Obstetrics staging. Pelvic control (PC), distant metastasis-free survival (DMFS), disease-free survival (DFS) and overall survival (OS) rates did not differ significantly in the data-derived cut points of 55·8 and 53 days. No statistically significant difference in treatment results between the two groups of OTT<49 and OTT≥62 days was observed.ConclusionsIn our data-derived cut point, OTT did not influence to PC, DMFS, DFS and OS. The influence of OTT on treatment results may be found in longer periods.


2021 ◽  
Vol 2 (4) ◽  
pp. 210-213
Author(s):  
Zheng-Feng Liu ◽  
◽  
Da-Dong Guo ◽  
Mei-Hua Ding ◽  
Hong-Sheng Bi ◽  
...  

AIM: To evaluate the one-year outcome of intravitreal conbercept injections for the treatment of choroidal neovascularization secondary to pathological myopia (pm-CNV) by optical coherence tomography angiography (OCTA). METHODS: The medical records of 26 consecutive eyes of 23 patients who received intravitreal injections of conbercept for pm-CNV with a follow-up of one year were retrospectively reviewed. All the patients were diagnosed by fundus fluorescein angiography (FFA) and OCTA at the first visit. All approaches were performed as “1+PRN” treatment. Outcomes included best-corrected visual acuity (BCVA), central foveal thickness (CFT) and the mean CNV area by OCTA. RESULTS: Mean Logarithm BCVA improved from (0.66±0.51) at baseline to (0.39±0.38) at one year (t=3.528, P=0.004). The CFT before treatment and after one year after were 275.08±48.74) μm and (205.15±43.74) μm respectively (t=4.630, P=0.001). The mean pm-CNV areas before treatment and after one year treatment were (0.48±0.24) mm2 and (0.15±0.11) mm2 respectively, with a significant difference among them (t=5.329, P=0.000). Twenty-one eyes had no needs after the first treatment. Four eyes received 2 injections and only one eye received 3 injections. No severe adverse events were noted relevant to the therapy. CONCLUSION: Intravitreal conbercept can improve the vision and relieve CFT and CNV area for the treatment of pm-CNV with “1+PRN” by OCTA for one year, however, long-term follow-up still need to be performed.


2019 ◽  
Vol 1 (Supplement_1) ◽  
pp. i17-i17
Author(s):  
Yosef Ellenbogen ◽  
Karanbir Brar ◽  
Nebras Warsi ◽  
Jetan Badhiwala ◽  
Alireza Mansouri

Abstract BACKGROUND: Upwards of 50% of patients with advanced breast cancer are diagnosed with brain metastases (BM). Treatment options for these patients have been rapidly evolving due to increased understanding of the tumor pathophysiology and its genetic underpinnings. This systematic review of randomized controlled trials (RCTs) aims to clarify the evidence guiding the treatment of brain metastases from breast cancer. METHODS: MEDLINE, EMBASE, Cochrane Controlled Register of Trials, ClincialTrials.gov, and Web of Science were searched from inception to October 2018 for RCTs comparing treatments for breast cancer BM. We screened studies, extracted data, and assessed risk of bias independently and in duplicate. Outcomes assessed were overall survival (OS), progression-free survival (PFS), and adverse events (Grade 3+). RESULTS: Among 3188 abstracts, only 3 RCTs (N=412; mean sample size per group N=54.7) meeting inclusion criteria were identified. The studies were phase II or III open-label parallel superiority trials. Inclusion criteria among these trials consisted of age &gt;18 with radiologic evidence of &gt;1 BM. Exclusion criteria consisted of poor-performance functional status (ECOG &gt;2 or KPS &lt; 70). The treatment groups included whole-brain radiation therapy (WBRT) vs WBRT + Temozolomide, WBRT vs WBRT + Efaproxiral, and Afatinib vs Vinorelbine vs investigators’ choice (86% of these patients received WBRT or SRS prior to study enrolment). While two trials found no significant difference in OS, one trial found significant improvement in OS with Efaproxiral in addition to WBRT compared to WBRT alone (HR 0.52; 95%CI 0.332–0.816). No significant differences were found with PFS or rate of adverse events amongst treatment groups. CONCLUSION: Considering the high prevalence of breast cancer BM and our improved understanding of genomic/molecular features of these tumors, a greater number of RCTs dedicated at this disease are needed.


2018 ◽  
pp. 1712-1719 ◽  
Author(s):  
Debajit Bhuyan ◽  
Ankur Das ◽  
Saurabh Kumar Laskar ◽  
Durlav Prasad Bora ◽  
Shantanu Tamuli ◽  
...  

Aim: An experiment was conducted to evaluate the nutritional, physicochemical, microbiological, and sensory attributes of pork sausages treated with conventional smoking (CS) and liquid smoke (LS). Materials and Methods: Pork sausages were prepared by employing CS (T1) and by addition of LS at 3% (T2A), 5% (T2B), and 7% (T2C) while smoking was not done in control (C) sausages. The ready-to-eat pork sausages were evaluated in terms of proximate composition, emulsion stability (ES), cooking loss (CL), pH, water activity (aw), texture profile analysis (TPA), and shear force on the day of preparation and the shelf life of the sausages was evaluated on the basis of thiobarbituric acid reactive substance (TBARS) value, organoleptic qualities, total viable plate count, total psychrophilic count, and yeast and mold counts at 5-day interval up to 15 days under refrigerated storage (6±1°C). Results: The mean percentage moisture and percentage ether extract contents of the conventionally smoked sausages (T1) exhibited significant difference (p≤0.01) with the rest of the formulations. However, in terms of mean percentage crude protein and percentage total solids, no significant difference (p≥0.05) was recorded between the treatment groups. The mean ES (ml of oil/100 g emulsion) of the different sausage emulsions ranged from 1.88 to 3.20, while the mean aw values among the sausage formulations were found to be non-significant. In terms of mean percentage, CL and pH values, significantly lowest (p≤0.01) values were recorded by the T1 sausages. The mean TBARS values recorded at different periods of time in respect of all the treatment groups ranged from 0.10 to 0.33 mg malanoldehyde [MDA]/kg of sausages which are well within the permissible limit. The highest shear force values (KgF) were recorded by the sausages of T1 formulation (p≤0.01), while TPA of the sausages did not record any significant difference (p≥0.05) among the treatments. Organoleptic studies revealed acceptability of the sausages up to 10 days of refrigerated storage irrespective of treatments employed; however, the sausages of T1 formulation scored significantly (p≤0.01) higher panel ratings. Microbiologically, sausages with different formulations were found to be within the acceptable limit up to the 15th day of refrigerated storage. Conclusion: The study revealed that traditional hot smoking has slightly higher edges over the LS-treated sausages in terms of lipid oxidation, microbiological safety, and sensory panel ratings. However, if not superior, the same was found to be well within the acceptable limit in case of LS-treated sausages proving the potentiality of the use of LS as a suitable replacement for the traditional hazardous hot smoking process.


2014 ◽  
Vol 58 (7) ◽  
pp. 731-736 ◽  
Author(s):  
Raquel de Carvalho Abi-Abib ◽  
Mário Vaisman

Objective It is believed that gastric pH interferes in levothyroxine absorption. Omeprazole, which acts by blocking the secretion of gastric acid, might interfere in hypothyroidism control in patients using levothyroxine and this effect could be dose dependent. The present study aimed to investigate this possibility. Subjects and methods Twenty-one patients with primary hypothyroidism who had been using a stabilized levothyroxine dosage for at least one year were selected and randomly assigned to take omeprazole at the dosage of 40 mg or 20 mg per day. The mean levels of thyroid-stimulating hormone (TSH) before and 3 months after omeprazole usage were compared in the entire sample and in each group. Results Ten patients concluded the entire treatment protocol in the 20 mg group and nine patients in the 40 mg group. There was no significant difference in TSH levels before and 3 months after omeprazole treatment in the entire patient sample (median levels: 2.28 vs. 2.30 mU/L, respectively: p = 0.56). Analysis of each subgroup (20 and 40 mg) showed no significant variation in TSH levels before and 3 months after omeprazole treatment (median levels: 2.24 vs. 2.42 mU/L, p = 0.62, and 2.28 vs. 2.30 mU/L, p = 0.82, respectively). No significant difference in the absolute (p = 0.93) or relative (p = 0.87) delta were observed between the two subgroups. Conclusion Omeprazole in the dosage of 20 or 40 mg/day does not interfere in a clinically relevant manner in the treatment of patients with hypothyroidism that was previously under control.


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