scholarly journals A Comparative Study of Endoscopic Versus Otomicroscopic Myringoplasty

2018 ◽  
Vol 6 (2) ◽  
pp. 11-15
Author(s):  
Bishow Tulachan ◽  
Roshan Acharya ◽  
Buddha Nath Borgohain
Keyword(s):  
Statistical Significance ◽  
Randomized Study ◽  
Neck Surgery ◽  
Good Alternative ◽  
Female Patients ◽  
Significant Difference ◽  
Group A ◽  
Graft Success ◽  
Group B ◽  
Age Range

 Introduction: Myringoplasty is one of the common surgical procedures done for closure of perforated tympanic membrane. Traditionally, it used to be performed with the help of operating microscope, however, the rigid endoscopes are being popular nowadays. So, we are comparing the success of graft uptake between endoscopic versus otomicroscopic myringoplasty.  Materials and methods: This is a prospective, comparative and randomized study done in the Department of Otorhinolaryngology and Head and Neck Surgery (ORL-HNS), Universal College of Medical Sciences-Teaching Hospital (UCMS-TH), Bhairahawa, Nepal. The study duration was for 18 months (1st December 2015 to 31st May 2017). There were 60 patients with age range of 12-60 years. All the patients fulfilling the inclusion criteria were included. Patients were randomized into Group A (endoscopic) and Group B (otomicroscopic).  Results: Patient's age ranged from 12-60 years. The mean ± standard deviation (S.D) of age (years) between two groups was 27.07 ± 11.96 years and 27.20 ± 9.65 years respectively. There were 33.33% male and 66.67% female patients in group A and 43.33% male and 56.67% female patients in group B. The graft uptake success rate was 93.33% in group A and 90% in group B. Statistically no significant difference was observed in graft success and failure rates between two groups (p =0.640). Conclusion: Comparatively the rate of graft uptake was higher in endoscopic group without statistical significance. Thus, endoscopic myringoplasty can be a good alternative of microscopic myringoplasty.  

scholarly journals P-B02 Does the length of  alimentary limb  make a significant difference  in the weight loss in  Roux en y gastric bypass patients?

2021 ◽  
Vol 108 (Supplement_9) ◽  
Author(s):  
Mayank Bhandari ◽  
Sabyasachi Chowdhary ◽  
Milind Rao ◽  
Gopinath Bussa ◽  
Julie Holm
Keyword(s):  
Weight Loss ◽  
Gastric Bypass ◽  
Statistical Significance ◽  
Limb Length ◽  
Alimentary Limb ◽  
Significant Difference ◽  
Alimentary Limb Length ◽  
Biliopancreatic Limb ◽  
Group A ◽  
Group B

Abstract Background Roux en Y gastric bypass (RYGB) surgery for morbid obesity is considered as gold standard, but there can be a difference in the length of alimentary and biliopancreatic limb to achieve optimum weight loss. Till now there is no agreed consensus on the ideal limb lengths and their effect on the weight loss. We would like to evaluate the change in the alimentary limb length on the weight loss after the gastric bypass surgery,  as a short to medium term single center study. Methods A retrospective analysis from prospectively maintained   database of 523 patients who underwent RYGB from  2012 till 2018 was done. Patient who had at least a follow up of 2 years(n = 388) were included.  At our center we use alimentary limb of 120 +/- 10 cm for Body Mass Index (BMI) < 40 kg/m2 (group A)  and 150+/-10 cm for the BMI >40 kg/m2  (Group B). The biliopancreatic limb length varies from 50 to 70 cm and this does not change with BMI.  The percentage excess weight(EWL) loss was measured and analyzed  at 1st  and 2nd year post operatively. We used paired t test to check for statistical significance. Results There were 172 patients in Group A and 216 in Group B. The number of females were 330 and  males were 58.   The average age was 44 years .  The mean  preoperative  BMI for the 120 cm limb group was  37.1 kg/m2 and  that for  150 cm limb was 45.3kg/m2. The EWL for the group A at 1 year and 2 year post op was a  Mean and standard deviation  of 79.3% +/- 39.4% and 78.3% +/- 35.2% respectively and for group B was 58.8% +/- 26.6% and 58.6% +/- 23.2% respectively. The difference was statistically significant (p < 0.001) . The analysis and interpretation for metabolic syndrome is yet to be determined.   Conclusions In our study, Increasing the alimentary limb length for higher BMI reduced  EWL. This is consistent with few other publications regarding the same. This has resulted in a  change in our practice namely keeping the length of alimentary limb constant and varying the BP limb length. We will be analyzing  and presenting this data in future.

Calcium dobesilate and oxerutin: effectiveness of combination therapy

2010 ◽  
Vol 25 (2) ◽  
pp. 66-71 ◽  
Author(s):  
B Akbulut
Keyword(s):  
Combination Therapy ◽  
Venous Insufficiency ◽  
Statistical Significance ◽  
Symptomatic Relief ◽  
Antioxidant Properties ◽  
Erythrocyte Aggregation ◽  
Calcium Dobesilate ◽  
Significant Difference ◽  
Group A ◽  
Group B

Objectives Chronic venous insufficiency (CVI) is an important cause of discomfort and inability to work. Hydroxyethylrutosides (Venoruton®; 0-[beta-hydroxyethyl]-rutosides) has been used for decades for the treatment of CVI. Studies have reported symptomatic relief and a decreased capillary filtration after the administration of the oral preparations. Calcium dobesilate is a synthetic venoactive drug acting on several levels. It inhibits capillary permeability; it has antioxidant properties; and it inhibits the synthesis of prostaglandins and thromboxanes, reducing platelet and erythrocyte aggregation, as well as blood viscosity. The aim of this study is to determine whether the combination of both drugs is more effective in decreasing patients' complaints. Methods One hundred and fifty patients with primary venous insufficiency were randomized into three groups: Group A receiving calcium dobesilate only, Group B receiving oxerutin only and Group C receiving both calcium dobesilate and oxerutin. Patients were evaluated with a questionnaire before and four weeks after treatment regarding following parameters: itching, fatigue, heaviness, numbness, cramp, swelling and sensitiveness. Patients rated their symptoms from 0 to 4 (0: absent; 1: mild; 2: moderate; 3: severe; 4: very severe). Results Complaints, which were scored by patients before and after treatment, decreased. Among the single-drug groups, itching score decreased more in Group B, whereas scores of fatigue, heaviness, numbness, cramp and swelling decreased more in Group A. But the difference was not significant, statistically. But all complaints decreased significantly in Group C. Difference of scores after treatment revealed no statistical significance in Group A and B, but scores of Group C produced a significant difference when compared with Group A and B. Conclusion Results demonstrate that a combination of calcium dobesilate and oxerutin shows a better improvement of complaints. These observations have to be confirmed in larger series with objective tests. Changes of quality of life after a combination therapy might also be of interest.

scholarly journals Comparative Evaluation of the Embrasure Wire versus Arch Bar Maxillomandibular Fixation in the Management of Mandibular Fractures: Are Arch Bars Replaceable?

2018 ◽  
Vol 11 (2) ◽  
pp. 118-123
Author(s):  
Sanjay Rastogi ◽  
Tousif Ahmed ◽  
Kolli Giri ◽  
Ramakant Dandriyal ◽  
Indra B. Niranjana Prasad ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Demographic Data ◽  
Study Data ◽  
Mandibular Fractures ◽  
Intermaxillary Fixation ◽  
Maxillomandibular Fixation ◽  
Arch Bar ◽  
Significant Difference ◽  
Group A ◽  
Group B

The aim of this prospective study was to appraise the role of embrasure wiring in the treatment of mandibular fractures over the arch bar as adjunctive techniques of maxillomandibular fixation (MMF). This study was conducted on 40 patients who were surgically treated for mandibular fractures with accessory use of MMF (embrasure: group A vs. arch bars: group B). All patients were evaluated for demographic data, etiology, and location of fracture. Characteristically, the complications, including wire injury, infection, and malocclusion, were recorded. The data were analyzed using Student's t-test and chi-square test as appropriate. Statistical significance was set at p < 0.05). In this study, data from 40 patients were included. In group A (embrasure wiring), time required for placement of MMF was significantly less than (7.85 ± 0.81 minutes) that in group B, and also there was less incidence of wire prick to the operator in group A than in group B ( p < 0.05). However, in terms of wire prick and malocclusion, no statistically significant difference was noted in groups A and B ( p > 0.05). Patient treated with embrasure wiring intermaxillary fixation had better outcomes especially in terms of time of placement and less incidence of wire prick injury when compared with arch bar.

scholarly journals FVC, FEV1 and FEV1 / FVC % in Hypothyroid Female and their Relationships with Thyroid Hormones

1970 ◽  
Vol 6 (1) ◽  
pp. 45-51
Author(s):  
Pervin Akter ◽  
Shelina Begum ◽  
Taskina Ali ◽  
Noorzahan Begum
Keyword(s):  
Lung Function ◽  
Thyroid Hormones ◽  
Female Patients ◽  
Normal Ranges ◽  
Significant Difference ◽  
Microparticle Enzyme Immunoassay ◽  
Group A ◽  
Predicted Values ◽  
Group B ◽  
Serum Tsh

Background: Hypothyroidism is a common hormonal disorder affecting various organs including lungs. It may be associated with respiratory symptoms and can decrease lung function. Objective: To observe FVC, FEV1 and FEV1/ FVC % in hypothyroid female patients. Methods: This crosssectional study was carried out in the Department of Physiology, BSMMU, Dhaka, from 1st July 2008 to 30th June 2009 on 60 hypothyroid female patients of 30-50 years age (Group B). For comparison, 30 age and BMI matched apparently healthy subjects (Group A) were also studied. Based on receiving treatment, hypothyroid patients were divided into B1 (untreated patients on their 1st day of diagnosis) and B2 (patients treated for at least 12-18 months). They were selected from the Out Patient Department of Endocrinology wing of department of Medicine, BSMMU, Dhaka. Serum TSH and FT4 levels were measured by Microparticle Enzyme Immunoassay (MEIA) principle in AxSYM system. The FVC, FEV1, FEV1/FVC%, of all the subjects were measured by a digital MicroDL spirometer. Data were analyzed by One way ANOVA test, Independent sample t- test and Pearson’s correlation coefficient test. Results: The mean percentage of predicted values of all the lung function variables in healthy female subjects and treated hypothyroids were within normal ranges. However, all of them were lower in untreated hypothyroids in comparison to those of control and treated hypothyroids.FVC and FEV1 showed statistically significant (p<0.001) difference and FEV1/FVC% showed non significant difference . In addition, all the ventilatory variables had negative correlation with serum TSH level and positive correlation with serum FT4 level and these relationships were statistically significant in control (p<0.001) and treated hypothyroids (p<0.01). Conclusion: This study reveals that lung function may be lower in untreated hypothyrod patients and correlated with thyroid hormones. Treatment of hypothyroids may reverse this changes. Key words: FVC, FEV1 , FEV1/FVC%, Hypothyroidism    DOI: http://dx.doi.org/10.3329/jbsp.v6i1.8084 J Bangladesh Soc Physiol. 2011 June; 6(1): 45-51

scholarly journals Closed versus open lateral internal anal sphincterotomy in a chronic anal fissure

2017 ◽  
Vol 4 (3) ◽  
pp. 1055 ◽  
Author(s):  
Anandaravi B. N. ◽  
Ramaswami B.
Keyword(s):  
Anal Fissure ◽  
Recurrence Rate ◽  
Chronic Anal Fissure ◽  
Randomized Study ◽  
Lateral Internal Sphincterotomy ◽  
Internal Sphincterotomy ◽  
Closed Technique ◽  
Significant Difference ◽  
Group A ◽  
Group B

Background: Anal fissure is a common proctological problem, which presents with pain in the anal region during and after defecation. The aim of the study was to determine the best technique for surgical treatment of chronic anal fissure patients.Methods: The study was designed as a prospective randomized study. The study was conducted in surgical unit, K.R. Hospital, MMCRI, Mysore, India from January 2015 to June 2016. A total of 100 patients undergoing surgery were divided into two groups. In group A there were 50 patients who were treated by closed lateral internal anal sphincterotomy, and in group B there were 50 patients who were managed by open lateral internal anal sphincterotomy method. Patients were followed up for 6 months following surgery to observe for pain, bleeding, infection, incontinence, and recurrence. The exclusion criteria were patients who had in addition haemorrhoids or any other anorectal diseases.Results: There was acceptable difference in postoperative acute complications between the two methods of internal anal sphincterotomy. However, in group A, three patients (6%) versus 10 (20%) were complicated with incontinence postoperatively, whereas the recurrence rate was 4 versus 4% in group A versus group B, respectively (P = 0.015).Conclusions: There was significant difference between closed and open methods of lateral internal sphincterotomy in recurrence rate, healing rate, and other complications. Closed lateral internal sphincterotomy is treatment of choice for chronic anal fissure and can be done effectively and safely with acceptable rate of complications. Our recommendations are that closed technique should be adopted by experienced surgeons and Trainee should be initially trained by open technique then be shifted to closed technique.

scholarly journals Comparison of Intralesional Meglumine Antimonite along withoral Itraconazole to Intralesional Meglumine Antimonitein the treatment of Cutaneous Leishmaniasis

2019 ◽  
Vol 35 (6) ◽  
Author(s):  
Uzma Bashir ◽  
Moizza Tahir ◽  
Muhammad Irfan Anwar ◽  
Faisal Manzoor
Keyword(s):  
Cutaneous Leishmaniasis ◽  
Clinical Cure ◽  
Statistical Significance ◽  
Military Hospital ◽  
P Values ◽  
Meglumine Antimoniate ◽  
Significant Difference ◽  
Group A ◽  
Oral Itraconazole ◽  
Group B

Background & Objective: Cutaneous leishmaniasis (CL) is endemic in developing countries like Pakistan. Pentavalent antimonials are still drug of choice, despite being toxic and intolerable for patients. Second line treatments have been extensively studied but the results of their efficacy are conflicting. This, to our knowledge, will be the first study in this regard. Our objective was to  determine if combination of oral itraconazole with intralesional (IL) meglumine antimoniate (MA) reduces the duration of treatment for cutaneous leishmaniasis, as compared to intralesional MA alone. Methods: A randomized controlled trial (single blinded) was carried out from August 2017 till December 2017 on 69 patients who fulfilled inclusion criteria. They were assigned to Group-A or B by lottery method. Group-A patients received IL MA once a week while Group-B received oral itraconazole 200mg, once daily, for six weeks along with similar regimen of IL MA as Group-A. The patients were assessed every three weeks by the blinded assessor till clinical cure was achieved. A follow up visit, two months after clinical cure was done to look for relapse of the disease. Results: Thirty patients in Group-A and 35 patients in Group-B completed the study. At 3, 6, 9 and 12 weeks the patients were assessed for: no, partial or complete response and results of the two groups were compared for statistical significance. The p-values of 0.20, 0.57 and 0.11 at 3, 6 and 9 weeks, respectively, depict that there was no significant difference at any step of assessment between the two groups in terms of healing. The p values of each t test was >0.05 refuting the hypothesis. Conclusion: Combination of oral itraconazole with intralesional MA offered no benefit over intralesional MA alone in the management of cutaneous leishmaniasis in terms of duration of therapy.  Abbreviations Used: IL = Intralesional,  MA = Meglumine Antimoniate, LD = Leishmania Donovan, CL = Cutaneous leishmaniasis, CMH = Combined Military Hospital. doi: https://doi.org/10.12669/pjms.35.6.363 How to cite this:Bashir U, Tahir M, Anwar MI, Manzoor F. Comparison of Intralesional Meglumine Antimonite along with oral Itraconazole to Intralesional Meglumine Antimonite in the treatment of Cutaneous Leishmaniasis. Pak J Med Sci. 2019;35(6):1669-1673.   doi: https://doi.org/10.12669/pjms.35.6.363 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

scholarly journals Dispositivos interespinosos en discectomías lumbares primarias. ¿Favorecen la recurrencia de la hernia de discos? [Interspinous device in primary lumbar discectomy. Does it favor the recurrence of disc herniation?]

2019 ◽  
Vol 84 (2) ◽  
pp. 105-111
Author(s):  
Joint Halley Guimbard Pérez ◽  
Mariano Pomba ◽  
Gustavo Alejandro González ◽  
Nicolás Ortiz
Keyword(s):  
Disc Herniation ◽  
Randomized Study ◽  
Herniated Disc ◽  
Recurrence Rates ◽  
Significant Difference ◽  
Group A ◽  
Interspinous Spacers ◽  
Group B ◽  
Lumbar Spinal ◽  
Lost To Follow Up

Objetivo: Evaluar si la colocación de los dispositivos interespinosos siliconados tipo DIAM favorecen una tasa más alta de recidiva de la hernia discal homolateral clínica y por imágenes comparada con la discectomía pura.Materiales y Métodos: Se realizó un estudio prospectivo, observacional, aleatorizado desde mayo de 2009 hasta mayo de 2013, en nuestro Centro. Se evaluó a 123 pacientes, 3 se perdieron en el seguimiento; l muestra incluyó 120 sujetos. Todos fueron operados por el mismo equipo quirúrgico. Se formaron dos grupos: grupo A: discectomía más colocación de dispositivo interespinoso siliconado, 30 pacientes (16 mujeres y 14 hombres), con mayor frecuencia L4-L5 (27 pacientes, 90%) y grupo B: discectomías puras, 90 pacientes (53 mujeres y 37 hombres) con más frecuencia L4 y L5 (72 pacientes, 80%).Resultados: Seis de los pacientes del grupo A (20%) tuvieron una recidiva clínica y por imágenes, y 3 (10%) fueron operados nuevamente; en el grupo B, hubo 4 recidivas discales (4,4%), uno fue operado nuevamente (1,1%). Se hallaron diferencias significativas en las tasas de recidiva y reintervención entre los grupos (p = 0,0073 y p = 0,0188, respectivamente).Conclusiones: Los beneficios de los dispositivos interespinosos para tratar el canal estrecho lumbar secundario a hernia de disco son controvertidos, pero en nuestro estudio, se halló una diferencia significativa según el grupo. Al mantener el movimiento del segmento y cambiar ligeramente las cargas fisiológicas aumentarían la tasa de recidiva discal; no obstante, son necesarios estudios con mayor evidencia científica para corroborar estas tendencias. AbstractObjective: The objective of this study was to evaluate if discectomy with placement of an interspinous silicon DIAM spacer is associated with a different rate of clinical and radiographic ipsilateral disc herniation recurrence than discectomy alone.Methods: A prospective, observational,randomized study was performed from May 2009 to May 2013 at XXXXX. Of the 123 patients included in the study, 3 were lost to follow-up, leaving 120 patients for data analysis. All patients were operated on by the same surgical team. Patients received one of two types of treatment. Group A consisted of 30 patients (16 women and 14 ment) who underwent discectomy with placement of an interspinous silicone DIAM spacer. Group B was composed of 90 patients (53 women and 37 men) who received discectomy alone.Results: Discectomy at L4-L5 was the most common level, occurring in 90% (27) Group A patients and 80% (72) Group B patients. Group A demonstrated clinical and radiographic disc herniation recurrence in 6/30 (20%) of patients. Disc herniation recurrence developed in 4/90 (4.4%) Group B patients. One patient underwent reoperation (1.1%). Both recurrence and reoperation was significantly higher in Group A (p = 0.007 and p = 0.019, respectively).Conclusions: The benefits of interespinosos devices for the treatment of the lumbar spinal stenosis secondary to herniated disc while they are controversial in the present study showed significant difference according to the Group. In this study, patients that underwent discectomy and interspinous spaceer placement had higher reoperation and recurrence rates than discectomy patients that did not receive an interspinous spacer. Interspinous spacers may increase the rate of disc herniation by maintaining movement at the level of prior disc herniation and changing the physiologic load. More studies are needed to corroborate and evaluate these trends.

scholarly journals 1379. Comparison of Inpatient Tuberculosis Screening Methods and Their Effect on Patient Duration in Airborne Isolation

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S501-S501
Author(s):  
Mary Katherine. Theoktisto ◽  
Delvina Ford ◽  
Omar Khan ◽  
Kelly R Reveles ◽  
Jose Cadena
Keyword(s):  
Statistical Significance ◽  
Nucleic Acid Amplification ◽  
Health Concern ◽  
Smear Microscopy ◽  
Screening Methods ◽  
Number Of Patients ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Crude Analysis

Abstract Background Tuberculosis (TB) remains a significant public health concern, and exposure in healthcare settings is prevalent. Current guidelines recommend testing for TB by acid-fast bacilli (AFB) smear microscopy with 3 sputum samples and/or using nucleic acid amplification test (NAAT), and mycobacterium culture. The purpose of this project is to compare how different TB diagnostic tests affect the duration of stay in respiratory isolation. Methods This study was conducted at the Veteran Affairs South Texas hospital, which includes a total of 437 beds. Data were collected retrospectively from medical records. Eligibility included patients admitted to the hospital and placed in airborne isolation for TB screening and diagnosis, had 3 sputum samples collected 8 hours apart and/or had 2 PCR MTB/RIF. Patients were excluded if they had TB or were not undergoing evaluation for TB. Three time periods analyzed included, 3 AFB sputum samples analyzed in-house from December 2012 to January 2014 (Group A), 3 AFB sputum samples analyzed at outside facility during 2013 to 2014 as well as 2 months in 2012 (Group B), and 2 MTB PCR/RIF in house during 2017 and 2018 (Group C). Duration of isolation was compared between groups using the Kruskal–Wallis test. A total number of 815 patients were screened, leaving 105 patients for analysis after exclusion. There were 49 patients analyzed from Group A, 28 from Group B, and 28 from Group C. Results Crude analysis of the data showed numerical differences in the total number of days and hours in isolation between the 3 groups. The average (mean) days in isolation were 4.2 for Group A, 7.4 for Group B, and 5.5 for Group C. There was no statistically significant difference in either days or hours of airborne precautions by “rule out” method. Days of isolation in airborne precautions (median IQR) was 4 for all groups (P = 0.3313). Likewise, hours of airborne precautions had a median IQR of 96 for all groups P = 0.4347. Conclusion Although there was no statistical significance between the groups, crude analysis did show a numerical difference in the mean total airborne days and hours. Lack of statistical difference may be due to low number of patients, timing of order placement for in-house PCR, and longer than expected stay in airborne precautions. Disclosures All authors: No reported disclosures.

scholarly journals Comparison of the anatomical and functional success of fascia and perichondrium grafts in transcanal endoscopic type 1 tympanoplasty

2019 ◽  
Vol 48 (1) ◽  
Author(s):  
Kadir Özdamar ◽  
Alper Sen
Keyword(s):  
Retention Rates ◽  
Success Rates ◽  
Temporal Muscle ◽  
Type 1 Tympanoplasty ◽  
Significant Difference ◽  
The Status ◽  
Group A ◽  
Group B ◽  
Age Range

Abstract Background There are no studies in the literature, comparing the functional and anatomical successes of the use of fascial and perichondrial grafts in endoscopic type 1 tympanoplasties. Objectives To compare the anatomical and functional outcomes of grafting with the fascia of the temporalis muscle and with the perichondrium of the tragal cartilage in patients undergoing primary transcanal type 1 tympanoplasty with endoscopy. Methods We enrolled a total of 151 patients (80 females and 71 males with a mean age of 26.0 ± 9.3 years in the age range between 18-57) with MERI scores ranging from 1 to 3 and who underwent a transcanal endoscopic type 1 tympanoplasty without tympanomeatal flap elevation. The patients were assigned to two groups according to the type of the graft used. The patients were assigned to either the tragal cartilage perichondrium group (Group A) or the fascia of the temporal muscle (Group B). The groups were compared according to the pre- and postoperative air-bone gaps and to the status of the tympanic membrane. Results There were no statistically significant differences in the distribution of the age, gender, localization, MERI scores, the duration of the operation, and the size of the perforation (all p values> 0.05). The pre-operative air-bone gap values of Group A and B did not show a statistically significant difference (p = 0.073). The postoperative improvement in the air-bone gap value did not demonstrate a significant difference between Group A and B (p = 0.202). The graft retention rates were 94.9 and 97.2% in Group A and in Group B respectively. There were no statistically significant differences between the two groups in terms of the graft retention success rates (p = 0.743). Conclusion Perichondrium and fascia were suitable for use in endoscopic tympanoplasties.

Therapeutic Superiority and Safety of Combined Hydroxyurea with Recombinant Human Erythropoietin Over Hydroxyurea in B-Thalassemia Intermedia Patients

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 252-252
Author(s):  
Mohsen Saleh Elalfy ◽  
Amira Adly ◽  
Yassmine Elhanawy
Keyword(s):  
Adverse Events ◽  
Short Form ◽  
Single Agent ◽  
Random Allocation ◽  
Thalassemia Intermedia ◽  
Transfusion Requirements ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Age Range

Abstract Abstract 252 Background: Both Hydroxyurea (HU) as a single agent or in combination with Erythropoietin (rHuEPO) became a therapeutic option for β-Thalassemia intermedia(TI) over last 2 decades. However superiority and safety of combination therapy over HU alone needs further evaluation. Aim: to assess the increase of hemoglobin levels in TI patients by at least 1g/dl above baseline during therapy using combined HUO and rHuEPO compared to single HUO therapy, also to report decline in transfusion requirements, quality of life (QoL), and any drug related adverse events. Patients and methods: An interventional prospective randomized open-labeled study; was approved from the local ethical committee and was registered in the Clinical Trials. Goverment (NCT01624038 ). Eighty Patients 18 years or less will be assigned into one of 2 groups using a random allocation method. Group A: Forty TI patients (age range: 5–18 years) considered as interventional arm 1 and received combined daily HUO (25 mg/kg/day orally) and rHuEPO (1000 IU/kg/week subcutaneously divided in three times/week). Group B: Forty TI patients (age range: 4–18 years) considered as arm 2 (control arm) and received daily single HUO therapy of 25 mg/kg/day. Both groups were followed up both clinically and laboratory for a mean period of one year with assessment of transfusion requirements, blood pressure weekly, liver and renal functions, Hemoglobin (Hb), HbF monthly, basal serum erythropiotin levels and QoL was assessed at study entry and end using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Diagnosis of TI was based on both genetic mutations and absence of transfusion during the 1st 2 years of life. Exclusion criteria were: evidence of active hepatitis (ALT>5 times) or renal impairment. Results: There were a significant improvement in the QoL in 80% and 60% of patients on combined compared to single therapy(p<0.05). There was a significant increase in both Hb and HbF (p <0.001), and the increments were strongly correlated (r =0.84; p <0.001) in both groups more in group A patients. The median Hb level in groups A and B during the study was 9.1 and 7.9 g/dL, respectively (p=0.03). In 68% (n=27) of TI patients group (A) were responded by a 0.5–3 g/dl increase in Hb level. There was significant difference between the 2 groups as only 20% (n=8) of patients in group B show intended improvement in their hemoglobin levels (p<0.01). In studied thalassemics 40%(n=16) of group A compared to 15%(n=6) of group B (p=0.01) became transfusion independent with 20% in group A showed decrease in their transfusion requirements with significant decrease in transfusion index compared to group B thalassemics (p<0.001). There was no significant change in absolute Hb-F, and serum ferritin levels during treatment. splenectomized patients and those with serum EPO less than 500 mU/mL, and intial HbF% > 40% had best response to combined therapy. Side effects from rHuEPO included bone pain in 2 patients, headache in 4 patients, however no uncontrolled hypertension was reported. Gastrointestinal irritation was observed in 3 patients and resolved when the dose was given at bedtime. No renal or hepatic toxicity were reported. A single case of mild neutropenia was reported and recovered within one week of temporary discontinuation Conclusions: Hu was effective in management of TI however combination with erythropiotin had an additive therapeutic effect and was well tolerated with no further serious adverse events. Disclosures: No relevant conflicts of interest to declare.

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