Treatment of Severe Aplastic Anaemia (SAA) with Antilymphocyte Globulin (ALG), Cyclosporine (CyA) and Granulocyte Colony Stimulating Factor (G-CSF) 5 μG vs 10 μG/Kg : A Gitmo Prospective Randomized Study.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3700-3700
Author(s):  
Anna Locasciulli ◽  
Barbara Bruno ◽  
Alessandro Rambaldi ◽  
Paola Saracco ◽  
Carlo Dufour ◽  
...  
Keyword(s):  
Peripheral Blood ◽  
Randomized Study ◽  
Prospective Trial ◽  
Actuarial Survival ◽  
Group A ◽  
Group B ◽  
Cox Analysis ◽  
Design And Methods ◽  
To Receive

Abstract Background and objective. In a previous study we showed encouraging outcome in severe aplastic anemia (SAA) patients treated with anti-lymphocyte globulin (ALG), cyclosporin (CyA) and G-CSF 5mg/Kg/day (Blood2000; 95: 1931–4.). However failure to respond, delayed responses, partial responses, relapses and early deaths remain signifcant problems. The aim of the present study was to test whether an increased dose of G-CSF (10 mg/Kg/day) would reduce these complications. Design and methods. This is a multicenter prospective trial in 77 SAA patients treated with horse ALG (15 mg/kg/day day1–5) and CyA (5 mg/kg/day day 1–180). Patients were randomized to receive G-CSF 5 mg/Kg/day (n=38, group A) or 10 mg/Kg/day (n=39, group B) from day +1 to day +30. All patients then received G-CSF 5 mg/Kg/day from day +31 to day +90. Primary end point was response at day +120. Secondary end points were early deaths , blood counts at day +120, and survival. Results. At day +120 responses were classified as absent, partial, complete in 12, 22, 4 patients in group A and in 23, 7, 9 patients in group B (p=0.001). At last follow up these figures were respectively 9,12,17 vs 19,2,18 (p=0.004). Thirteen patients (5 in group A and 8 in group B) died before day 120 (p=0.3). Median peripheral blood counts an day 120 were comparable in the two groups: Hb 10.5 vs 9.5 gr% (p=0.6), Neutrophils 2.4 vs 1.9x10^9/l (p=0.4) and platelets 42 vs 36 x10^9/l (p=0.3). The actuarial survival at 4 years is 72% in group A vs 67% in group B (p=0.3). An additional finding of this study is a strong age effect, with an actuarial 4 year survival of 81% in patients aged 0–20 , 80% in patients aged 21–40 and 34% in patients over 40 (p=0.0002). This correlated with the inability of older patients to increase their white blood cell (WBC) counts above 5x10^9/L, during G-CSF treatment. In a multivariate COX analysis patient age and highest WBC counts during G-CSF, were both significant predictors of survival. Interpretation and conclusions. Increasing the dose of G-CSF does not appear to reduce early deaths, does not improve peripheral blood counts nor survival, and may reduce the response rate in patients with SAA receiving ALG and CyA. Older age and failure to improve WBC are negative predictors of survival.

scholarly journals Banded Sleeve Gastrectomy Improves Weight Loss Compared to Nonbanded Sleeve: Midterm Results from a Prospective Randomized Study

2020 ◽  
Vol 2020 ◽  
pp. 1-7 ◽  
Author(s):  
Paolo Gentileschi ◽  
Emanuela Bianciardi ◽  
Leandro Siragusa ◽  
Valeria Tognoni ◽  
Domenico Benavoli ◽  
...  
Keyword(s):  
Weight Loss ◽  
Sleeve Gastrectomy ◽  
Weight Regain ◽  
Randomized Study ◽  
Banded Sleeve Gastrectomy ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
To Receive

Background. Weight regain after laparoscopic sleeve gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short term. We report the results of a randomized study comparing LSG and laparoscopic banded sleeve gastrectomy (LBSG) over a 4-year follow-up. Objectives. To evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the midterm. Methods. Between 01/2014 and 01/2015, we randomly assigned 50 patients to receive one of the two procedures. Patients’ management was exactly the same, apart from the band placement. We analyzed differences in weight loss, operative time, complication rate, and mortality, with a median follow-up of 4 years. Results. Twenty five patients were assigned to receive LSG (Group A) and 25 LBSG (Group B). The mean preoperative BMI (body mass index) was 47.3 ± 6.58 kg/m2 and 45.95 ± 5.85 kg/m2, respectively. There was no significant difference in the operative time. No intraoperative or postoperative complications occurred. At 12-month follow-up, the mean BMI was 29.72 ± 4.40 kg/m2 in Group A and 27.42 ± 4.47 kg/m2 in Group B (p=0.186). After a median follow-up of 4 years, the mean BMI in Group B was significantly lower than Group A (24.10 ± 4.52 kg/m2 vs 28.80 ± 4.62 kg/m2; p=0.00199). Conclusions. LBSG is a safe procedure, with no impact on postoperative complications. The banded sleeve showed a significant greater weight loss in the midterm follow-up. Considering the issue of weight regain observed after LSG, the placement of a perigastric ring during the first procedure may be a strategy to improve the results. This trial is registered with NCT04228185.

Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽  
2021 ◽  
pp. 170853812110100
Author(s):  
Mohamed Shukri Abdelgawad ◽  
Amr M El-Shafei ◽  
Hesham A Sharaf El-Din ◽  
Ehab M Saad ◽  
Tamer A Khafagy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Radiofrequency Ablation ◽  
Controlled Trial ◽  
Compression Therapy ◽  
Randomized Controlled ◽  
Venous Ulcers ◽  
Group A ◽  
Group B ◽  
To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p  = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

Anterior approach levator plication for congenital ptosis, absorpable versus non absorpable sutures

2021 ◽  
pp. 112067212110053
Author(s):  
Moustafa Salamah ◽  
Ashraf Mahrous Eid ◽  
Hani Albialy ◽  
Sherif Sharaf EL Deen
Keyword(s):  
Randomized Study ◽  
Early Postoperative Period ◽  
Polyglactin 910 ◽  
Exclusion Criteria ◽  
Congenital Ptosis ◽  
History Of ◽  
Group A ◽  
Group B ◽  
Over Time

Purpose: To compare the efficacy of two different suture types in levator plication for correction of congenital ptosis. Subjects and methods: Prospective comparative interventional randomized study involving 42 eyes of 42 patients aged more than 6 years with congenital ptosis and good levator action. The exclusion criteria were as follows: bilateral ptosis, history of previous surgery, fair or poor levator action, and associated other ocular diseases. Patients were randomized into group A, in which double-armed 5/0 polyester Ethibond were used, and group B, in which double-armed 5/0 Coated Vicryl® (polyglactin 910) suture material we used. Outcomes including eyelid height and stability of eyelid height over time were compared with follow-up data. The MRD was 4.05 ± 0.36 mm and 3.95 ± 0.34 after 1 week for both groups A and B, respectively. At the end of study follow up period (24 weeks), the MRD was 3.60 ± 0.42 mm in group A, and 2.52 ± 0.85 mm in group B. Conclusion: No difference in eyelid height between two groups in early postoperative period, but the postoperative eyelid height was more stable over time in the 5/0 polyester Ethibond group (group A) than in the 5/0 Coated Vicryl® (polyglactin 910) group (group B).

PROSPECTIVE RANDOMIZED STUDY BETWEEN OPEN VS CLOSED LATERAL ANAL INTERNAL SPHINCTEROTOMY IN PATIENTS WITH CHRONIC FISSURE IN ANO AT SKMCH, MUZAFFARPUR, BIHAR

2021 ◽  
pp. 65-66
Author(s):  
Kumar Vikram ◽  
Sanjay Kumar ◽  
Manoj Kumar ◽  
Debarshi Jana
Keyword(s):  
Randomized Study ◽  
Young Patients ◽  
Fissure In Ano ◽  
Common Cause ◽  
Internal Sphincterotomy ◽  
Acute Complications ◽  
Group A ◽  
Group B ◽  
Cause Of Pain

Background: One of the most common cause of pain during defecation in young patients is chronic ssure in ano. Surgical treatment of choice for chronic ssure in ano is internal sphincterotomy. This procedure can be performed by open or closed method. The aim of the study was to compare the closed and open anal internal sphincterotomy in patients admitted in our hospital with chronic anal ssure. Subjects and Methods: 105 patients admitted in department of general surgery with chronic ssure in ano were divided into two groups. 50 patients (Group A) who were treated by closed method and 55 patients (Group B) who were managed by open lateralanal sphincterotomy method. A3 months follow up done in both postsurgery to observe for pain, bleeding, infection, incontinence, and recurrence. Results: Signicant difference was observed in postoperative acute complications between the two methods of internal anal sphincterotomy. Conclusion: Lateral anal sphincterotomy is the treatment of choice for chronic anal ssure, either open or closed method. However, the closed method was observed to have lesserpost operative complication compared to the open method

Cryosurgery as a Single Agent and in Combination with Intralesional Corticosteroids Is Effective on Young, Small Keloids and Induces Characteristic Histological and Immunohistological Changes: A Prospective Randomized Trial

Dermatology ◽  
2020 ◽  
pp. 1-11
Author(s):  
Christos C. Zouboulis ◽  
Eftychia Zouridaki
Keyword(s):  
Treatment Failure ◽  
Normal Skin ◽  
Randomized Study ◽  
Single Agent ◽  
Interferon Γ ◽  
Efficacy And Safety ◽  
Rete Ridge ◽  
Group A ◽  
Group B

<b><i>Background:</i></b> As the pathogenesis of keloids is poorly understood, there is no sound biological basis of keloid management. Few controlled therapeutic studies have been published, and recurrences are a major reason for treatment failure. <b><i>Objective:</i></b> To detect efficacy and safety of cryosurgery regimens on keloids and the occurring biological changes caused by the treatment. <b><i>Methods:</i></b> This prospective randomized study compared efficacy and tolerability as well as histological/immunohistochemical effects of liquid nitrogen contact cryosurgery as a single regimen (group A) and combined with intralesional corticosteroids (group B) on young (&#x3c;2 years old), small (≤10 cm<sup>2</sup>) keloids in 40 patients (2-sided effect, α-error 1%, power 95%). <b><i>Results:</i></b> Marked flattening of the lesions was achieved by both regimens. Median lesional volumes decreased from 106 to 7 mm<sup>3</sup> in group A (<i>p</i> = 0.001) and from 138 to 6 mm<sup>3</sup> in group B (<i>p</i> &#x3c; 0.0001; ns, between groups). Good to excellent responses were registered in 83.3 and 90% of patients in groups A and B, respectively, by evaluating the lesional volume, in 80 and 95% of patients by the physician’s evaluation and in 95% of patients in either group by the patient’s assessment. Follow-up of 6–36 months revealed no further significant changes. Cryosurgery was generally well tolerated, with minor pain during treatment not requiring (27.5%) or requiring local anaesthesia (5%) – but not analgesics –, and hypopigmentation (25%). Histological examination showed increased vessel number and lumen dilatation after treatment in group B and reduction of rete ridge length in both groups with more prominent changes in group A. Tenascin C staining demarcated keloids from normal skin before therapy, while after therapy the entire treated tissue was labelled. Interferon-γ expression was significantly decreased after therapy both regarding positively stained cells and intensity in both groups. <b><i>Conclusion:</i></b> Cryosurgery without and with intralesional corticosteroids is effective and safe on young, small keloids not only as a destructive physical procedure, but also by inducing biochemical and immunological scar rejuvenation.

scholarly journals Prospective Randomized Study between Open Vs Closed Lateral Anal Internal Sphincterotomy in Patients with Chronic Fissure in Ano

2020 ◽  
Vol 3 (1) ◽  
pp. 167-171
Author(s):  
Anand Shanmugaiah ◽  
Saravanan Pandian
Keyword(s):  
Anal Fissure ◽  
Chronic Anal Fissure ◽  
Randomized Study ◽  
Fissure In Ano ◽  
Internal Sphincterotomy ◽  
Post Surgery ◽  
Significant Difference ◽  
Group A ◽  
Group B

Background: One of the the most common cause of pain during defecationin young patientsis chronic fissure in ano. Surgical treatment of choice for chronic fissure in ano is internal sphincterotomy. This procedure can be performed by open or closed method. The aim of the study was to compare the closed and open anal internal sphincterotomy in patients admitted in our hospital with chronic anal fissure. Subjects and Methods: 105 patients admitted in department of general surgery with chronic fissure in ano were divided into two groups. 50 patients (Group A) who were treated by closed method and 55 patients (Group B) who were managed by open lateralanal sphincterotomy method. A 3 months follow up done in both post-surgery to observe for pain, bleeding, infection, incontinence, and recurrence. Results: Significant difference was observed in postoperative acute complications between the two methods of internal anal sphincterotomy. Conclusion: Lateral anal sphincterotomy is the treatment of choice for chronic anal fissure, either open or closed method. However, the closed method was observed to have lesserpost operative complication compared to the open method.

An Initial Test of Reconsolidation in Disgust-Related Learning and Extinction

2016 ◽  
Vol 30 (3) ◽  
pp. 190-202 ◽  
Author(s):  
Bunmi Olatunji ◽  
Shivali Sarawgi ◽  
Megan Viar-Paxton
Keyword(s):  
Control Group ◽  
Initial Test ◽  
Conditioned Stimuli ◽  
Extinction Learning ◽  
Group A ◽  
Group B ◽  
Unpaired Presentation ◽  
To Receive ◽  
Control Group Group

This study examines whether the spacing of a single unreinforced retrieval trial relative to extinction learning allows for “rewriting” the original disgust association, thereby preventing the return of disgust using a paradigm that employs disgust-relevant unconditioned stimuli (US). During conditioning, disgusting US were paired with a color square that served as the conditioned stimuli (CS). Participants (n = 54) then returned to the lab 24 hours later and received a “reactivation” intervention which consisted of one unpaired presentation of the CS+. Participants were then randomized to receive extinction trials either 10 min (Group A) or 6 hours (Group B) after reactivation. A third control group (Group C) did not receive the reactivation manipulation before extinction. Participants returned 24 hours later for additional extinction trials and at a 1-month follow-up for disgust reinstatement. Although the paradigm resulted in participants evaluating the CS+ as significantly more unpleasant after being associated with a disgust-relevant US, extinction learning within the reconsolidation window did not influence self-reported reduction or return of disgust. However, there was some evidence suggesting that those who received reactivation (Groups A and B), regardless of timing, evaluated the CS+ as less unpleasant after extinction relative to acquisition, whereas this pattern was not observed among those who did not receive reactivation (Group C). The implications of these findings for anxiety-related disorders in which disgust has been implicated will be discussed.

Continuous versus intermittent chemotherapy in metastatic colorectal cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3582-3582 ◽  
Author(s):  
C. G. Alexopoulos ◽  
A. A. Kotsori
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Stable Disease ◽  
Randomized Study ◽  
Intermittent Chemotherapy ◽  
Group A ◽  
Group B ◽  
Line Chemotherapy

3582 Background: The current policy concerning the duration of chemotherapy in metastatic colorectal cancer (MCC) varies considerably (Clin Oncol 1997;9:248) while no benefit of continuous versus intermittent 5-FU was found in a published randomized study (Lancet 2003;361:457). Serious cumulative toxicity is not usually a problem with long-term 5-FU/FA, but this is not the case with contemporary triple regimens (FOLFIRI, FOLFOX). We, therefore, performed a randomized study of continuous versus intermittent FOLFIRI as first line chemotherapy in MCC. Methods: Patients with MCC and ECOG 0–2 were given 6 biweekly courses of FOLFIRI (Irinotecan 180mg/m2 + De Gramont). Patients with response or stable disease were randomized to continue with another 6 FOLFIRI (group A) or discontinue until relapse when 6 FOLFIRI were readministered (group B). Time to progression (TTP) was calculated from study entrance until 1st progression for group A, and 2nd progression for group B, and overall survival (OS) from study entrance until death. Results: Fifty eight (M=38, F=20) patients entered into the study. Two (3.4%) withdrew before evaluation, 1 (1.7%) died of stroke, 1 (1.7%) was lost to FU and 15 (26%) progressed before or at the completion of 6 FOLFIRI. Thirty nine (67%) patients (M=25, F=14), median age 69 (38–79) responded (21=54%) or had stable disease (18=46%) and were randomized: 19 (49%) to group A and 20 (51%) to group B. Median TTP was 8 months 95% CI: 5.3–10.7) for group A and 9 (95% CI: 7.8–10) for group B (p=NS). 10/19 (52%) in group A received 2nd line chemotherapy vs 7/20 (35%) in group B (p=NS). With a median follow-up of 13 months, 21 patients are alive (12 in group A and 9 in group B). Median OS was 21 months (95% CI: 15 - 26.7) in group A vs 15 (95% CI: 12.6 - 17.3) in group B (p=NS), and 18 months (95% CI: 15.5 - 21) for all 39 patients. Conclusions: In MCC, when response or stability has been achieved after 6 courses ofFOLFIRI there seemstobe little more benefit from continuing chemotherapy than from retreating patients at relapse No significant financial relationships to disclose.

scholarly journals Effect of Immunomodulatory Supplements Based on Echinacea Angustifolia and Echinacea Purpurea on the Posttreatment Relapse Incidence of Genital Condylomatosis: A Prospective Randomized Study

2019 ◽  
Vol 2019 ◽  
pp. 1-7
Author(s):  
Nicoletta De Rosa ◽  
Pierluigi Giampaolino ◽  
Giada Lavitola ◽  
Ilaria Morra ◽  
Carmen Formisano ◽  
...  
Keyword(s):  
Randomized Study ◽  
Echinacea Purpurea ◽  
Hpv Infection ◽  
Echinacea Angustifolia ◽  
Group A ◽  
Extension Degree ◽  
Group B ◽  
Random Groups ◽  
Relapse Rates

Introduction.HPV infection is a highly infectious disease; about 65% of partners of individuals with genital warts will develop genital condylomatosis. Only in 20-30% it regresses spontaneously and relapse rates range deeply (9-80%). Echinacea extracts possess antiviral and immunomodulator activities. The aim of this study was to evaluate the efficacy of the therapy, using a formulation based on HPVADL18® (on dry extracts of 200 mg Echinacea Purpurea (EP) roots plus E. Angustifolia (EA)), on the posttreatment relapse incidence of genital condylomatosis.Materials and Methods.It is a prospective single-arm study. Patients with a satisfactory and positive vulvoscopy, colposcopy, or peniscopy for genital condylomatosis were divided into two random groups and subjected to destructive therapy with Co2 Laser. Group A (N=64) immediately after the laser therapy started a 4-month treatment with oral HPVADL18®; Group B (N=61) did not undergo any additional therapy. Patients were subjected to a follow-up after 1, 6, and 12 months. Differences in relapse incidence between the two groups during follow-up controls were evaluated byχ2-test; the groups were stratified by age, gender, and condylomatosis extension degree.Results and Discussion.Gender, age, and condyloma lesions’ extension degree showed no statistically significant differences between the two trial groups. The relapse incidence differs statistically between the two studied groups and progressively decreases during the 12 months after treatment in both groups. Statistically significant reduction of relapse rates has been shown in Group A in patients over 25 years old. This difference is significant for both men and women. The relapse incidence is superior in case of extended condylomatosis.Conclusions.In conclusion, the presence of a latent infection causes condylomatosis relapse; in order to reduce the relapse risk an induction of a protective immune response seems to be essential to allow rapid viral clearance from genital areas surrounding lesion and treatment zones. Echinacea promotes this process. EP and EA dry root extracts seem to be a valid adjuvant therapy in reducing relapse incidence of lesions in patients treated for genital condylomatosis.

Use of modified PCV chemotherapy as principal therapy for adults with incompletely resected or recurrent low-grade glioma: A retrospective review

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 1571-1571
Author(s):  
E. B. Arenson ◽  
J. Bank ◽  
M. Pierick ◽  
C. Greenwald ◽  
J. McVicker ◽  
...  
Keyword(s):  
Disease Progression ◽  
Prospective Trial ◽  
Progression Free Survival ◽  
Additional Treatment ◽  
Low Grade Glioma ◽  
Low Grade ◽  
Minimal Risk ◽  
Group A ◽  
Group B

1571 Background: In order to assess outcomes of patients treated with chemotherapy versus a more standard approach of radiotherapy (RT), we reviewed 48 patients with newly diagnosed, partially resected or recurrent low-grade glioma (LGG) treated between 1996 and the present. Methods: Patients were divisible into three groups: those treated with chemotherapy ± RT before (Group A, 28 patients) or after (Group B, 13 patients) radiographic progression, and those with recurrences after treatment with RT (Group C, 7 patients). Diagnoses included astrocytoma (23%), oligodendroglioma (48%) and mixed glioma (29%). 39 patients were treated with chemotherapy alone and 9 received post-chemotherapy RT. Chemotherapy consisted of PCV in one case; all other patients received modified PCV (MPCV) which variably included addition of carboplatin (200–360 mg/m2) and etoposide (150 mg/m2) and substitution of temozolomide (150 mg/m2 × 5 doses) for procarbazine. The intent was to treat monthly for one year. Results: Patients received a mean of 10 courses of MPCV; 481 cycles were given. There were no deaths or admissions during chemotherapy. Grade III/IV toxicities occurred in 108 cycles (25 patients), 107 hem. and 1 GI. Late events included 1 case of MDS and 1 AML. There were no cases of disease progression during chemotherapy. Two patients stopped MPCV early, one because of worsening seizures (2 cycles) and one by personal preference (1 cycle); both died of disease. With median follow-up of 46 months (range 4–120) from initiation of chemotherapy, overall survival and progression-free survival were 89% and 79% for Group A, 91% and 83% for Group B, and 100% and 86% for Group C. Of 7 patients (15%) who recurred after completing chemotherapy, 2 have died; both had received post-chemotherapy RT and had clinical features of GBM. Four patients are either lost to follow-up (2) or alive with stable disease (2) following additional treatment. Conclusions: 1. MPCV is a tolerable regimen which can be given more aggressively than standard PCV. 2. There is minimal risk of early disease progression with MPCV. 3. Results support a prospective trial comparing MPCV to RT in patients with progressive unresectable LGG, and use of MPCV as salvage therapy for patients who fail RT. No significant financial relationships to disclose.

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