Recurrence and survival after robotic-assisted radical hysterectomy (RRH) for early-stage cervical cancer (CC): Experience may matter.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5535-5535 ◽  
Author(s):  
Christine K. Fitzsimmons ◽  
Amanda J. Stephens ◽  
Jessica A. Kennard ◽  
Madhavi Manyam ◽  
Julie W. Pepe ◽  
...  
Keyword(s):  
Learning Curve ◽  
Radical Hysterectomy ◽  
Early Stage ◽  
Phase Iii ◽  
Inclusion Criteria ◽  
Free Survival ◽  
Uterine Manipulator ◽  
Group A ◽  
Group B

5535 Background: The phase III LACC Trial found that minimally invasive surgery (MIS) / radical hysterectomy was inferior to open radical hysterectomy (ORH) with reduced disease-free survival (86% v 96.5%) and a higher disease-specific death rate (DSDR) (4.4% v 0.6%). We evaluated our experience with attention to the learning curve. Methods: Patients (pts) with early-stage CC (4/2007-12/2017) who underwent RRH with a uterine manipulator were evaluated in a contemporaneously maintained database. First 10 learning curve cases per surgeon (Group A) were compared to all subsequent cases (Group B). Inclusion criteria mirrored the LACC trial: > one-year follow-up, adenocarcinoma, adenosquamous, or squamous carcinoma, stage IA2 or IB1 using FIGO 2014 guidelines, and pathologic tumor size (TS) of 4 cm or less. Atypical histologies and lesions > 4 cm were excluded. Study parameters assessed included recurrence free survival (RFS), DSDR, and pattern of recurrence. Results: 144 RRH pts were identified and 90 met inclusion criteria with mean age of 45.6±14.3 years. Exclusions included stage 1A1 without LVSI (n = 13), atypical histology (n = 10), lost to follow-up (n = 13), and occult stage 1B2 (n = 18). 40 pts met Group A and 50 met Group B criteria. Median follow-up was 61±34.3 months (A = 71.5, B = 52.5). The 5-year RFS was 92% (95 CI ±4%) and the DSDR 5.5% (n = 5). There were 7 (7.8%) recurrences with median time to recurrence of 12±8.3 mos. Recurrence in Group A (n = 6, 15%) exceeded Group B (n = 1, 2%), p= 0.025. DSDR was 10% Group A v 2% B ( p= 0.184). The 4.5 yr RFS was 84.8% (95 CI ±7%) in Group A v 98% (95 CI ±3%) in Group B. There were no differences in risk factors for recurrence between A & B (TS > 2 cm, LN (+), adjuvant therapy (AT), and LVSI p> 0.05), except (+) vaginal margin status (A = 10% v B = 0%, p= 0.034). Three recurrences involved carcinomatosis, which may be insufflation related. All recurrent cases had TS > 2 cm and 5 received AT. Conclusions: In this study, recurrence of disease in early-stage CC clustered in the first 10 cases per surgeon and occurred in TS > 2 cm. This data suggests a possible learning curve effect and argues against a uterine manipulator cause. Carcinomatosis may be insufflation related, unique to MIS, and deserves further study.

A Comparative Study of Amalaki Choorna along with Madhu and Vata Twak Kashaya Yoni Pichu Dharana in the Management of Shweta Pradara

2017 ◽  
Vol 2 (4) ◽  
Author(s):  
Renuka M. Tenahalli
Keyword(s):  
Vitamin C ◽  
Early Stage ◽  
Pathological Condition ◽  
Before And After ◽  
Group A ◽  
Phosphorus Iron ◽  
Group B ◽  
Busy Schedule ◽  
Iron And Calcium

Shweta Pradara (Leucorrhoea) is the disease which is characterized by vaginal white discharge. Vaginal white discharge this symptom is present in both physiological and pathological condition, when it becomes pathological it disturbs routine life style of the woman. Most of the women in the early stage will not express the symptoms because of hesitation and their busy schedule. If it is not treated it may leads to chronic diseases like PID (Garbhashaya Shotha etc.) Charaka mentioned Amalaki Choorna along with Madhu and Vata Twak Kashaya Yoni Pichu Dharana. This treatment is used in Shweta Pradara shown positive results, hence a study was under taken to assess its clinical efficacy. 30 diagnosed patients of Shweta Pradara were randomly selected, allocated in three groups. Group A and Group B received Amalaki Choorna with Madhu and Vata Twak Kashaya Yoni Pichu Dharana respectively and Group C received Amalaki Choorna with Madhu followed by Vata Twak Kashaya Yoni Pichu Dharana for 15 days. The patients were assessed for the severity of the symptoms subjectively and objectively before and after the treatment and at the end of the follow up. Data from each group were statistically analyzed and were compared. No side effects were noted and it may be considered as an effective alternative medicine in Shweta Pradara (leucorrhea). Amalaki is rich in natural source of vitamin C and contains phosphorus, iron and calcium. Honey contains carbohydrate, vitamin C, phosphorus iron and calcium. All together these help to increase Hb% and immunity. Vata Twak Kashaya contains tannin which helps to maintain normal pH of the vagina.

scholarly journals Hip hemiarthroplasty with modular neck: is it useful in residents’ learning curve? A prospective clinical trial

2020 ◽  
Vol 30 (2_suppl) ◽  
pp. 30-36
Author(s):  
Giuseppe Solarino ◽  
Lorenzo Moretti ◽  
Giovanni Vicenti ◽  
Davide Bizzoca ◽  
Andrea Piazzolla ◽  
...  
Keyword(s):  
Learning Curve ◽  
Surgical Procedures ◽  
Harris Hip Score ◽  
Modular Neck ◽  
Hip Hemiarthroplasty ◽  
Orthopaedic Surgeons ◽  
Group A ◽  
Group B ◽  
Hardinge Approach

Background: The number of femoral neck fractures (FNFs) worldwide will drastically increase in the next few decades, reaching 6.3 million by 2050. In the future, therefore, newly-qualified orthopaedic surgeons will treat this kind of injury more frequently than in past decades. This prospective observational study aims to assess whether hip hemiarthroplasty with modular neck, performed via the Hardinge approach, can be safely carried out by orthopaedic residents. Methods: Patients referred to our Level I trauma centre, between January 2016 and June 2017, with displaced intra-articular femoral fractures, were prospectively recruited. All patients underwent cemented modular bipolar hip hemiarthroplasty (Profemur Z, MicroPort Orthopedics Inc., Arlington, TN, USA) via the Hardinge approach, with the patient positioned in lateral decubitus. The surgical procedures were performed by the same surgical and anesthesiology team, under spinal anaesthesia. All patients underwent clinical and radiographic follow-up up to 24 months. Complications and re-operations were recorded. Clinical evaluation was performed using the Harris Hip Score (HHS), Osteoporosis Quality of Life Questionnaire QUALEFFO-41 and EuroQol-5D (EQ-5D) questionnaire. Anteroposterior pelvis x-rays were performed preoperatively, postoperatively and at 1, 3, 6, 12 and 24 months follow-up. Results: 118 patients met the inclusion criteria (male: 50; female: 68; mean age: 74.3 years; range 65–88 years) and were included in the current study. 67 patients out of 118 (56.8%) were managed by senior orthopaedic surgeons (Group A), whereas the remaining 51 patients out of 118 (43.2%) were treated by orthopaedic residents (Group B). Hip hemiarthroplasties performed by senior surgeons showed the prevalent use of straight (short or long) necks, whereas, in surgical procedures performed by residents, there was a significantly higher use of varus/valgus, anteverted or retroverted necks. The overall complication rate was significantly higher in Group-B patients, compared with Group-A patients ( p = 0.002). The length of hospital stay and the mean clinical scores at 24 months follow-up showed no significant differences. Conclusions: Hip hemiarthroplasty with modular neck can be safely employed during the learning curve of orthopaedic residents. Great efforts, however, should be made in future to improve residents’ training in the management of FNFs.

Thalidomide Based Regimens (TBR) for Relapsed/Refractory Multiple Myeloma Patients: Long Term Follow Up, Unmaintained Remissions and Disease Control after Subsequent Treatments.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4812-4812
Author(s):  
Maria Roussou ◽  
Efstathios Kastritis ◽  
Athanasios Anagnostopoulos ◽  
Evangelos Eleftherakis-Papaiakovou ◽  
Charis Matsouka ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Progression Free Survival ◽  
Free Survival ◽  
Refractory Multiple Myeloma ◽  
Long Term Follow Up ◽  
Group A ◽  
Pulse Dexamethasone ◽  
Group B

Abstract Introduction: The effectiveness of thalidomide based regimens (TBR) in patients with relapsed/refractory multiple myeloma is well established. However, there are still limited data regarding the long term follow up after such regimens and the outcome of patients when they progress and they receive further treatment. In order to answer these questions we evaluated a series of 114 patients with relapsed/refractory multiple myeloma who were treated with TBR. None of these patients had previously received thalidomide, bortezomib or lenalidomide. Patients and Methods: All patients were treated with thalidomide and dexamethasone with or without other oral agents. More specifically 41 patients had received continuous thalidomide and pulse dexamethasone, 25 patients clarithromycin, continuous thalidomide and pulse dexamethasone, 43 patients intermittent thalidomide, pulse dexamethasone and cyclophosphamide and 5 patients continuous thalidomide, pulse dexamethasone and cyclophosphamide. Type of treatment at the time of progression after TBR, response to this treatment and progression free survival were recorded for each patient. Moreover, patients who received novel agents after progression to TBR, were divided into 2 subgroups, according to their resistance to thalidomide. In group A, patients had refractory or progressive myeloma while on TBR or within 2 months after discontinuation of TBR. In group B, myeloma progressed more than 2 months after discontinuation of TBR. Results: Among the 114 patients, 41 had not responded to TBR and 73 (64%) had achieved at least a partial response. The median PFS for all patients was 8 months. As of June 2007, 10 patients remain without progression from 28 to 81 months (median 54 months). Eight patients remain off treatment and without progression for a median of 56 months (range 28–81). Patients who did not respond to or progressed after TBR were analyzed for further treatment and outcome. Thirty eight patients (37%) died before receiving further treatment, 23 patients (23%) received conventional chemotherapy and 41 patients (40%) received continuous thalidomide and dexamethasone +/− clarithromycin or cyclophosphamide (17 patients), bortezomib and dexamethasone (7 patients), melphalan-bortezomib-dexamethasone and intermittent thalidomide (12 patients) or lenalidomide with dexamethasone (5 patients). Among these 41 patients, 24 were classified in group A (thalidomide resistant) and 17 in group B. Overall 17 (41%) achieved at least partial response after retreatment with novel agent-based regimens. A response was observed in 46% of patients in group A and in 35% of patients in group B. The median progression free survival of the 41 patients who received retreatment with novel agents was 9.2 months and the median survival was 17 months. Among the 23 patients who received conventional chemotherapy only five (21%) patients responded and the progression free survival and the median survival were 5.3 and 10.2 months, respectively. Conclusions: After an oral TBR regimen 6 (5%) patients remain without treatment and free of progression for more than 4 years. A significant number of patients who progressed after TBR and who received further treatment which included a novel agent achieved a response, including several patients who were resistant to TBR.

A population-based study evaluating metastatic renal cell cancer (mRCC) patients treated with interferon (IFN) alone, first-line IFN then second-line sunitinib, or sunitinib alone

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15572-15572 ◽  
Author(s):  
C. K. Kollmannsberger ◽  
D. Y. Heng ◽  
N. Murray ◽  
K. N. Chi
Keyword(s):  
Overall Survival ◽  
Standard Treatment ◽  
Population Based ◽  
Phase Iii ◽  
Second Line ◽  
First Line ◽  
Group A ◽  
Group B ◽  
The Impact

15572 Background: Previously, immunotherapy agents such as IFN were the only treatments available for mRCC. Sunitinib has demonstrated prolonged progression free survival in a phase III trial but overall survival benefit has yet to be determined and few patients (pts) with poor MSKCC prognostic profiles were included. Methods: The province-wide BC Cancer Agency Registry was cross-referenced to the central pharmacy database to identify all pts with the diagnosis of mRCC who were treated with IFN and/or sunitinib. Sunitinib became available after October 2005 under an expanded access program or as standard treatment. Three groups of pts were identified: Group A consisted of pts who received IFN alone between January 2003 to October 2005, Group B was all pts who progressed on first-line IFN after October 2005 and subsequently were treated with second-line sunitinib and Group C was all pts treated with first-line sunitinib. Baseline characteristics and overall survival were collected on all patients. Results: A total of 75 patients were identified with 36 patients in Group A, 23 patients in Group B, and 16 patients in Group C. Data are reported from the initiation of IFN in Group A and the initiation of sunitinib in Groups B and C. Median follow-up was 6.0 months in group A, 7.6 months in group B, and 6.2 months in group C. Median age of treatment initiation (62y vs. 60y vs. 62y), number of metastatic sites (>1 site in 63% vs. 61% vs. 56%), and Karnofsky performance status (79 vs. 86 vs. 81) were similar between groups A, B and C, respectively. The MSKCC prognostic profiles were favorable, intermediate and poor in 26%, 51% and 23% in group A, 17%, 65% and 17% in group B and 31%, 38% and 31% in group C, respectively. The estimated 6-month overall survival in groups A, B and C was 56%, 72% and 100%, respectively (log rank A vs C p=0.009; log rank B vs C p=0.042). Conclusion: With the limitations of retrospective analysis and preliminary follow-up, the introduction of sunitinib as standard treatment into the general population of patients with mRCC appears to be associated with a longer overall survival compared to patients treated with IFN alone. Population-based analysis on the impact of the introduction of sunitinib therapy is ongoing. No significant financial relationships to disclose.

A pilot study of preoperative (Pre-op), single-dose ipilimumab (Ipi) and/or cryoablation (Cryo) in women (pts) with early-stage/resectable breast cancer (ESBC).

2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 67-67 ◽  
Author(s):  
Adi Diab ◽  
Stephen Barnett Solomon ◽  
Christopher Comstock ◽  
Majid Maybody ◽  
Virgilio Sacchini ◽  
...  
Keyword(s):  
Immune Modulation ◽  
Early Stage ◽  
Delay Group ◽  
Technical Failure ◽  
Free Survival ◽  
History Of ◽  
Group A ◽  
Grade 3 ◽  
Group B ◽  
To Receive

67 Background: Intratumoral cryo combined with immune modulation generates a potent systemic anti-tumor immune response that might improve recurrence free survival in ESBC. In this study, we evaluate the safety of pre-op cryo and/or ipi (10mg/kg) in pts with ESBC. Radiographic correlates and intratumoral/serologic immune responses are also explored. Methods: Eligible pts are ≥18y of age with operable ≥1.5 cm invasive ESBC, no history of autoimmune disease and planned mastectomy. Pts are sequentially assigned to receive pre-op: cryo alone (Group-A), ipi alone (B), or ipi with cryo (C). Cryo is administered 7-10d prior to surgery. Ipi is administered 8-15d prior to surgery (1-5d prior to cryo). If at least 5/6 pts in each group proceed with surgery without delay, the regimen will be considered safe/tolerable. Toxicity evaluation continues for 12 wks after ipi administration for Groups B and C. Results: As of May 1, 2013, 7/7 pts were enrolled to Group-A (expanded after a possible technical failure in 1 pt) and 6/6 pts were enrolled to Group-B. The median age was 45y (range 39-69y). All 13 pts in Groups A and B underwent mastectomy without delay. Group C is now accruing with 1/6 patients enrolled and awaiting surgery. 6/7 pts in Group-A and none in Group-B had ischemic tumor necrosis/infarction in the mastectomy tissue. Overall, pre-op cryo or ipi alone have been well tolerated with no study related grade 3/4 adverse events (AE) reported (Table). Conclusions: To date, pre-op cryo or ipi is safe and tolerable in pts with ESBC. A Phase II study of pre-op ipi and cryo in ESBC is planned. Clinical trial information: NCT01502592. [Table: see text]

A Preliminary Case-Control Study: Peritoneal Approach in Congestive Heart Failure Treatment

2021 ◽  
pp. 1-7
Author(s):  
Paolo Ria ◽  
Gianluca Borio ◽  
Carlo Rugiu ◽  
Isabella Corino ◽  
Luisa Zanolla ◽  
...  
Keyword(s):  
Case Control Study ◽  
Case Control ◽  
Major Event ◽  
Event Free Survival ◽  
Free Survival ◽  
Group A ◽  
Number Of Visits ◽  
Group B ◽  
Control Study

<b><i>Background:</i></b> Congestive heart failure (CHF) associated with worsening renal function is a very common disorder, and, as well known, the goal of the treatment is reducing venous congestion and maintaining a targeted extracellular volume. The objective of the study is to evaluate regular peritoneal ultrafiltration treatment compared to a standard conservative approach in NYHA III–IV CHF patients. In particular, the primary endpoints of the study were the major event-free survival and the total days of medical care per month (which consist of the days of hospitalization and the number of outpatient visits). <b><i>Material and Methods:</i></b> This is a retrospective case-control study. Twenty-four patients were included in the present study. Twelve consecutive patients were treated with peritoneal treatment (group A) and 12 matched for age, gender, and severity of disease with a standard approach. Patients were observed over a maximum period of 18 months. Information on events, hospitalizations, and number of visits was collected during follow-up. <b><i>Results:</i></b> During the follow-up, we observed a major event in 4 patients in group A (33.3%) and in 8 patients in group B (66.7%). In group B, we observed 7 deaths and 1 ICD shock, while in group A, 3 deaths and 1 ICD shock. The number of visits per month was significantly lower in patients treated with the peritoneal method (1.2 [0.4–4.1] vs. 2.5 [2.0–3.1]; <i>p</i> = 0.03). The total days of medical care was significantly lower in group A (2.0 [1.1–5.5] vs. 4.4 [3.0–8.7]; <i>p</i> = 0.034). A multiple event analysis according to the Andersen-Gill model showed a significant event-free survival for group A. During the follow-up, we did not observe any episode of peritonitis in the treated group. <b><i>Conclusions:</i></b> Our study shows that the peritoneal technique is a good therapeutic tool in well-selected patients with CHF. In accordance with prior experience, this intervention has not only an important and significant clinical impact but also potential economic and social consequences.

scholarly journals Pegaspargase Plus Gemcitabine, Oxaliplatin(P-Gemox) and Thalidomide Versus Aspermetdex Regimen for the Patients with Early or Advanced/Relapsed Extranodal Natural Killer/T Cell Lymphoma: Interim Analysis of a Prospective,Multicenter, Randomized, Phase III Non-Inferiority Clinical Trial

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1819-1819
Author(s):  
Yan Gao ◽  
Huiqiang Huang ◽  
Yujing Zhang ◽  
Hang Su ◽  
Xiaoxiao Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Stage I ◽  
Phase Iii ◽  
Stage Iii ◽  
Newly Diagnosed ◽  
Natural Killer T Cell ◽  
Group A ◽  
Group B ◽  
Killer T Cell

Abstract Backgroud and Purpose Extranodal natural killer/T-cell lymphoma (ENKTL) is an uncommon, aggressive form of non-Hodgkin's lymphoma. Optimal therapeutic strategies have not been fully defined yet. Both AsperMetDex and P-Gemox is recommended as major effective regimen by 2016 NCCN guideline. Therefore, we try to evaluate the efficacy and toxicity for P-Gemox plus thalidomide and AsperMetDex followed by EIFRT as first-line treatment for newly diagnosed stage I/II patients and as salvage regimen for newly diagnosed stage III/IV or relapsed/refractory ENKTL in this study. Patients and methods We initiated a prospective, multicentre, randomized, phase III ,non-inferiority clinical trial at 12 centers in China at March 2014. Patients were randomly assigned to receive either P-Gemox+thalidomide regimen (Group A: Pegaspargase 2000U/m2; im d1, Gemcitabine 1000mg/m2; ivdrip , d1, d8. Oxaliplatin 130mg/m2; ivdrip, d1, thalidomide 100mg/d po, for one year.) or AsperMetDex regimen(Group B: Pegaspargase 2000U/m2; im, d1, Methotrexate 3000mg/ m2; civ 6-hour, d1, calcium folinate 30mg iv, q6h, until reach safe serum MTX concentration, Dexamethasone 40mg/d ivdrip, d1-4.). For newly diagnosed stage I/II patients, both regimens were repeated every three weeks for a maximum four cycles as induction chemotherapy and followed by EIFRT at the dosage of 56Gy in 28 fractions over 4 weeks. Primary EIFRT was delivered using 6-MeV linear accelerator using 3-dimensional conformal treatment planning. For newly diagnosed stage III/IV or relapsed/refractory ENKTL, the regimens were repeated every three weeks for a maximum six cycles. Patients underwent autologous hematopoietic stem cell transplantation (ASCT) as consolidation if they achieved response (complete remission, CR or partial remission, PR). The primary endpoint was progression-free survival(PFS), with a non-inferiority margin of 15%. Results 110 patients were enrolled (56 patients in Group A, 54 in Group B) and 96 patients were evaluable for response. Among 63 newly diagnosed stage I/II patients, 32 patients were assigned to Group A (27 assessed), and 31 to Group B (27 assessed). At median follow-up of 13.5 months (IQR 0.5¨C27.5), 2-year PFS were 82.9%(95%CI:17.574-24.111) and 84.5% (95%CI:18.849- 25.688). 2-year OS were 95.0%(95%CI:13.023-22.896) and 75.8%(95%CI:11.647-21.269), P=0.089, (Figure1). CR rate of both group were all 59.3%(16/27), and objective response rate(ORR) were 85.2%(23/27) and 81.5%(16/27), respectively. After EIFRT, ORR of Group A increased to 92.6% (25/27), CR rate was 88.8% (24/27). ORR of Group B increased to 88.8% (24/27), CR rate was 85.1% (23/27). For 47 newly diagnosed stage III/IV or relapsed/refractory patients, 24 patients were assigned to Group A (22 assessed) and 23 to Group B (20 assessed). At median follow-up of 14.5 months (IQR 0.6¨C28.1), median PFS was longer in the Group A than Group B(12.2 vs. 7.6 months, P=0.365). 2-year OS were 52.5%(95%CI:13.023-22.896) and 48.9% (95%CI:11.647- 21.269), P=0.935 (Figure2). The ORR were 86.4%(19/22) and 70%(14/20), respectively. CR rate were similar for both group with 50%. Six cases (3 cases in each group ) had received ASCT after response, 3 patients relapsed in 6 months after ASCT(2 cases in group A, 1 case in group B) , 2 patients died of disease progression. Group B was better tolerated than Group A, with lower rates of agranulocytosis, thrombocytopenia and infections. While anemia, hyperbilirubinemia, edema, and increased BUN/Cr were more common in Group B. Three patients died of treatment related toxicity only in Group B. Two patients died of severe acute renal failure and sepsis at the first cycle, and one patient died of sepsis at the third cycle (Table 1). Median hospitalization time were 1.9 days for Group A and 4.9 days for Group B(P<0.01), respectively. CONCLUSION: Induction chemotherapy of both P-Gemox+Thalidomide and AsperMetDex regimen followed by ENKTL yielded promising efficacy for patients with stage I/II ENKTL. For advanced or relapsed patients, both regimen showed unsatisfied survival outcome. Meanwhile, P-Gemox+ Thalidomide may be less toxic with more simple and convenient administration in outpatients clinics in comparison to AsperMetDex. This clinical trial is still ongoing . (ClinicalTrials.gov, NCT 2085655). Funding: 5010 Program for Clinical Research , Sun Yat -Sen University. Disclosures No relevant conflicts of interest to declare.

scholarly journals EVALUATION OF EFFICACY OF JALOUKAVACHARANA AND SIRAVYADHANA IN THE MANAGEMENT OF VATARAKTA: A COMPARATIVE STUDY

2020 ◽  
pp. 47-55
Author(s):  
Rajeshwari ◽  
Deenaprakash Bharadwaj ◽  
Harshavardhana K
Keyword(s):  
Dietary Habits ◽  
Alternative Hypothesis ◽  
Total Duration ◽  
Standard Technique ◽  
Signs And Symptoms ◽  
Cost Effective ◽  
Inclusion Criteria ◽  
Group A ◽  
Group B

Vatarakta is the illness that exhibits different signs and symptoms based upon the Dosha, Utthana and Gambheera Avastha. Dietary habits and life style modalities play a major role in the causation of Vatarakta. Though various remedies are there to treat it, Raktamokshana is said to be an effective, and standard technique. Hence it is claimed to be an important affective tool in the management of Vatarakta. This study is undertaken to explore and compare the efficacy of Jaloukavacharana and Siravyadhana in Vatarakta. Randomized comparative clinical trial was adopted in this study. 40 subjects fulfilling diagnostic and inclusion criteria were selected and divided into two groups. The day on which the procedure was conducted was considered as first day of the trail. Follow up was on 8th & 15th day. Total duration of Study was 15 days. In both the group there is a significant improvement of subjective and objective symptoms except on Vaivarnya. The collected data is statistically analysed Jaloukavacharana is found to be more effective in the features Daha and Shopha. Siravydhana is more effective in Shoola and Vivarnya. Both the procedure shows equal effect on Sparshaasahatva. The overall results of Group A are 82.11% and Group B is 82.76%. Both the treatments are equally effective in Vatarakta. Hence alternative hypothesis H3 is proved. This simple and cost-effective treatments are painless do not require any anaesthesia. Hence it can be easily performed in OPD level on day-care basis.

scholarly journals OSTEOARTHRITIS;

2014 ◽  
Vol 21 (03) ◽  
pp. 471-476
Author(s):  
Malik Muhammad Yasin Awan ◽  
Ijaz Ahmad ◽  
Amer Aziz
Keyword(s):  
Case Report Form ◽  
Inclusion Criteria ◽  
Double Blind ◽  
Treatment Groups ◽  
End Of Treatment ◽  
Womac Questionnaire ◽  
Group A ◽  
Vas Scores ◽  
Group B

Objective: To assess the efficacy and safety of aceclofenac in the treatment ofosteoarthritis. Study design: Randomized double blind Phase IV trial. Place and Duration ofstudy: This study was conducted in the department of Orthopaedics & Spine Surgery, GhurkiTrust Teaching Hospital, Lahore. The duration was eight weeks. Methodology: A total of 90subjects, fulfilling the inclusion criteria and willing to give free informed consent were enrolled inthis trial. All these subjects were randomized into two treatment groups (A & B). Subjects eitherreceived Aceclofenac 100 mg twice daily or Diclofenac 75 mg twice daily for 08 weeks. During thescreening visit, information on their demographic characteristics, medical history and previousand current medications were collected. A thorough physical examination and necessarylaboratory investigations were carried out before drug administration and after the completion oftreatment (end of week 8). Clinical examination was done at baseline visit, randomization and 2, 4and 8 weeks. Gastrointestinal (GI) safety was assessed using adverse drug reaction (ADR)reports. WOMAC questionnaire was used to see improvement in activities of daily living and painwas assessed using visual analogue scale (VAS). All data was collected in the case report form(CRF). Statistical evaluation was performed at the end of the trial and results were analyzed usingSPSS. Results: 70 subjects completed the study while 20 were lost in follow-up. There were 28males and 34 females in the study with mean age of 56 years. There was a significant decrease inWOMAC and VAS scores in both groups. In group A (Diclofenac group) VAS decreased from7.107 to 2.538 (p= 0.000) and WOMAC decreased from 32.75 to 7.38 (p=0.000). In group B(Aceclofenac group), VAS decreased from 7.912 to 6.0 (p=0.001) while WOMAC decreased from37.29 to 21.50 (p=0.000) showing the efficacy of both drugs. There was also significant decreasein the disease severity in both groups at the end of treatment. But the safety profile of (Diclofenac)group A was not significant (p=0.767) as compared to (Aceclofenac) group B (p=0.022).Conclusions: Aceclofenac is efficacious and safe drug for the treatment of osteoarthritis in adultsas compared to Diclofenac.

6128Losartan vs Nebivolol vs the association of both on the progression of aortic root dilation in genotyped Marfan Syndrome: 48 months open label randomized controlled phase III trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Di Toro ◽  
C Klersy ◽  
L Giuliani ◽  
A Serio ◽  
E Disabella ◽  
...  
Keyword(s):  
Aortic Root ◽  
Combined Treatment ◽  
Root Diameter ◽  
Phase Iii ◽  
Z Score ◽  
Open Label ◽  
Aortic Root Aneurysm ◽  
Group A ◽  
Group B

Abstract Background Marfan Syndrome (MFS) is a rare multisystemic genetic disease caused by mutations in the Fibrillin 1 (FBN1) gene. Aortic root aneurysm, potentially evolving to dissection and rupture, is the most important clinical complication. Beta blockers (BB) and Angiotensin II receptor blockers (ARB), these latter exerting an anti-TGFbeta1 effect, are current cornerstones of medical therapy in patients diagnosed with MFS and presenting aortic root aneurysm. The study aimed at comparing the effect of single drug (nebivolol and losartan) vs. the combination of both (losartan + nebivolol) in limiting the progression of the growth of the aortic root diameter (ARD) in FBN1 genotyped patients with aortic root aneurysm (z-score>2), who had not undergone prior aortic surgery. Methods We designed a controlled, open-label, single-blinded, 1:1:1 randomized, phase III single-centre study [NCT00683124]. Calculated sample size was 291 (power 90%, type I error 5%, 20% attrition, expected dropout 20%). ARD data collection was performed with annual 2D-transthoracic echocardiograms for four years. ARDs were measured with 2D-transthoracic echocardiogram as absolute values, aortic root ratio (ARR), and z-score. The primary endpoint was the modification of ARD z-score at 48 months. The analysis of the primary endpoint aimed at showing differences of ARD z-score comparing: – The combined treatment arm (group A). – The group aggregating both single treatment arms (group B). – The nebivolol arm (group C). – The losartan arm (group D). Results We enrolled 262 patients (126 adults, aged 17–55, and 136 children, aged 1–16); 236/262 (22 dropout; 4 lost at follow-up) completed the planned follow-up: 81 in the group A, 79 in the BB in the group C and 76 in the group D. No patient developed acute aortic dissection. Both drugs administered either individually or in combination were well tolerated without evidence of side effects. At 48 months, the ARD Z-score decreased from baseline to end-follow-up in all treatment arms. The decrease was significantly higher in the combined treatment arm (A) than in the single treatment aggregated arm (group B) with a difference in ARD z-score change of 0.17 (p=0.009) in the combined arm (A). Similarly, the decrease of z-score was inferior in the nebivolol arm and in the losartan arm than in the combined arm (by 0.16, p=0.032, and by 0.18, p=0.019, respectively). After Bonferroni correction for these post-hoc comparisons only the decrease of z-score in the losartan arm remained significantly inferior (p<0.025). Conclusions This study shows that the current cornerstones of medical therapy in MFS (ARB and BB) are effective in limiting the progression of the growth of the aortic root diameter: their combination exploits a synergistic effect. The combined administration of BB and ARB in patients with aortic root aneurysm is a sustainable, well tolerated treatment that effectively limits the rate of progression of aortic root dilation. Acknowledgement/Funding The financial support of Telethon, Italy (Grant no. GGP08238) is gratefully acknowledged.The drugs are a gift of Menarini and MSD

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