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 Clinical Outcome of an Multicentre, Randomized, Phase II Clinical Trial for Patients with Extranodal NK/T Cell Lymphoma Treated By P-Gemox or Aspametdex

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1569-1569 ◽  
Author(s):  
Hui-qiang Huang ◽  
Gao Yan ◽  
Hang Su ◽  
Yunhong Huang ◽  
Yuhuan Gao ◽  
...  
Keyword(s):  
T Cell ◽  
Progression Free Survival ◽  
Stage I ◽  
Stage Iii ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Overall Response ◽  
Randomized Phase Ii ◽  
Group A ◽  
Group B

Intruduction 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. Nasal NK/T-cell lymphomas present mostly with stage I/II disease. For stage I/II nasal lymphoma, a combination of chemotherapy and radiotherapy yields optimal results. Concomitant chemoradiotherapy and sequential chemotherapy and radiotherapy give similar response rates and survivals. For stage III/IV nasal, nonnasal, and disseminated ENKTL, systemic chemotherapy is indicated. Conventional anthracycline-based regimens are ineffective. Regimens containing L-asparaginase are most effective. Both AspaMetDex and P-Gemox is recommended as major effective combined chemotherapy regimen by NCCN guideline. Therefore, we try to evaluate the efficacy and toxicity for P-Gemox plus thalidomide and AspaMetDex followed by extensive involved field radiotherapy (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 clinical study. Methods We initiated a prospective, multicentre, randomized, phase II 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 AspaMetDex 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). Results Between March 2014 and March 2018, 165 patients were randomly assigned. 85 patients to Group A, 80 patients to Group B. 156 patients were evaluable for response. Investigator-assessed overall response at the end of induction was 88.2% in the Group A and 75.0% in the Group B. Complete remission (CR) rate were 60.0% and 55.0%. Among 107 newly diagnosed stage I/II patients, 54 patients were assigned to Group A (52 assessed), and 53 to Group B (47 assessed). Overall response during induction in Group A and B was similar in both groups, were 64.8% and 64.2%. 58 newly diagnosed stage III/IV or relapsed refractory patients were enrolled. 31 patients were assigned to Group A (30 assessed), and 27 to Group B. The efficacy rate of Group A was higher than that of Group B. Overall response rate were 87.1% and 66.6%, respectively. At median follow-up of 24.6 (1.0-60.9)months, 3-year progression-free survival (PFS) and overall survival (OS) of whole cohort were 61.4% and 63.4%. PFS and OS rate of Group A were similar to Group B(Figure 1). 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. CONCLUSION: Induction chemotherapy of both P-Gemox+Thalidomide and AspaMetDex regimen followed by EIFRT yielded promising efficacy for patients with stage I/II ENKTL. There is little difference therapeutic effect between the two regimens. For advanced or relapsed patients, both regimen showed unsatisfied survival outcome. Meanwhile, P-Gemox+ Thalidomide was less toxic with more convenient administration in outpatients clinics in comparison to AspaMetDex. ( ClinicalTrials.gov, NCT 2085655 ). Disclosures Li: Guangdong Province Hospital: Employment.

Cisplatin, vinblastine, and mitoguazone chemotherapy for epidermoid and adenocarcinoma of the esophagus.

1987 ◽  
Vol 5 (8) ◽  
pp. 1143-1149 ◽  
Author(s):  
A A Forastiere ◽  
M Gennis ◽  
M B Orringer ◽  
F P Agha
Keyword(s):  
Pilot Trial ◽  
Transhiatal Esophagectomy ◽  
Newly Diagnosed ◽  
Surgical Specimen ◽  
Carcinoma Of The Esophagus ◽  
Group A ◽  
Tumor Measurements ◽  
Regional Disease ◽  
Group B

Thirty-six patients with adenocarcinoma or epidermoid carcinoma of the esophagus were entered into a phase II trial evaluating the combination of cisplatin 100 mg/m2 intravenously (IV) day 2, vinblastine 1.6 mg/m2 IV days 1 to 4, and mitoguazone (MGBG) 500 mg/m2 IV days 1 and 8. Twenty-nine patients (group A) were newly diagnosed with local-regional disease only and were candidates for transhiatal esophagectomy (THE). These patients received two courses of chemotherapy at 3-week intervals prior to surgery. Response was assessed by measuring changes in the primary tumor length and depth on serial biphasic contrast esophagrams and comparing this result with tumor measurements obtained from the surgical specimen. Complete (CR) and partial responders (PR) received three additional postoperative cycles. Seven patients had recurrent or metastatic disease (group B) and were treated every 4 weeks until disease progression. Of 34 patients evaluable for response, there was one pathologically confirmed CR and 15 PRs (47%). This consisted of 12 of 27 (44%) group A patients (seven of 11 epidermoid, five of 16 adenocarcinoma) and four of seven (57%) group B patients (two of four epidermoid, two of three adenocarcinoma). Toxicity included leukopenia in one third of treatment courses and thrombocytopenia in 21%. Nausea and vomiting occurred in 60% of patients, diarrhea in 18%, transient nephrotoxicity in 18%, peripheral neuropathy in 12%, and ototoxicity in 3%. Twenty-five group A patients underwent resection. Four chemotherapy nonresponders (NR) and one PR had known disease left at surgery; all others (80%) had gross total removal of their disease. The median survival time (MST) of the 29 group A patients was 14 months, with 21% alive at 36 months. The MST of group A chemotherapy responders was 15 months compared with 9 months for NRs (P = .032). Initial sites of recurrence in 14 patients were local-regional in six, distant only in six, both local-regional and distant in two. This regimen, administered in maximally tolerated doses, was active in epidermoid and adenocarcinoma histologies, recurrent disease and newly diagnosed patients. However, nearly all responses were PRs and the MST of resected patients was similar to a prior series of patients treated with esophagectomy alone. Observations from this pilot trial and those of others have led to a follow-up study, in progress, evaluating intensive preoperative chemotherapy and concurrent radiation therapy (RT).

scholarly journals Comparison between Autologous Blood and Fibrin Glue for Adhering Conjunctival Autografts after Pterygium Excision- A Randomised Clinical Trial

2021 ◽  
Author(s):  
Mona Sune ◽  
Pradeep Sune
Keyword(s):  
Clinical Trial ◽  
Fibrin Glue ◽  
Autologous Blood ◽  
Randomised Clinical Trial ◽  
Mild Degree ◽  
Group A ◽  
Pterygium Surgery ◽  
Pterygium Excision ◽  
Group B

Introduction: Fibrin glue is a biological tissue adhesive and acts on the principle of final stages of the coagulation cascade. The cost of commercially available products is very high and not affordable for the patients of low socio-economic strata. As an alternative, pterygium surgery was done using patient’s own blood to adhere the conjunctival autograft to scleral bed by the process of coagulation of fibrin from the oozing blood from the blood vessels under the flap. Aim: To compare autologous blood and fibrin glue for adhering conjunctival autografts after pterygium excision. Materials and Methods: It was a randomised clinical trial. Total 97 subjects with primary pterygium who visited the Ophthalmology Department were randomised into two groups. In group A (n=31), patients had undergone pterygium excision wherein conjunctival autograft was attached by fibrin glue. In group B (n=66) the graft was attached by autologous blood present on the scleral bed. Mean operative time for the procedures were compared. Follow- up was done for 12 months and all subjects were examined for postoperative pain, foreign body sensation, inflammation, graft stability and recurrence. Results: The mean age of patients in group A was 48.32±14.3 years (21-65 years), and in group B was 54.48±15.67 (23-74 years). Mean operating time in group A was 23.21±9.4 minutes and 13.7±4.3 minutes in group B, (p-value=0.001). Postoperative pain of mild degree was present in all the 31 (100%) subjects of group A. In group B, pain was absent in 32 (48.5%) and mild degree in 34 (51.5%) subjects. No recurrence was found in both the groups. Mean follow-up period was 11.4 months. Conclusion: This study concludes that autologous blood is a useful alternative method for graft attachment in pterygium surgery without the untoward complications related to fibrin glue.

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.

Efficacy and Safety Of Pegaspargase With Gemcitabine and Oxaliplatin In Patients With Treatment-naïve, Refractory Extranodal Natural Killer/T-Cell Lymphoma: A Single-Centre Experience

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 642-642 ◽  
Author(s):  
Yan Gao ◽  
Hui-qiang Huang ◽  
Cai QiChun ◽  
XiaoXiao Wang ◽  
QinfQing Cai ◽  
...  
Keyword(s):  
T Cell ◽  
Natural Killer ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Newly Diagnosed ◽  
Efficacy And Safety ◽  
Natural Killer T Cell ◽  
Treatment Naïve ◽  
Killer T Cell

Abstract Purpose Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive lymphoma with poor prognosis. The response rate to L-asperagenase(L-ASP) based multi-agent regimens is highly effective. Several clinical trials demonstraed good response and less toxicity for pegaspargase (PEG-ASP) in comparison to L-ASP. This is the first prospective study to evaluate the efficacy and safety of PEG-ASP combined with gemcitabine and oxaliplatin (PEG-ASP + Gemox) for patients with treatment-naïve and refractory or relapsed ENKTL. Patients and methods 61 eligible patients treated by PEG-ASP + Gemox from March 2010 to March 2013 were analyzed. 36 newly -diagnosed patients and 25 refracrory/replased patients were enrolled, we also conducted extra matched-pair analysis between 20 stage IE/IIE cases selected from 36 newly -diagnosed patients in PEG-ASP + Gemox group and 18 stage IE/IIE patients in L-ASP + Gemox regimen group(unpublished data, Table 1,2). PEG-ASP + Gemox dosages were as follows: Gemcitabine 1000 mg/m2; day 1,8; oxaliplatin 130 mg/m2 day 1, PEG-ASP 2500 U/m2 im day1. The regimen was repeated every 3 weeks for a maximum of 6 cycles including 3 cycles induction chemotherapy for stage IE/IIE patients followed by involved-field radiotherapy. Furthermore autologous haematopoietic stem cell transplantation(AHSCT) was recommended to refractory/relapsed patients after achieved good response. Results 55 patients were evaluable for response after a median 4 (1¨C6 ) cycles. The overall response(OR) rate was 90.9% (50/55), with a complete remission (CR) rate of 60.0% (33/55). After a median follow-up of 16.2 (4.0-39.5)months, the 1-, 2-year OS rates were 88.2%, 83.2%, and the 1-, 2- year PFS rates were all 85.2%. The median follow-up time was 19.6 (4.0-39.5)months for treatmen-naive patients. their OR, CR, partial remission(PR) rates were 94.0% (31/33), 66.7% (22/33), 27.3% (9/33), respectively. Both 1-, 2-year OS rates were 94.0%, 1-, 2-year PFS rates were all 93.9%. The median follow-up time was 18.7(4.5-36.2) months for refractory/replased patients. The OR and CR rates were 86.4% (19/22), 50.0% (11/22). The 1-, 2-year OS rates were 80.4% ,70.4%, the 1-, 2-year PFS rates were all 72.7%. Patients who achieved CR had undergone a median of two cycles (2¨C6). All patients received 187 cycles of chemotherapy, the incidence of rates of grade 1 and 2 adverse events were as follows: neutropenia, 69.6%; vomit 39.5%, transaminase elevation, 37.9%. Grade 3 and 4 adverse reactions were rare. Conclusion Our clinical trisl have demonstrated high efficacy and quick achievement of CR for the first time for PEG-ASP+Gemox regimen in the management of treatment-naïve and refractory/relapsed ENKTL patients. It also provided good chance of AHSCT as consolidation for chemosensitive patients. Meanwhile, PEG-ASP+Gemox regimen was conveniant and less toxic. Further investigation for PEG-ASP + Gemox regimen is warranted. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Lacrimal stenting versus three-snip punctoplasty for treatment of punctal stenosis or occlusion: An open-label, randomized clinical trial

2021 ◽  
Vol 10 (1) ◽  
pp. 24-31
Author(s):  
Haitham Rashdan ◽  
Ali Mahmoud Ismail ◽  
Mohammed Ezz-Eldawla ◽  
Mohammed Iqbal
Keyword(s):  
Clinical Trial ◽  
Patient Satisfaction ◽  
Randomized Clinical Trial ◽  
Open Label ◽  
Punctal Plugs ◽  
Silicon Tube ◽  
Group A ◽  
Group B ◽  
Punctal Stenosis

Background: To compare the short-term anatomical and functional outcomes of, as well as patient satisfaction with, lacrimal stenting and three-snip punctoplasty for the treatment of punctal stenosis or occlusion. Methods: In this open-label, randomized clinical trial, we included 50 eyes of 30 patients diagnosed with punctal stenosis or occlusion. They were randomly allocated to two groups of 25 eyes each, using central telephone randomization. Group A underwent a lacrimal stenting procedure and was subdivided into two subgroups: Group A1 (13 eyes) received polyvinylpyrrolidone-coated perforated punctal plugs, and Group A2 (12 eyes) received closed intubation using a bicanalicular silicon tube. Group B included 25 eyes that underwent three-snip punctoplasty. All eyes were examined after 1 day, 1 week, 1 month, 3 months, and 6 months. Postoperative anatomical success assessing the punctum size, functional success using the fluorescein disappearance test, and patient satisfaction based on epiphora scoring were recorded. Results: Both study groups were comparable in terms of sex and age distribution. Compared to Group B, Group A had a significantly larger punctum size at one, three, and 6-month postoperatively (P = 0.009, 0.01, and 0.02, respectively). The difference in FDT results was significant between the two groups at all follow-up visits (P = 0.008, 0.0001, 0.003, and 0.002, at postoperative one week, one-months, three-month, and six-month, respectively). Likewise, patient satisfaction was significantly different between both groups at all follow-up visits (P = 0.007, 0.001, 0.005, and 0.002, at postoperative one week, one-months, three-month, and six-month, respectively). Conclusions: Lacrimal stenting is an effective method for the treatment of punctal stenosis or occlusion. Overall, the FDT results and patient satisfaction outcomes were significantly better. Keywords: punctal occlusion, punctal stenosis, epiphora, lacrimal stenting, closed intubation, bicanalicular silicon tube, perforated punctal plugs, three-snip punctoplasty, 3-snip punctoplasty

scholarly journals COMPARATIVE EVALUATION OF THE EFFICACY OF 4% MANGOSTEEN GEL AND 1% CHLORHEXIDINE DIGLUCONATE GEL IN MANAGEMENT OF PATIENTS WITH CHRONIC GINGIVITIS: A RANDOMIZED CLINICAL TRIAL

2022 ◽  
Vol 12 (6) ◽  
pp. 6-11
Author(s):  
Vinayaka A.M. ◽  
Gayathri G.V. ◽  
Triveni M.G.
Keyword(s):  
Clinical Trial ◽  
Plaque Index ◽  
Age Group ◽  
Chlorhexidine Digluconate ◽  
Gingival Index ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

To clinically evaluate & compare the efficacy of 4% Mangosteen Gel and 1% chlorhexidine digluconate gel in managing patients with chronic gingivitis. Materials and Methods: A total of 50 patients with an age group of 20-45 years diagnosed with generalized plaque-induced gingivitis were selected for this clinical trial once attaining their informed consent. A thorough case history was chronicled comprising plaque index (P.I.), gingival index (G.I.) and Sulcus bleeding index (SBI) at baseline; then full-mouth scaling and polishing (SAP) was performed by a solitary attuned examiner. Patients were then randomly assigned into two groups using a computer-generated random numbering sequence system. Patients in group A received 4% Mangosteen Gel, and group B received 1% chlorhexidine digluconate gel for home application. The post-treatment follow-up examination for P.I., G.I. and SBI changes were assessed after 14 days and 21 days and compared with baseline data. Results: In both the groups, the mean plaque index, gingival index and sulcus bleeding index scores were significantly decreased after the 14th and 21st day compared to baseline scores. There was no significant difference between the groups, but only in group B, there was a substantial difference in SBI scores observed on day 21. Conclusion: 4% Mangosteen Gel and 1% chlorhexidine digluconate gel were clinically effective when used as an adjunct to SAP in managing patients with gingivitis. Hence, 4% Mangosteen Gel can be considered an alternative to 1% chlorhexidine digluconate gel without any side effects in managing generalized plaque-induced gingivitis.

scholarly journals Efficacy of 0.05% cyclosporine A on the lipid layer and meibomian glands after cataract surgery: A randomized, double-masked study

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0245329
Author(s):  
Min Seung Kang ◽  
Jonghoon Shin ◽  
Jeong Min Kwon ◽  
Jin Huh ◽  
Ji Eun Lee
Keyword(s):  
Clinical Trial ◽  
Cataract Surgery ◽  
Cyclosporine A ◽  
Ocular Surface ◽  
Lipid Layer ◽  
Significant Difference ◽  
Group A ◽  
Meibomian Glands ◽  
Group B

Purpose To quantitatively evaluate the effects of 0.05% cyclosporine A (CsA) on lipid layer thickness (LLT) and meibomian glands after cataract surgery using the LipiView® ocular surface interferometer. Methods This study was a prospective randomized double-masked clinical trial conducted by Pusan National University Yangsan Hospital between April 04, 2019, and November 31, 2019. Sixty-two participants were recruited, and 12 of them were not enrolled because they had undergone previous treatments for ocular surface diseases. The participants were adult patients with cataract, exhibiting normal lid position; they did not present any other ocular disease and did not meet the exclusion criteria of the clinical trial. Fifty subjects were enrolled in the study. The randomized subjects received treatment with 0.05% CsA (group A) or 0.5% carboxymethyl cellulose (CMC) (group B) over the 3 months following the cataract surgery. Subjective and objective assessments were performed at preoperative and postoperative visits. Ocular Surface Disease Index (OSDI), tear breakup time (TBUT), and Schirmer’s I test were performed by the same surgeon, and LLT and meiboscore were determined using the LipiView® interferometer. Results Fifty subjects subjects enrolled consisted of men (50%) and women (50%), with a mean (SD) age of 65.94 (10.35) years. Four subjects in group A and five in group B were excluded from the analysis as they were lost to follow-up within 1 month after cataract surgery. Thus, the study comprised 41 eyes of 41 subjects; 21 subjects were treated with CsA and 20 subjects with CMC. Comparing the clinical measurements between groups A and B taken at the last visit, while controlling the effects of the preoperative values, TBUT and LLT showed significant differences (p = 0.035 and p = 0.047, respectively, by ANCOVA). The TBUT between the subjects using CsA and those using CMC after cataract surgery showed a significant difference during follow up (p = 0.003 by repeated measures ANOVA). In the multivariate analysis, preoperative LLT and the use of CsA were found to be independent parameters for postoperative LLT (R2 = 0.303; p = 0.008 and p = 0.045, respectively), whereas the follow-up duration exhibited a positive correlation with the difference between the preoperative and postoperative values of LLT in the group treated with CsA (R2 = 0.738 and p < 0.001). Conclusion Treatment with 0.05% CsA following cataract surgery is effective in improving TBUT and LLT in comparison with 0.5% CMC. A higher preoperative value of LLT and the postoperative use of CsA could be significant determinants of a higher postoperative LLT value. Trial registration ISRCTN registry with ISRCTN 10173448.

scholarly journals Effectiveness of Chlorhexidine and Metronidazole Gels in the management of gingivitis. A clinical trial

2021 ◽  
Vol 37 (5) ◽  
Author(s):  
Maryam Panhwar ◽  
Shazia Perveen Rajpur ◽  
Eisha Abrar ◽  
Mansour Alqutub ◽  
Tariq Abduljabbar
Keyword(s):  
Clinical Trial ◽  
Subjective Evaluation ◽  
Substantial Improvement ◽  
Significance Level ◽  
Creative Commons ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Root Planning

Objectives: The purpose of the present study was to compare the topical application of chlorohexidine (CHX) and Metronidazole (MTZ) gels, individually and in combination in patients with gingivitis for up to 12 weeks follow-up. Methods: The clinical trial was conducted at Liaquat University of Medical Health Sciences (LUMHS) Jamshoro and Hyderabad, Institute of Dentistry from 1st March 2019 to 1st March 2020. Patients were selected based on inclusion criteria. Out of 125 screened patients, ninety-nine patients agreed to participate in the study. At the beginning of study all patients were assessed for gingival inflammation by using gingival index (GI) (Loe and silness, 1963). Scaling root planning (SRP) was performed in all patients. Subjects were randomly selected in three groups (n=33 each). In Group-A CHX gel was applied, Group-B Metronidazole gel was applied and the combination of two was applied to patients of Group-C. Patient follow up was done and gingival parameters were assessed at baseline, fourth week and twelve weeks. Apart from the clinical evaluation, a subjective evaluation was also undertaken. Significance level of 0.05 and a desired study power of at least 80% was estimated. Analysis of Variance (ANOVA) test for comparison was used within groups. Results: A significant improvement in gingival scores was noted in all groups from baseline. At 4 weeks CHX (1.25±0.21) MTZ (1.81±0.38) CHX+MTZ (1.29±0.34) compared to baseline CHX (2.77±0.24) MTZ (2.84±0.54) CHX+MTZ (2.74±0.31) demonstrated substantial improvement (p<0.001). However, gingival scores showed inclination at 12 weeks CHX (1.18±0.41) MTZ (1.21±0.48) CHX+MTZ (1.11±0.14) with no significant difference to week 4 (p>0.001). Conclusion: Local MTZ gel and MTZ+CHX gel showed effectiveness similar to CHX gel application adjunct to scaling and root planning in the treatment of gingivitis. doi: https://doi.org/10.12669/pjms.37.5.4236 How to cite this:Panhwar M, Rajpar SP, Abrar E, Alqutub M, Abduljabbar T. Effectiveness of Chlorhexidine and Metronidazole Gels in the management of gingivitis. A clinical trial. Pak J Med Sci. 2021;37(5):---------. doi: https://doi.org/10.12669/pjms.37.5.4236 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.

Bevacizumab in combination with radiotherapy plus concomitant and adjuvant temozolomide for newly diagnosed glioblastoma: Update progression-free survival, overall survival, and toxicity

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2017-2017 ◽  
Author(s):  
M. L. Gruber ◽  
S. Raza ◽  
D. Gruber ◽  
A. Narayana
Keyword(s):  
Overall Survival ◽  
Progression Free Survival ◽  
Newly Diagnosed ◽  
Similar Treatment ◽  
Macdonald Criteria ◽  
Newly Diagnosed Glioblastoma ◽  
Group A ◽  
Group B ◽  
Cycle Group

2017 Background: Prognosis of glioblastoma (GBM) is very poor. Standard treatment includes surgical resection (SR), radiation (RT), concomitant and adjuvant chemotherapy with temozolomide (TMZ). Our objective is to assess the treatment efficacy, safety and survival in patients with newly-diagnosed GBM treated with RT, TMZ, and bevacizumab in the upfront management. Methods: From 2006–2008, 51 eligible patients (age >18, KPS >70) with newly-diagnosed GBM divided into two groups. Group A (n = 20) was treated with RT (60Gy) and concomitant TMZ (75mg/m2 daily for 42 days) with bevacizumab (10mg/kg every 2 weeks), 29 days following surgery, followed by up to six cycles of adjuvant TMZ (150mg/m2,daily x 7d, q28 with bevacizumab at 10mg/kg days 8 and 22 of each 28 day cycle. Group B (n = 31) received similar treatment without bevacizumab. Both groups were followed up until tumor progression (PFS). Recurrence was defined according to MacDonald Criteria. The end points were PFS, overall survival (OS) and toxicity. Results: Median bevacizumab infusions were 12 (4–32). Median follow-up was14 months for both groups. 6 months PFS survival in Group A was 77.5% and in Group B was 51.6%. Median PFS in Group A was 17 months compared to 7 months in Group B (p < 0.0001, HR = 0.26). Median OS has not been reached in Group A and was 17 months in Group B. One and 2 year OS were 83% and 57% in Group A compared to 72% and 6.5% in Group B (p = 0.02) ). Post-RT and temodar toxicities include thrombocytopenia (1 patient; Gr 3 and fatigue (3 patient;1 Gr 3), bevacizumab related toxicities with RT include leg ulcer with cellulites (1 patient; Gr 3) and pulmonary embolism with thrombocytopenia (1 patient; Gr 4), hypertension (2 patients; Gr 1), and asymptomatic blood products on MRI (2 patients). Conclusions: Bevacizumab has demonstrated efficacy, acceptable toxicity, improved PFS and OS in the upfront management of GBM. No significant financial relationships to disclose.

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