scholarly journals Long-term effect of azithromycin in bronchiolitis obliterans syndrome

2019 ◽  
Vol 6 (1) ◽  
pp. e000465
Author(s):  
C.Tji-Joong Gan ◽  
Chris Ward ◽  
Gerard Meachery ◽  
James Laurence Lordan ◽  
Andrew J Fisher ◽  
...  
Keyword(s):  
Overall Survival ◽  
Placebo Group ◽  
Bronchiolitis Obliterans ◽  
Bronchiolitis Obliterans Syndrome ◽  
Term Effect ◽  
Rank Test ◽  
Open Label ◽  
Log Rank Test ◽  
Long Term Effect

IntroductionAzithromycin stabilises and improves lung function forced expiratory volume in one second (FEV1) in lung transplantation patients with bronchiolitis obliterans syndrome (BOS). A post hoc analysis was performed to assess the long-term effect of azithromycin on FEV1, BOS progression and survival .MethodsEligible patients recruited for the initial randomised placebo-controlled trial received open-label azithromycin after 3 months and were followed up until 6 years after inclusion (n=45) to assess FEV1, BOS free progression and overall survival.ResultsFEV1 in the placebo group improved after open-label azithromycin and was comparable with the treatment group by 6 months. FEV1 decreased after 1 and 5 years and was not different between groups. Patients (n=18) with rapid progression of BOS underwent total lymphoid irradiation (TLI). Progression-free survival (log-rank test p=0.40) and overall survival (log-rank test p=0.28) were comparable. Survival of patients with early BOS was similar to late-onset BOS (log-rank test p=0.74).DiscussionLong-term treatment with azithromycin slows down the progression of BOS, although the effect of TLI may affect the observed attenuation of FEV1 decline. BOS progression and long-term survival were not affected by randomisation to the placebo group, given the early cross-over to azithromycin and possibly due to TLI in case of further progression. Performing randomised placebo-controlled trials in lung transplantation patients with BOS with a blinded trial duration is feasible, effective and safe.

Long-term effect of HCV eradication in patients with mixed cryoglobulinemia: A prospective, controlled, open-label, cohort study

Hepatology ◽  
2015 ◽  
Vol 61 (4) ◽  
pp. 1145-1153 ◽  
Author(s):  
Laura Gragnani ◽  
Elisa Fognani ◽  
Alessia Piluso ◽  
Barbara Boldrini ◽  
Teresa Urraro ◽  
...  
Keyword(s):  
Cohort Study ◽  
Mixed Cryoglobulinemia ◽  
Term Effect ◽  
Open Label ◽  
Long Term Effect

scholarly journals Long-term Effect of Injection Treatment for Osteoarthritis in the Knee by Orthokin Autologous Conditioned Serum

Cartilage ◽  
2017 ◽  
Vol 9 (2) ◽  
pp. 140-145 ◽  
Author(s):  
Danial Zarringam ◽  
Joris E. J. Bekkers ◽  
Daniel B. F. Saris
Keyword(s):  
Surgical Treatment ◽  
Knee Osteoarthritis ◽  
Surgical Intervention ◽  
Term Effect ◽  
Rank Test ◽  
Injection Treatment ◽  
Autologous Conditioned Serum ◽  
Long Term Effect ◽  
End Stage

Background Orthokin is an intra-articular autologous conditioned serum (ACS). Its use might have a beneficial biological effect on pain and function of osteoarthritis in the knee. However, earlier studies lack any consensus on its clinical application and disease modifying effect. Objective The aim of this study was to investigate the long-term effect of Orthokin injection treatment on prevention of surgical treatment for end-stage knee osteoarthritis. Study Design Prospective cohort study. Methods Patients of the previously published Orthokin cohort were contacted to determine whether any intra-articular surgical intervention or osteotomy of the study knee had taken place during the past decade. A log-rank test was performed to evaluate the differences in the survival distribution for the 2 types of intervention: Orthokin versus placebo. Results The survival distributions for the 2 interventions were not statistically significantly different, χ2(1) = 2.069, P = 0.150. After 7.5 ± 3.9 years, 46.3% of the placebo and 40.3% of the Orthokin group had been treated surgically. Conclusion The use of Orthokin in knee osteoarthritis patients did not result in a delay regarding surgical treatment. Clinical Relevance The intra-articular use of Orthokin does not seem to prevent or delay surgical intervention at 10 years after treatment for end-stage knee osteoarthritis.

Fludarabine Treated CLL Patients Showed an Increased Chemoresistance Ex-Vivo.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2791-2791
Author(s):  
Timo Schinkothe ◽  
Michael J. Hallek ◽  
Peter Staib
Keyword(s):  
Overall Survival ◽  
Response Rates ◽  
Term Effect ◽  
Chemosensitivity Test ◽  
Primary Therapy ◽  
Secondary Resistance ◽  
Long Term Effect ◽  
Pre Treatment

Abstract Fludarabine is the most successful drug in patients with relapsed, progradient or refractory chronic lymphocytic leukemia (CLL). But also the use of fludarabine in primary therapy as an alternative to chlorambucil is in trial. Fludarabine induces higher response rates, but showed no improvement in overall survival. The reason for this clinical observation is unclear. In the present study we wanted to answer the question, if the induction of secondary resistance might be the cause for this contradiction. METHODS. Peripheral blood samples from 42 patients with B-CLL were tested in the in-vitro chemosensitivity-test DiSC-assay with 11 drugs. 10 patients had received no therapy before the time of carrying out the In vitro test. 23 patients were pre-treated with prednisone, 8 patient with fludarabine and 5 patients with vincristine. Most of the patients received more then one drug before testing. The chemosensitivity were determined using the LC90. RESULTS. The patients were divided into those who were pre-treated vs. not pre-treated with the fludarabine, prednisone or vincristine. The influences of pre-treatment to the sensitivity were analysed using the Mann-Whitney-U test for two independent groups. With fludarabine pre-treated patients had an significantly increased chemoresistance against fludarabine (2.4-fold; p=.004). The increase was also significant for bendamustin (4.4-fold), 2-CdA (3.4-fold), Gemcitabine (2.7-fold) and daunorubicin (1.5-fold). There was no significant influence observed onto the other drugs. Pre-treatment with vincristine or prednisone had no impact onto the chemosensitivity of any tested drug. INTERPRETATION AND CONCLUSIONS. The results of this study demonstrate the capability of fludarabine to increase the chemoresistance against various drugs in CLL. The use of fludarabine in primary therapy should be discussable. The fact that fludarabine induces higher response rates, without an improvement in overall survival, might be understandable if the fludarabine treatment induces a negative long-term effect. The widely increase of the chemoresistance is such a negative long-term effect. Based on the presented data, we postulate that fludarabine induces a so called secondary resistance by selecting leukemic cells with a lower chemosensitivity under treatment.

scholarly journals Robot-assisted minimally invasive thoracolaparoscopic esophagectomy versus open esophagectomy: long-term follow-up of a randomized clinical trial

2020 ◽  
Vol 33 (Supplement_2) ◽  
Author(s):  
Eline M de Groot ◽  
Sylvia van der Horst ◽  
B Feike Kingma ◽  
Lucas Goense ◽  
Pieter C van der Sluis ◽  
...  
Keyword(s):  
Overall Survival ◽  
Disease Free Survival ◽  
Rank Test ◽  
Robot Assisted ◽  
Short Term ◽  
Free Survival ◽  
Log Rank Test ◽  
Disease Free

ABSTRACT Initial results of the ROBOT, which randomized between robot-assisted minimally invasive esophagectomy (RAMIE) and open transthoracic esophagectomy (OTE), showed significantly better short-term postoperative outcomes in favor of RAMIE. However, it is not yet clarified if RAMIE is equivalent to OTE regarding long-term outcomes. The aim of this study was to report the long-term oncological results of the ROBOT trial in terms of survival and disease-free survival. This study is a follow-up study of the ROBOT trial, which was a randomized controlled trial comparing RAMIE to OTE in 112 patients with intrathoracic esophageal cancer. Both the trial protocol and short-term results were previously published. The primary outcome of the current study was 5-year overall survival. Secondary outcomes were disease-free survival and recurrence patterns. Analysis was by intention to treat. During the recruitment period, 109 patients were included in the survival analysis (RAMIE n = 54, OTE n = 55). Majority of patients had clinical stage III or IV (RAMIE 63%, OTE 55%) and received neoadjuvant chemoradiotherapy (80%). Median follow-up was 60 months (range 31–60). The combined 5-year overall survival rates for RAMIE and OTE were 41% (95% CI 27–55) and 40% (95% CI 26–53), respectively (log rank test P = 0.827). The 5-year disease-free survival rate was 42% (95% CI 28–55) in the RAMIE group and 43% (95% CI 29–57) in the OTE group (log rank test P = 0.749). Out of 104 patients, 57 (55%) developed recurrent disease detected at a median of 10 months (range 0–56) after surgery. No statistically difference in recurrence rate nor recurrence pattern was observed between both groups. Overall survival and disease-free survival of RAMIE are comparable to OTE. These results continue to support the use of robotic surgery for esophageal cancer.

scholarly journals Protocol for long-term effect of pulmonary rehabilitation under nintedanib in IPF

2021 ◽  
pp. 00321-2021
Author(s):  
Osamu Nishiyama ◽  
Kensuke Kataoka ◽  
Masahiko Ando ◽  
Shinichi Arizono ◽  
Akira Morino ◽  
...  
Keyword(s):  
Pulmonary Rehabilitation ◽  
Term Effect ◽  
Controlled Study ◽  
Control Group ◽  
Long Term Effects ◽  
Short Term ◽  
Open Label ◽  
Long Term Effect ◽  
Term Maintenance

BackgroundPulmonary rehabilitation (PR) causes short-term improvement in exercise capacity, dyspnea, and health-related quality of life in idiopathic pulmonary fibrosis (IPF); however, long-term maintenance of the improvement is difficult. Nintedanib, an antifibrotic drug, has been shown to delay the worsening of pulmonary function in IPF. Therefore, the concomitant use of nintedanib with PR is anticipated to contribute to the long-term maintenance of the PR effects. The long-term effect of PR under nintedanib treatment in IPF (FITNESS) study is a multicenter, randomised, prospective, parallel-group, open-label trial.MethodsThe study will enroll 82 patients with IPF who have been treated with nintedanib. Patients in the PR group will receive a programmed short-term induction PR program, followed by a maintenance home-based PR program, while patients in the control group will receive usual outpatient care. Patients in both groups will continue to receive nintedanib treatment throughout the study period. The primary endpoint of the study is to compare the change in the 6-min walk distance from the baseline to 12-months between the PR and control groups. The main secondary endpoint is endurance exercise time, measured using a bicycle ergometer.DiscussionFITNESS is the first randomised controlled study to evaluate the long-term effects of PR in IPF treated with nintedanib. This study will address the hypothesis that concomitant use of nintedanib contributes to the maintenance of long-term effects of PR, thus leading to a comprehensive therapeutic approach of “nintedanib and PR” in the antifibrotic era.

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