scholarly journals ArthroRad trial: multicentric prospective and randomized single-blinded trial on the effect of low-dose radiotherapy for painful osteoarthritis depending on the dose—results after 3 months’ follow-up

2021 ◽  
Author(s):  
Marcus Niewald ◽  
Lara Natalie Müller ◽  
Matthias G. Hautmann ◽  
Yvonne Dzierma ◽  
Patrick Melchior ◽  
...  
Keyword(s):  
Pain Relief ◽  
Total Dose ◽  
Low Dose ◽  
Short Form ◽  
Standard Dose ◽  
Vascular Diseases ◽  
Low Doses ◽  
Conventional Dose ◽  
Low Dose Radiotherapy ◽  
Significant Difference

Abstract Purpose Randomized comparison of the effect of radiotherapy on painful osteoarthritis (OA) applying a standard-dose vs. a very-low-dose regime Patients and methods Patients with OA of the hand and knee joints were included. Further inclusion criteria: symptoms for more than 3 months, favorable general health status, age above 40 years. Patients with prior local radiotherapy, trauma, rheumatoid arthritis, or vascular diseases were excluded. After randomization (every joint was randomized separately), the following protocols were applied: standard arm: total dose 3.0 Gy, single fractions of 0.5 Gy twice weekly; experimental arm: total dose 0.3 Gy, single fractions of 0.05 Gy twice weekly. The dosage was not known to the patients. The patients were examined 3 and 12 months after radiotherapy. Scores like VAS (visual analogue scale), KOOS-SF (the knee injugy and osteoarthritis outcome score), SF-SACRAH (short form score for the assessment and quantification of chronic rheumatic affections of the hands), and SF-12 (short form 12) were used. Results A total of 64 knees and 172 hands were randomized. 3.0 Gy was applied to 87 hands and 34 knees, 0.3 Gy was given to 85 hands and 30 knees. After 3 months, we observed good pain relief after 3 Gy and after 0.3 Gy, there was no statistically significant difference. Side effects were not recorded. The trial was closed prematurely due to slow recruitment. Conclusion We found favorable pain relief and a limited response in the functional and quality of life scores in both arms. The effect of low doses such as 0.3 Gy on pain is widely unknown. Further trials are necessary to compare a conventional dose to placebo and to further explore the effect of low doses on inflammatory disorders.

Comparative Analysis on Low- and Standard-Dose Regimes of Alteplase Thrombolytic Therapy for Acute Ischemic Stroke: Efficacy and Safety

2017 ◽  
Vol 79 (1-2) ◽  
pp. 68-73 ◽  
Author(s):  
Guangjian Zhao ◽  
Tingfen Huang ◽  
Mei Zheng ◽  
Yansen Cui ◽  
Yunyong Liu ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Thrombolytic Therapy ◽  
Acute Ischemic Stroke ◽  
Dose Group ◽  
Low Dose ◽  
Standard Dose ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Symptomatic Intracranial Hemorrhage ◽  
Intravenous Alteplase

Objective: This study analyzed the efficacy and safety of low-dose and standard-dose alteplase intravenous thrombolytic therapy for acute ischemic stroke (AIS). Methods: Patients with AIS who underwent intravenous alteplase thrombolysis from July 2012 to December 2016 were retrospectively analyzed and correspondingly divided into low-dose (0.6–0.89 mg/kg) group and standard-dose group (0.9 mg/kg) according to alteplase dosage. The clinical outcome was evaluated by modified Rankin Scale (mRS) at 90 days after onset. The safety index was the mortality at 90 days after onset and the incidence of symptomatic intracranial hemorrhage (SICH) within 7 days. Results: A total of 1,486 patients were included (1,115 cases in low-dose group and 371 cases in standard-dose group). There were no significant differences in baseline data between the 2 groups. As mRS, good outcome rate as well as mortality rate in both groups had no significant difference (36.1 vs. 37.6%; χ2 = 10.882, p = 0.890; 5.5 vs. 7.3%; χ2 = 2.163, p = 0.076), but the incidence of SICH in low-dose group was significantly lower than that of the standard-dose group (2.2 vs. 5.9%; χ2 = 3.157, p = 0.001). Conclusion: The efficacy of low-dose alteplase intravenous thrombolytic therapy for AIS was equivalent to the standard-dose regimen but with higher safety.

Preservation of Cheese and Plain Yogurt by Low-dose Irradiation

1980 ◽  
Vol 43 (2) ◽  
pp. 114-118 ◽  
Author(s):  
S. YÜCEER ◽  
G. GÜNDÜZ
Keyword(s):  
Side Effects ◽  
Shelf Life ◽  
Total Dose ◽  
Room Temperature ◽  
Low Dose ◽  
Sorbic Acid ◽  
Low Doses ◽  
Dose Irradiation ◽  
Refrigerator Temperature ◽  
Number Of Bacteria

Irradiation preservation of Turkish kashar cheese and plain yogurt was studied using very low doses of Co-60 radiation. No side effects were observed below 0.15 Mrad. The number of bacteria killed was directly related to total dose up to 0.02 Mrad, then the effectiveness of the dose decreased. Coating cheese samples with a sorbic acid solution helped in reducing the number of bacteria by about 10–12% in irradiated samples. The shelf-life of irradiated samples stored at refrigerator temperature was almost the same as that of ones coated with sorbic acid but stored at room temperature. Mold formation in irradiated samples took three to four times longer than in nonirradiated ones. With plain yogurt the effect of total dose seemed to be the same as in cheese. Irradiation increased the shelf-life of yogurt three- to four-fold. Preservation by irradiation combined with refrigeration increased the shelf-life about five-fold.

scholarly journals Effect of low-dose lidocaine on objective upper extremity strength and immediate pain relief following cervical interlaminar epidural injections: a double-blinded randomized controlled trial

2020 ◽  
Vol 45 (10) ◽  
pp. 767-773
Author(s):  
Zachary L. McCormick ◽  
Taylor Burnham ◽  
Shellie Cunningham ◽  
Richard W Kendall ◽  
David Bougie ◽  
...  
Keyword(s):  
Pain Relief ◽  
Upper Extremity ◽  
Low Dose ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Radicular Pain ◽  
Spinal Block ◽  
Epidural Injections ◽  
Significant Difference ◽  
Double Blinded

BackgroundLow-dose lidocaine is a common diluent for analgesia following cervical interlaminar epidural steroid injection (CIESI). Concerns with this practice exist. A single-arm cohort reported that 20% of patients develop postprocedural upper extremity weakness when using lidocaine as a diluent. Furthermore, a high-cervical spinal block with unintended intrathecal or subdural administration is possible.ObjectiveDetermine if low-dose lidocaine as a diluent during CIESI causes clinically meaningful (1) upper extremity weakness and (2) immediate pain relief when compared with saline.DesignDouble-blinded randomized control trial.MethodsPatients with cervical radicular pain scheduled for CIESI were enrolled. Participants received lidocaine (CIESI-L) or saline (CIESI-S) as a diluent for the epidural injectate. Myotomal strength was measured with dynamometry before and between 20 and 30 min after CIESI. Pre-pain and post-pain scores were obtained. Primary and secondary outcomes were post-CIESI weakness of ≥20% (minimal clinically important difference (MCID)) in >1 myotome and ≥50% pain reduction on the numerical scale.Results120 participants (64 females (53%), mean age, 56 (SD 13.7) years) completed the study and were analyzed (CIESI-L n=60; CIESI-S n=60). There was no significant between-group difference in the proportion of participants with postprocedural weakness, CIESI-L 41.7% (95% CI, 29.8% to 54.5%), CIESL-S 50% (95% CI, 37.5% to 62.5%). Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).ConclusionLow-dose lidocaine as a diluent in CIESI does not significantly increase the risk of post-CIESI myotomal weakness when compared with saline, but also does not substantially increase the likelihood of immediate, meaningful pain relief.Trial registration detailsClinicalTrials.gov (NCT03127137); December 26, 2017.

BuCy Provides Equivalent Outcomes to VCyTBI as Conditioning Prior to Auto-SCT in Patients with Relapsed/Refractory NHL and Is a Valuable Option in Older (≥60 years) Patients.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2176-2176
Author(s):  
Shannon L Smiley ◽  
Theresa Hahn ◽  
Wei Tan ◽  
Gregory Wilding ◽  
Minoo Battiwalla ◽  
...  
Keyword(s):  
Stem Cells ◽  
Total Dose ◽  
Disease Risk ◽  
Standard Dose ◽  
Intensive Therapy ◽  
Conditioning Regimen ◽  
Progression Free Survival ◽  
Eligibility Criteria ◽  
Peripheral Blood Stem Cells ◽  
Significant Difference

Abstract Cyclophosphamide+total body irradiation +/− etoposide (CyTBI+/−V) is a standard conditioning regimen prior to auto-SCT for NHL patients. However, TBI-based dose intensive therapy is often contraindicated in older patients, or those with prior radiation. We performed a single-institution Phase II non-randomized prospective study of VCyTBI vs. Busulfan+Cy (BuCy) to determine if BuCy provides comparable disease control to standard dose intensive therapy with VCyTBI. BuCy was used in patients ≥60 years and when TBI was contraindicated. Seventy-five relapsed or refractory NHL patients underwent auto-SCT at Roswell Park Cancer Institute from 8/92 to 7/05. All patients were treated on a single IRB-approved protocol with standard eligibility criteria including age ≥18 and ≤70, adequate cardiac, pulmonary, hepatic and renal function and KPS ≥70. All patients signed informed consent and were followed prospectively. All data have been de-identified. Survival status for all patients was updated through 8/1/08. VCyTBI (N=47) consisted of V 1800 mg/m2 26-hour continuous iv infusion on day -5, Cy 60 mg/kg day -4 (12 patients received 180 mg/kg total dose), and TBI 200 cGy on days -3, -2, and -1 for total dose of 1000 cGy (8 patients received 1200 cGy). BuCy (N=28) consisted of iv Bu 0.8 mg/kg every 6 hours on days -7, -6, -5, -4 (total 12.8mg, one patient received oral Bu total dose 16 mg/kg) and Cy 60 mg/kg on days -3 and -2 (total 120 mg/kg, one patient received total dose 200 mg/kg). Eight patients received iv Bu without dose adjustment and 19 received iv Bu with dose adjusted to maintain a steady state level between 600– 900 ng/ml. Stem cells were re-infused on day 0. Patients received peripheral blood stem cells (n=53), bone marrow (n=14) or both (n=8). The median age was significantly higher in the BuCy compared to the VCyTBI group (61.5 vs 53 years, p=0.0002), and there were fewer patients with a KPS of 90–100 in the VCyTBI group (75% vs 93%, p=0.07). There were no significant differences on the following patient characteristics by BuCy vs VCyTBI: gender, disease risk, stem cell source, histology (diffuse, follicular, mantle, other), or remission status at SCT. Treatment-related mortality at day+100 post-auto SCT was very low in both groups: 0% in BuCy and 2% in VCyTBI. However, 3 patients in the VCyTBI group and none in the BuCy group developed AML at 1.3, 1.8 and 6.5 years post-auto-SCT. At a median follow-up of 4.6 years, the 5-year progression-free survival for BuCy and VCyTBI was 32% (95% CI 14–50%) and 24% (95% CI, 11–39%, P>0.8), respectively. The 5-year overall survival for BuCy and VCyTBI was 46% (95% CI 25– 64%) and 49% (95% CI 33–64%, P>0.7), respectively. Multivariate analysis controlling for age and KPS at BMT also demonstrated no significant difference between BuCy and VCyTBI for either progression-free (RR=0.9, 95% CI 0.5–1.8) or overall (RR=0.7, 95% CI 0.3–1.6) survival. This is the largest reported study evaluating the efficacy of BuCy as alternative conditioning for auto-SCT in relapsed/refractory NHL. BuCy provides equivalent survival outcomes to VCyTBI as conditioning for auto-SCT in NHL patients. Based on these results, our practice continues to use BuCy for NHL patients ≥60 years.

scholarly journals Ultra-Low-Dose Radiotherapy for Palliation of Mycosis Fungoides

2020 ◽  
Vol 2020 ◽  
pp. 1-4
Author(s):  
İpek Pınar Aral ◽  
Neşe Göçer Gürok ◽  
Aykut Oğuz Konuk ◽  
Özlem Üçer
Keyword(s):  
Case Report ◽  
T Cell ◽  
Total Dose ◽  
Mycosis Fungoides ◽  
Outpatient Clinic ◽  
Low Dose ◽  
Systemic Treatment ◽  
Multiorgan Failure ◽  
T Cell Lymphomas ◽  
Low Dose Radiotherapy

Introduction. Mycosis fungoides (MF) is a form of primary cutaneous T-cell lymphomas, and radiotherapy (RT) has been used to treat localized/limited lesions of MF. In this case report, the results of low-dose RT applied for palliative purpose are shared. Case Report. A 70-year-old male patient was admitted to the outpatient clinic 7 months ago with a generalized itchy rash. The result of the biopsy was reported as mycosis fungoides. Systemic treatment was not performed due to comorbid diseases. The hemibody RT was applied. 2 Gy was given per fraction, with a total dose of 6 Gy. The significant clinical relief was observed with 6 Gy RT. The patient died due to multiorgan failure 2 months later, and no recurrence was observed. Conclusion. The palliation was achieved in the advanced MF patient with fractionated 6 Gy hemibody RT for the remaining 2 months of life.

Randomised, placebo-controlled, trial comparing low dose versus standard dose Lenograstim (L) following myeloablative chemotherapy (HDT) and peripheral blood progenitor cell rescue (PBPCR) for lymphoma

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7624-7624
Author(s):  
L. Nolan ◽  
S. Chilton ◽  
P. Lorigan ◽  
R. Else ◽  
P. Smith ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Peripheral Blood ◽  
Low Dose ◽  
Standard Dose ◽  
Controlled Trial ◽  
White Cell Count ◽  
N Recovery ◽  
Antibacterial Prophylaxis ◽  
Normal Peripheral Blood ◽  
Significant Difference

7624 Background: This trial was performed to determine whether low-dose or standard dose L would influence recovery of haematopoiesis following HDT and PBPCR. Methods: 61 patients (pts) with non-Hodgkin lymphoma (40) or Hodgkin’s disease (21) undergoing HDT were randomised. Pts had normal peripheral blood counts prior to HDT (Hb ≥100g/L, total white cell count ≥ 3.0, neutrophils (N) ≥ 1.0 and platelets ≥ 50, and had a minimum 2.5 million CD34+ cells/kg PBPC previously collected following mobilisation with Cyclophosphamide 3g/m2 and G-CSF. All received HDT with BCNU 300mg/m2 d-7, Etoposide 200mg/m2 od d-5-d-2, Cytosine arabinoside 200mg/m2 bd d-5-d-2 and Melphalan 140mg/m2 d-1 before return of PBPC on D0. Pts were allocated standard dose L 263mcg daily (20 pts), low dose L 105mcg daily (21 pts) or placebo injections (20 pts). These commenced on day +5 following PBPCR and continued until N≥0.5. Pts received standard supportive care including prophylactic Fluconazole and Acyclovir, but not routine antibacterial prophylaxis, until haemopoietic recovery. Results: L at any dose resulted in a significantly shorter median time to N recovery ≥0.1 (10.0 vs 11.0 days, P=0.02) and ≥0.5 (11.0 vs 14.0 days, p=0.0003) compared to placebo. The only significant difference between standard- and low-dose L was in hospital stay (21.0 vs 22.0 days, p=0.04), however L at any dose showed a significant reduction over placebo (22.0 vs 23.0 days, p=0.01). Conclusions: Short course low dose L is as effective as standard dose in reducing neutrophil engraftment time following HDT and PBSCR. L at any dose reduces hospital stay when compared to placebo. This approach should be considered for those patients in whom growth factor support is indicated. Long-term follow-up data will be presented. [Table: see text] No significant financial relationships to disclose.

Are low doses of non-vitamin K antagonists effective in Chinese patients with atrial fibrillation? A report from the Optimal Thromboprophylaxis in Elderly Chinese Patients with Atrial Fibrillation (ChiOTEAF) registry

2021 ◽  
pp. 174749302110531
Author(s):  
Agnieszka Kotalczyk ◽  
Yutao Guo ◽  
Yutang Wang ◽  
Gregory YH Lip ◽  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Low Dose ◽  
Standard Dose ◽  
Vitamin K Antagonists ◽  
Chinese Patients ◽  
Low Doses ◽  
Composite Outcome ◽  
Elderly Chinese ◽  
Anticoagulated Patients

Background Suboptimal low dosages of non-vitamin K antagonist oral anticoagulants (NOACs) are often inappropriately used due to a fear of bleeding, particularly among elderly patients. Such practice is common in Asia, and we aimed to evaluate the use of low-dose NOACs and their impact on clinical outcomes among Chinese patients with atrial fibrillation. Methods The Optimal Thromboprophylaxis in Elderly Chinese Patients with Atrial Fibrillation (ChiOTEAF) registry was a prospective, multicenter study conducted in China from October 2014 to December 2018. For this report, we included NOAC-treated patients with available data on NOAC dosage and one-year follow-up. Logistic regression analysis assessed the association (adjusted for age, sex, prior ischemic stroke, prior major bleeding, heart failure, coronary artery disease, hypertension, diabetes mellitus, chronic kidney disease, liver disease, current anemia) between the low doses and study outcomes among NOAC-treated patients, as well as comparisons with non-anticoagulated patients. Results The eligible cohort included 1310 NOAC-treated patients (mean age of 72.1 ± 10.9; 38.9% female), of whom 341 (26.0%) received a low “off-label” dose. The use of low-dose NOACs was independently associated with higher odds of the composite outcome (OR: 2.51; 95% CI: 1.11–5.71) and thromboembolism (OR: 4.73; 95% CI: 1.11–20.01). Compared with non-anticoagulated patients, lower rates of the composite outcome (7.3% vs. 11.3%; p = 0.025) and all-cause death (5.3% vs. 9.7%; p = 0.007) were seen in the low-dose group (ORs 0.50; 95% CI: 0.32–0.78, and 0.42; 95% CI: 0.26–0.70, respectively). Conclusions Low doses of NOACs should not be recommended as a part of standard therapy among Chinese patients with atrial fibrillation as their use was associated with a higher odds ratio of the composite outcome and thromboembolic events compared with standard dose NOAC regimens. Compared to non-treatment, the use of low-dose NOAC may result in a survival benefit (but not thromboembolic reduction) among high-risk patients.

scholarly journals Characteristics, management and response to alteplase in China versus non-China participants of the ENCHANTED trial

2017 ◽  
Vol 2 (2) ◽  
pp. 53-58 ◽  
Author(s):  
Lily Song ◽  
Xia Wang ◽  
Thompson Robinson ◽  
Richard I Lindley ◽  
Hisatomi Arima ◽  
...  
Keyword(s):  
Low Dose ◽  
Standard Dose ◽  
Artery Occlusion ◽  
Lipid Lowering ◽  
Large Artery ◽  
Stroke Study ◽  
Significant Difference ◽  
Scale Scores ◽  
Management Factors ◽  
Artery Disease

BackgroundThe characteristics of patients with acute ischaemic stroke (AIS) and their management vary across regions, which may influence outcomes. We examined for differential patterns of outcome between China and non-China participants of the ENhanced Control of Hypertension And Thrombolysis strokE stuDy (ENCHANTED), which tested different alteplase doses in AIS.MethodsENCHANTED was an international, multicentre, open, blinded-endpoint trial of the effects of low-dose (0.6 mg/kg) versus standard-dose (0.9 mg/kg) intravenous alteplase on 90-day disability outcomes and symptomatic intracerebral haemorrhage (sICH) in 3310 patients with AIS.ResultsParticipants (n=1419, 48%) in China were younger, and more often male, hypertensive and with prior stroke and coronary artery disease, but less likely to have atrial fibrillation and use antihypertensive, antithrombotic and lipid-lowering agents, compared with non-China patients with AIS. Although China participants had more AIS due to large artery occlusion, were treated later and had differing ancillary management, there was no significant difference in 90-day modified Rankin scale scores 2–6 (55.6% vs 47.8%; OR, adjusted for baseline and management factors 0.87 (95% CI 0.71 to 1.07; p=0.20)) and risk of sICH (Safe Implementation of Thrombolysis in Stroke-Monitoring Study criteria: 1.4% vs 1.8%; p=0.12) compared with non-China participants. There was no heterogeneity in the treatment effects of low-dose versus standard-dose alteplase between China and non-China participants.ConclusionPatients with AIS recruited to the ENCHANTED trial in China had similar outcomes in response to thrombolysis treatment despite significantly differing demographic, clinical and management factors to patients with AIS in other regions.

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