scholarly journals Effect of pulsed intravenous methylprednisolone with alternative low-dose prednisone on high-risk IgA nephropathy: a 18-month prospective clinical trial

2022 ◽  
Vol 12 (1) ◽  
Author(s):  
Yan Li ◽  
Rongguo Fu ◽  
Jie Gao ◽  
Li Wang ◽  
Zhaoyang Duan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Low Dose ◽  
Cushing Syndrome ◽  
Oral Prednisone ◽  
Immunoglobulin A ◽  
Intravenous Methylprednisolone ◽  
Clinical Trial Registry ◽  
Favorable Safety ◽  
Dose Prednisone

AbstractFull-dose prednisone (FP) regimen in the treatment of high-risk immunoglobulin A nephropathy (IgAN) patients, is still controversial. The pulsed intravenous methylprednisolone combined with alternative low-dose prednisone (MCALP) might have a more favorable safety profile, which has not been fully investigated. Eighty-seven biopsy-proven IgAN adult patients and proteinuria between 1 and 3.5 g/24 h after ACEI/ARB for at least 90 days were randomly assigned to 6-month therapy: (1) MCALP group: 0.5 g of methylprednisolone intravenously for three consecutive days at the beginning of the course and 3rd month respectively, oral prednisone at a dose of 15 mg every other day for 6 months. (2) FP group: 0.8–1.0 mg/kg/days of prednisone (maximum 70 mg/day) for 2 months, then tapered by 5 mg every 10 days for the next 4 months. All patients were followed up for another 12 months. The primary outcome was complete remission (CR) of proteinuria at 12 months. The percentage of CR at 12th and 18th month were similar in the MCALP and FP groups (51% vs 58%, P = 0.490, at 12th month; 60% vs 56%, P = 0.714, at 18th month). The cumulative dosages of glucocorticoid were less in the MCALP group than FP group (4.31 ± 0.26 g vs 7.34 ± 1.21 g, P < 0.001). The analysis of the correlation between kidney biopsy Oxford MEST-C scores with clinical outcomes indicated the percentages of total remission was similar between two groups with or without M1, E1, S1, T1/T2, and C1/C2. More patients in the FP group presented infections (8% in MCALP vs 21% in FP), weight gain (4% in MCALP vs 19% in FP) and Cushing syndrome (3% in MCALP vs 18% in FP). These data indicated that MCALP maybe one of the choices for IgAN patients with a high risk for progression into ESKD.Trial registration: The study approved by the Chinese Clinical Trial Registry (registration date 13/01/2018, approval number ChiCTR1800014442, https://www.chictr.org.cn/).

scholarly journals Low-dose warfarin in high-risk pregnant patients with mechanical valves: A randomized clinical trial

2014 ◽  
Vol 66 (1) ◽  
pp. 14
Author(s):  
Ahmed Hassouna ◽  
Ayman Ammar ◽  
Yasser Elnahas ◽  
Ahmed Toema ◽  
Hemat Allam
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Randomized Clinical Trial ◽  
Low Dose ◽  
Mechanical Valves ◽  
Dose Warfarin

scholarly journals Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Yongliang Feng ◽  
Jing Chen ◽  
Tian Yao ◽  
Yue Chang ◽  
Xiaoqing Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Neutralizing Antibodies ◽  
Health Care Systems ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Neutralizing Antibody ◽  
Shanxi Province ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have a substantial burden on health-care systems around the world. This is a randomized parallel controlled trial for assessment of the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, aiming to determine an appropriate vaccination interval of the vaccine for high-risk occupational population. Methods In an ongoing randomized, parallel, controlled phase IV trial between January and May 2021 in Taiyuan City, Shanxi Province, China, we randomly assigned the airport ground staff and public security officers aged 18 to 59 years to receive two doses of inactivated SARS-CoV-2 vaccine at 14 days, 21 days, or 28 days. The serum neutralizing antibody to live SARS-CoV-2 was performed at baseline and 28 days after immunization. Long-term data are being collected. The primary immunogenicity endpoints were neutralization antibody seroconversion and geometric mean titer (GMT) at 28 days after the second dose. Analysis of variance (ANOVA), chi-square, and logistic regression analysis were used for data analysis. Results A total of 809 participants underwent randomization and received two doses of injections: 270, 270, 269 in the 0–14, 0–21, and 0–28 vaccination group, respectively. By day 28 after the second injection, SARS-CoV-2 neutralizing antibody of GMT was 98.4 (95% CI: 88.4–108.4) in the 0–14 group, which was significantly lower compared with 134.4 (95% CI: 123.1–145.7) in the 0–21 group (P < 0.001 vs 0–14 group) and 145.5 (95% CI: 131.3–159.6) in the 0–28 group (P < 0.001 vs 0–14 group), resulting in the seroconversion rates to neutralizing antibodies (GMT ≥ 16) of 100.0% for all three groups, respectively. The intention-to-treat (ITT) analysis yielded similar results. All reported adverse reactions were mild. Conclusions Both a two-dose of inactivated SARS-CoV-2 vaccine at 0–21 days and 0–28 days regimens significantly improved SARS-CoV-2 neutralizing antibody level compared to the 0–14 days regimen in high-risk occupational population, with seroconversion rates of 100.0%. Trial registration Chinese Clinical Trial Registry, ChiCTR2100041705, ChiCTR2100041706. Registered 1 January 2021, www.chictr.org.cn. Graphical Abstract

Low-Dose Prednisone Decreases the Severity but Not the Frequency of Lenalidomide Associated Tumor Flare Feaction (TFR) in Chronic Lymphocytic Leukemia (CLL) Patients.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4987-4987
Author(s):  
Laurie Musial ◽  
Kena C. Miller ◽  
Amy Tonelli ◽  
Rami Manochakian ◽  
Swaminathan Padmanabhan ◽  
...  
Keyword(s):  
Low Dose ◽  
Oral Prednisone ◽  
Single Agent ◽  
Lymphocytic Leukemia ◽  
Common Side Effect ◽  
Low Grade ◽  
Group A ◽  
Considerable Morbidity ◽  
Group B ◽  
Dose Prednisone

Abstract Introduction: Lenalidomide (L) is clinically active in pts with CLL. TFR is a common side effect of L, unique to CLL pts and is characterized by tender enlargement of lymph nodes (LN), spleen and/or liver with low-grade fever, rash and/or increase in white blood cell count. Onset is usually with 24 hours of first dose and it is rarely seen after the 1st cycle. The underlying etiology of TFR remains undetermined though clinical presentation is suggestive of an immune activation phenomenon. Diagnosis, management and effective prophylaxis of TFR is crucial for the pt care as it is associated with considerable morbidity and mimics disease progression. We investigated the effectiveness of low-dose prednisone prophylaxis in CLL pts treated with L. Method & Results: Forty five pts (36 male, 9 female), median age 64 years (range 42–75) with rel/ref CLL were enrolled on a phase II clinical trial. Single agent L (max. dose 25mg/day) was given to all pts enrolled. No prophylaxis was given to the first 29 pts (group A). Subsequently 16 pts (group B) were treated with prednisone 20mg PO QD × 5 days followed by 10mg PO QD × 5 days, starting day 1 of treatment. Median age was 64 years (range 42–75) with 36M and 9F. Stage III/IV disease was noted in 64% (n=18) of the pts. Twenty four (83%) pts in group A and 13 (81%) in group B developed TFR with &gt; grade II TFR was seen in 31% and 6%, respectively. Among pts with TFR, 4 achieved complete remission (CR) and had grade &gt; 2 reaction vs. 19 pts with a &lt; partial remission who had a median of grade 1 (range 1–2) TFR. Conclusion: Although the sample size investigated is small, we observed that use of oral prednisone prophylaxis decreased the severity but not the overall incidence of TFR. We therefore recommend that low-dose prednisone be considered for lenalidomide associated TFR in patients with CLL.

Corticosteroids in the Treatment of Acute Optic Neuritis

2020 ◽  
pp. 285-290
Author(s):  
Alan D. Penman ◽  
Kimberly W. Crowder ◽  
William M. Watkins
Keyword(s):  
Clinical Trial ◽  
Optic Neuritis ◽  
Visual Loss ◽  
Oral Prednisone ◽  
Visual Outcome ◽  
Controlled Clinical Trial ◽  
Treatment Trial ◽  
Intravenous Methylprednisolone ◽  
Acute Optic Neuritis ◽  
Optic Neuritis Treatment Trial

The Optic Neuritis Treatment Trial (ONTT) was a randomized, placebo-controlled, clinical trial in patients with a history consistent with acute unilateral optic neuritis to determine whether treatment with either oral prednisone or intravenous methylprednisolone speeded the recovery of vision and improve visual outcome. The study found that intravenous methylprednisolone (started within eight days of symptom onset) followed by oral prednisone speeded the recovery of visual loss due to optic neuritis and resulted in slightly better vision at six months. Oral prednisone alone, however, was an ineffective treatment and may increase the risk of new episodes of optic neuritis.

INNOVA: Interval or neoadjuvant chemotherapy in rectal cancer—A phase II randomized study comparing interval versus neoadjuvant chemotherapy in magnetic resonance imaging-defined high-risk rectal cancer.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 91-91
Author(s):  
Ramakrishnan Ayloor Seshadri ◽  
Trivadi S. Ganesan ◽  
Manikandan Dhanushkodi ◽  
Arunkumar M N ◽  
Shirley Sundersingh
Keyword(s):  
Clinical Trial ◽  
Rectal Cancer ◽  
High Risk ◽  
Neoadjuvant Chemotherapy ◽  
Randomized Study ◽  
Neoadjuvant Treatment ◽  
Complete Response ◽  
Phase Iii ◽  
Clinical Trial Registry ◽  
Grade 3

91 Background: Total neoadjuvant treatment is a promising option in rectal cancer. We aim to compare neoadjuvant versus interval chemotherapy in high risk rectal cancer to identify the optimal sequencing of treatment. Methods: Using a Simon two-stage design, newly diagnosed MRI defined high risk rectal cancer patients were randomly assigned in a 1:1 ratio to receive three 21 day cycles of chemotherapy with Capecitabine 1000 mg/m2 and Oxaliplatin 130 mg/m2 either before (Arm A-neoadjuvant) or after (Arm B-interval) chemoradiation followed by surgery. Primary end point was the pathological complete response (pCR) following surgery. A heirarchial model was used to assess the primary and secondary end points (toxicity and compliance) and compare the two regimens. (Clinical Trial Registry of India No. CTRI/2015/01/005385). Results: In this single centre study conducted between November 2015 and February 2020, 42 patients were randomised in the first stage. A pCR was seen in 4 patients in Arm A and 6 in Arm B. Hence another 52 patients were randomised in the second stage of which an additional 3 and 2 patients had a pCR leading to an overall pCR of 7 and 8 patients (15.5% vs 17% and 18.4% vs 19.5% in the intent-to-treat and per-protocol populations in Arm A and B respectively. This exceeded the minimum predetermined number of 5 pCR needed to qualify for further evaluation for each arm. Grade ≥3 toxicity was observed in 2.2% of 132 cycles and 4.6% of 129 cycles of chemotherapy delivered in 45 and 43 patients in Arm A and B respectively while 11/43 (25.5%) and 10/47 (21.2%) patients experienced grade ≥3 toxicity during chemoradiation. Treatment break of > 7 days was seen in 23.2% and 29.7% of patients in Arm A and B respectively while 93.3% in Arm A and 100% of patients in Arm B completed all 3 planned cycles of pre-operative chemotherapy. A non-significant trend towards greater pathological downstaging was seen in Arm B than in Arm A (ypT1-2 39% vs 26.3%; p = 0.1 and ypN0 68.3% vs 57.9%; p = 0.5 respectively). Conclusions: In this phase two study, both neoadjuvant and interval chemotherapy emerged eligible for further evaluation against the standard of care in a future phase III study. Although we could not pick one winner based on pCR, toxicity or compliance, the greater downstaging observed with interval chemotherapy suggests it could play a greater role in an organ preservation approach. Clinical trial information:CTRI/2015/01/005385, UTN no: U111111650578.

scholarly journals Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2)

2012 ◽  
Vol 72 (2) ◽  
pp. 204-210 ◽  
Author(s):  
Frank Buttgereit ◽  
Daksha Mehta ◽  
John Kirwan ◽  
Jacek Szechinski ◽  
Maarten Boers ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Low Dose ◽  
Randomised Clinical Trial ◽  
Dose Prednisone

scholarly journals Low-Dose Prednisone Treatment for IVIG-Resistant Kawasaki Disease with Severe Arthritis and Joint Effusion in Two 3-Year-Old Children

2021 ◽  
Vol 2021 ◽  
pp. 1-5
Author(s):  
Lingling Fan ◽  
Huimin Lv ◽  
Shujuan Jiang ◽  
Daogang Qin
Keyword(s):  
Kawasaki Disease ◽  
Joint Pain ◽  
Low Dose ◽  
Oral Prednisone ◽  
Joint Effusion ◽  
Severe Arthritis ◽  
Dose Oral ◽  
Magnetic Resonance Imaging Mri ◽  
Dose Prednisone ◽  
Ivig Administration

Kawasaki disease (KD) is a global disease in children. The etiology and pathogenesis are unknown. Complications vary among patients. Fever can persist in some after immune globulin (IVIG) administration, termed IVIG-resistant KD. Here, we report two cases of IVIG-resistant KD with severe arthritis. The diagnosis of arthritis was confirmed by magnetic resonance imaging (MRI) showing joint effusion. Remarkably, fever and joint pain had not receded after the second dose of IVIG. To further manage the symptoms, we prescribed low-dose oral prednisone with success. Both fever and joint pain were diminished. We ponder that the low-dose prednisone might be an option to treat IVIG-resistant KD with severe arthritis.

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