Intraductal Tetracycline Therapy for the Treatment of Chronic Recurrent Parotitis

1994 ◽  
Vol 73 (4) ◽  
pp. 262-274 ◽  
Author(s):  
Lcdr David M. Bowling ◽  
Steven D. Rauch ◽  
Max L. Goodman
Keyword(s):  
Radiation Therapy ◽  
High Risk ◽  
Success Rate ◽  
Acute Inflammation ◽  
Double Blind ◽  
Cytotoxic Effects ◽  
Therapeutic Implications ◽  
Duct Ligation ◽  
Chronic Recurrent Parotitis ◽  
Histologic Changes

Chronic recurrent parotitis (CRP) is recurrent parotid inflammation with non-obstructive sialectasis. Therapies which produce acinar atrophy or remove the acini are effective in treating CRP. Parotidectomy, tympanic neurectomy, duct ligation, and radiation therapy have either a low success rate or a high risk of morbidity. Intraductal antibiotic instillation has been proposed as a possible method of treatment. We hypothesized that the cytotoxic effects of tetracycline could produce acinar atrophy. A double-blind experiment of intraductal tetracycline instillation was performed in ten rabbits. Acinar atrophy and acute inflammation were found in 40% of the tetracycline treated glands; controls had a complete absence of these histologic changes. These results support the use of tetracycline instillation to produce acinar atrophy and therefore, intraductal tetracycline may be an effective, low-risk therapy for CRP. The clinical features of CRP will be reviewed and therapeutic implications discussed.

Phase III randomized trial of PSMA PET prior to definitive radiation therapy for unfavorable intermediate-risk or high-risk prostate cancer [PSMA dRT]: Study protocol NCT04457245.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. TPS172-TPS172
Author(s):  
Jeremie Calais ◽  
Shaojun Zhu ◽  
Nader Hirmas ◽  
Matthias Eiber ◽  
Boris A. Hadaschik ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Radiation Therapy ◽  
High Risk ◽  
Randomized Trial ◽  
Success Rate ◽  
Primary Endpoint ◽  
Intermediate Risk ◽  
Curative Intent ◽  
Psma Pet

TPS172 Background: Definitive radiation therapy (dRT) is an effective initial treatment of intermediate-risk (IR) and high-risk (HR) prostate cancer (PCa). Positron emission tomography (PET) using small molecule probes targeting prostate-specific membrane antigen (PSMA PET) is superior to standard of care imaging (CT, MRI, bone scan) for detecting regional and distant metastatic PCa. PSMA PET thus has the potential to guide primary radiotherapy planning in patients and improve outcomes. The purpose of the present randomized trial is to evaluate the success rate of dRT for IR or HR PCa with and without planning based on PSMA PET. Methods: We will randomize 312 patients to proceed with standard dRT (control Arm 1, n=150), or undergo a PSMA PET scan prior to dRT planning (intervention arm 2, n = 162). In the control arm, dRT will be performed as routinely planned in accordance with initial stratification. In the intervention arm, the treating radiation oncologist can incorporate PSMA PET findings into the RT planning. We assume that approximately 8% of subjects randomized to arm 2 will be found to have M1 disease and thus will be more appropriate candidates for long-term systemic or multimodal therapy, rather than curative intent dRT. PET M1 patients will thus not be included in the analysis of the primary endpoint. The primary endpoint is the success rate of dRT measured as PFS after initiation of dRT. Progression is defined as (whichever occurs first): biochemical recurrence defined as a rise by 2 ng/mL or more above the nadir PSA (defined as the lowest PSA achieved) after radiotherapy with or without short-term hormonal therapy; appearance of metastasis or loco-regional recurrence (diagnosed by any imaging or biopsy); initiation of any new salvage therapy, or death from any cause. Discussion: This is the first randomized phase 3 prospective trial designed to determine whether PSMA PET molecular imaging can improve outcomes in patients with PCa who receive dRT. In this trial the incorporation of PSMA PET may improve the success rate of curative intent radiotherapy in two ways: to optimize patient selection and to personalizes the radiotherapy plan. Clinical trial registration: IND#147591, UCLA IRB #20-000378, ClinicalTrials.gov Identifier NCT04457245. Clinical trial information: NCT04457245.

scholarly journals Atorvastatin is unlikely to prevent rheumatoid arthritis in high risk individuals: results from the prematurely stopped STAtins to Prevent Rheumatoid Arthritis (STAPRA) trial

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001591
Author(s):  
Laurette van Boheemen ◽  
Samina Turk ◽  
Marian van Beers-Tas ◽  
Wouter Bos ◽  
Diane Marsman ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
High Risk ◽  
Cox Regression ◽  
Controlled Trial ◽  
Pharmacological Intervention ◽  
Trial Participation ◽  
Double Blind ◽  
Cox Regression Analysis ◽  
Atorvastatin Group ◽  
Clinical Arthritis

ObjectivesPersons at high risk of rheumatoid arthritis (RA) might benefit from a low-risk pharmacological intervention aimed at primary prevention. Previous studies demonstrated disease-modifying effects of statins in patients with RA as well as an association between statin use and a decreased risk of RA development. A randomised, double-blind, placebo-controlled trial investigated whether atorvastatin could prevent arthritis development in high-risk individuals.MethodsArthralgia patients with anticitrullinated protein antibody (ACPA) >3 xULN or ACPA and rheumatoid factor, without (a history of) arthritis, were randomised to receive atorvastatin 40 mg daily or placebo for 3 years. The calculated sample size was 220 participants. The primary endpoint was clinical arthritis. Cox regression analysis was used to determine the effect of atorvastatin on arthritis development.ResultsDue to a low inclusion rate, mainly because of an unwillingness to participate, the trial was prematurely stopped. Data of the 62 randomised individuals were analysed. Median follow-up was 14 (inner quartiles 6–35) months. Fifteen individuals (24%) developed arthritis: 9/31 (29%) in the atorvastatin group; 6/31 (19%) in the placebo group: HR 1.40, 95% CI 0.50 to 3.95.ConclusionsIn this small set of randomised high-risk individuals, we did not demonstrate a protective effect of atorvastatin on arthritis development. The main reason for the low inclusion was unwillingness to participate; this may also impede other RA prevention trials. Further research to investigate and solve barriers for prevention trial participation is needed.

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