scholarly journals Treatment of mild to moderate Graves' ophthalmopathy with sodium diclofenac: a pilot study

2011 ◽  
Vol 55 (9) ◽  
pp. 692-695 ◽  
Author(s):  
Walter Bloise ◽  
Lidia Yuri Mimura ◽  
Janete Moura ◽  
Wilian Nicolau
Keyword(s):  
Therapeutic Option ◽  
Ppar Gamma ◽  
Controlled Study ◽  
Clinical Activity ◽  
Ocular Pain ◽  
Sodium Diclofenac ◽  
Graves Ophthalmopathy ◽  
Number Of Patients ◽  
New Treatment ◽  
Oral Sodium

OBJECTIVE: To report the use of sodium diclofenac, an antagonist of PPAR-gamma and cyclooxigenase-2 (COX-2) inhibitor in the treatment of mild to moderate Graves' ophthalmopathy. SUBJECTS AND METHODS: Thirteen patients with clinical activity score (CAS) 2 to 7 were treated during a period ranging from 3 to 12 months (mean 7.8 ± 3.4) with oral sodium diclofenac, 50 mg every 12 hours. RESULTS: Extra-ocular muscle restriction and CAS improved significantly, p = 0.003 and = 0.004, respectively. Ocular pain and diplopia disappeared, except for one patient who reported improvement of these symptoms. No recurrence was found after interruption of treatment. CONCLUSIONS: Treatment of moderate Graves' ophthalmopathy with oral sodium diclofenac is a good, safe and less expensive therapeutic option. Like others new treatment trials, findings must be confirmed in a greater number of patients in a controlled study.

scholarly journals Clinical Trials of Oncolytic Viruses in Breast Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Mary E. Carter ◽  
André Koch ◽  
Ulrich M. Lauer ◽  
Andreas D. Hartkopf
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Neutralizing Antibodies ◽  
Viral Gene Expression ◽  
Oncolytic Viruses ◽  
Viral Gene ◽  
Clinical Activity ◽  
Routes Of Administration ◽  
Number Of Patients ◽  
New Treatment

Breast cancer is the second most common kind of cancer worldwide and oncolytic viruses may offer a new treatment approach. There are three different types of oncolytic viruses used in clinical trials; (i) oncolytic viruses with natural anti-neoplastic properties; (ii) oncolytic viruses designed for tumor-selective replication; (iii) oncolytic viruses modified to activate the immune system. Currently, fourteen different oncolytic viruses have been investigated in eighteen published clinical trials. These trials demonstrate that oncolytic viruses are well tolerated and safe for use in patients and display clinical activity. However, these trials mainly studied a small number of patients with different advanced tumors including some with breast cancer. Future trials should focus on breast cancer and investigate optimal routes of administration, occurrence of neutralizing antibodies, viral gene expression, combinations with other antineoplastic therapies, and identify subtypes that are particularly suitable for oncolytic virotherapy.

scholarly journals Methylprednisolone pulse therapy for patients with moderately severe Graves' orbitopathy: a prospective, randomized, placebo-controlled study

2008 ◽  
Vol 158 (2) ◽  
pp. 229-237 ◽  
Author(s):  
Rob J van Geest ◽  
Inna V Sasim ◽  
Hans P F Koppeschaar ◽  
Rachel Kalmann ◽  
Simone N Stravers ◽  
...  
Keyword(s):  
Treatment Outcome ◽  
Severe Disease ◽  
Clinical Signs ◽  
Pulse Therapy ◽  
Controlled Study ◽  
Clinical Activity ◽  
Number Of Patients ◽  
Significant Difference ◽  
Graves Orbitopathy ◽  
Minor Criteria

ObjectiveTo assess whether methylprednisolone (MP) pulse therapy is efficacious in the treatment of moderately severe Graves' orbitopathy (GO).DesignProspective, placebo (PL)-controlled, double-blind, randomized study.MethodsFifteen previously untreated patients with active, moderately severe GO participated in the study; 6 patients received MP and 9 patients a PL. Moderately severe disease was defined using the NOSPECS classification of clinical signs of GO . Activity was measured with the clinical activity score (CAS). A dose of 500 mg MP or only solvent was administered intravenously, over three consecutive days, in four cycles at 4 weekly intervals (6 g of MP in total). Qualitatively, a successful treatment outcome was defined as an improvement in one major and/or two minor criteria in the worst eye at week 48. The major criteria were: improvement in diplopia grade; improvement in eye movement; a decrease in CAS of three points. The minor criteria were: decrease of eyelid retraction; decrease of proptosis; improvement in grade of soft tissue swelling; a decrease in CAS of two points.ResultsThe qualitative treatment outcome was successful at the end of the trial in five out of six (83%) patients receiving MP and in one out of nine (11%) patients given the PL (relative risk=7.5; (95% confidence interval 1.1–49.3), P=0.005). The treatment was well tolerated.ConclusionsIn spite of the small number of patients, a significant difference in outcome was observed between MP- and PL-treated patients. We conclude that MP pulse therapy appears to be an effective treatment for active, moderately severe GO.

scholarly journals AB0642 SACROILIAC JOINT INJECTIONS PERFORMED WITH ULTRASOUND GUIDANCE IN PATIENTS WITH SACROILIITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1615.2-1616
Author(s):  
A. R. Cunha ◽  
C. Mazeda ◽  
R. Aguiar ◽  
A. Barcelos
Keyword(s):  
Sacroiliac Joint ◽  
Ultrasound Guidance ◽  
Disease Duration ◽  
Corticosteroid Injection ◽  
Controlled Study ◽  
Ultrasound Guided ◽  
Sonographic Guidance ◽  
Number Of Patients ◽  
Joint Injections

Background:Sacroiliitis is the hallmark of axial Spondyloarthritis (axSpA). ASAS-EULAR management recommendations for axSpA, consider glucocorticoid injections directed to the local site of musculoskeletal inflammation as a treatment option for pain relief, besides treatment with oral non-steroidal anti-inflammatory (NSAIDs) before starter biotechnological treatment. However, there are few studies to evaluate efficacy of this technique with a small number of patients and a short follow-up. Ultrasonography has been used as a valuable option to guide this technique.Objectives:To evaluate the efficacy and safety of ultrasound-guided injections of sacroiliac joints (SIJs) in patients with sacroiliitis using clinical and laboratory outcomes at baseline and at 4-6thweeks.Methods:This study involved patients with axSpA with acute sacroiliitis, ≥18 and ≤ 65 years old, with body mass index (BMI) < 30kg/m2attending the Rheumatology Outpatient Clinic, which had been poorly controlled (ASDAS>2.1) by conventional therapy (physiotherapy, NSAIDs at maximum tolerated dosing during ≥ 4 weeks). Sociodemographic, clinical (disease duration, BMI, BASDAI, BASFI, ASDAS) and laboratory (CRP) data was collected from the medical records at baseline and at 4-6thweeks.Statistical analyses were conducted using SPSS version 25. Continuous variables were described with mean/median ± standard deviation (SD).SIJs injection was performed, under ultrasound guidance, using standard procedures with 2mL of lidocaine 1% and 40mg of methylprednisolone, with a 22-gauge needle. The procedure was performed by the same operator. Written informed consents were obtained from all patients.Results:We performed eleven sacroiliac injection in eleven consecutive patients (one procedure per patient). Nine patients (81.8%) were female, mean age (±SD) of 40.6(±9.4) years, median disease duration(±SD) of 0.9(±6.2) years and median BMI(±SD) of 24.2(±3.3). Eight patients (72.7%) had Nr-axSpA. All patients were non-responders to NSAIDs.At 4-6thweeks there was a decreased in median (±SD) BASDAI (5.4±1.9 vs 4.1±1.9), BASFI (4.2±1.4 vs 3.5±2.3) and ASDAS (3.2±0.8 vs 2.2±0.6) indexes.Conclusion:As previous studies demonstrated, this technique seems to be safe and quite effective.Our goal is to increase the number of patients undergoing this technique and have a longer follow up to evaluate its efficacy. The study has several limitations: the mid- and long-term effects should be evaluated in the future based on the results of the short-term effects and the study was not conducted as a double-blinded, controlled study.References:[1]van der Heijde D, Burgos-Vargas R, Ramiro S.,et al. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2017; 76:978–991[2]Maugars Y, Mathis C, Vilon P, Prost A. Corticosteroid injection of the sacroiliac joint in patients with seronegative spondylarthropathy. Arthritis Rheum 1992; 35:564–8.[3]Pekkafahli MZ, Kiralp MZ, Basekim CC et al. Sacroiliac joint injections performed with sonographic guidance. J Ultrasound Med 2003;22:553–9[4]Klauser A, De Zordo T, Feuchtner G et al. Feasibility of ultrasound-guided sacroiliac joint injection considering sonoanatomic landmarks at two different levels in cadavers and patients. Arthritis Rheum 2008; 59:1618–1624.Disclosure of Interests:Ana Rita Cunha: None declared, Carolina Mazeda: None declared, Renata Aguiar: None declared, Anabela Barcelos Speakers bureau: Bene, Eli-Lilly, Pfizer, MSD, Novartis

scholarly journals Extraocular muscle repositioning as the last therapeutic option for a patient with a severe course of Graves’ Ophthalmopathy: a case report

2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Andrea Rau ◽  
Matthias Klopfer ◽  
Niklas Rommel ◽  
Mechthild Rau-Fornefeld ◽  
Andreas Kolk
Keyword(s):  
Case Report ◽  
Extraocular Muscle ◽  
Therapeutic Option ◽  
Graves Ophthalmopathy

scholarly journals New advances in understanding thyroid-associated ophthalmopathy and the potential role for insulin-like growth factor-I receptor

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 134 ◽  
Author(s):  
Terry J Smith
Keyword(s):  
Growth Factor ◽  
Phase Iii ◽  
Controlled Study ◽  
Clinical Activity ◽  
Insulin Like Growth Factor ◽  
Factor I ◽  
Thyroid Associated Ophthalmopathy ◽  
Clinical Responses ◽  
Growth Factor I ◽  
Favorable Safety

Thyroid-associated ophthalmopathy (TAO), a localized periocular manifestation of the autoimmune syndrome known as Graves’ disease, remains incompletely understood. Discussions of its pathogenesis are generally focused on the thyrotropin receptor, the proposed role for which is supported by substantial evidence. Considerations of any involvement of the insulin-like growth factor-I receptor (IGF-IR) in the disease are frequently contentious. In this brief, topically focused review, I have attempted to provide a balanced perspective based entirely on experimental results that either favor or refute involvement of IGF-IR in TAO. Discussion in this matter seems particularly timely since the currently available treatments of this disfiguring and potentially sight-threatening disease remain inadequate. Importantly, no medical therapy has thus far received approval from the US Food and Drug Administration. Results from a very recently published clinical trial assessing the safety and efficacy of teprotumumab, an inhibitory human anti–IGF-IR monoclonal antibody, in active, moderate to severe TAO are extremely encouraging. That double-masked, placebo-controlled study involved 88 patients and revealed unprecedented clinical responses in the improvement of proptosis and clinical activity as well as a favorable safety profile. Should those results prove reproducible in an ongoing phase III trial, therapeutic inhibition of IGF-IR could become the basis for paradigm-shifting treatment of this vexing disease.

scholarly journals Abbreviated (8 hours) versus Traditional (24 hours) Postpartum MgSO4 Prophylaxis in Severe Preeclampsia: A Randomised Control Trial

2021 ◽  
Author(s):  
Shyamal Dasgupta ◽  
Anindya Das ◽  
Anurag Mallick ◽  
Chiranjit Ghosh
Keyword(s):  
Magnesium Sulphate ◽  
Total Duration ◽  
Severe Preeclampsia ◽  
Randomised Control Trial ◽  
Controlled Study ◽  
P Value ◽  
Time Duration ◽  
Traditional Group ◽  
Suitable Alternative ◽  
Number Of Patients

Introduction: Preeclampsia is a multisystem disorder affecting pregnancy after 20 weeks of gestation featured by hypertension and proteinuria. Magnesium Sulphate (MgSO4) has been used for 24 hours following delivery to prevent eclampsia in patients with severe preeclampsia. Aim: To determine the need to continue magnesium sulphate therapy 8 hours following delivery. Materials and Methods: The double blinded randomised controlled study was performed in the Department of Gynaecology and Obstetrics at R.G. Kar Medical College, Kolkata, West Bengal, India, from 1st July 2015 to 30th June 2016. Total 90 patients with severe preeclampsia were randomised in two group. In group A MgSO4 was discontinued 8 hours following delivery (abbreviated group) and in the group B it was continued for 24 hours following delivery (traditional group). The primary objective of study was to determine the need to continue MgSO4 therapy 8 hours following delivery. Secondary objectives were monitoring time by doctors, nursing care time, postpartum ambulation time, duration of urinary catheterisation, minor complication like urinary tract infection, duration and total dose of MgSO4 therapy. In order to calculate statistical significance of the different variables in between two groups, Student’s independent sample’s t-test was used for normally distributed numerical values and Chi-square test or Fischer’s-exact test was used for unpaired proportion data. Results: In abbreviated group, the number of patients (n=1) who did not need to continue MgSO4 therapy beyond 8 hours following delivery as safety measures were statistically significant (p-value <0.0001) in comparison to traditional group. Total duration and dose of MgSO4 therapy were significantly less (p-value <0.0001) in the abbreviated group. There was statistically significant reduction in time from delivery to postpartum ambulation and duration of indwelling urinary catheter in the abbreviated group. Conclusion: The abbreviated (8 hours) regime of postpartum MgSO4 for seizure prophylaxis is a suitable alternative to the traditional (24 hours) regime.

The Shapiro Cards Scale as a Method of Assessment of Obsessional Symptoms in Clomipramine Therapy

1975 ◽  
Vol 20 (1_suppl) ◽  
pp. 17-20 ◽  
Author(s):  
N. Capstick
Keyword(s):  
Number Of Patients ◽  
New Treatment ◽  
Method Of Assessment

One of the major problems encountered in research into the value of a new treatment for obsessional states is the small number of patients seen in any one centre. Another problem is the great diversity of symptoms which obsessional patients display. These two problems may be partly overcome by the use of the method of rating devised by Shapiro. The technique is described and its application to the treatment of obsessional disorders illustrated.

scholarly journals Anti-IL-6 Receptor Tocilizumab in Refractory Graves’ Orbitopathy: National Multicenter Observational Study of 48 Patients

2020 ◽  
Vol 9 (9) ◽  
pp. 2816
Author(s):  
Lara Sánchez-Bilbao ◽  
David Martínez-López ◽  
Marcelino Revenga ◽  
Ángel López-Vázquez ◽  
Elia Valls-Pascual ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Disease Activity ◽  
Therapeutic Option ◽  
Clinical Activity ◽  
Open Label ◽  
Serious Adverse Events ◽  
Low Disease Activity ◽  
Multicenter Observational Study ◽  
Graves Orbitopathy ◽  
One Year

Graves’ orbitopathy (GO) is the most common extrathyroidal manifestation of Graves’ disease (GD). Our aim was to assess the efficacy and safety of Tocilizumab (TCZ) in GO refractory to conventional therapy. This was an open-label multicenter study of glucocorticoid-resistant GO treated with TCZ. The main outcomes were the best-corrected visual acuity (BVCA), Clinical Activity Score (CAS) and intraocular pressure (IOP). These outcome variables were assessed at baseline, 1st, 3rd, 6th and 12th month after TCZ therapy onset. The severity of GO was assessed according to the European Group on Graves’ Orbitopathy (EUGOGO). We studied 48 (38 women and 10 men) patients (95 eyes); mean age ± standard deviation 51 ± 11.8 years. Before TCZ and besides oral glucocorticoids, they had received IV methylprednisolone (n = 43), or selenium (n = 11). GO disease was moderate (n =29) or severe (n = 19) and dysthyroid optic neuropathy (DON) (n = 7). TCZ was used in monotherapy (n = 45) or combined (n = 3) at a dose of 8 mg/kg IV every four weeks (n = 43) or 162 mg/s.c. every week (n = 5). TCZ yielded a significant improvement in all of the main outcomes at the 1st month that was maintained at one year. Comparing the baseline with data at 1 year all of the variables improved; BCVA (0.78 ± 0.25 vs. 0.9 ± 0.16; p = 0.0001), CAS (4.64 ± 1.5 vs. 1.05 ± 1.27; p = 0.0001) and intraocular pressure (IOP) (19.05 ± 4.1 vs. 16.73 ± 3.4 mmHg; p = 0.007). After a mean follow-up of 16.1 ± 2.1 months, low disease activity (CAS ≤ 3), was achieved in 88 eyes (92.6%) and TCZ was withdrawn in 29 cases due to low disease activity (n = 25) or inefficacy (n = 4). No serious adverse events were observed. In conclusion, TCZ is a useful and safe therapeutic option in refractory GO treatment.

Efficacy of Phenazone in the Treatment of Acute Migraine Attacks: A Double-Blind, Placebo-Controlled, Randomized Study

Cephalalgia ◽  
2004 ◽  
Vol 24 (10) ◽  
pp. 888-893 ◽  
Author(s):  
H Göbel ◽  
A Heinze ◽  
U Niederberger ◽  
T Witt ◽  
V Zumbroich
Keyword(s):  
Adverse Events ◽  
Randomized Study ◽  
Controlled Study ◽  
Acute Migraine ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Number Of Patients ◽  
Significant Difference ◽  
Main Target

In this study we compared the efficacy of 1000 mg phenazone with that of placebo in the treatment of acute migraine attacks in a randomized double-blind, placebo-controlled study of 208 patients. The main target criterion was the number of patients with a pain reduction from severe or moderate to slight or no pain 2 h after taking the pain medication. The percentage of patients satisfying the main target criterion was 48.6% for phenazone and 27.2% ( P < 0.05) for placebo. Freedom from pain after 2 h was reported by 27.6% with phenazone treatment and 13.6% ( P < 0.05) with placebo. Compared with placebo, the phenazone treatment also resulted in a significant improvement in the associated migraine symptoms of nausea, phonophobia and photophobia. Of patients treated with phenazone 11.4%, and 5.8% of those treated with placebo reported adverse events. There was no significant difference between the groups with regard to numbers of patients with adverse events. No serious adverse events occurred. The results show that phenazone at a dosage of 1000 mg is effective and well tolerated in the treatment of acute migraine attacks.

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