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The New England Journal of Medicine Dec 2005Oral contraceptives are rarely prescribed for women with systemic lupus erythematosus, because of concern about potential negative side effects. In this double-blind,... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Oral contraceptives are rarely prescribed for women with systemic lupus erythematosus, because of concern about potential negative side effects. In this double-blind, randomized, noninferiority trial, we prospectively evaluated the effect of oral contraceptives on lupus activity in premenopausal women with systemic lupus erythematosus.
METHODS
A total of 183 women with inactive (76 percent) or stable active (24 percent) systemic lupus erythematosus at 15 U.S. sites were randomly assigned to receive either oral contraceptives (triphasic ethinyl estradiol at a dose of 35 microg plus norethindrone at a dose of 0.5 to 1 mg for 12 cycles of 28 days each; 91 women) or placebo (92 women) and were evaluated at months 1, 2, 3, 6, 9, and 12. Subjects were excluded if they had moderate or high levels of anticardiolipin antibodies, lupus anticoagulant, or a history of thrombosis.
RESULTS
The primary end point, a severe lupus flare, occurred in 7 of 91 subjects receiving oral contraceptives (7.7 percent) as compared with 7 of 92 subjects receiving placebo (7.6 percent). The 12-month rates of severe flare were similar: 0.084 for the group receiving oral contraceptives and 0.087 for the placebo group (P=0.95; upper limit of the one-sided 95 percent confidence interval for this difference, 0.069, which is within the prespecified 9 percent margin for noninferiority). Rates of mild or moderate flares were 1.40 flares per person-year for subjects receiving oral contraceptives and 1.44 flares per person-year for subjects receiving placebo (relative risk, 0.98; P=0.86). In the group that was randomized to receive oral contraceptives, there was one deep venous thrombosis and one clotted graft; in the placebo group, there was one deep venous thrombosis, one ocular thrombosis, one superficial thrombophlebitis, and one death (after cessation of the trial).
CONCLUSIONS
Our study indicates that oral contraceptives do not increase the risk of flare among women with systemic lupus erythematosus whose disease is stable.
Topics: Adolescent; Adult; Contraceptives, Oral, Combined; Double-Blind Method; Ethinyl Estradiol; Female; Humans; Lupus Erythematosus, Systemic; Norethindrone; Pregnancy; Severity of Illness Index
PubMed: 16354891
DOI: 10.1056/NEJMoa051135 -
Indian Journal of Dermatology 2022Previous studies have shown that erythema nodosum-like lesions in patients with Behçet's disease show cutaneous vasculitis of either phlebitis or dermal venulitis. To...
Previous studies have shown that erythema nodosum-like lesions in patients with Behçet's disease show cutaneous vasculitis of either phlebitis or dermal venulitis. To analyse the clinicopathological characteristics of superficial thrombophlebitis as well as cutaneous venulitis in Behçet's disease. We re-evaluated the histopathological features of superficial thrombophlebitis in patients with Behçet's disease. Five patients, one man and four women, developed superficial thrombophlebitis on the lower extremities. Two of the patients had vascular Behçet's disease, both also developed deep vein thrombosis. One patient had intestinal Behçet's disease. In all cases, venulitis in the overlying lower dermis or adjacent subcutis spreading from the main affected subcutaneous thrombophlebitis lesions was observed. Both neutrophilic venulitis (n = 2) and lymphocytic venulitis (n = 3) were observed at the same depth level or upper/lower location of the thrombophlebitis in the same specimens. In addition, concurrent venulitis with fibrin thrombus and fibrinoid necrosis was observed in one case, suggesting that fibrin thrombus affected both venules and muscular veins. By contrast, arteritis or arteriolitis at the same depth level was not observed. Our results showed histopathological features of coexistent thrombophlebitis and venulitis without involvement of either arteries or arterioles in the biopsied specimens of superficial thrombophlebitis. Further studies are necessary to support that those unique histopathological findings are the characteristic features and significant diagnostic indicators of Behçet's disease.
PubMed: 36998880
DOI: 10.4103/ijd.ijd_229_22 -
Annals of Vascular Diseases Mar 2018Vascular Behçet's disease (BD) would keep risk of anastomotic pseudoaneurysm due to deterioration of the disease even after vascular surgery was successfully done.... (Review)
Review
Vascular Behçet's disease (BD) would keep risk of anastomotic pseudoaneurysm due to deterioration of the disease even after vascular surgery was successfully done. Therefore, it is one of the least-welcome diseases for vascular surgeons. There still exist several points on a concept and criteria of the vascular BD which not only general practitioners but also the vascular surgeons do not understand. Clinical findings strongly suspecting vascular BD are follows; saccular aneurysms without atherosclerosis developed in younger than 50-year-old patients, superior vena cava syndrome or deep vein thrombosis in bilateral legs without apparent causes, and multiple superficial thrombophlebitis, etc. It is very difficult to make a diagnosis of BD in the patients whose onset of the disease is a vascular lesion, because vascular BD combines few ocular lesions. In such case, it is very important to find out not only oral and genital ulceration, but also past history of arthritis. To establish the vascular BD, we vascular surgeons have to collect cases of the vascular BD and to revise criteria of the disease. (This is a translation of Jpn J Vasc Surg 2017; 26: 19-23.).
PubMed: 29682107
DOI: 10.3400/avd.ra.18-00002 -
Internal Medicine (Tokyo, Japan) Sep 2018Mondor's disease (MD) is a rare disease that manifests with a palpable cord-like induration on the body surface. In general, MD is a self-limited, benign... (Review)
Review
Mondor's disease (MD) is a rare disease that manifests with a palpable cord-like induration on the body surface. In general, MD is a self-limited, benign thrombophlebitis that resolves in four to eight weeks without any specific treatment. Cases of MD can be roughly categorized into three different groups based on the site of the lesion as follows: original MD of the anterolateral thoracoabdominal wall, penile MD with dorsum and dorsolateral aspects of the penis, and axillary web syndrome with mid-upper arm after axillary surgery. The diagnosis of MD is rather straightforward and based on a physical examinations. However, some case occur "secondary" with another underlying disease, including malignancy, a hypercoagulative state, and vasculitis. Therefore, it is critical to identify MD precisely, evaluate any possible underlying disease, and avoid any unnecessary invasive tests or treatment. In this paper, we comprehensively review the clinical characteristics of MD.
Topics: Arm; Humans; Male; Penile Diseases; Rare Diseases; Thrombophlebitis
PubMed: 29780120
DOI: 10.2169/internalmedicine.0495-17 -
Jornal Vascular Brasileiro Nov 2019Superficial venous thrombosis (SVT) or superficial thrombophlebitis is characterized by thrombi within superficial veins, with partial involvement or occlusion of the...
Superficial venous thrombosis (SVT) or superficial thrombophlebitis is characterized by thrombi within superficial veins, with partial involvement or occlusion of the lumen and inflammatory reaction along the course of the vein. Clinical diagnosis tends to be straightforward, but supplementary tests and examinations are needed to confirm thrombosis extension and possible thromboembolic complications. SVT can be associated with deep venous thrombosis in 6 to 40% of cases, with asymptomatic pulmonary embolism (PE) in 20 to 33%, and with symptomatic PE in 2 to 13%. Despite the morbidity and complications, there are currently no Brazilian guidelines for SVT. These guidelines cover the most important issues related to SVT definition, terminology, and etiology, and set out recommendations for diagnosis and treatment.
PubMed: 31807127
DOI: 10.1590/1677-5449.180105 -
Basic and Clinical Andrology 2014Mondor's disease is a rare, self-limiting, benign process with acute presentation characterized by subcutaneous bands in several parts of the body. Penile Mondor's...
Mondor's disease is a rare, self-limiting, benign process with acute presentation characterized by subcutaneous bands in several parts of the body. Penile Mondor's disease (PMD) is thrombophlebitis of the superficial dorsal vein of the penis. It is usually considered as thrombophlebitis or phlebitis of subcutaneous vessels. Some findings suggest that it might be of lymphatic origin. The chest, abdominal wall, penis, upper arm, and other parts of the body may also be involved by the disease. Although its physiopathology is not exactly known, transection of the vessel during surgery or any type of trauma such as external compression may trigger its possible development. This disease almost always limits itself. It may be associated with psychological distress and sexual incompatibility. The patients usually feel the superficial vein of the penis like a hard rope and present with complaint of pain around this hardness. Diagnosis is usually easy with physical examination but color Doppler ultrasound examination is important for differential diagnosis. Thus, a close collaboration is required between radiologist and urologist in order to determine the correct diagnosis and appropriate therapies.
PubMed: 25780580
DOI: 10.1186/2051-4190-24-5 -
The Cochrane Database of Systematic... Nov 2015Although superficial thrombophlebitis of the upper extremity represents a frequent complication of intravenous catheters inserted into the peripheral veins of the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Although superficial thrombophlebitis of the upper extremity represents a frequent complication of intravenous catheters inserted into the peripheral veins of the forearm or hand, no consensus exists on the optimal management of this condition in clinical practice.
OBJECTIVES
To summarise the evidence from randomised clinical trials (RCTs) concerning the efficacy and safety of (topical, oral or parenteral) medical therapy of superficial thrombophlebitis of the upper extremity.
SEARCH METHODS
The Cochrane Vascular Group Trials Search Co-ordinator searched the Specialised Register (last searched April 2015) and the Cochrane Register of Studies (2015, Issue 3). Clinical trials registries were searched up to April 2015.
SELECTION CRITERIA
RCTs comparing any (topical, oral or parenteral) medical treatment to no intervention or placebo, or comparing two different medical interventions (e.g. a different variant scheme or regimen of the same intervention or a different pharmacological type of treatment).
DATA COLLECTION AND ANALYSIS
We extracted data on methodological quality, patient characteristics, interventions and outcomes, including improvement of signs and symptoms as the primary effectiveness outcome, and number of participants experiencing side effects of the study treatments as the primary safety outcome.
MAIN RESULTS
We identified 13 studies (917 participants). The evaluated treatment modalities consisted of a topical treatment (11 studies), an oral treatment (2 studies) and a parenteral treatment (2 studies). Seven studies used a placebo or no intervention control group, whereas all others also or solely compared active treatment groups. No study evaluated the effects of ice or the application of cold or hot bandages. Overall, the risk of bias in individual trials was moderate to high, although poor reporting hampered a full appreciation of the risk in most studies. The overall quality of the evidence for each of the outcomes varied from low to moderate mainly due to risk of bias and imprecision, with only single trials contributing to most comparisons. Data on primary outcomes improvement of signs and symptoms and side effects attributed to the study treatment could not be statistically pooled because of the between-study differences in comparisons, outcomes and type of instruments to measure outcomes.An array of topical treatments, such as heparinoid or diclofenac gels, improved pain compared to placebo or no intervention. Compared to placebo, oral non-steroidal anti-inflammatory drugs reduced signs and symptoms intensity. Safety issues were reported sparsely and were not available for some interventions, such as notoginseny creams, parenteral low-molecular-weight heparin or defibrotide. Although several trials reported on adverse events with topical heparinoid creams, Essaven gel or phlebolan versus control, the trials were underpowered to adequately measure any differences between treatment modalities. Where reported, adverse events with topical treatments consisted mainly of local allergic reactions. Only one study of 15 participants assessed thrombus extension and symptomatic venous thromboembolism with either oral non-steroidal anti-inflammatory drugs or low-molecular-weight heparin, and it reported no cases of either. No study reported on the development of suppurative phlebitis, catheter-related bloodstream infections or quality of life.
AUTHORS' CONCLUSIONS
The evidence about the treatment of acute infusion superficial thrombophlebitis is limited and of low quality. Data appear too preliminary to assess the effectiveness and safety of topical treatments, systemic anticoagulation or oral non-steroidal anti-inflammatory drugs.
Topics: Anti-Inflammatory Agents; Anticoagulants; Catheterization, Peripheral; Dalteparin; Diclofenac; Drug Combinations; Drugs, Chinese Herbal; Escin; Gels; Heparin; Heparinoids; Humans; Ibuprofen; Nitroglycerin; Pentosan Sulfuric Polyester; Phospholipids; Polydeoxyribonucleotides; Randomized Controlled Trials as Topic; Thrombophlebitis; Upper Extremity
PubMed: 26588711
DOI: 10.1002/14651858.CD011015.pub2 -
Journal of Vascular Surgery. Venous and... Jan 2021Initial phase III clinical studies with polidocanol endovenous microfoam (PEM) demonstrated its safety and efficacy in the treatment of superficial venous reflux. In... (Observational Study)
Observational Study
BACKGROUND
Initial phase III clinical studies with polidocanol endovenous microfoam (PEM) demonstrated its safety and efficacy in the treatment of superficial venous reflux. In those studies, the primary outcome requirement was to assess the improvement in symptoms related to superficial venous disease. The goal of the present study was to evaluate the efficacy of PEM technology in routine clinical practice-specifically, the closure rates after treatment.
METHODS
We performed an observational study during which data were prospectively collected from 2 vein centers using an electronic database. Patients with CEAP (clinical, etiologic, anatomic, pathophysiologic) class ≥2 and symptomatic superficial axial reflux (great saphenous vein, anterior accessory saphenous vein, and small saphenous vein) were included and followed up prospectively. PEM was used to treat the saphenous vein and varicosities. The CEAP classification was used to classify chronic venous disease, and the venous clinical severity score (VCSS) was applied to measure the disease severity. Pain and discomfort were assessed using a visual analog scale, and the residual veins were assessed by physical examination.
RESULTS
PEM was used to treat superficial reflux in 60 patients. The CEAP classification was C2 for 32 patients, C3 for 14, C4 for 10, and C5 for 4 patients. The average pretreatment VCSS was 7.3. The saphenous vein diameter was 6.5 mm, and the average length was 31 cm. The average volume of PEM used to treat the saphenous veins was 9.3 mL. The closure rate at 3 and 6 months was 93% (54 of 58) and 93% (51 of 55), respectively. The VCSS had improved from 7.3 to 1.4. Complications included 1 case of deep vein thrombosis (1.7%), 5 patients (8.3%) with thrombophlebitis, and 4 patients (6.6%) with skin pigmentation.
CONCLUSIONS
PEM is safe and effective for the treatment of saphenous reflux and varicosities. The early closure rates using PEM were maintained at 6 months and are comparable to the results reported with nonthermal, nontumescent technologies and thermal tumescent technologies.
Topics: Female; Humans; Male; Middle Aged; New Jersey; New York; Polidocanol; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Varicose Veins; Venous Insufficiency
PubMed: 32353594
DOI: 10.1016/j.jvsv.2020.04.015 -
Annals of Family Medicine 2010The association of spontaneous venous thromboembolism with occult malignancy is well established. Less clear is the incidence of subsequent cancer in patients with...
PURPOSE
The association of spontaneous venous thromboembolism with occult malignancy is well established. Less clear is the incidence of subsequent cancer in patients with superficial thrombophlebitis. We wanted to determine the incidence of cancer after an episode of spontaneous superficial thrombophlebitis in a large general practice population.
METHODS
The objective of this study was to assess the incidence of newly diagnosed malignancies in patients within 2 years after the diagnosis of a spontaneous episode of superficial thrombophlebitis and to compare this incidence with nonexposed matched control patients and the Dutch population. The patients and their controls were identified by a search in the electronic patient records of 5 primary health care centers in Amsterdam, the Netherlands. A standardized morbidity ratio was calculated using data of the Dutch cancer registry.
RESULTS
A total number of 277 patients with superficial thrombophlebitis were identified, of which 250 patients had no cancer at study entry. In 5 of these 250 patients (2%; 95% confidence interval [CI], 1%-5%), a new malignancy was diagnosed within 2 years after their superficial thrombophlebitis compared with 2% (95% CI, 1%-4%) in the control group. The standardized morbidity ratio was 1.1 (95% CI, 0.5-2.7). A recurrent episode of superficial thrombophlebitis was observed in 18 of the 250 patients, and in 1 patient cancer was diagnosed within 24 months after the first episode of superficial thrombophlebitis.
CONCLUSION
We conclude that a single episode of unprovoked superficial thrombophlebitis diagnosed by a family physician is not associated with an increased risk of subsequent cancer.
Topics: Case-Control Studies; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Neoplasms; Netherlands; Primary Health Care; Risk Factors; Thrombophlebitis
PubMed: 20065278
DOI: 10.1370/afm.1058