Polidocanol
Sources réglementaires consultées
Indications approuvées
- Sclérose des télangiectasies non compliquées jusqu'à 1 mm et des veines réticulaires non compliquées de 1 à 3 mm des membres inférieurs. Le produit n'a pas été étudié dans les varices de plus de 3 mm.
- Profil espagnol (Etoxisclerol) : sclérothérapie des varices et des télangiectasies ; la concentration est choisie selon la taille et la gravité des varices et, en cas de doute, la concentration inférieure est retenue.
Contre-indications
Absolues
- Allergie connue au polidocanol.
- Maladie thromboembolique aiguë.
- Profil espagnol : immobilisation.
- Profil espagnol : maladie systémique aiguë sévère, en particulier si elle n'est pas traitée.
- Profil espagnol : maladie artérielle occlusive sévère, stade III ou IV de Fontaine.
- Profil espagnol : risque élevé de thrombose, notamment thrombophilie héréditaire connue ou facteurs de risque thrombotiques multiples.
- Profil espagnol avec micro-mousse : shunt droite-gauche symptomatique connu, tel qu'un foramen ovale perméable.
Mises en garde cliniques
- Mise en garde majeure · Une anaphylaxie, parfois mortelle, peut survenir ; réduire la dose au minimum, disposer d'un traitement d'urgence et surveiller après l'injection. — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb1f342b-5352-4059-a0b2-e60fd652fd28
- Mise en garde majeure · Une thrombose veineuse, une embolie pulmonaire et d'autres événements thrombotiques peuvent survenir ; respecter la technique d'administration et surveiller les signes de thrombose, notamment en cas de mobilité réduite, d'antécédents thromboemboliques, de chirurgie ou d'hospitalisation récente, ou de grossesse. — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb1f342b-5352-4059-a0b2-e60fd652fd28
- Mise en garde majeure · Ne pas injecter par voie intra-artérielle : une injection artérielle ou une extravasation peut provoquer une ischémie, une nécrose ou une gangrène. Utiliser le plus petit volume efficace et consulter en urgence un chirurgien vasculaire en cas d'injection artérielle. — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb1f342b-5352-4059-a0b2-e60fd652fd28
- Mise en garde majeure · Profil américain (Asclera) : éviter la mousse préparée avec de l'air ambiant ; sa sécurité et son efficacité ne sont pas établies et des embolies artérielles, accidents vasculaires cérébraux, accidents ischémiques transitoires, infarctus du myocarde et altérations de la fonction cardiaque ont été rapportés. — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb1f342b-5352-4059-a0b2-e60fd652fd28
Interactions médicamenteuses
- ModéréeAutres anesthésiques locaux
Mécanisme: Le lauromacrogol 400 possède une activité anesthésique locale et peut produire des effets cardiovasculaires additifs avec d'autres anesthésiques.
Recommandation: Évaluer l'effet additif et surveiller la fonction cardiovasculaire lors de l'association.
https://cima.aemps.es/cima/dochtml/ft/55550/FT_55550.html
Effets indésirables
Communs (≥1%)
Hématome au site d'injection · Irritation au site d'injection · Coloration au site d'injection · Douleur au site d'injection · Prurit ou chaleur au site d'injection · Néovascularisation
Rares mais graves
Anaphylaxie ou choc anaphylactique · Thrombose veineuse profonde ou embolie pulmonaire · Accident vasculaire cérébral, perte de connaissance ou collapsus circulatoire · Nécrose au site d'injection ou lésion nerveuse
Grossesse et allaitement
Profil américain (Asclera) : les cas disponibles n'ont pas mis en évidence de risque associé, mais le bénéfice du traitement des varices non compliquées pendant la grossesse est minime et celles-ci peuvent régresser après l'accouchement ; pendant l'allaitement, une interruption avec expression et élimination du lait jusqu'à 8 heures peut être envisagée. Profil espagnol (Etoxisclerol) : si une sclérothérapie est nécessaire pendant l'allaitement, interrompre celui-ci pendant 2 à 3 jours.
Bibliographie récente (PubMed)
This review article provides an updated review of a relatively common pathology with various manifestations. Superficial venous diseases (SVDs) are a broad spectrum of venous vascular disease that predominantly affects the body's lower extremities. The most serious manifestation of this disease includes varicose veins, chronic venous insufficiency, stasis dermatitis, venous ulcers, superficial venous thrombosis, reticular veins, and spider telangiectasias. The anatomy, pathophysiology, and risk factors of SVD were discussed during this review. The risk factors for developing SVD were related to race, age, sex, lifestyle, and certain genetic conditions as well as comorbid deep vein thrombosis. Various classification systems were listed, focusing on the most common one-the revised Clinical-Etiology-Anatomy-Pathophysiology classification. The clinical features including history and physical examination findings elicited in SVD were outlined. Imaging modalities utilized in SVD were highlighted. Duplex ultrasound is the first line in evaluating SVD but magnetic resonance imaging and computed tomography venography, plethysmography, and conventional venography are feasible options in the event of an ambiguous venous duplex ultrasound study. Treatment options highlighted in this review ranged from conservative treatment with compression stockings, which could be primary or adjunctive to pharmacologic topical and systemic agents such as azelaic acid, diuretics, plant extracts, medical foods, nonsteroidal anti-inflammatory drugs, anticoagulants and skin substitutes for different stages of SVD. Interventional treatment modalities include thermal ablative techniques like radiofrequency ablationss, endovenous laser ablation, endovenous steam ablation, and endovenous microwave ablation as well as nonthermal strategies such as the Varithena (polidocanol microfoam) sclerotherapy, VenaSeal (cyanoacrylate) ablation, and Endovenous mechanochemical ablation. Surgical treatments are als
Skin hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants is a common local side effect. Sclerotherapists should be familiar with factors that trigger hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants. A systematic literature review of works reporting hyperpigmentation after sclerotherapy for telangiectasias, reticular veins, side branches and truncal varices with polidocanol-containing sclerosants was performed. Reported incidence rates, follow-up periods and potentially triggering factors were assessed and analysed. The search yielded 1687 results; of these, 27 reports met the inclusion criteria. The incidence of hyperpigmentation seemed to increase with higher concentrations of polidocanol and was more evident after sclerotherapy for epifascial veins than for intrafascial truncal veins when the polidocanol concentration was more than 0.25%. Regarding sclerotherapy for telangiectasias and reticular veins, the incidence of hyperpigmentation ranged between 2% and 25% for polidocanol 0.25% (liquid and foam), between 12.5% and 67.9% for polidocanol 0.5% (liquid and foam) and between 13% and 73% for polidocanol 1% (liquid and foam). Regarding truncal veins, the incidence ranged from 7% to 45.8% for polidocanol 1% (liquid and foam), from 16% to 17% for polidocanol 2% (foam) and from 7.4% to 32.5% for polidocanol 3% (liquid and foam). Regarding the treatment of side branches, the incidence of hyperpigmentation ranged from 5.6% to 53% for both foam and liquid sclerotherapy. Regarding the duration of hyperpigmentation, there are few data describing reticular veins and telangiectasias. Hyperpigmentation persisting for more than 6 months has been reported to have an incidence of up to 7.5%. Hyperpigmentation persisting for more than 1 year after foam polidocanol 1%-3% treatment for truncal veins has an incidence ranging from 8.1% to 17.5%. Other factors such as higher volumes and compression therapy after treatment seem to
The Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society collaborated to update the 2011 Society for Vascular Surgery/American Venous Forum clinical practice guidelines and provide new evidence-based recommendations on critical issues affecting the care of patients with varicose veins. Each recommendation is based on a recent, independent systematic review and meta-analysis of the diagnostic tests and treatments options for patients with lower extremity varicose veins. Part I of the guidelines includes evidence-based recommendations for the evaluation of patients with CEAP (Clinical Class, Etiology, Anatomy, Pathology) class 2 varicose vein using duplex ultrasound scanning and other diagnostic tests, open surgical treatment (ligation and stripping) vs endovenous ablation techniques, thermal vs nonthermal ablation of the superficial truncal veins, and management of incompetent perforating veins in CEAP class 2 disease. We have also made recommendations on the concomitant vs staged treatment of varicose tributaries using phlebectomy or liquid or foam sclerotherapy (with physician-compounded foam or commercially prepared polidocanol endovenous microfoam) for patients undergoing ablation of incompetent superficial truncal veins.
Varicose veins are enlarged and tortuous veins, affecting up to one-third of the world's population. They can be a cause of chronic venous insufficiency, which is characterised by oedema, pigmentation, eczema, lipodermatosclerosis, atrophie blanche, and healed or active venous ulcers. Injection sclerotherapy (liquid or foam) is widely used for treatment of varicose veins aiming to transform the varicose veins into a fibrous cord. However, there is limited evidence regarding its effectiveness and safety, especially in patients with more severe disease. This is the second update of the review first published in 2002. To assess the effectiveness and safety of injection sclerotherapy for the treatment of varicose veins. For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED, CINAHL, and LILACS databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries, on 20 July 2021. We included all randomised controlled trials (RCTs) (including cluster-randomised trials and first phase cross-over studies) that used injection sclerotherapy for the treatment of varicose veins. Two review authors independently assessed, selected and extracted data. Disagreements were cross-checked by a third review author. We used Cochrane's Risk of bias tool to assess the risk of bias. The outcomes of interest were cosmetic appearance, complications, residual varicose veins, quality of life (QoL), persistence of symptoms, and recurrent varicose veins. We calculated risk ratios (RRs) or mean difference (MD) with 95% confidence intervals (CIs). We used the worst-case-scenario for dichotomous data imputation for intention-to-treat analyses. For continuous outcomes, we used the 'last-observation-carried-forward' for data imputation if there was balanced loss to follow-up. We assessed the certainty of the evidence using the GRADE approach. We i