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Journal of Cosmetic Dermatology Jun 2024The foam's structural longevity, linked to the effectiveness of sclerotherapy, depends on preparation conditions. The factors enhancing the treatment's effectiveness and...
BACKGROUND
The foam's structural longevity, linked to the effectiveness of sclerotherapy, depends on preparation conditions. The factors enhancing the treatment's effectiveness and efficacy are still under discussion.
METHODS
We conducted an in vitro preclinical research, which included 144 independent trials. A total of 8 combinations involving 18 trials were designed according to settings of +4°C and room temperature (20-22°C), liquid-to-air ratios of 1/1 and 1/4, and polidocanol concentrations of 0.5% and 1% using the modified Tessari method. Our study aimed to examine the effect of air ratio, agent temperature, and polidocanol concentration on stability by assessing the foam half-time (FHT) and defining the optimal preparation conditions.
RESULTS
The mean FHT was 117 ± 30.4 s. The longest FHT was in a 1:4 air-to-sclerosant ratio at +4°C, regardless of the sclerosant concentration (for %0.5 mean FHT: 146.2 ± 13.9 s, for % 1 mean FHT: 146.9 ± 18 s). There was a significant interaction among the three variables on FHT (p = 0.001). Temperature emerged as the primary factor (F(1, 136) = 124, p < 0.001, ηp = 0.477), with lower temperatures markedly enhancing the longevity (p < 0.001). Preparation at a temperature of 4°C resulted in an extended FHT of 32.5 s compared to 22°C (95% CI: 24.06-41.04 s).
CONCLUSION
The temperature, agent concentration, and gas ratio significantly influence the stability of the physician-compounded foam. The low temperature at +4°C may offer better FHT for sclerotherapy.
PubMed: 38837644
DOI: 10.1111/jocd.16398 -
Dermatologic Surgery : Official... Dec 2020Foam sclerotherapy is an effective treatment strategy for venous malformations. Both polidocanol (POL) and bleomycin are effective sclerosants; however, no studies have...
BACKGROUND
Foam sclerotherapy is an effective treatment strategy for venous malformations. Both polidocanol (POL) and bleomycin are effective sclerosants; however, no studies have reported POL-bleomycin foam.
OBJECTIVE
To introduce a method for producing POL-bleomycin foam and evaluate the stability of POL-bleomycin foam with bleomycin concentrations.
MATERIALS AND METHODS
Group A: 2 mL of 1% POL + 8 mL of air; Group B: 2 mL of 1% POL + 3 U bleomycin + 8 mL of air; Group C: 2 mL of 1% POL + 6 U bleomycin + 8 mL of air; Group D: 2 mL of 1% POL + 12 U bleomycin + 8 mL of air. Tessari method was used for foam generation. The foam half-life time (FHT) was used to evaluate foam stability. Five recordings were made for each group.
RESULTS
The FHT was 148.6 ± 2.9 seconds in Group A, 148.8 ± 4.0 seconds in Group B, 148.4 ± 2.6 seconds in Group C, and 148.8 ± 1.6 seconds in Group D. The FHT in different groups showed no significant differences.
CONCLUSION
The POL-bleomycin foam was prepared successfully and its FHT was as long as the POL foam.
Topics: Bleomycin; Drug Combinations; Drug Compounding; Drug Stability; Half-Life; Humans; Polidocanol; Sclerosing Solutions; Sclerotherapy; Vascular Malformations; Veins
PubMed: 32769523
DOI: 10.1097/DSS.0000000000002533 -
Journal of Drugs in Dermatology : JDD Nov 2019Polidocanol is an FDA-approved sclerosant indicated for treating uncomplicated spider veins and reticular veins in the lower extremities. Despite restrictions against...
Polidocanol is an FDA-approved sclerosant indicated for treating uncomplicated spider veins and reticular veins in the lower extremities. Despite restrictions against compounding drugs that are essentially copies of FDA-approved or commercially available products, polidocanol is also available from compounding pharmacies and outsourcing facilites. Compounded drug products are not FDA-approved and have not undergone premarket FDA review for safety, effectiveness, and quality. Seven samples of polidocanol were obtained from three compounding pharmacies and analyzed using high pressure liquid chromatography. None of the samples contained the labeled concentration of polidocanol and five contained excessive levels of impurities. Since the potency and purity of compounded polidocanol injection cannot be assured, physicians who use these products should consider FDA-approved products to ensure optimal safety and efficacy. J Drugs Dermatol. 2019;18(11):1124-1127.
Topics: Chromatography, High Pressure Liquid; Drug Compounding; Humans; Polidocanol; Sclerosing Solutions; Varicose Veins
PubMed: 31741355
DOI: No ID Found -
Journal of Vascular Surgery. Venous and... Jan 2023Sclerotherapy for venous malformation has been widely used; however, no guidelines are available to assess the effectiveness of different sclerotherapy agents. We... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Sclerotherapy for venous malformation has been widely used; however, no guidelines are available to assess the effectiveness of different sclerotherapy agents. We conducted a systematic review and network meta-analysis to investigate the effectiveness of sclerotherapy agents for venous malformations.
METHODS
Three electronic databases were searched from their inception (1950) to April 29, 2021. Studies comparing the effectiveness of different sclerotherapy agents were included. The risk of bias within and across studies was assessed. Pairwise meta-analyses were conducted, followed by a network meta-analysis. We also assessed inconsistency and publishing bias using various approaches.
RESULTS
Seven studies with 547 patients in six arms were included in the present study. We defined the response and complete response as two separate outcomes. Significant differences were observed in four comparisons with respect to the response (ethanol vs bleomycin, ethanol vs polidocanol, ethanol vs sodium tetradecyl sulfate, polidocanol vs sodium tetradecyl sulfate). No statistically significant differences were found in the other comparisons. The evidence network revealed that for the response outcome, ethanol ranked first, followed by pingyangmycin, polidocanol, sodium morrhuate, bleomycin, and, finally, sodium tetradecyl sulfate. For the complete response outcome, pingyangmycin had the best results, followed by sodium morrhuate, polidocanol, ethanol, bleomycin, and, finally, sodium tetradecyl sulfate. Major complications, such as facial nerve palsy, serious local swelling, and necrosis, had occurred mostly in the ethanol group and rarely in the other groups. Because of the limited data, no further analysis of major complications was conducted. Our confidence in the comparisons and rankings was low. We found no verified inconsistency or publishing bias in the present study using the existing approaches.
CONCLUSIONS
Ethanol showed a significantly better response statistically compared with the other agents. However, ethanol had also resulted in the highest incidence of complications. Pingyangmycin showed the second-best response, best complete response, and a low rate of complications, respectively. Overall, pingyangmycin achieved excellent performance and balance in terms of the different outcomes. However, they could not be adequately recommended from the available data. More superior trials, especially randomized controlled trials, are needed in the future.
Topics: Humans; Sclerotherapy; Polidocanol; Sclerosing Solutions; Sodium Tetradecyl Sulfate; Sodium Morrhuate; Network Meta-Analysis; Treatment Outcome; Vascular Malformations; Bleomycin; Ethanol
PubMed: 36179784
DOI: 10.1016/j.jvsv.2022.08.004 -
Frontiers in Pediatrics 2022The aim of this study was to investigate the efficacy of polidocanol against venous malformations (VMs).
OBJECTIVE
The aim of this study was to investigate the efficacy of polidocanol against venous malformations (VMs).
METHODS
Studies reporting the treatment of VMs using polidocanol (published until February 15, 2020) were reviewed in the Embase and PubMed databases. After excluding the same literature, part of the studies were excluded by reading the title, abstract, full text. Eleven studies (with 287 participants) that fulfilled the inclusion criteria were included. Systematic meta-analysis was performed using Reviews Manager 5.2, and a fixed-effects model was used to calculate the pooled effective rate of polidocanol against VMs and the 95% confidence intervals (CI).
RESULTS
Lesion reduction of more than 50% was considered effective. A total of 287 patients were treated, and treatment in 271 was considered effective. The efficacy of polidocanol was 0.89 (95% CI = 0.83-0.93). Heterogeneity among the studies was small ( = 0%, = 0.47). T The funnel plot was roughly symmetric.
CONCLUSION
Our study suggested that polidocanol is effective in the treatment of VMs. VMs at different sites can be treated without serious complications. Therefore, we have reason to believe that polidocanol is a safe and an effective drug for VMs.
PubMed: 35967557
DOI: 10.3389/fped.2022.925318 -
Cell Reports Dec 2020There is an increasing appreciation for the heterogeneity of myeloid lineages in the lung, but relatively little is known about populations specifically associated with...
There is an increasing appreciation for the heterogeneity of myeloid lineages in the lung, but relatively little is known about populations specifically associated with the conducting airways. We use single-cell RNA sequencing, flow cytometry, and immunofluorescence to characterize myeloid cells of the mouse trachea during homeostasis and epithelial injury/repair. We identify submucosal macrophages, similar to lung interstitial macrophages, and intraepithelial macrophages. Following injury, there are early increases in neutrophils and submucosal macrophages, including M2-like macrophages. Intraepithelial macrophages are lost after injury and later restored by CCR2 monocytes. We show that repair of the tracheal epithelium is impaired in Ccr2-deficient mice. Mast cells and group 2 innate lymphoid cells are sources of interleukin-13 (IL-13) that polarize macrophages and directly influence basal cell behaviors. Their proximity to the airway epithelium establishes these myeloid populations as potential therapeutic targets for airway disease.
Topics: Animals; Cells, Cultured; Cytokines; Epithelial Cells; Epithelium; Female; Homeostasis; Lung; Lung Injury; Macrophages, Alveolar; Male; Mice; Mice, Inbred C57BL; Mice, Knockout; Models, Animal; Monocytes; Myeloid Cells; Polidocanol; Receptors, CCR2; Regeneration; Sequence Analysis, RNA; Single-Cell Analysis; Trachea
PubMed: 33378665
DOI: 10.1016/j.celrep.2020.108553 -
Expert Opinion on Pharmacotherapy Aug 2020Tendinopathies are common in elite and recreational athletes: traditionally considered overuse injuries, they involve excessive tensile loading and subsequent breakdown... (Review)
Review
INTRODUCTION
Tendinopathies are common in elite and recreational athletes: traditionally considered overuse injuries, they involve excessive tensile loading and subsequent breakdown of the loaded tendon. Many pharmacological treatments have been proposed for the management of tendinopathy, with no agreement regarding the overall best option available both for Achilles and patellar tendinopathy.
AREAS COVERED
The present article reports the best scientific evidence regarding the efficacy and safety of different pharmacological treatments in different types of tendinopathy, focusing on Achilles and patellar tendinopathy, the conditions on which more studies have been published.
EXPERT OPINION
No univocal evidence exists regarding the best non-operative management, which includes non-steroidal anti-inflammatory drugs, platelet-rich plasma, high volume image-guided injections, hyaluronic acid, and prolotherapy, for tendinopathy (in particular Achilles and patellar tendinopathies) as a suitable alternative to the commonly used eccentric loading rehabilitation regimen. It is unclear whether the combination of pharmacological substances with physical therapy would produce better results than physical therapy alone. There is an overall lack of published well-performed randomized controlled trials comparing the various options available for the management of tendinopathy, studying large cohorts of patients for adequately long follow-up periods and with well-validated standardized scores and scales.
Topics: Achilles Tendon; Anti-Inflammatory Agents; Clinical Trials as Topic; Combined Modality Therapy; Humans; Patellar Ligament; Physical Therapy Modalities; Platelet-Rich Plasma; Polidocanol; Tendinopathy; Treatment Outcome
PubMed: 32511031
DOI: 10.1080/14656566.2020.1763306 -
Hepatology Research : the Official... Jun 2022Simple hepatic cysts are typically benign; however, when they are large and symptomatic, therapeutic intervention is required. We previously reported our initial...
AIM
Simple hepatic cysts are typically benign; however, when they are large and symptomatic, therapeutic intervention is required. We previously reported our initial experience with ultrasound (US)-guided polidocanol foam sclerotherapy in three patients with symptomatic giant hepatic cysts. In the present study, we examined the efficacy and safety of polidocanol foam sclerotherapy in a larger number of patients with long-term follow-up.
METHODS
Between May 2016 and April 2021, 15 patients with symptomatic giant hepatic cysts were referred to our hospital. All patients were prospectively included in the study and underwent US-guided polidocanol foam sclerotherapy.
RESULTS
The mean maximum diameter and estimated cyst volume were 128.4 mm (77-223 mm) and 922.3 ml (123.2-2797 ml), respectively. Polidocanol foam was successfully administered through an 8.5-Fr pigtail catheter in all patients. The percentages of cyst diameter/volume after 1-3 months, 3-6 months, 6 months-1 year, 1-2 years, and 2-4 years of sclerotherapy were 66.8%/36.5%, 48.1%/14.8%, 34.1%/6.9%, 28.2%/3.7%, and 26.2%/3.1%, respectively. During the follow-up period, there were no cases of symptom recurrence or need for additional treatment due to cyst re-growth. Six patients (40%) had fever, one had nausea, and one had right-sided chest pain, but none of these adverse events required prolonged hospitalization or readmission.
CONCLUSIONS
US-guided polidocanol foam sclerotherapy may be an effective and safe method for the treatment of symptomatic giant hepatic cysts.
PubMed: 35355375
DOI: 10.1111/hepr.13769 -
Dermatologic Surgery : Official... Feb 2020Varicose veins are common clinical entities. Foam sclerotherapy is a minimally invasive and simple procedure; however, the side effects, efficacy, and stability of... (Review)
Review
BACKGROUND
Varicose veins are common clinical entities. Foam sclerotherapy is a minimally invasive and simple procedure; however, the side effects, efficacy, and stability of sclerosing foam are not ideal.
OBJECTIVE
To summarize the current studies on sclerosing foam stability and promote foam sclerotherapy development.
MATERIALS AND METHODS
We reviewed the literature before June 2018 and included only representatives studies on sclerosing foam stability. We summarized the foam half-life time (FHT) of polidocanol (POL) under 17 preparation conditions and the FHT of sodium tetradecyl sulfate under 21 preparation conditions. The preparation conditions included various combinations of temperature, liquid-gas ratio, preparation method, etc. RESULTS: The FHT of POL varied between 40 and 4,000 seconds under different conditions. The FHT of sodium tetradecyl sulfate varied from 25.7 to 390 seconds. The higher the drug concentration, the lower the temperature required to increase foam stability. The addition of surfactant greatly increased foam stability. For different gas compositions, the FHT sequence was as follows: CO2 < CO2 + O2 < O2 < air.
CONCLUSION
Foam stability can be improved by changing the preparation conditions; therefore, the role of surfactants and predictive methods for FHT are worth investigating further.
Topics: Drug Compounding; Drug Stability; Gases; Half-Life; Humans; Injections, Intravenous; Polidocanol; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Surface-Active Agents; Temperature; Time Factors; Varicose Veins
PubMed: 31569112
DOI: 10.1097/DSS.0000000000002039 -
Techniques in Coloproctology Aug 2022The aim of the present study was to evaluate the efficacy and safety of 3% polidocanol foam for treating 2nd-degree haemorrhoids.
A multicentre, open-label, single-arm phase II trial of the efficacy and safety of sclerotherapy using 3% polidocanol foam to treat second-degree haemorrhoids (SCLEROFOAM).
BACKGROUND
The aim of the present study was to evaluate the efficacy and safety of 3% polidocanol foam for treating 2nd-degree haemorrhoids.
METHODS
A multicentre, open-label, single-arm, phase 2 trial involving 10 tertiary referral centres for haemorrhodal disease (HD) was performed. Between January and June 2019, patients with 2nd-degree haemorrhoids were prospectively included in this study. The primary outcome was to establish the success rate after one sclerotherapy session in terms of complete resolution of bleeding episodes one week after the injection. The Hemorrhoidal Disease Symptom Score (HDSS), the Short Health Scale for HD (SHS-HD) score and the Vaizey incontinence score were used to assess symptoms and their impact on quality of life and continence. Pain after the procedure, subjective symptoms and the amount and type of painkillers used were recorded. Patients were followed up for 1 year.
RESULTS
There were 183 patients [111 males; 60.7%, mean age 51.3 ± 13.5 (18-75) years]. Complete resolution of bleeding was reached in 125/183 patients (68.3%) at 1 week and the recurrence rate was 12% (15/125). Thirteen patients (7.4%) underwent a second sclerotherapy session, while only 1 patient (1.8%) had to undergo a third session. The overall 1-year success rate was 95.6% (175/183). The HDSS and the SHS score significantly improved from a median preoperative value of 11 and 18 to 0 and 0, respectively (p < 0.001). There were 3 episodes of external thrombosis. No serious adverse events occurred.
CONCLUSIONS
Sclerotherapy with 3% polidocanol foam is a safe, effective, painless, repeatable and low-cost procedure in patients with bleeding haemorrhoids.
Topics: Adolescent; Adult; Aged; Female; Hemorrhoids; Humans; Male; Middle Aged; Polidocanol; Quality of Life; Sclerotherapy; Treatment Outcome; Young Adult
PubMed: 35334004
DOI: 10.1007/s10151-022-02609-w