-
British Journal of Sports Medicine Jul 2009To appraise existing evidence for prolotherapy, polidocanol, autologous whole blood and platelet-rich plasma injection therapies for lateral epicondylosis (LE). (Review)
Review
OBJECTIVE
To appraise existing evidence for prolotherapy, polidocanol, autologous whole blood and platelet-rich plasma injection therapies for lateral epicondylosis (LE).
DESIGN
Systematic review.
DATA SOURCES
Medline, Embase, CINAHL, Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine.
SEARCH STRATEGY
names and descriptors of the therapies and LE.
STUDY SELECTION
All human studies assessing the four therapies for LE.
MAIN RESULTS
Results of five prospective case series and four controlled trials (three prolotherapy, two polidocanol, three autologous whole blood and one platelet-rich plasma) suggest each of the four therapies is effective for LE. In follow-up periods ranging from 9 to 108 weeks, studies reported sustained, statistically significant (p<0.05) improvement in visual analogue scale primary outcome pain score measures and disease-specific questionnaires; relative effect sizes ranged from 51% to 94%; Cohen's d ranged from 0.68 to 6.68. Secondary outcomes also improved, including biomechanical elbow function assessment (polidocanol and prolotherapy), presence of abnormalities and increased vascularity on ultrasound (autologous whole blood and polidocanol). Subjects reported satisfaction with therapies on single-item assessments. All studies were limited by small sample size.
CONCLUSIONS
There is strong pilot-level evidence supporting the use of prolotherapy, polidocanol, autologous whole blood and platelet-rich plasma injections in the treatment of LE. Rigorous studies of sufficient sample size, assessing these injection therapies using validated clinical, radiological and biomechanical measures, and tissue injury/healing-responsive biomarkers, are needed to determine long-term effectiveness and safety, and whether these techniques can play a definitive role in the management of LE and other tendinopathies.
Topics: Blood Transfusion, Autologous; Humans; Injections; Naturopathy; Platelet-Rich Plasma; Polidocanol; Polyethylene Glycols; Randomized Controlled Trials as Topic; Sclerosing Solutions; Tennis Elbow
PubMed: 19028733
DOI: 10.1136/bjsm.2008.052761 -
PloS One 2021Polycystic kidney disease (PKD) is a common genetic disorder that results in a proliferating and enlarging cyst and ultimately leads to loss of kidney function. Because...
Polycystic kidney disease (PKD) is a common genetic disorder that results in a proliferating and enlarging cyst and ultimately leads to loss of kidney function. Because an enlarged cyst is a primary factor for limited kidney function, the large cyst is surgically removed by laparoscopic deroofing or sclerosant. This a relatively nascent treatment method entails complications and sometimes fail due to the cyst fluid refilling and infection. This study proposes using a more stable and effective polidocanol foam with glycerol and Rose Bengal (GRP form) to prevent cyst regeneration and irritation, which is caused by the required body movement during the treatment. Specifically, the foam retention time and viscosity were increased by adding glycerol up to 10% (w/v). The GRP form inhibited cellular proliferation and disrupted cellular junctions, e-cadherin, and cyst formation, demonstrated by the LDH, Live and Dead, and re-plating culture assays. The GRP foam was shown to be a safe and effective treatment as a commercial grade polidocanol foam form by an in vivo study in which subcutaneously injected mice injected with commercial 3% polidocanol, and the GRP foam showed no difference in inflammation. Thus, this study provides an advanced polidocanol form by adding glycerol and Rose-Bengal to help existing sclerotherapy.
Topics: Animals; Biocompatible Materials; Dogs; Glycerol; Madin Darby Canine Kidney Cells; Male; Mice, Inbred BALB C; Polidocanol; Polycystic Kidney Diseases; Rose Bengal; Sclerosing Solutions; Mice
PubMed: 33400697
DOI: 10.1371/journal.pone.0244635 -
Case Reports in Cardiology 2020A 66-year-old female was brought to the emergency department for acute-onset left-sided chest pain. Prior to arrival, she was at an outpatient appointment with a...
A 66-year-old female was brought to the emergency department for acute-onset left-sided chest pain. Prior to arrival, she was at an outpatient appointment with a vascular surgeon for elective sclerotherapy treatment of her lower extremity varicose veins. After receiving an IV injection of polidocanol, she developed severe chest pain with left arm and jaw numbness for the first time in her life. Upon arrival to the ED, the patient reported that her symptoms had resolved. Electrocardiogram (ECG) on presentation was significant for T-wave inversions in leads V1-V3. An initial set of cardiac enzymes showed a troponin I level of 0.62 ng/mL, which subsequently increased to 2.26 ng/mL. Her echocardiogram was significant for mild left ventricular systolic dysfunction with apical hypokinesis (ejection fraction 50%). A repeat ECG showed new T-wave inversions compared to that from the time of admission. The patient eventually agreed to cardiac catheterization, which revealed patent vessels without coronary artery disease, supporting our diagnosis of Takotsubo syndrome and what is the first reported case of likely polidocanol-induced Takotsubo syndrome in the United States.
PubMed: 32082640
DOI: 10.1155/2020/5626078 -
Journal of Vascular Surgery Jan 2011
Topics: Cerebral Infarction; Embolism, Air; Endovascular Procedures; Humans; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Varicose Veins
PubMed: 21184934
DOI: 10.1016/j.jvs.2010.07.058 -
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 -
International Journal of Nanomedicine 2023Endoscopic ultrasound-guided fine-needle injection (EUS-FNI) offers a promising minimally invasive approach for locally targeted management of advanced pancreatic...
PURPOSE
Endoscopic ultrasound-guided fine-needle injection (EUS-FNI) offers a promising minimally invasive approach for locally targeted management of advanced pancreatic cancer. However, the efficacy is limited due to the rapid plasma clearance of chemotherapeutic agents. Injectable hydrogels can form drug release depots, which provide a feasible solution for optimizing targeted chemotherapy through EUS-FNI.
METHODS
A drug delivery system was developed, consisting of gemcitabine (GEM) and thermo-sensitive hydrogel (PLGA-PEG-PLGA, PPP). The injectability, gel formation ability, biocompatibility and sustained drug delivery properties of PPP hydrogel were verified in vitro and in vivo. The effects of GEM/PPP hydrogel on cell proliferation, invasion, metastasis, and apoptosis were explored through co-culturing with PANC-1 cells. The therapeutic effects of GEM/PPP hydrogel on xenograft mice were compared with those of GEM, ethanol and polidocanol using the precisely targeted EUS-FNI technology. Tumor sections were examined by H&E, Ki-67, and TUNEL staining.
RESULTS
GEM/PPP hydrogel exhibited excellent injectability, biocompatibility, and the capability of sustained drug delivery for up to 7 days by forming a gel triggered by body temperature. It demonstrated the best therapeutic effects, significantly reducing proliferation, invasion and migration of PANC-1 cells while promoting apoptosis. After precise injection using EUS-FNI technology, GEM/PPP hydrogel resulted in a reduction of tumor weight by up to 75.96% and extending the survival period by 14.4 days with negligible adverse effects. Pathological examination revealed no systemic toxicity and significant apoptosis and minimal proliferation as well.
CONCLUSION
The combination of GEM/PPP hydrogel and EUS-FNI technology provides an optimal approach of precise chemotherapy for pancreatic cancer, builds a bridge for clinical translation of basic research, and brings great hope for innovation of minimally invasive treatment modalities. The first-hand EUS image data obtained in this study also serves as a crucial reference for future clinical trials.
Topics: Humans; Animals; Mice; Hydrogels; Pancreatic Neoplasms; Gemcitabine; Ultrasonography, Interventional
PubMed: 37496690
DOI: 10.2147/IJN.S417445 -
Frontiers in Surgery 2022In the last 2 years, anorectal surgery has been strongly affected and even surgery for urgent cases cannot be scheduled; also, patients with III- and IV-degree bleeding...
BACKGROUND
In the last 2 years, anorectal surgery has been strongly affected and even surgery for urgent cases cannot be scheduled; also, patients with III- and IV-degree bleeding hemorrhoids should be treated conservatively. The aim was to evaluate the effectiveness of sclerotherapy in patients who had to postpone surgery.
METHODS
We included all patients with III- and IV-degree bleeding hemorrhoids who underwent outpatient sclerotherapy. The visual analog scale and the hemorrhoid severity score were used at the baseline and at 4 weeks after the procedure with a telephone interview, and all patients were outpatient-evaluated 1 week, 1 month, and 1 year after the treatment. All pre- and postoperative data were recorded.
RESULTS
From October 2020 to November 2021, 19 patients with III- (12 patients; 63%) and IV-degree (7 patients; 37%) bleeding hemorrhoids were enrolled. The mean operative time was 4.5 min, and no intraoperative complications occurred. One case of tenesmus and three failures were detected. Six months after the procedure, the overall success rate was 84%, although all of the patients enrolled reported persistent bleeding at the end of the study period. Of these, 5 patients (26%) were scheduled for surgery and 11 patients (58%) refused surgery and asked to undergo a re-do sclerotherapy.
CONCLUSION
Sclerotherapy with 3% polidocanol foam is a safe and effective procedure also in III- and IV-degree bleeding hemorrhoids. The long-term data on the length of the foam remain to be evaluated in additional studies.
PubMed: 36117836
DOI: 10.3389/fsurg.2022.978574 -
Seminars in Interventional Radiology Jun 2021Chronic venous insufficiency is a common and treatable medical condition which has a high morbidity if left untreated, progressing to lower extremity edema, skin changes... (Review)
Review
Chronic venous insufficiency is a common and treatable medical condition which has a high morbidity if left untreated, progressing to lower extremity edema, skin changes of lipodermatosclerosis, and venous ulceration. Treatment options have significantly expanded over the last several decades, shifting away from the traditional surgical approach to more minimally invasive procedures such as endoluminal venous laser ablation or radiofrequency ablation. Even more recently, several techniques using nonthermal methods to ablate varicose veins have been developed, which offer the advantage of not requiring labor-intensive and painful tumescent anesthesia to protect the surrounding tissues. These techniques include mechanochemical ablation, cyanoacrylate closure, or polidocanol microfoam injection and can be offered to a wider range of patients without the need for sedation while offering similar closure rates and improved postprocedure symptom profile. Furthermore, certain patient characteristics which might preclude or complicate the use of thermal ablation methods might not pose a problem with nonthermal nontumescent methods.
PubMed: 34108808
DOI: 10.1055/s-0041-1729155 -
Phlebology May 2016To compare foam bubble size and bubble size distribution, stability, and degradation rate of commercially available polidocanol endovenous microfoam (Varithena®) and... (Clinical Trial)
Clinical Trial
OBJECTIVE
To compare foam bubble size and bubble size distribution, stability, and degradation rate of commercially available polidocanol endovenous microfoam (Varithena®) and physician-compounded foams using a number of laboratory tests.
METHODS
Foam properties of polidocanol endovenous microfoam and physician-compounded foams were measured and compared using a glass-plate method and a Sympatec QICPIC image analysis method to measure bubble size and bubble size distribution, Turbiscan™ LAB for foam half time and drainage and a novel biomimetic vein model to measure foam stability. Physician-compounded foams composed of polidocanol and room air, CO2, or mixtures of oxygen and carbon dioxide (O2:CO2) were generated by different methods.
RESULTS
Polidocanol endovenous microfoam was found to have a narrow bubble size distribution with no large (>500 µm) bubbles. Physician-compounded foams made with the Tessari method had broader bubble size distribution and large bubbles, which have an impact on foam stability. Polidocanol endovenous microfoam had a lower degradation rate than any physician-compounded foams, including foams made using room air (p < 0.035). The same result was obtained at different liquid to gas ratios (1:4 and 1:7) for physician-compounded foams. In all tests performed, CO2 foams were the least stable and different O2:CO2 mixtures had intermediate performance. In the biomimetic vein model, polidocanol endovenous microfoam had the slowest degradation rate and longest calculated dwell time, which represents the length of time the foam is in contact with the vein, almost twice that of physician-compounded foams using room air and eight times better than physician-compounded foams prepared using equivalent gas mixes.
CONCLUSION
Bubble size, bubble size distribution and stability of various sclerosing foam formulations show that polidocanol endovenous microfoam results in better overall performance compared with physician-compounded foams. Polidocanol endovenous microfoam offers better stability and cohesive properties in a biomimetic vein model compared to physician-compounded foams. Polidocanol endovenous microfoam, which is indicated in the United States for treatment of great saphenous vein system incompetence, provides clinicians with a consistent product with enhanced handling properties.
Topics: Female; Humans; Male; Polidocanol; Polyethylene Glycols; Sclerosing Solutions
PubMed: 26036246
DOI: 10.1177/0268355515589063 -
Frontiers in Medicine 2022To evaluate the safety and outcome of image-guided sclerotherapy for treating venous malformations (VMs) of the face.
OBJECTIVES
To evaluate the safety and outcome of image-guided sclerotherapy for treating venous malformations (VMs) of the face.
MATERIALS AND METHODS
A multicenter cohort of 68 patients with VMs primarily affecting the face was retrospectively investigated. In total, 142 image-guided sclerotherapies were performed using gelified ethanol and/or polidocanol. Clinical and imaging findings were assessed to evaluate clinical response, lesion size reduction, and complication rates. Sub-analyses of complication rates depending on type and injected volume of the sclerosant as well as of pediatric versus adult patient groups were conducted.
RESULTS
Mean number of procedures per patient was 2.1 (±1.7) and mean follow-up consisted of 8.7 months (±6.8 months). Clinical response ( = 58) revealed a partial relief of symptoms in 70.7% (41/58), 13/58 patients (22.4%) presented symptom-free while only 4/58 patients (6.9%) reported no improvement. Post-treatment imaging ( = 52) revealed an overall objective response rate of 86.5% (45/52). The total complication rate was 10.6% (15/142) including 4.2% (7/142) major complications, mostly (14/15, 93.3%) resolved by conservative means. In one case, a mild facial palsy persisted over time. The complication rate in the gelified ethanol subgroup was significantly higher compared to polidocanol and to the combination of both sclerosants (23.5 vs. 6.0 vs. 8.3%, = 0.01). No significant differences in complications between the pediatric and the adult subgroup were observed (12.1 vs. 9.2%, = 0.57). Clinical response did not correlate with lesion size reduction on magnetic resonance imaging (MRI).
CONCLUSION
Image-guided sclerotherapy is effective for treating VMs of the face. Clinical response is not necessarily associated with size reduction on imaging. Despite the complex anatomy of this location, the procedures are safe for both adults and children.
PubMed: 36582288
DOI: 10.3389/fmed.2022.1066412