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The effects of poloxamer and sodium alginate mixture (Guardix-SG®) on range of motion after axillary lymph node dissection: A single-center, prospective, randomized, double-blind pilot study.
Lee, SB, Gwark, SC, Kang, CM, Sohn, G, Kim, J, Chung, IY, Lee, JW, Kim, HJ, Ko, BS, Ahn, SH, et al
PloS one. 2020;(9):e0238284
Abstract
PURPOSE Restricted shoulder mobility is a major upper extremity dysfunction associated with lower quality of life and disability after breast cancer surgery. We hypothesized that a poloxamer and sodium alginate mixture (Guardix-SG®) applied after axillary lymph node dissection (ALND) would significantly improve shoulder range of motion (ROM) in patients with breast cancer. METHODS We conducted a double-blind, randomized, prospective study to evaluate the clinical efficacy and safety of Guardix-SG® for the prevention of upper extremity dysfunction after ALND. The primary outcome measure was shoulder ROM at baseline (T0) and 3 (T1), 6 (T2), and 12 months (T3) after surgery. Secondary outcome measures were the Disabilities of the Arm, Shoulder, and Hand score(DASH), pain associated with movement, which was assessed using a numeric rating scale, and lymphedema assessed using body composition analyzer. RESULTS A total of 83 women with breast cancer were randomly assigned to either the Guardix-SG® group or the control group. In the Guardix-SG® group (n = 37), Guardix-SG® was applied to the axillary region after ALND. In the control group (n = 46), ALND was performed without using Guardix-SG®. Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182). No adverse effect was observed in either group. CONCLUSIONS The results of this study have shown that Guardix-SG® help improve shoulder ROM without causing adverse effects in patients who underwent breast cancer surgery. However, there was no statistically significant difference from the control group. A further large-scale study is needed to obtain a more conclusive conclusion. TRIAL REGISTRATION CRISKCT0003386; https://cris.nih.go.kr (20181207).
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Hyaluronan oligosaccharides modulate inflammatory response, NIS and thyreoglobulin expression in human thyrocytes.
D'Ascola, A, Scuruchi, M, Ruggeri, RM, Avenoso, A, Mandraffino, G, Vicchio, TM, Campo, S, Campo, GM
Archives of biochemistry and biophysics. 2020;:108598
Abstract
Autoimmune thyroid diseases, such as Hashimoto's thyroiditis, are characterized by lymphocytic infiltration and altered function of the thyroid. During inflammation, it has been reported a decreased expression in Tg and NIS, accompanied by an increase in HA production that accumulates in the gland. HA fragments produced in different pathological states can modulate gene expression in a variety of cell types and may prime inflammatory response by interacting with the TLR-2, TLR-4 and CD44 that, in turn, induce NF-kB activation finally responsible of inflammatory mediator transcription, such as IL-1β, TNF-α and IL-6. The aim of this study was to investigate the potential inflammatory effect and the biochemical pathways activated by 6-mer HA oligosaccharides in cultured human thyrocytes. 6-mer HA treatment induced up-regulation of TLR-2, TLR-4, CD44 mRNA and related protein levels, increased HA production and NF-kB activation, that in turn increased IL-1β and IL-6 concentrations. Instead, we found evidence of an opposite effect on thyroid specific-gene Tg and NIS, that were decreased after 6-mer HA addition. Thyrocytes exposition to specific blocking antibodies for TLR-2, TLR-4 and CD44 abolished up-regulation of NF-κB activation and the consequent pro-inflammatory cytokine production, while restored Tg and NIS levels. A further goal of this study was demonstrate that also other LMW HA have pro inflammatory proprieties. These data suggest that HA fragments, through the involvement of TLR-2, TLR-4 and CD44 signaling cascade, contribute to prime the inflammatory response in thyrocytes and, by reducing the expression of thyroid-specific genes, could promote the loss of function of gland such as in Hashimoto's thyroiditis.
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Pumpkin seeds, Centella asiatica, Boswellia, Helichrysum, acetate vitamin E, Melaleuca alternifolia and hyaluronic acid phytocomplex monotherapy effects in patients with chronic pelvic pain syndrome.
Di Vico, T, Durante, J, Polito, C, Tognarelli, A, Canale, D, Caglieresi, C, Morelli, G, Bartoletti, R
Minerva urologica e nefrologica = The Italian journal of urology and nephrology. 2020;(2):236-242
Abstract
BACKGROUND Proxelan® and antibiotics combined therapy was successfully previously used in the treatment of symptoms of patients with chronic prostatitis. Aim of the present study was to investigate the effects of Proxelan® monotherapy on pain symptoms of patients with chronic prostatitis (CP) or chronic pelvic pain syndrome (CPPS) in a prospective pilot study. METHODS Thirty consecutive patients with CP/CPPS symptoms younger than 50, without urinary obstruction, total prostate-specific antigen (PSA) <4 ng/mL, negative microbiology testing on prostate fluid and urethral swab, naïve from other treatments during the previous three months were enrolled in a pilot study. IPSS and NIH-CPSI questionnaires were administered to all the patients. Patients could choose to be investigated regarding semen quality and IL6/IL8 seminal markers for inflammatory disease prior and after the therapy course. Proxelan® suppositories were prescribed for each patient for a month with a daily dosage of 1 suppository at bed-time. The primary endpoint of the study included at least a 30% reduction of pain symptoms because similar results can be obtained in each previously investigated placebo group. Effects on semen parameters such as leukocytospermia, spermatozoa concentration and motility, cytokine levels were considered as secondary endpoints. RESULTS Subjective pain relief was obtained in all the patients with significant decrease of NIH-CPSI pain items (P=0.04). Urinary symptoms, investigated by IPSS questionnaire, decreased significantly (P=0.04) as well as quality of life items (P=0.04). Leukocytospermia was found in 5/15 patients available for further investigations. IL6 decreased by 11.55% one month after the treatment while sperm motility resulted increased by 17.3%. CONCLUSIONS Proxelan® monotherapy may represents a promising valid alternative to combined treatment with antibiotics in patients with CP/CPPS symptoms although the results obtained should be investigated in randomized controlled trials.
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Effect of an oral preparation containing hyaluronic acid, chondroitin sulfate, hydrolyzed collagen type II and hydrolyzed keratin on synovial fluid features and clinical indices in knee osteoarthritis. A pilot study.
Oliviero, F, Ramonda, R, Hoxha, A, Scanu, A, Galozzi, P, Favero, M, Frallonardo, P, Punzi, L
Reumatismo. 2020;(3):125-130
Abstract
The aim of this study was to evaluate the effect of an oral preparation containing a naturally occurring matrix of hydrolyzed collagen type II, chondroitin sulfate (CS), and hyaluronic acid (HA), and bioactive oligopeptides of natural hydrolyzed keratin (K) in patients affected by knee OA through the evaluation of synovial fluid (SF) and clinical changes before and after treatment. Thirty patients with knee OA and swollen joint were included in the study and submitted to arthrocentesis. Patients were randomized in two groups: 1) the treatment group (N.15) took a dietary supplement containing 120 mg HA, 240 mg CS and 300 mg K once a day for 4 weeks; 2) the control group (N.15) was only submitted to arthrocentesis. Patient symptoms were evaluated at the beginning and at the end of the study by the WOMAC self-assessment questionnaire, the Lequesne algofunctional index, and the VAS forms. SF changes were evaluated by measuring local inflammatory indices, cytokines IL-1β, IL-8, IL-6, IL-10 and GM-CSF. The group of patients treated with the oral supplement showed an improvement in the clinical indices WOMAC (p<0.01), Lequesne (p=0.014) and VAS pain (p<0.01). On the contrary, no significant changes were found in the control group. The SF collected from the treated group showed a reduction of IL-8 (p=0.015), IL-6 and IL-10 levels, while no changes in cytokines were observed in the control group. This pilot study suggests that an oral administration of a preparation containing a combination of HA, CS and K can improve some clinical parameters and affect cytokine concentrations in SF in patients with knee OA.
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In vitro investigation of hyaluronan-based polymeric micelles for drug delivery into the skin: The internalization pathway.
Starigazdová, J, Nešporová, K, Čepa, M, Šínová, R, Šmejkalová, D, Huerta-Angeles, G, Velebný, V
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. 2020;:105168
Abstract
In our previous research, we concluded that polymeric micelles based on hyaluronic acid are able to penetrate into the deeper layers of skin tissue. The aim of this work was to characterize the mechanisms involved in the uptake by skin cells, which is important for understanding the influence of the carrier composition on the drug penetration. To reach this goal, we used micelles encapsulating curcumin made of oleyl-hyaluronan (HAC18:1) and hexyl-hyaluronan (HAC6) covalently linked with fluorescent Nile Blue. This labeling enabled us to track the micelle-forming derivative and also micelle payload into the keratinocytes and fibroblasts by fluorescent microscopy and flow cytometry. The regulation of both the passive and active cellular uptake was used to determine the mechanism of micelle internalization. Furthermore, the changes of membrane fluidity were measured for these derivatives by FRAP. Using these methods we concluded that carriers entered the cells using both active and passive transport. Passive transport was facilitated by the affinity of the carrier to the cell membrane, especially in the case of HAC18:1 carrier, which changed significantly the membrane fluidity. The active transport was dependent on cell type, but mainly driven by the clathrin-mediated endocytosis and macropinocytosis. Surprisingly, the main HA receptor, CD44, was not involved in the uptake. We can conclude that these carrier systems could be used for the local transport of active substances or hydrophobic drugs into the skin cells using the advantage of passive transport of oleyl-HA derivative.
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Effectiveness of micronized nasal irrigations with hyaluronic acid/isotonic saline solution in non-polipoid chronic rhinosinusitis: A prospective, randomized, double-blind, controlled study.
Savietto, E, Marioni, G, Maculan, P, Pettorelli, A, Scarpa, B, Simoni, E, Astolfi, L, Marchese-Ragona, R, Ottaviano, G
American journal of otolaryngology. 2020;(4):102502
Abstract
BACKGROUND Sodium hyaluronate has been proposed as a treatment for improving the symptoms of chronic rhinosinusitis. The present study evaluated the effect of the intranasal administration of hyaluronic acid in a group of patients affected by chronic rhinosinusitis without nasal polyps (CRSsNP). MATERIALS AND METHODS Thirty subjects aged 18-65 years affected by CRSsNP were enrolled. The subjects were randomly administered hyaluronic acid or isotonic saline solution by nasal nebulizer twice per day for 30 days. They were evaluated before (T0) and after the treatment (T1) with Sino-Nasal Outcome Test-22, visual analogue scale for rhinorrhea, nasal obstruction, facial pain and hyposmia/hypogeusia, nasal endoscopy, active anterior rhinomanometry, peak nasal inspiratory flow and nasal cytology. RESULTS Comparing the study and the control group, at T1 no significant differences were observed in both objective and subjective parameters. Being included in the study group rather than in the control group did not have a significant effect on the variation of the considered parameters between T0 and T1. Considering the effects of the micronized douches independently from the type of solution used (either hyaluronic acid or isotonic saline solution), although no difference emerged between study and control group for any of the objective parameters, there was an improvement of Sino-Nasal Outcome Test-22 scores (p = .0005), visual analogue scale for nasal obstruction (p = .0006) and for hyposmia/hypogeusia (p = .04). CONCLUSIONS The treatment with micronized nasal douches can improve the sino-nasal symptoms of CRSsNP, in particular nasal obstruction and olfactory ability. No advantage of the use of hyaluronic acid over isotonic saline solution emerged.
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Pneumatic Delivery of Hyaluronan for Skin Remodeling: A Comparative Review.
Vinshtok, Y, Cassuto, D, Belenky, I
Journal of drugs in dermatology : JDD. 2020;(2):170-175
Abstract
Jet Volumetric Remodeling (JVR) utilizes the principle of superficial soft tissue delivery of fluids, such as hyaluronic acid (HA) and other therapeutic materials. Dermal delivery of HA activates fibroblasts increasing collagen and elastin synthesis with a long-lasting dermal remodeling and thickening effect. JVR-injected HA causes immediate and diffuse skin hydration resulting in an aesthetically pleasing aspect. JVR technology is able to target different layers during the same treatment with only minor side effects. The article reviews JVR delivery of hyaluronan in comparison to current skin remodeling treatment modalities. J Drugs Dermatol. 2020;19(2)170-175. doi:10.36849/JDD.2020.3641
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Randomised trial on performance, safety and clinical benefit of hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline nasal sprays in patients suffering from dry nose symptoms.
Thieme, U, Müller, K, Bergmann, C, Bock, B, Wurzer-Materna, N, Shahab, T, Zeman, F, Eberhardt, Y, Huppertz, G, Koller, M, et al
Auris, nasus, larynx. 2020;(3):425-434
Abstract
OBJECTIVE Limited data exist on the clinical benefits of nasal applications for moistening the nasal mucosa. We therefore investigated the effects of hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline nasal sprays in patients suffering from dry nose symptoms in an otorhinolaryngological outpatient setting. METHODS 240 patients were randomised into this prospective, three-armed clinical trial with two assessment points (baseline and 4 weeks later). Patients received either hyaluronic acid, hyaluronic acid plus dexpanthenol or isotonic saline nasal spray over a period of four weeks. Rhinitis Sicca Symptom Score (RSSS) was assessed as primary endpoint, and individual symptoms and tolerability of all treatments as secondary endpoints. Patient perceptions after first application of the allocated nasal spray were recorded using the Nasal Spray Sensory Scale. Treatment effects were analysed for each study arm first and subsequently compared against each other. RESULTS RSSS (hyaluronic acid: mean difference = 8.90 [98.33% CI = 7.34/10.45]; hyaluronic acid plus dexpanthenol: mean difference = 8.42 [98.33% CI = 6.91/9.94]; isotonic saline: mean difference = 8.94 [98.33% CI = 7.33/10.54]), individual symptoms and Endoscopy Score improved significantly (p < 0.001) in all treatment arms. Tolerability was assessed as "flawless" in more than 85% of all treatments, which is reflected in overall high rankings in the Nasal Spray Sensory Scale. Perception of nasal moisturisation was reported to be significantly higher in patients receiving hyaluronic acid plus dexpanthenol as compared to patients receiving hyaluronic acid or isotonic saline. No further significant differences were observed between the three treatments. CONCLUSION All three tested sprays (hyaluronic acid, hyaluronic acid plus dexpanthenol and isotonic saline) proved to be suitable treatments for patients suffering from dry nose symptoms. (DRKS-ID: DRKS00013357).
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Ectoine lozenges in the treatment of acute viral pharyngitis: a prospective, active-controlled clinical study.
Dao, VA, Overhagen, S, Bilstein, A, Kolot, C, Sonnemann, U, Mösges, R
European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery. 2019;(3):775-783
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Abstract
PURPOSE Acute pharyngitis is an uncomfortable disorder mostly caused by viruses and for which antibiotics are unwarranted. This study compared lozenges containing ectoine, a natural extremolyte, with hyaluronic acid lozenges and hypertonic saline gargle for symptomatic treatment of acute viral pharyngitis. METHODS This prospective, controlled clinical study, recruited 90 patients with moderate-to-severe pharyngitis symptoms who chose to use either ectoine (n = 35), hyaluronic acid (n = 35), or saline gargle (n = 20). Patients applied their 7-day treatment from the inclusion visit (V1) until the end-of-study visit (V2). Patients' pharyngitis symptoms, general health, general treatment effectiveness and tolerability, and patient compliance were assessed by investigators and patients. RESULTS The sum score for three primary symptoms (pain on swallowing, urge to cough, and hoarseness) decreased by 79.5% (ectoine), 72.2% (hyaluronic acid), and 44.8% (saline gargle). Both lozenges were significantly superior to saline gargle (P < 0.05). Regarding general health improvement, ectoine was significantly superior to saline gargle (72.5% vs. 45.2%, P < 0.05), but hyaluronic acid (63.3%) was not. At V2, 65.7% of patients receiving ectoine reported "very good" general health vs. 48.6% of those receiving hyaluronic acid and 20.0% using saline gargle. Ectoine was significantly superior (P < 0.05) to both hyaluronic acid and saline gargle in terms of tolerability and patient compliance. No patients taking ectoine reported unpleasant sensations while applying their treatment, whereas almost half of patients using hyaluronic acid lozenges and saline gargle did. CONCLUSION Treatment with ectoine lozenges significantly relieves moderate-to-severe symptoms of acute viral pharyngitis and is more effective and tolerable than treatments with hyaluronic acid lozenges and hypertonic saline gargle.
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Comparison of the Efficacy of Topical Chloramphenicol 0.5%-Betamethasone 0.2% (CB) and CB Associated with Sodium Hyaluronate/Trehalose/Carbomer Gel Following Strabismus Surgery.
Vagge, A, Giannaccare, G, Traverso, CE
Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics. 2019;(7):403-406
Abstract
Purpose: To compare the efficacy of topical chloramphenicol 0.5%-betamethasone 0.2% (CB) and CB associated with sodium hyaluronate/trehalose/carbomer (HTC-gel) gel following strabismus surgery. Methods: Longitudinal, single-arm, study case series analysis involved patients undergoing bilateral symmetrical horizontal strabismus surgery. One eye received CB alone and the contralateral eye CB and HTC-gel. Both treatments were instilled 3 times a day for 4 weeks postoperatively. Ocular inflammation was assessed objectively at 1 and 4 weeks by Efron scale for conjunctival redness. Foreign body sensation, burning/stinging, itching, pain, stick feeling, and blurred vision were evaluated by the numerical rating scale. Results: There were 31 patients included in the study. The mean age at presentation was 51 years (standard deviation 24, range 19-85). Conjunctival inflammatory at 1 and 4 weeks showed no statistically significant difference between the 2 treatments (P = 0.75 and P = 0.33, respectively). At 1 week postsurgery, all the subjective parameters showed a significant difference (P < 0.0001) between the 2 groups of treatment to the exclusion of "itching" and "pain" (P = 0.18 and P = 0.67, respectively) with higher scores, to the exception of "blurred vision" in the CB treatment. At 4 weeks postoperatively, no statistically significant differences between the 2 groups (P > 0.16) of treatments were observed, with the exception of the symptom "blurred vision" (0.00 vs. 1.65, CB vs. CB and HTC-gel, respectively, P < 0.0001). Conclusion: CB associated with HTC-gel seems to be an effective treatment option following strabismus surgery.