A clinical study of the local injection of a freshly manufactured 35 kDa hyaluronan fragment for treating chronic wounds.

This study manufactured a 35 kDa hyaluronan fragment (HA35) by enzymatically degrading high-molecular-weight HA using hyaluronidase PH20 derived from bovine testis. The research then examined the therapeutic efficacy of locally administered, tissue-permeable HA35 in alleviating chronic wounds and their associated neuropathic pain. For 20 patients with nonhealing wounds and associated pain lasting over three months, 100 mg of HA35 was injected daily into the healthy skin surrounding the chronic wound for 10 days. Self-assessments before and after treatment indicated that HA35 significantly enhanced wound healing. This was evidenced by the formation of fresh granulation tissue on the wounds (p < 0.0001); reduced darkness, redness, dryness, and damage in the skin surrounding the wounds (p < 0.0001), and a decrease in wound size (p < 0.001). Remarkably, HA35 injections alleviated pain associated with chronic wounds within 24 hours (p < 0.0001). It can be concluded that the low-molecular-weight hyaluronan fragment HA35 potentially enhances the immune response and angiogenesis during wound healing.

A treatment algorithm for hyaluronic acid filler related complications of the face.

BACKGROUND: Throughout the last decade, a notable increase in HA-filler-related complications have been observed, owing to the increase in demand for filler injections and availability of multiple products. OBJECTIVES: The aim is to provide practical advice on the best way to prevent and treat HA-filler-related complications. METHODS: Thirty patients who experienced visible and/or symptomatic complications localized within the facial area were treated according to our algorithm. Patients with inflammatory lesions underwent antibiotic and anti-inflammatory therapy, followed by hyaluronidase injections. Patients with abscesses were treated with antibiotics, incision, and drainage. Each patient completed the dermatology-specific quality of life questionnaire (DLQI) at the first and last examinations. RESULTS: Among the 29 patients who received antibiotic therapy, 3 healed without further treatment. However, 18 received hyaluronidase injections, 9 underwent incision and drainage, and 5 presented with fistulas and developed retracted scars. Moreover, 80% of the patients were completely healed, 13% significantly improved, and 3% did not show any improvement. The DLQI scores analysis showed a notable impact of patients' diseases on their quality of life, mainly in the terms of personal relationships and symptoms, with minor impacts on intimate relationships, ability to work, and study. We demonstrated that our algorithm resulted in a significant improvement in the overall quality of life at the last follow-up (p < 0.001). CONCLUSIONS: The use of filler injections requires caution and specific training because they can lead to serious complications. If these complications are recognized promptly, healing can be optimized. Our treatment algorithm demonstrated high rate of healing and significant improvement in the patients' quality of life.

[Effectiveness and interest of retrobulbar hyaluronidase injections in the treatment of blindness complicating facial hyaluronic acid injections: A literature review]. / Efficacité et intérêt des injections rétrobulbaires de hyaluronidase dans le traitement des cécités compliquant une injection faciale d'acide hyaluronique : revue de la littérature.

INTRODUCTION: Hyaluronic acid injections are becoming increasingly common among both the general public and the medical community, but they are not without risks. The occurrence of blindness, although rare, is a tragic event for both the patient and the practitioner. One of the treatments proposed in the literature is to inject hyaluronidase as close as possible to the site of ischemia, retrobulbarly. The aim of our study is to evaluate the effectiveness and potential benefits of retrobulbar hyaluronidase injections. MATERIALS AND METHODS: A literature review was conducted using the PubMed database. Only articles addressing retrobulbar hyaluronidase injections for the treatment of blindness following hyaluronic acid injections were included. RESULTS: We identified 12 case reports or series, comprising a total of 16 patients. Among these 16 patients, 3 regained their vision. Hyaluronidase was injected between 20minutes and 7days after the onset of the complication, with injected doses ranging from 3×150IU to 3×1500IU. DISCUSSION: Literature reveals only 3 cases of successful treatment out of the 16 reported injections. The time interval before retrobulbar injection, as well as the dose and the experience of the injecting practitioner, may influence the success rate of this treatment. Other treatments, such as intravascular hyaluronidase injections, remain to be explored.

[Vascular occlusion following profile harmonization of the chin with hyaluronic acid fillers]. / Vasculaire occlusie na profielharmonisatie van de kin met hyaluronzuur fillers.

The use of dermal fillers for cosmetic procedures has increased rapidly both worldwide and in the Netherlands in recent years, which has led to an absolute increase in reported side effects and complications. Although most of these complications are mild, serious complications such as vascular occlusion can also occur. In this article, we describe a case of a 35-year-old woman who showed signs of reduced tissue perfusion and the early stage of skin necrosis following injection of hyaluronic acid fillers in the chin. This complication was successfully treated by ultrasound-guided injection of hyaluronidase, resulting in a full recovery without residual symptoms. To minimize the risk of serious complications treatment with hyaluronic acid fillers should be carried out by an experienced practitioner.

A Phase 1 Open-Label Study to Assess the Tolerability, Safety, and Immunogenicity of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 20% in Healthy Adults.

PURPOSE: Hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 20% will allow reduced infusion volumes and frequency versus existing subcutaneous therapies such as fSCIG 10% and conventional subcutaneous immunoglobulin 20%, respectively. We assessed the tolerability, safety, and immunogenicity of warmed and unwarmed fSCIG 20%. METHODS: This phase 1, single-dose, open-label, three-arm study enrolled healthy adults aged 19-50 years (inclusive) at a single US center (NCT05059977). Post-screening, participants received a single fSCIG 20% dose comprising recombinant human hyaluronidase and varying doses of in-line warmed or unwarmed immunoglobulin G (IgG) during a 4-day treatment period in a sentinel and sequential dosing design (treatment arm 1, warmed IgG 20% 0.4 g/kg; treatment arm 2, warmed IgG 20% 1.0 g/kg; treatment arm 3, unwarmed IgG 20% 1.0 g/kg). Participants were followed for 12 (± 1) weeks post-infusion. The primary endpoint was tolerability ("tolerable" infusions were not interrupted, stopped, or reduced in rate owing to fSCIG 20%-related treatment-emergent adverse events (TEAEs)). Secondary endpoints included occurrence of TEAEs. RESULTS: Overall, 24 participants were included, 8 per treatment arm (mean age 39.0 years, 54.2% men). All participants tolerated the infusions. All TEAEs were mild (107 events, in all participants), and all participants experienced fSCIG 20%-related (105 events) and local (102 events) TEAEs. Infusion site erythema and infusion site swelling were most frequently reported. No serious TEAEs occurred, and no participants discontinued the study owing to TEAEs. CONCLUSION: fSCIG 20% was well-tolerated with a favorable safety profile in healthy adults. Future studies will evaluate fSCIG 20% in primary immunodeficiency diseases. Trial registration number (ClinicalTrials.gov): NCT05059977 (registered 28 September 2021).

Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial.

BACKGROUND AND AIMS: ADVANCE-CIDP 1 evaluated facilitated subcutaneous immunoglobulin (fSCIG; human immunoglobulin G 10% with recombinant human hyaluronidase) efficacy and safety in preventing chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) relapse. METHODS: ADVANCE-CIDP 1 was a phase 3, double-blind, placebo-controlled trial conducted at 54 sites in 21 countries. Eligible adults had definite or probable CIDP and adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores of 0-7 (inclusive), and received stable intravenous immunoglobulin (IVIG) for ≥12 weeks before screening. After stopping IVIG, patients were randomized 1:1 to fSCIG 10% or placebo for 6 months or until relapse/discontinuation. fSCIG 10% was administered at the same dose (or matching placebo volume) and interval as pre-randomization IVIG. The primary outcome was patient proportion experiencing CIDP relapse (≥1-point increase in adjusted INCAT score from pre-subcutaneous treatment baseline) in the modified intention-to-treat population. Secondary outcomes included time to relapse and safety endpoints. RESULTS: Overall, 132 patients (mean age 54.4 years, 56.1% male) received fSCIG 10% (n = 62) or placebo (n = 70). CIDP relapse was reduced with fSCIG 10% versus placebo (n = 6 [9.7%; 95% confidence interval 4.5%, 19.6%] vs n = 22 [31.4%; 21.8%, 43.0%], respectively; absolute difference: -21.8% [-34.5%, -7.9%], p = .0045). Relapse probability was higher with placebo versus fSCIG 10% over time (p = .002). Adverse events (AEs) were more frequent with fSCIG 10% (79.0% of patients) than placebo (57.1%), but severe (1.6% vs 8.6%) and serious AEs (3.2% vs 7.1%) were less common. INTERPRETATION: fSCIG 10% more effectively prevented CIDP relapse than placebo, supporting its potential use as maintenance CIDP treatment.

Short term treatment of secondary lymphedema with hyaluronidase injections reduces mouse hindlimb lymphedema.

Lymphedema is a common complication following breast cancer treatment with axillary lymphadenectomy and radiotherapy. Currently, there is no curative treatment for this disease, hence there is a need for new therapeutic suggestions. The aim of this study was to investigate the effect of hyaluronidase (HYAL) injections after inducing hindlimb lymphedema in 36 female C57BL/6 mice. HYAL injections were administered every second day for 14 days in three groups: (1) HYAL for 1 week followed by saline for 1 week, (2) HYAL for 2 weeks, and (3) saline injections for 2 weeks. Volume of the lymphedema limb was weekly assessed with micro-computed tomography (µ-CT) scans for a total course of 6 weeks. Lymph vessel morphometry was assessed in the end of the study after staining cross-sections of the hindlimb for anti-LYVE-1 blindly. Lymphatic function was assessed by lymphoscintigraphy to assess lymphatic clearance. There was a significant reduction of the volume of lymphedema in mice treated with HYAL-7 compared with mice treated with HYAL-14 (p < 0.05) and saline (p < 0.05). No differences were detected in lymph vessel morphometry and the lymphoscintigraphy between groups. Short-term treatment with HYAL-7 might be a potential therapeutic suggestion for secondary lymphedema induced in mouse hindlimbs. In the future, clinical studies are needed to investigate the potential of HYAL treatment in human beings.

Ultrasonography-Guided Intra-Arterial Hyaluronidase Treatment of Vascular Occlusions.

The purpose of this article is to introduce a recommendation for an adjunct approach to the current treatment protocol for vascular occlusion (VO). Current guidelines for treatment of VO do not incorporate the use of ultrasonographic technology. Using bedside ultrasonography has gained recognition as an effective way to map out the vessels of the face to prevent VO. Ultrasonography has also been found to be helpful for treating VO as well as other hyaluronic acid filler-related complications.

Successful management of delayed hyaluronidase hypersensitivity after subtenon's anesthesia during the COVID-19 pandemic: A rare case report.

Subtenon's block is commonly used to achieve akinesia, analgesia, and anesthesia for ophthalmic surgeries. This case study detailed a rare hypersensitivity report in a 65-year-old female who had underwent manual small incision cataract surgery under subtenon's anesthesia (STA) in the left eye. On postoperative day 1, she presented with acute onset proptosis, periorbital edema, conjunctival chemosis, and restriction of extraocular movements. The pupillary reaction and dilated fundus examination were normal. A differential diagnosis of orbital cellulitis, Mucormycosis, and hyaluronidase hypersensitivity (HH) was considered. Since the patient was afebrile, and pupillary reactions, ENT, neurological, and fundus examination were normal, the diagnosis was narrowed down to delayed HH. The patient was managed with a 1 cc IV injection of dexamethasone once a day for 3 days, along with routine postoperative drugs. As per detailed literature review, this is probably a second case report of delayed HH post-STA.

Comparative effectiveness of medicinal interventions for oral submucous fibrosis: A network meta-analysis.

OBJECTIVES: This network meta-analysis presents an exhaustive description and comparison of the available medical interventions for the management of oral submucous fibrosis (OSMF). MATERIALS AND METHODS: A systematic review and network meta-analysis was conducted after registration with PROSPERO. (PROSPERO ID CRD42022303441). Databases (PubMed, Cochrane, EMBASE, Web of Science, and others) were searched for randomized clinical trials (RCT) trials from inception till September 2022 for the medical interventions in OSMF. The primary outcome was the improvement in mouth opening. The secondary outcomes were improvement in burning sensation, tongue protrusion, and cheek flexibility. The interventions were ranked according to their efficacy based on the surface under the cumulative ranking. RESULTS: 47 studies including 2393 patients were assessed for quantitative analysis. For mouth opening, the combined treatment with steroid, hyaluronidase, and antioxidant was most effective [MD, 7.05 (95%CI 1.76,12.34)], followed by the combination of oral antioxidants with injectable steroids, [MD, 3.80 (95%CI -0.44,8.03)]. Additionally, the combined treatment with steroid, hyaluronidase, and antioxidant was most effective in reducing the burning sensation [MD, -8.62(-10.95,-6.30)], followed by aloe vera [MD, -8.45(-10.40,-6.49)] and pentoxifylline [MD -7.57(-9.46,-5.68)]. For tongue protrusion, curcumin was most effective followed by antioxidants. Most of the drugs used were reported to cause negligible or mild adverse effects. CONCLUSION: This network meta-analysis reported the efficacy of medicinal interventions in OSMF patients compared to the placebo in the improvement of mouth opening and burning sensation, and cheek flexibility. The methodological quality of included RCTs was low. Well-designed studies are recommended to obtain strong evidence.

Hyaluronidase Availability in Emergency Rooms: A Statewide Analysis.

Objective: Authors sought to determine the immediate availability of hyaluronidase (HYAL) among emergency rooms (ERs) in California. Background: Hyaluronic acid (HA) fillers are regarded as a safe procedure; however, major ischemic complications do exist, notably blindness and tissue necrosis. The successful management of these vascular events relies on an injector's immediate HYAL, the enzymatic reversal agent for HA. Unfortunately, many barriers exist for injector sites to stock HYAL. As a result, ERs serve as unofficial safety nets in cases when providers encounter an ischemic complication and do not have HYAL in supply. Materials and Methods: Telephone survey inquiring about HYAL availability in all California ERs. Results: This study included 330 California ERs and achieved an 89.7% response rate (n = 296). 45.6% of the surveyed ERs did not have immediate access to HYAL. HYAL availability was positively associated with level I-III adult trauma center status, pediatric trauma center status, children's hospital status, higher bed counts, and regional geography (p < 0.05, all). Conclusions: HYAL availability is unreliable among Californian ERs, posing a potential risk to patient safety.

Early ultrasound for diagnosis and treatment of vascular adverse events with hyaluronic acid fillers.

BACKGROUND: Hyaluronic acid fillers are known for a reliable safety profile, but complications do occur, even serious vascular adverse events. OBJECTIVE: To improve the treatment outcome after a vascular adverse event with use of hyaluronic acid filler treatments. METHODS: Duplex ultrasonography is used to detect the hyaluronic acid filler causing the intra-arterial obstruction. RESULTS: If treated in time, 1 single treatment of ultrasonographically guided injections of hyaluronidase into the filler deposit will prevent skin necrosis. CONCLUSION: Because the use of duplex ultrasonography adds extra essential information, its use may become an integral part of the prevention and treatment of injection adverse events.

Use of the high-dose pulsed hyaluronidase protocol in the management of impending skin necrosis associated with hyaluronic acid fillers: a systematic review.

Impending skin necrosis resulting from inadvertent intravascular injection of hyaluronic acid (HA) fillers can lead to tissue loss and significant scarring. In recent years, management trends have shifted from multimodal approaches to the sole use of high doses of hyaluronidase. The aim of this systematic review was to evaluate the effectiveness of the high-dose pulsed hyaluronidase management protocol in preventing skin necrosis and possible subsequent scarring. An online search of the bibliographic databases PubMed and Embase yielded 3039 articles. A total of 72 studies reporting 186 cases were found to be eligible for inclusion. The selection and evaluation process was done according to the PRISMA criteria. Included studies were assessed using the JBI and STROBE critical appraisal tools. The analysis of treatment outcomes was done according to the timing of treatment initiation and the type of intervention used. This review found that an immediate intervention using the high-dose pulsed hyaluronidase management protocol provided predictable and satisfactory outcomes. Initiating the protocol within 24 h of filler injection halted the progression of necrosis and prevented permanent sequelae. The conclusions are limited by the lack of a high level of evidence, since the only available sources of data are case reports and case series.

The Utility of Hyaluronidase for the Free and Pedicle Flap Salvage.

Hyaluronidase is commonly used to treat swelling and hematoma for aesthetic and reconstructive purposes. It has also been reported as a stimulator of angiogenesis. The purpose of this study was to introduce the utility of hyaluronidase in patients with flap compromise after free and pedicle flap reconstructions. This study was a retrospective study of 1 case of radial forearm free flap salvage, 2 cases of keystone perforator flap salvage, and 1 case of pectoralis major myocutaneous flap salvage. A radial forearm free flap reconstruction of unilateral mouth floor and tongue defect was complicated with hematoma formation on a postoperative day 1 after taking clopidogrel due to acute-onset non-ST-elevation myocardial infarction but dramatically resolved with hyaluronidase injection into the flap and contralateral unaffected tongue. After this intervention, the flap color dramatically returned to normal and became soft without further treatments. Two keystone design perforator flaps were performed to reconstruct the sacral defect after the debridement of pressure ulcers. Two cases were related to the patients' medical conditions, such as low platelet count caused by liver cirrhosis. We also salvaged pectoralis major myocutaneous flap in a 91-year-old female patient with large breasts. This study introduced our experience of salvaging the free and pedicled flaps using hyaluronidase. Hyaluronidase is an excellent option when arterial or venous insufficiency occurs after free and perforator flap surgeries.

Comparison Of Efficacy Of Steroids Alone And Combination Of Steroids With Hyaluronidase On Mouth Opening In Oral Submucous Fibrosis Patients.

BACKGROUND: Eventually Oral submucous fibrosis causes pronounced stiffness and failure to open the mouth. Objectives are to determine compare the efficacy of intralesional steroids alone and combination of steroids with hyaluronidase on mouth opening in oral submucous fibrosis. METHODS: It was a prospective comparative cohort study. Total of 74 patients both male and female having history of pan chewing and limited mouth opening and burning sensations were included in the study. Informed consent was taken and divided into two groups. Patients of group 1 were managed with mixture of betamethasone 1 ml and hyaluronidase 1500 IU and patients of group 2 were treated with only steroid injection of betamethasone 1 ml given intralesional, both injections were given intralesional, by multiple puncture technique and once a week and continued for twelve weeks (3 months). And data compiled and analyzed in SPSS-20. RESULTS: The mean age of group 1 was 40.027±6.97 years, and mean age of Group 2 was 37.351±5.48 years. In both groups, the greatest number of cases aged from 31-59 years. Compared to females in both groups, the majority of patients were males. In 32 (86.4)% patients of group 1 showed efficacy compared with 18[43.2] patients in group 2 [p-0.000]. Conclusion: In this study Intralesional steroids with hyaluronidase injections are more efficient for opening the mouth in patients with oral sub-mucus fibrosis.

Use of liquid concentrated growth factor in the management of necrotic tissue after facial vascular complications induced by hyaluronic acid injection.

INTRODUCTION: HA fillers may induce facial vascular embolism. The resulting tissue ischemia and necrosis are severe iatrogenic complications for which no effective treatments are available. OBJECTIVE: This single-center case series studied the use of liquid CGF in the management of facial tissue necrosis due to HA injection. METHODS: All 12 patients with facial tissue necrosis (2 mild, 3 moderate, 7 severe) were previously treated with hyaluronidase injection in outside hospitals. They received a routine injection of hyaluronidase (dose of 400-1500 U) at the site of ischemia immediately after admission to the authors' hospital, but CGF was also injected. CGF injection was repeated once weekly until wound healing. Efficacy was assessed at 4 weeks (mean, 24.08 days). RESULTS: No patient experienced wound expansion or aggravation or infection at the sites of necrosis. A complete healing rate of 91.67% was noted at the 4-week follow-up. No scarring was evident in patients with mild to moderate necrosis. Those with moderate necrosis exhibited varied degrees of scarring after recovery, and scarring was evident in those with severe necrosis. No severe adverse effects occurred. CONCLUSION: CGF promoted the healing of ischemic and necrotic tissue wounds induced by facial vascular embolism following injection of HA fillers. CGF should be considered as a nonsurgical treatment method for vascular embolism following HA filler injection.

Pentoxifylline - A Novel Adjunct in the Management of Patients with Oral Submucous Fibrosis in Terai Population of Nepal: A Prospective Case Control Study.

Oral submucous fibrosis is a premalignant condition largely seen in the South-Asian countries mainly due to the consumption of areca nut. Pentoxifylline is a methylxanthine derivative, with vasodilating, anti-inflammatory and immune modulatory properties and is believed to increase the vascularity of the mucosal layer. The study was conducted to clinically assess the effectiveness of orally given pentoxifylline with dexamethasone (4mg/ml) given intralesionally and hyaluronidase 1500 IU with 0.5ml of 2.0% lignocaine plus multivitamins in the management of Oral submucous fibrosis patients pertaining to the Terai belt of Nepal. This study was conducted as an experimental study consisting of 70 oral submucous fibrosis patients who were divided blindly into two groups i.e. control or standard drug group (n=35) and experimental drug group (n=35). Standard drug group were given biweekly intralesional injections of dexamethasone (4mg/ml) and hyaluronidase 1500IU with 0.5ml of 2.0% lignocaine plus one capsule of multivitamins daily for a period of 12 weeks whereas experimental drug group were given pentoxifylline tablets 400mg 3 times daily for 12 weeks in addition to the drugs given to the standard drug group. Variables considered in the study were burning sensation, mouth opening, tongue protrusion and cheek flexibility using visual analog scale, vernier caliper, cheek retractor and a metric scale. On comparing, statistically significant results were seen in experimental drug group as far as reduction in burning sensation (p<0.001) and increase in mouth opening (p<0.001) was concerned. As far as improvement in tongue protrusion and cheek flexibility were concerned, the results were appreciating but statistically not significant (p=0.231) and (p=0.251) respectively. This study showed the effectiveness of pentoxifylline as an adjunct in the routine management of oral submucous fibrosis.

Effects of photobiomodulation (660 nm laser) on anthracycline extravasation: An experimental study.

OBJECTIVE: to investigate the effect of using different agents (topical hyaluronidase, photobiomodulation, and the association of photobiomodulation with topical hyaluronidase) in preventing the formation of lesions caused by doxorubicin extravasation, as well as in the reduction of lesions formed by extravasation of this drug. METHOD: a quasi-experimental study conducted with 60 Wistar rats, randomized into four groups with 15 animals each. Group 1 (Control); Group 2 (Hyaluronidase); Group 3 (Photobiomodulation); and Group 4 (Hyaluronidase + Photobiomodulation). A wound was induced by applying 1 mg of doxorubicin to the subcutaneous tissue of the back of the animals. The concentration of topical hyaluronidase was 65 turbidity units/g and the energy employed was 1 joule of 100 mW red laser per square centimeter. With macroscopic evaluation every two days for 28 days, the following variables were observed: skin integrity, presence of blisters, hyperemia, exudate, bleeding, edema, crust, peeling and granulation tissue. RESULTS: the animals from the groups subjected to photobiomodulation obtained better results in the assessment of the following variables: bleeding, hyperemia, exudate, intact skin and edema. CONCLUSION: it was evidenced that the association of photobiomodulation with topical hyaluronidase was effective in reducing the local effects and assisted in the wound healing process, and that PBM alone was able to prevent appearance of lesions.

Muscle Activity in Pre-Treatment and Post-Treatment Oral Submucous Fibrosis Patients: Electromyography Study.

Background: Oral submucous fibrosis (OSMF) is a premalignant condition of insidious onset which affects the oral mucosa, pharynx, and esophagus. The muscles of mastication are known to be affected resulting in limited mouth opening. Electromyography (EMG) is a sophisticated method of measuring and evaluating muscle activity. Previously, EMG was primarily utilized in medical sciences, but it is currently being used extensively in both the medical and dentistry fields. Objectives: The aim of the study is to evaluate the electromyographic activity of masseter muscle in OSMF patients before and after treatment and to compare with healthy controls. Materials and Methods: This prospective case-control clinical study comprised 180 OSMF patients who were divided into four groups and 45 healthy individuals served as the control group. The OSMF individuals were injected with hyaluronidase 1,500 IU mixed in 1.5 ml of dexamethasone and 0.5 ml of lignocaine HCL intralesionally twice a week for one month along with a basic physiotherapy regimen consisting of mouth exercises two times daily. The control subjects were given placebo capsules. The treatment was carried out for a month and the electromyographic masseter muscle activity was evaluated among the OSMF patients and control group before and after treatment. Results: The results revealed that the electromyographic activity of master muscles in OSMF patients showed increased activity when compared with healthy controls. Patients with OSMF showed decreased muscle activity after treatment. Conclusion: When compared with healthy controls, OSMF patients had higher electromyographic activity of the masseter muscles and the muscle activity was decreased following treatment. In OSMF patients, EMG may help in determining the involvement of the mastication and facial expression muscles. It can also be used as a diagnostic tool to assess the treatment outcome of muscle activity in OSMF patients.

Virulence, phenotype and genotype characteristics of invasive group B Streptococcus isolates obtained from Swedish pregnant women and neonates.

Group B streptococci (GBS) are bacteria that can cause preterm birth and invasive neonatal disease. Heterogeneous expression of virulence factors enables GBS to exist as both commensal bacteria and to become highly invasive. A molecular epidemiological study comparing GBS bacterial traits, genotype and host characteristics may indicate whether it is possible to predict the risk of perinatal invasive GBS disease and more accurately target intrapartum antibiotic prophylaxis. A total of 229 invasive GBS isolates from Swedish pregnant women or neonates were assessed for virulence and phenotypic traits: hemolysis zone, hemolytic pigment (Granada agar), Streptococcus B Carrot Broth (SBCB) assay, CAMP factor, and hyaluronidase activity. Genes regulating hemolytic pigment synthesis (covR/covS, abx1, stk1, stp1) were sequenced. Of the virulence factors and phenotypes assessed, a Granada pigment or SBCB score ≥ 2 captured more than 90% of EOD isolates with excellent inter-rater reliability. High enzyme activity of hyaluronidase was observed in 16% (36/229) of the invasive GBS isolates and notably, in one case of stillbirth. Hyaluronidase activity was also significantly higher in GBS isolates obtained from pregnant/postpartum individuals versus the stillbirth or neonatal invasive isolates (p < 0.001). Sequencing analysis found that abx1 (g.T106I), stk1 (g.T211N), stp1 (g.K469R) and covS (g.V343M) variants were present significantly more often in the higher (Granada pigment score ≥ 2) versus lower pigmented isolates (p < 0.001, each variant). Among the 203 higher Granada pigment scoring isolates, 22 (10.8%) isolates had 3 of the four sequence variants and 10 (4.9%) had 2 of the four sequence variants. Although heterogeneity in GBS virulence factor expression was observed, the vast majority were more highly pigmented and contained several common sequence variants in genes regulating pigment synthesis. High activity of hyaluronidase may increase risk for stillbirth and invasive disease in pregnant or postpartum individuals. Our findings suggest that testing for GBS pigmentation and hyaluronidase may, albeit imperfectly, identify pregnant people at risk for invasive disease and represent a step towards a personalized medical approach for the administration of intrapartum antibiotic prophylaxis.