Local Adverse Effects Research Articles

Oral erythema multiforme after Pfizer-BioNTech COVID-19 vaccination: a report of four cases

BackgroundThe 2019 Coronavirus disease (Covid-19) has affected thousands of people worldwide. To date, vaccines appear to be the only method to prevent and reduce mortality. Four vaccinations have been outwardly approved by European Medicine Agency (EMA) in Europe: BNT162b2 (Comirnaty-BioNTech/Pfizer), mRNA-1273 (Spikevax-Moderna), ChAdOx1 (VaxzevriaAstrazeneca), and Ad26.COV2-S (Janssen-Johnson&Johnson). After vaccination, local and systemic adverse effects can occur. Cutaneous reactions like urticaria, local injection site pain, morbilliform rash have been documented after vaccination.Cases presentationWe report four cases of oral erythema multiforme flare arising after BNT162b2 vaccination administration. All the patients denied previous erythema-like and herpetic manifestations history. Two of the reported cases (number 1 and 2) presented with both oral and cutaneous lesions, while cases 3 and 4 showed only oral manifestations. Three of the cases presented the erythema after the first vaccination dosage administration, only one case reported lesions after the second vaccination dosage administration. All the cases were treated with prednisone via oral administration and topical 0.05% clobetasol ointment.ConclusionsThe present reports represent some of the few cases of erythema multiforme occurring as a side effect of the BNT162b2 COVID-19 vaccination. The causal role of the vaccine for the erythema multiforme has not been proven yet; nevertheless, it is not uncommon for medications to trigger this disease. The vaccine could surface a silent herpes virus infection, which would induce the erythema multiforme instead.

Local and Systemic Reactions due to Subcutaneous Allergen Immunotherapy: Our Single-Center 5-Year Experience

Aim: Subcutaneous allergen immunotherapy (SCIT) currently represents the only disease-modifying therapeutic option for the treatment of allergic rhinitis/conjunctivitis, asthma, and venom sensitization. Although SCIT represents a fairly safe therapeutic option in the hands of experienced physicians and centers, it may also be associated with certain adverse effects. In this study, we describe the local and systemic adverse effects in our adult patients undergoing immunotherapy over a 5-year period in an effort to define the causative factors. Materials and Methods: A total of 4413 injections administered to 119 patients (58 female, 61 male) were analyzed. Results: A total of 119 patients with a mean age of 33.7 ± 12 years were included (Female: 58, 48%; Male: 61, 51.3%). In the total population of 119 patients, 6 (5%) developed local reactions, 21 (17.7%) developed large local reactions, and 9 (7.6%) had systemic reactions. Of all injections administered throughout the study period, 0.14% were associated with local reactions, 0.48% with large local reactions, and 0.20% with systemic reactions. Four patients with systemic reactions (44.4%) required epinephrine injection. Patients who did or did not develop adverse effects were significantly different with regard to IgE levels and eosinophil counts (p=0.001 and p=0.002). There was a significant difference between the rates of total adverse reactions developing during the build-up or maintenance phase (p=0.025). Conclusion: Clinicians’ awareness regarding the local, large local, and systemic reactions associated with SCIT should be improved, and clinicians should be more careful during the immunotherapy, especially in the build-up phase, for adverse events.

Efficacy and Safety of FX201, a Novel Intra-Articular IL-1Ra Gene Therapy for Osteoarthritis Treatment, in a Rat Model.

Osteoarthritis (OA) is a disabling, degenerative disease characterized by progressive cartilage and bone damage. There remains a need for local therapies that, following a single injection, can provide long-term pain relief and functional improvement and potentially delay disease progression. FX201 is a novel, intra-articular (IA), interleukin-1 receptor antagonist (IL-1Ra) gene therapy in development for the treatment of OA. In this study, we assessed the efficacy, biodistribution, and safety of helper-dependent adenovirus (HDAd)-ratIL-1Ra, the rat surrogate of FX201, and the biodistribution of FX201, in the anterior cruciate ligament transection (ACLT) rat OA model. A single IA injection of HDAd-ratIL-1Ra administered 7 days post-ACLT mitigated OA-related changes to cartilage, bone, and the synovial membrane at week 12 following surgery. Furthermore, FX201 and HDAd-ratIL-1Ra persisted for at least 92 days in the injected joint and proximal tissues with minimal evidence of vector spreading peripherally. Finally, HDAd-ratIL-1Ra showed a favorable safety profile without any local or systemic adverse effects. In conclusion, HDAd-ratIL-1Ra demonstrated local therapeutic and disease-modifying effects and was well tolerated, supporting further clinical development of FX201.

Strategies to Improve Drug Strength in Nasal Preparations for Brain Delivery of Low Aqueous Solubility Drugs.

Intranasal administration is a promising route for brain drug delivery. However, it can be difficult to formulate drugs that have low water solubility into high strength intranasal solutions. Hence, the purpose of this work was to review the strategies that have been used to increase drug strength in intranasal liquid formulations. Three main groups of strategies are: the use of solubilizers (change in pH, complexation and the use cosolvents/surfactants); incorporation of the drugs into a carrier nanosystem; modifications of the molecules themselves (use of salts or hydrophilic prodrugs). The use of high amounts of cosolvents and/or surfactants and pH decrease below 4 usually lead to local adverse effects, such as nasal and upper respiratory tract irritation. Cyclodextrins and (many) different carrier nanosystems, on the other hand, could be safer for intranasal administration at reasonably high concentrations, depending on selected excipients and their dose. While added attributes such as enhanced permeation, sustained delivery, or increased direct brain transport could be achieved, a great effort of optimization will be required. On the other hand, hydrophilic prodrugs, whether co-administered with a converting enzyme or not, can be used at very high concentrations, and have resulted in a fast prodrug to parent drug conversion and led to high brain drug levels. Nevertheless, the choice of which strategy to use will always depend on the characteristics of the drug and must be a case-by-case approach.

Adalimumab for the Treatment of Pediatric Populations With Non-Infectious Uveitis


 Two systematic reviews, 1 economic evaluation, and 2 evidence-based guidelines were identified regarding the clinical effectiveness (including safety), cost-effectiveness, and use of adalimumab in pediatric populations with non-infectious uveitis.
 Pooled data of the SYCAMORE and ADJUVITE randomized controlled trials comparing adalimumab to placebo demonstrated that adalimumab significantly increased the likelihood of reducing or interrupting corticosteroid use (which is beneficial as long-term corticosteroid use can result in cataracts and glaucoma). Adalimumab significantly increased the event of a satisfactory response rate, but there was no difference in safety assessed as systemic adverse events and local adverse effects.
 Specific to the ADJUVITE trial, visual acuity slightly worsened before and after treatment with adalimumab and it was unclear if adalimumab increased control of intraocular inflammation.
 Specific to the SYCAMORE trial, adalimumab significantly lowered the risk of treatment failure and the rate and number of adverse events and serious adverse events were higher in the adalimumab group compared to the placebo group. For the adalimumab group, the most common adverse event type was infections and infestations and the most common serious adverse events were glaucoma, cataracts, injection site reactions, arthritis, and arthralgia.
 In the perspective of the health care system in the UK, adalimumab plus methotrexate was not found to be cost-effective compared to methotrexate alone (modelled by placebo data) in uveitis associated with juvenile idiopathic arthritis.
 Cost-effectiveness analyses of adalimumab at a discounted price lowered the incremental cost-effectiveness ratio, which supports the potential use of biosimilars in the future due to cost savings.
 Both guidelines recommended the use of treatment that blocks proteins that cause inflammation (tumour necrosis factor-alpha inhibitors) such as adalimumab in combination with an immunosuppressive agent such as methotrexate (i.e., adalimumab plus methotrexate) in patients with uveitis associated with juvenile idiopathic arthritis who are not responsive to initial treatment (e.g., topical corticosteroids) and are at risk for severe uveitis or vision threatening complications.
 The American College of Rheumatology/ Arthritis Foundation recommended the use of adalimumab and infliximab over etanercept with no preference between adalimumab and infliximab. Conversely, the guideline from multiple interdisciplinary German groups recommended that adalimumab and infliximab are the first- and second-choice tumour necrosis factor-alpha inhibiting drugs, respectively. They recommended a treatment switch to infliximab then golimumab when adalimumab is not effective or there is treatment failure with adalimumab.

Topical Steroid Damaged Face: A Cross-Sectional Study from Saudi Arabia.

Corticosteroids are one of the anti-inflammatory drugs that are used widely by dermatologists. Significant local adverse effects can happen if topical corticosteroids (TCs) are used incorrectly. This study aimed to assess the prevalence of facial TCs misuse and its adverse effects. This was cross-sectional research: a self-reported questionnaire was distributed among a population of Saudi Arabians aged 16 years and above who were using TCs consecutively. Statistical analysis was performed using SPSS version 26. A total of 611 participants were enrolled in the survey: 401 (65.6%) were university graduates, while 187 (30.6%) were below high school level of education. The number of participants using TCs was 279 (45.7%), while 332 (54.3%) did not use steroids topically. The most used TCs were Mometasone furoate 0.1% cream (18.2%), followed by Fusidic acid/Betamethasone cream (16.7%). A total of 46 reported facial TCs’ side effects. Peeling (52.2%) was the most reported side effect, followed by redness (41.3%). In conclusion, the use of facial TCs among the Saudi population is not uncommon (16.5%). A large population are not aware of the side effects of the unsupervised use of TCs. An effort should be made to increase awareness of the adverse effects of TCs.

Clinical Experience of Use of Percutaneous Continuous Nervemonitoring in Robotic Bilateral Axillo-Breast Thyroid Surgery.

Introduction and ObjectiveThere is a need for a simplified technique for C-IONM in robotic surgery. The primary aim of this study was to describe our clinical experience with the use of percutaneous C-IONM in robotic bilateral axillary thyroid surgery.MethodsThis study prospectively enrolled 304 consecutive patients who underwent robotic thyroidectomy via the bilateral axillo-breast approach and standardized C-IONM via percutaneous probe stimulation.Results323 RLNs were analyzed. C-IONM with percutaneous probes was feasible in all cases. During this study, we did not record any cases of probe displacement, and no additional robotic maneuvers were required. The average stimulation intensity was 2 mA. There were no adverse local or systemic C-IONM side effects. The mean time required for probe positioning was 3 minutes. The EMG amplitude signal of 48 RLNs decreased significantly, < 50% from the original V1 signal. In these cases, the surgical procedure was modified.ConclusionThe proposed percutaneous C-IONM provides a simplification of the continuous monitoring procedure for robotics. The advantage of percutaneous C-IONM is that it does not require additional trocar space, repeated instrument changes, and unmodified cosmesis. To our knowledge, this is the first study on the application of percutaneous C-IONM in robotic thyroid surgery.

Efficacy of Multivalent, Cochleate-Based Vaccine against Salmonella Infantis, S. Enteritidis and S. Typhimurium in Laying Hens.

Salmonella enterica is an important foodborne pathogen. Commercial poultry are the main reservoirs of Salmonella enterica, leading to the contamination of food and outbreaks in humans. The vaccination of chickens is one of the most important strategies to reduce the number of Salmonella in poultry farms. Unfortunately, commercial vaccines have not been fully effective in controlling the spread and do not contain all the Salmonella serovars that circulate on farms. In this study, we evaluate a new, cochleate-based, trivalent injectable vaccine against S. Enteritidis, S. Typhimurium and S. Infantis, describing the vaccine security, capacity to induce specific anti-Salmonella serovar IgY and the gene expression of immune markers related to CD4 and CD8 T-cell-mediated immunity. Efficacy was evaluated through oral challenges performed separately for each Salmonella serotype. The efficacy and safety of the trivalent vaccine was proven under controlled conditions. The vaccine has no local or systemic reactions or adverse effects on poultry performance related to the vaccine. The vaccine provided significantly increased serum IgY titer levels, significantly reduced Salmonella CFU/g present in the cecum and an increased CD4+/CD8+ ratio in vaccinated animals when challenged with S. Infantis, S. Enteritidis and S. Typhimurium. These results indicate that this new trivalent vaccine does not generate adverse effects in poultry and produces an increase in neutralizing antibodies against the three Salmonella serovars.

Titanium elastic nail used for repair of radius-ulna fracture in dogs

Two young dogs with history of traumatic injury were presented with primary complaint of not bearing weight on one forelimb. Radiographic examinations of the limb had revealed complete transverse diaphyseal fracture of distal third of radius-ulna in both the cases. The fracture in both the cases was repaired under general anesthesia by introduction of titanium elastic nail through the pre-drilled hole in the metaphyseal cortex followed by passing the nail through the medullary canal into the other fracture fragment after reducing both the fracture fragments by open reduction technique. Both the dogs had shown uneventful recovery with partial weight bearing on the operated limb in between 5th-7th and complete weight bearing at 60th post-operative day. The nail in both the cases was removed at 60th post-operative day after radiographic examinations which had shown callus formation along with bridging of both the cortices at the fractured site. All the physiological and haemato-biochemical parameters were found within the normal clinical range at different time intervals of examination. Overall both the cases had shown good clinical outcome without any local or systemic adverse effect.

Evaluating the safety and efficacy of mesenchymal stem cell-derived exosomes for treatment of refractory perianal fistula in IBD patients: clinical trial phase I.

Exosome administration is a novel medical approach that promises excellent immunomodulatory properties without the conventional side effects of current antitumor necrosis factor drugs and stem cells. This study aimed to assess the safety and efficacy of using mesenchymal stem cell (MSC) exosomes to treat refractory fistulas in patients with inflammatory bowel disease. MSCs were derived from the umbilical cords and their exosomes were isolated. Five patients with refractory perianal Crohn's disease fistulas with a median age of 35 years (range 31-47 years) were enrolled in the study. Exosome injections were administered in the operating room to patients with refractory fistula (fistulas that are irresponsive to anti-tumor necrosis factor-α administration within 6 months). Six months later, a physical examination, face-to-face interviews, and magnetic resonance imaging were employed to evaluate the therapy responses of patients. The outcomes within 6 months after initiation of therapy showed that four patients had responded to therapy. Three patients who received exosome injections exhibited complete healing, while one reported no improvement and active discharge from the fistula site. In addition, five patients (100%) reported neither systemic nor local adverse effects. Injection of exosomes extracted from MSCs demonstrates safety and a satisfactory therapeutic effect, as evidenced in this and other studies, and may play a significant role in the future treatment of gastrointestinal fistulas.

Biodistribution of Cy5-labeled Thiolated and Methylated Chitosan-Carboxymethyl Dextran Nanoparticles in an Animal Model of Retinoblastoma.

PurposeThe use of more potent medicine for local chemotherapy of retinoblastoma in order to minimize local and systemic adverse effects is essential. The main goal of this investigation was to assess the biodistribution of thiolated and methylated chitosan-carboxymethyl dextran nanoparticles (CMD-TCs-NPs and CMD-TMC-NPs) following intravitreal (IVT) injection into rat eyes with retinoblastoma.MethodsAn ionic gelation method was used to fabricate Cy5-labelled CMD-TCs-NPs and CMD-TMC-NPs. The NPs were characterized. Cellular internalization of Cy5-labelled NPs was investigated using confocal microscopy and the absorption of labeled NPs was quantified by flow cytometry in human retinoblastoma (Y79) cells. In addition, the Cy5-labeled distribution of nanoparticles in the posterior segment of the eye was histologically imaged by confocal microscopy after IVT injection of NPs into the eyes of rats with retinoblastoma.ResultsCMD-TCs-NPs and CMD-TMC-NPs showed a mean diameter of 34 3.78 nm and 42 4.23 nm and zeta potential of +11 2.27 mV and +29 4.31mV, respectively. The in vivo study of intraocular biodistribution of Cy5-labeled CMD-TCs-NPs and CMD-TMC-NPs revealed that there is more affinity of CMD-TCs-NPs to the retina and retinoblastoma tumor after IVT administration while methylated chitosan nanoparticles are immobilized in the vitreous and are not able to reach the retina even after 24 hr.ConclusionThe ionic gelation technique was efficient in synthesizing a biocompatible polymeric nanosystem for drug delivery into the posterior segment of the eye. The current study demonstrated increased ocular bioavailability of CMD-TCs-NPs relative to CMD-TMC-NPs in retinoblastoma induced rat eyes.

Multidisciplinary management of type 2 inflammatory diseases.

Greater understanding of molecular pathophysiology has led to the recognition that an excessive type 2 inflammatory response is at the basis of the pathophysiology of several inflammatory diseases including atopic dermatitis (AD), asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP). Given the availability of biological agents that can permit management of specific disease endotypes, this reinforces the need for detailed characterization of these diseases through a multidisciplinary approach. Herein, these three conditions are briefly overviewed and practical guidance for a multidisciplinary approach to management is presented. Since type 2 inflammation is suppressed by steroids, drugs such as glucocorticoids have long been the workhorse of medical therapy. However, steroids have well-known local and systemic adverse effects, especially when used at high doses over prolonged periods of time, which is problematic when treating chronic diseases such as AD, asthma, and CRSwNP. Moreover, a substantial proportion of patients remain refractive to therapy. In the attempt to overcome these limitations, greater understanding of the molecular mechanisms of type 2 inflammation have led to the development of targeted biological drugs such as dupilumab, a fully human monoclonal antibody that targets the α chain of the IL-4 receptor. Dupilumab represents a unique therapy for type 2 inflammatory diseases and to date is the only therapy approved for AD, asthma, and CRSwNP. In terms of multidisciplinary management of type 2 inflammatory conditions, the main healthcare professionals involved include a dermatologist, pneumologist or allergologist, and ENT specialist. The model proposed herein takes into account the complex management of patients with type 2 inflammatory conditions and the new biological agents available. A multidisciplinary team can provide a central point for patient management, improve outcomes and specialist referrals, reduce costs, and guarantee that the most appropriate therapeutic decisions are made, as well as aid in management of adverse events. The multidisciplinary model should be structured and dedicated, but at the same time simple and flexible in order to not risk slowing down the patient's care. At present, it is believed that a structured multidisciplinary approach is currently the best means to optimize care of patients with type 2 inflammatory conditions.

Oral Candidiasis as a Local Adverse Effect of Inhaled Corticosteroids: What the Dental Practitioner Should Know

Inhaled corticosteroids are increasingly recommended at all stages of asthma in all age groups as a first-line treatment for controlling symptoms and minimizing oral corticosteroid dependence in chronic asthma owing to their anti-inflammatory and immunosuppressive effects. Despite the fact that they are highly effective, their use can be accompanied by systemic and local adverse effects. Systemic adverse effects are infrequent, but oral candidiasis, the most common oral fungal infection, is a frequently observed local adverse effect of inhaled corticosteroid use. This adverse effect may lead to discomfort and cause reduced patient compliance. In this review, clinical findings of oral candidiasis, potential pathogenity mechanisms following such therapy along with the specific prophylactic measures that should be undertaken to minimize this adverse effect are discussed extensively. Understanding the factors leading to increased risk can give the opportunity of focusing on the patients who need timely intervention.

Improvement of Facial Skin Laxity by a Combined Technique With Hyaluronic Acid and Calcium Hydroxylapatite Fillers: A Clinical and Ultrasonography Analysis.

Facial aging involves skeletal changes, loss of volume in the fat compartment, and skin component changes. The current objective of cosmetic facial filling is to reestablish the overall aspect that was lost during the aging process. Hyaluronic acid (HA) and calcium hydroxyapatite (CaHA) fillers are indicated for facial rejuvenation, and these agents promote dissimilar effects regarding volume restoration and dermal biostimulation. This study aimed to assess clinical and ultrasonographic improvements in facial skin laxity using a technique that combines the injection of HA and CaHA. A 120-day follow-up, quasi-experimental study was conducted based on the enrollment of fifteen women (36&ndash;47 years old) with mild face flaccidity scores who underwent subcutaneous injection of up to 3 mL of HA (zygomatic-malar region, pyriform aperture, temporal region, and jaw) followed by 3 mL of 1:1 diluted CaHA using a fan technique (temporal, zygomatic-malar, and jaw regions). Adverse effects were registered, and the monthly assessed outcomes included clinical improvement, satisfaction, and high-frequency ultrasonography (dermal thickness) parameters. At 120 days of follow-up, clinical assessment by blinded physicians yielded six (40%) very improved patients and nine (60%) exceptionally improved patients. All the participants were highly satisfied with the results and reported exceptional improvement. Dermal thickness increased 11.1% (8.8&ndash;13.4%), and augmented dermal homogeneity was evidenced by ultrasonography. Local adverse effects were mild and transient. In conclusion, the combined technique with HA and CaHA fillers was well-tolerated and yielded high satisfaction and safe improve in facial skin laxity and dermal thickness in women with mild midface aging. J Drugs Dermatol. 2022;21(1): 102-106. doi:10.36849/JDD.633.

Терапевтические возможности секнидазола в лечении бактериального вагиноза

Background: the research is still focused on bacterial vaginosis (BV) in view of its high prevalence among women and potential damaging effects on fertility The treatment regimens which are presented in the current guidelines and available for obstetricians and gynecologists may cause adverse local and systemic effects. In addition, female patients frequently experience BV recurrences. Aim: to assess the efficacy of taking secnidazole once as a single dose in the treatment of BV based on clinical findings and laboratory-based test results Patients and Methods: the study included 40 female patients with diagnosed BV. The patients were split into two groups, 20 women in each group. The treatment group patients received secnidazole 2 g once as a single dose, and the control group patients received the standard treatment with metronidazole 500 mg twice daily for 7 days. The evaluation of patients included the vaginal pH value and laboratory-based diagnostic tests, such as microscopy of the vaginal discharge and Florocenosis/Bacterial vaginosis-FRT PCR assay whose prognostic value indicators are comparable with the international clinical and laboratory-based diagnostic criteria. Results: before therapy, the mean leucocyte count in the vaginal smear in the treatment group patients was 12.4±3.0 per field of vision and in the control group patients — 11.3±1.8; after therapy — 9.2±1.2 and 10.1±4.4, respectively. A statistically significant decrease (р&lt;0.05) in vaginal pH was recorded after the therapy: to 4.4±0.1 in the treatment group and 4.3±0.1 in the control group. The average concentration of BV-associated species after the administered therapy was lower than that at the baseline (the difference was statistically significant). Conclusion: сonsidering the comparable clinical and microbiological outcomes of the alternative and standard BV treatment regimens, as well as the convenience of administration associated with single-dose therapy, secnidazole can be used to treat bacterial vaginosis. KEYWORDS: bacterial vaginosis, microbiota, pelvic inflammatory disease, secnidazole, metronidazole. FOR CITATION: Dobrokhotova Yu.E., Shadrova P.A. Therapeutic capabilities of secnidazole in the treatment of bacterial vaginosis. Russian Journal of Woman and Child Health. 2022;5(4):297–302 (in Russ.). DOI: 10.32364/2618-8430-2022-5-4-297-302.

The objective evaluation of triamcinolone acetonide efficacy in keloids management using Antera3D® imaging system.

Keloids are pathological scars characterized by nodular fibrous tissue that extends beyond the border of initial damage. These lesions do not spontaneously regress and can cause cosmetic disfigurements and functional disabilities. IntraLesional Injection of Triamcinolone Acetonide (ILITA), alone or in combination with other therapy, is one of the first-line treatment modalities. In this study the authors evaluated the objective efficacy of ILITA treatment in keloids management using this new imaging system. 37 patients with 45 keloid scars were treated with intralesional injection of triamcinolone acetonide (TAC) 20 mg/ml at an interval of three weeks. Antera3D® camera took the images and dates of the treated area in each patient, before the treatment (T0) and at three weeks after the last injection (T1). The system processed the levels of color, elevations, melanin and hemoglobin expression. All the scars were also evaluated, at the same times, by validated Vancouver Scar Scale (VSS). Comparison of the variables was performed using a Wilcoxon signed-rank test with a p < 0.05. At T0, mean VSS score was 8.67 ± 1.35 which reduced to 3.62 ± 1.72 at final follow up. Antera3D® scores were statistically significant differences in color (8.14 ± 2.41 vs 9.54 ± 1.81), protrusion (381.3 ± 15.6 vs 198.6 ± 21.3), melanin (0.53 ± 0.02 vs 0.62 ± 0.2) and hemoglobin (1.26 ± 0.41 vs 2.21 ± 0.41) expression levels after the treatment. In our clinical trial, the data results demonstrated that ILITA seems to be effective in reducing keloid dimensions and symptoms such as itching and pain, even if the treatment has local minimal adverse effects such as pain, telangiectasias and atrophy. Keloids are pathological scars characterized by nodular fibrous tissue that extends beyond the border of initial damage. Large keloids can cause cosmetic disfigurements and functional disabilities that affect quality of life. In literature, several treatment approaches have been described but, to date, no single method is considered superior. The International Advisory Panel on Scar Management recommended the use of intralesional steroid injections for keloids treatment. The efficacy of treatment may be evaluated with subjective scale; as no one can guarantee an objective evaluation. To eliminate the observer and/or patient factors, and to obtain a reliable, consistent, feasible, valid and objective evaluation a skin analysis camera system called Antera3D® (Miravex, Dublin, Ireland) can be used.In this study the authors evaluated the objective efficacy of triamcinolone acetonide treatment in keloids management using this imaging system. In this series, for Antera3D® scores there were statistically significant differences in color, protrusion, melanin and hemoglobin expression levels before and after treatment. The device directly shows the treatment changes, measured objectively and accurately, without bias of traditional evaluation scoring scale.Antera3D® system guarantees an objective evaluation of effectiveness of scar treatment enabling clinicians to modulate the therapy according to the scores registered.

Role of oral pentosan polysulfate in Bacillus Calmette-Guérin therapy in patients with non-muscle-invasive bladder cancer.

PurposeIntravesical Bacillus Calmette–Guérin (BCG) instillation, although an important treatment for non-muscle-invasive bladder cancer, exerts local and systemic adverse effects. Pentosan polysulfate (PPS) is a bladder mucosal protective drug that acts by replacing mucus in the glycosaminoglycan layer of the damaged urothelium. We hypothesized that co-administration of oral PPS with BCG instillation would relieve BCG-related adverse effects without affecting its efficacy.Materials and MethodsA total of 217 patients receiving BCG instillation were enrolled. They were placed in two groups and analyzed retrospectively: group A (n=122) received BCG instillation only and group B (n=95) received 100 mg of PPS thrice daily during the BCG treatment.ResultsAfter BCG instillation, the rate of BCG-treatment discontinuation owing to adverse effects was 15.6% in group A and 6.3% in group B (p=0.034). The proportion of patients with bacteriuria after BCG was higher in group B; however, no statistical difference was observed (28.7% vs. 41.1%; p=0.057). The proportion of patients with pyuria was significantly higher in group B (81.1% vs. 91.6%; p=0.029). The proportion of patients using antibiotics was significantly higher in group A (73.8% vs. 43.2%; p=0.001). The recurrence rate within 1 year was 29 (23.8%) in group A vs. 19 (20.0%) in group B (p=0.507). Univariate and multivariate analyses showed that antibiotic use had a statistically significant effect on BCG discontinuation.ConclusionsOral PPS effectively decreased the discontinuation rate and antibiotic use without affecting the BCG efficacy.

Field evaluation of the safety and immunogenicity of a classical swine fever virus E2 subunit vaccine in breeding and nursery animals on Jeju Island, South Korea.

Classical swine fever (CSF) reemerged on CSF-free Jeju Island where vaccination is not practiced by the unintentional injection of a live attenuated vaccine (modified live attenuated vaccines-low-virulence Miyagi [MLV-LOM]) in 2014. Since the Jeju provincial authority is considering adopting a voluntary immunization policy using a CSF-E2 subunit vaccine to combat LOM-derived CSF endemic, this study aimed to evaluate in Jeju herds. Two vaccination trials using the Bayovac CSF-E2 vaccine licensed for use in South Korea assessed the safety and humoral immunity of the CSF-E2 vaccine in breeding (trial 1) and nursery animals (trial 2) under farm application conditions. Neither local nor systemic (including reproductive) adverse effects were objectively observed in pregnant sows and young piglets following a respective vaccination regime at pregnancy or weaning, respectively. Trial 1 showed that sows immunized with the CSF-E2 vaccine possessed high and consistent E2-specific and neutralizing antibody levels. The CSF-E2 vaccine-immunized pregnant sows subsequently conferred appropriate and steady passive immunity to their offspring. In trial 2, a double immunization scheme of the CSF-E2 vaccine in piglets at 40 and 60 days of age could elicit a consistent and long-lasting adequate antibody response. Additionally, the two trials detected no Erns-specific antibody responses, indicating that CSF-E2 vaccine can differentiate infected from vaccinated animals (DIVA). Our trial data collectively provide invaluable information on applying the CSF-E2 subunit vaccine to circumvent the possible drawbacks associated with the MLV-LOM concerning the safety, efficacy, and DIVA, in the LOM-endemic field farms and contribute to advanced CSF eradication on Jeju Island.

Improvement of Facial Skin Laxity by a Combined Technique With Hyaluronic Acid and Calcium Hydroxylapatite Fillers: A Clinical and Ultrasonography Analysis

Background: Facial aging involves skeletal changes, loss of volume in the fat compartment, and skin component changes. The current objective of cosmetic facial filling is to reestablish the overall aspect that was lost during the aging process. Hyaluronic acid (HA) and calcium hydroxyapatite (CaHA) fillers are indicated for facial rejuvenation, and these agents promote dissimilar effects regarding volume restoration and dermal biostimulation. Objective: This study aimed to assess clinical and ultrasonographic improvements in facial skin laxity using a technique that combines the injection of HA and CaHA. Methods: A 120-day follow-up, quasi-experimental study was conducted based on the enrollment of fifteen women (36–47 years old) with mild face flaccidity scores who underwent subcutaneous injection of up to 3 mL of HA (zygomatic-malar region, pyriform aperture, temporal region, and jaw) followed by 3 mL of 1:1 diluted CaHA using a fan technique (temporal, zygomatic-malar, and jaw regions). Objective: Adverse effects were registered, and the monthly assessed outcomes included clinical improvement, satisfaction, and high-frequency ultrasonography (dermal thickness) parameters. Results: At 120 days of follow-up, clinical assessment by blinded physicians yielded six (40%) very improved patients and nine (60%) exceptionally improved patients. All the participants were highly satisfied with the results and reported exceptional improvement. Dermal thickness increased 11.1% (8.8–13.4%), and augmented dermal homogeneity was evidenced by ultrasonography. Local adverse effects were mild and transient. Conclusion: In conclusion, the combined technique with HA and CaHA fillers was well-tolerated and yielded high satisfaction and safe improve in facial skin laxity and dermal thickness in women with mild midface aging. J Drugs Dermatol. 2022;21(1): 102-106. doi:10.36849/JDD.633Hyaluronic Acid and Calcium Hydroxylapatite Fillers

Metal wear debris generation in primary total knee arthroplasty: is it an issue?

More durable total knee arthroplasties (TKAs) are needed, due to the rising life expectancy, the higher activity levels of patients and the growing concerns about aseptic loosening being caused by metal hypersensitivity. In response, different hypoallergenic metal coatings have been developed for TKAs. However, possible adverse effects of these different metals (cobalt-chromium-molybdenum, zirconium, titanium and tantalum) have been neglected. The aim was to summarize the local and systemic adverse effects (including metal hypersensitivity), survival ratios, patient-reported outcome measures (PROMs) and the plasma metal ion concentrations of the different TKA coatings. A literature search on PubMed and EMBASE was performed. In total, 15 studies were found eligible. Common adverse effects of TKA were infection, loosening, pain, instability and hyper- coagulation disorders. Serious adverse effects related to TKA implants were not reported. The survival ratios and patient-reported outcome measures seem to confirm these good results. In contrast with chromium and cobalt, no significant differences were reported in the nickel, molybdenum and titanium concentrations. No significant differences between the hypoallergenic and standard TKA implants were found in terms of adverse effects, survival ratios and PROMs. A causal relationship between the common adverse effects and the different metals is unlikely. Due to the heterogeneity of the TKA implants used, no firm conclusions could be made. Further research with longer follow-up studies are needed to find possible adverse effects and differences. Thus far, the hypoallergenic implants seem to perform equal to the standard implants.