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1.
Eur Arch Otorhinolaryngol ; 281(4): 2167-2173, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38329526

ABSTRACT

INTRODUCTION: Biologic therapies for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) have emerged as an auspicious treatment alternative. However, the ideal patient population, dosage, and treatment duration are yet to be well-defined. Moreover, biologic therapy has disadvantages, such as high costs and limited access. The proposal of a novel Artificial Intelligence (AI) algorithm offers an intriguing solution for optimizing decision-making protocols. METHODS: The AI algorithm was initially programmed to conduct a systematic literature review searching for the current primary guidelines on biologics' clinical efficacy and safety in treating CRSwNP. The review included a total of 12 studies: 6 systematic reviews, 4 expert consensus guidelines, and 2 surveys. Simultaneously, two independent human researchers conducted a literature search to compare the results. Subsequently, the AI was tasked to critically analyze the identified papers, highlighting strengths and weaknesses, thereby creating a decision-making algorithm and pyramid flow chart. RESULTS: The studies evaluated various biologics, including monoclonal antibodies targeting Interleukin-5 (IL-5), IL-4, IL-13, and Immunoglobulin E (IgE), assessing their effectiveness in different patient populations, such as those with comorbid asthma or refractory CRSwNP. Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha subunit, demonstrated significant improvement in nasal symptoms and quality of life in patients with CRSwNP in several randomized controlled trials and systematic reviews. Similarly, mepolizumab and reslizumab, which target IL-5, have also shown efficacy in reducing nasal polyp burden and improving symptoms in patients with CRSwNP, particularly those with comorbid asthma. However, additional studies are required to confirm the long-term efficacy and safety of these biologics in treating CRSwNP. CONCLUSIONS: Biologic therapies have surfaced as a promising treatment option for patients with severe or refractory CRSwNP; however, the optimal patient population, dosage, and treatment duration are yet to be defined. The application of AI in decision-making protocols and the creation of therapeutic algorithms for biologic drug selection, could offer fascinating future prospects in the management of CRSwNP.


Subject(s)
Asthma , Biological Products , Nasal Polyps , Rhinitis , Sinusitis , Humans , Interleukin-5 , Rhinitis/complications , Rhinitis/drug therapy , Artificial Intelligence , Quality of Life , Asthma/epidemiology , Nasal Polyps/complications , Nasal Polyps/drug therapy , Nasal Polyps/epidemiology , Chronic Disease , Sinusitis/complications , Sinusitis/drug therapy , Sinusitis/epidemiology , Biological Products/therapeutic use , Biological Therapy
2.
Altern Ther Health Med ; 30(1): 220-225, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37773680

ABSTRACT

Objective: Fungal bulb sinusitis (FBS) is mainly caused by fungal infection. Due to its similar clinical symptoms to other sinus diseases such as chronic sinusitis and sinus tumors, it is very easy to have adverse events such as missed diagnosis and misdiagnosis during diagnosis, which further affects patients' negative emotions of quality of life. Therefore, this study investigated the differences between FBS and CRS in Yunnan and western Yunnan, and analyzed the independent risk factors for the diagnosis of FBS, so as to predict the probability of diagnosis of FBS in patients with inflammatory diseases of nasal cavity and sinuses. Methods: A total of 128 FBS patients diagnosed in the First Affiliated Hospital of Dali University from January 2015 to December 2019 were retrospectively selected as the study objects, and 112 FBS patients eligible for this study were selected according to the inclusion and exclusion criteria such as Otolaryngology, Head and Neck Surgery and were set as the study group. And 112 patients with CRS diagnosed in the same period were selected as the control group. Single factor analysis (χ2 test) was applied to screen out the factors with significant differences in the preoperative clinical data of the two diseases, which were incorporated into the multivariate Logistic regression model to find independent risk factors for the diagnosis of FBS, establish the diagnosis prediction equation of the disease, and verify the sensitivity and specificity of the equation by using the collected clinical data. Results: Multifactorial analysis indicated that age, blood in aspirin, calcified spots, unilateral or bilateral lesions, single or multiple sinus tract lesions, and osteophytes were influential as independent risk factors for diagnosing FBS. The O.R.s for unilateral or bilateral lesions, calcified points, single or multiple sinus tract lesions, and blood in aspirin correlated stronger than 10 with the diagnosis of FBS. Based on these results, a logistic regression prediction equation for the diagnosis of FBS was developed: y = -6.879 + 1.295x1 + 2.519x2 + 3.010x3 + 3.605x4 + 2.977x5 + 1.596x6. P = exp(y)/[1 + exp(y)]. Validation revealed that 91.1% of FBS patients had a diagnostic probability of P>0.5 and 79.5% had a diagnostic probability of P > .9. In contrast, only 4.5% of CRS patients had a diagnostic probability of P > .5 and 0 patients had a diagnostic probability of P > .9. Conclusions: FBS remains diagnostic in unilateral or bilateral lesions, calcified spots, single or multiple sinus lesions, and aspirin-containing blood. In addition, the multifactorial regression prediction equation can calculate the probability of a preoperative diagnosis of FBS in patients with inflammatory nasal and sinus diseases, and the prediction efficacy of the established prediction model is good. In addition, the multifactor regression prediction equation has a wide range of applications and can also be used to verify the correlation of other subsequent experiments.


Subject(s)
Mycoses , Sinusitis , Humans , Retrospective Studies , Logistic Models , Quality of Life , China/epidemiology , Sinusitis/diagnosis , Sinusitis/complications , Sinusitis/surgery , Chronic Disease , Aspirin , Mycoses/complications
3.
Expert Opin Investig Drugs ; 32(10): 909-919, 2023.
Article in English | MEDLINE | ID: mdl-37855222

ABSTRACT

INTRODUCTION: Chronic rhinosinusitis with nasal polyps (CRSwNP), especially CRSwNP with type 2 inflammation, remains the most difficult-to-treat subtype with high prevalence worldwide. The emergence of biologics has the potential to fulfill the unmet medical needs of patients with CRSwNP driven by type 2 inflammation. AREAS COVERED: A current review of the literature was performed to overview current and emerging biological therapies in the treatment of CRSwNP. EXPERT OPINION: In an era of precision medicine, biologics have been given expectations to provide customized therapies to patients with CRSwNP, particularly those with refractory CRSwNP. Large clinical trials and real-world experiences are both essential for the application of biologics. Moreover, to make biological therapy more tailored to patients, an in-depth understanding of the different mechanisms of biologics, further elucidating the relationship between biologics and conventional medical and surgical treatments, and identifying predictive biomarkers warrant thorough investigations.


Subject(s)
Biological Products , Nasal Polyps , Rhinitis , Sinusitis , Humans , Rhinitis/drug therapy , Nasal Polyps/complications , Nasal Polyps/drug therapy , Inflammation/drug therapy , Sinusitis/complications , Sinusitis/drug therapy , Biological Therapy , Biological Products/pharmacology , Biological Products/therapeutic use , Chronic Disease
4.
Altern Ther Health Med ; 29(8): 638-643, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37678868

ABSTRACT

Objective: In the context of the rising prevalence of eosinophilic chronic sinusitis accompanied by nasal polyps, this study aims toinvestigate the role of CD23 in the pathogenesis of eosinophilic chronic sinusitis with nasal polyps. Methods: The cross-sectional study was conducted, 75 patients with chronic sinusitis and nasal polyps treated in our hospital from January 2019 to May 2021 were selected, including 40 cases of eosinophilic patients with the average age of 29.92 years and 35 cases of non-eosinophilic patients with the average age of 30.05 years and 30 patients with the average age of 30.14 years who underwent skull base benign tumor resection in our hospital were selected as the control group, the expression of CD23 in polyp tissue was detected by immunohistochemistry, and the expression of CD23, p-ERK and CCL20 in polyp tissue were detected by Western blot. Specifically, tissue samples were processed and subjected to staining using specific antibodies targeting CD23. The stained sections were then visualized under a microscope to determine the expression levels of CD23. CD23, p-ERK, and CCL20 expressions in polyp tissue were evaluated via Western blot. Total protein was extracted, separated on a gel, transferred to a membrane, and probed with specific antibodies. Chemiluminescence allowed visualization and quantification of protein expressions. Results: Immunohistochemistry showed that CD23 expression was high in the eosinophilic group but low in the non-eosinophilic and control groups. The relative expression levels of CD23 protein, p-ERK protein, and CCL20 protein in polyp tissue s of the eosinophilic group were (0.892 ± 0.092), (0.733 ± 0.101) and (0.813 ± 0.106), respectively, which were significantly higher than those in non-eosinophilic group and control group (P < .05). The relative expression levels of CD23 protein, p-ERK protein, and CCL20 protein in the non-eosinophilic group were (0.461 ± 0.087), 0.412 ± 0.096) and (0.424 ± 0.098), which were significantly higher than those in the control group (P < .05). The relative expression level of CD23 protein in the eosinophilic group was positively correlated with the relative expression levels of p-ERK protein and CCL20 protein (P < .05). The Lund-Kennedy score in the eosinophilic group was (6.10 ± 1.01), which was significantly higher than that in the non-eosinophilic group (P < .05). The relative expression level of CD23 protein in the eosinophilic group was positively correlated with Lund-Kennedy score (P < .05). Conclusion: Eosinophilic chronic sinusitis with nasal polyp mucosal tissue CD23 expression is up-regulated, which is positively correlated with the ERK signaling pathway and disease severity. This study provides valuable insights into potential therapeutic targets that could be explored to develop future treatment modalities. The potential clinical significance of the study is to reveal the important role of CD23 in the pathogenesis of chronic sinusitis with nasal polyps. The upward adjustment of CD23 is positively related to the severity of the disease, which provides valuable guidance for future treatment strategies. This discovery may provide new ways for the development of CD23 treatment methods, so as to better control the progress of the disease of eosinophilic chronic sinusitis with nasal polyps. Further research can explore the molecular mechanism of CD23 regulation, further verify the feasibility of CD23 as the treatment target, and evaluate the potential value of CD23 as a prognostic logo.


Subject(s)
Nasal Polyps , Rhinitis , Sinusitis , Humans , Adult , Rhinitis/complications , Nasal Polyps/complications , Nasal Polyps/pathology , Cross-Sectional Studies , Sinusitis/complications , Sinusitis/pathology , Signal Transduction , Chronic Disease
5.
Vestn Otorinolaringol ; 88(2): 51-58, 2023.
Article in Russian | MEDLINE | ID: mdl-37184555

ABSTRACT

Recurrent chronic rhinosinusitis with nasal polyps (CRSwNP) with a predominant Th2 endotype of inflammation, including associated with bronchial asthma and/or allergic rhinitis, aspirin triad, refers to diseases with an insufficient level of control, despite the use of a wide range of options for conservative and surgical treatment. OBJECTIVE: To analyze our own experience, clinical and organizational features of the application of the method of biological therapy in patients with severe forms of recurrent CRSwNP. MATERIAL AND METHODS: 25 patients with severe and moderate forms of CRSwNP were examined, who, in a round-the-clock hospital (model CSG 36.018) was treated with Dupilumab, in the form of subcutaneous injections of 300 mg/2 ml 1 every two weeks. The diagnosis was confirmed on the basis of anamnestic data, SNOT-22 quality of life questionnaires, visual endoscopic examination, evaluation of CT data (Lund-Mackay scale), laboratory data. The effectiveness of treatment was monitored after 16 weeks, based on endoscopic examination data, evaluation of CT and SNOT-22 data. In 3 observations, a study of pathomorphological material for tissue eosinophilia was performed. RESULTS: The duration of the course of treatment ranged from 10 to 56 weeks. The most striking clinical effect was observed for signs such as sense of smell and nasal breathing (in some cases-after the first injection). The degree of regression of polyps according to CT and endoscopic examination was more prolonged in time, the same dynamics was observed in the level of total IgE. In a number of patients, the phenomenon of eosinophilia growth was observed against the background of treatment (with regression of clinical symptoms). Pathomorphological examination confirmed a high level of tissue eosinophilia as one of the fundamental signs of Th2 inflammation. One patient with concomitant chronic tubar dysfunction had an improvement in hearing. All patients with AD noted a subjective improvement in disease control (a decrease in the frequency and severity of choking attacks). The cancellation (break in treatment) of treatment was accompanied by a gradual return of symptoms in all patients at various times. CONCLUSIONS: Patients who have not achieved an acceptable level of control of CRSwNP,that meets the criteria of Th2 inflammation can be considered as candidates for the use of targeted biological therapy. With strict compliance with the selection criteria, there is a good clinical effect, primarily in relation to nasal symptoms (sense of smell and nasal breathing) and improved control of asthma symptoms.


Subject(s)
Asthma , Eosinophilia , Nasal Polyps , Rhinitis , Sinusitis , Humans , Nasal Polyps/complications , Nasal Polyps/diagnosis , Nasal Polyps/drug therapy , Quality of Life , Rhinitis/complications , Rhinitis/diagnosis , Rhinitis/drug therapy , Sinusitis/complications , Sinusitis/diagnosis , Sinusitis/drug therapy , Eosinophilia/complications , Eosinophilia/diagnosis , Eosinophilia/drug therapy , Inflammation , Biological Therapy , Delivery of Health Care , Chronic Disease
6.
Otolaryngol Clin North Am ; 56(1): 157-168, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36266108

ABSTRACT

Concurrent chronic rhinosinusitis with nasal polyps (CRSwNP) in the upper airway, and asthma in the lower airway, often have a shared underlying pathophysiology, namely type 2 inflammation; hence, the term "unified airway disease." The combination of CRSwNP and asthma is associated with uncontrolled disease. The range of treatment of CRSwNP includes intranasal corticosteroids, nasal saline irrigation, oral corticosteroids, antibiotics, and biologics. A combined clinical algorithm for the management of the upper and lower airways in type 2 inflammation will be beneficial, especially for patients with uncontrolled disease who may benefit from biologics.


Subject(s)
Asthma , Biological Products , Nasal Polyps , Rhinitis , Sinusitis , Humans , Rhinitis/drug therapy , Nasal Polyps/therapy , Nasal Polyps/complications , Sinusitis/complications , Asthma/therapy , Adrenal Cortex Hormones/therapeutic use , Inflammation/complications , Chronic Disease , Biological Products/therapeutic use
7.
Acta Biomed ; 93(5): e2022211, 2022 10 26.
Article in English | MEDLINE | ID: mdl-36300245

ABSTRACT

Rhinosinusitis (RS) is a common disease and is currently classified into two main types: acute RS (ARS) and chronic RS (CRS), which in turn includes CRS with or without nasal polyps. Different guidelines consider this classification. However, in clinical practice, other phenotypes exist. The current article would propose new clinical-based phenotyping of RS, including the following clinical phenotypes: simple catarrhal RS, Acute RS, acute bacterial RS, severe (complicated) acute RS, chronic RS, and recurrent chronic RS. Treatment strategy should be tailored considering the clinical phenotype and could include phytomedicines, intranasal non-pharmacological remedies, and local bacteriotherapy. In conclusion, RS requires thorough diagnostic work-up, and the therapeutic approach should be mainly based on appropriate management.


Subject(s)
Nasal Polyps , Rhinitis , Sinusitis , Humans , Rhinitis/diagnosis , Rhinitis/therapy , Rhinitis/complications , Sinusitis/diagnosis , Sinusitis/therapy , Sinusitis/complications , Nasal Polyps/diagnosis , Nasal Polyps/therapy , Nasal Polyps/complications , Acute Disease , Chronic Disease
8.
Am J Otolaryngol ; 43(6): 103615, 2022.
Article in English | MEDLINE | ID: mdl-36057193

ABSTRACT

The management of chronic rhinosinusitis with nasal polyps (CRSwNP) is challenging due to disease recurrence and adverse effects. Both surgical and medical treatment modalities impact the quality of patients' lives. Monoclonal antibody treatment has recently been used successfully in CRS with limited reported adverse events. We aimed to review the literature to shed more light on the safety and adverse events associated with the biological therapy of CRSwNP. A comprehensive systematic review was conducted on the safety of different biological treatments when used for managing CRSwNP. We have included 13 studies in the present systematic review, including 12 randomized controlled trials (RCTs) and one cross-sectional study. The total sample size for the included studies was 2282 patients. Six studies investigated the safety and adverse events of dupilumab; three investigated omalizumab, three investigated mepolizumab, and only one investigated reslizumab. Some studies have reported that adverse events were common with these types of drugs. However they were not specific and self-limited. Headaches, injection site reactions, and pharyngitis were the most common adverse events found among the reported adverse events. The Dupilumab trial reported pharyngitis in 225 patients (22.4 %) followed by erythema in 9.4 %, headache in 8.1 %, epistaxis in 5.1 %, and asthma in 1.7 % of patients. Trials which used omalizumab reported headaches, nasal pharyngitis, injection-site reactions to be the most common adverse events with estimated prevalence rates of 8.1 %, 5.9 %, and 5.2 %, respectively. Mepolizumab and reslizumab studies reported that 40 % of patients were complicated by nasal polyps/congestion/pharyngitis/infections, 14 had a headache (15.5 %), two developed asthma (2.2 %), and only one patient (1.1 %) had epistaxis as an adverse event. Although the literature's current investigations indicate the safety of the biologic treatment modalities, further studies are needed as some uncertainty among the trials have been reported.


Subject(s)
Asthma , Biological Products , Nasal Polyps , Pharyngitis , Rhinitis , Sinusitis , Humans , Nasal Polyps/complications , Nasal Polyps/drug therapy , Rhinitis/complications , Rhinitis/drug therapy , Omalizumab/therapeutic use , Epistaxis/therapy , Sinusitis/complications , Sinusitis/drug therapy , Chronic Disease , Biological Therapy , Antibodies, Monoclonal/therapeutic use , Biological Products/therapeutic use , Headache/therapy , Pharyngitis/drug therapy , Quality of Life
9.
Allergy ; 77(12): 3593-3605, 2022 12.
Article in English | MEDLINE | ID: mdl-36067036

ABSTRACT

Chronic rhinosinusitis with nasal polyps (CRSwNP) associated with type 2 inflammation and non-steroidal anti-inflammatory drug (NSAID)-exacerbated respiratory disease (N-ERD) can be difficult to control with standard medical therapy and sinus surgery. In this group, biologicals are potentially promising treatment options. The phase III clinical trials for omalizumab, dupilumab, mepolizumab and benralizumab in CRSwNP have demonstrated favourable outcomes. Moving forward, direct comparisons among biologicals, refining patient selection criteria for specific biologicals, determining optimal treatment duration and monitoring long-term outcomes are areas of emerging interest. This review summarizes the clinical evidence from the recent 2 years on the role of biologicals in severe CRSwNP and N-ERD, and proposes an approach towards decision-making in their use.


Subject(s)
Biological Products , Nasal Polyps , Respiration Disorders , Rhinitis , Sinusitis , Humans , Nasal Polyps/drug therapy , Nasal Polyps/complications , Rhinitis/drug therapy , Rhinitis/complications , Sinusitis/drug therapy , Sinusitis/complications , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Chronic Disease , Biological Therapy , Respiration Disorders/therapy , Biological Products/therapeutic use
10.
PLoS One ; 17(8): e0272371, 2022.
Article in English | MEDLINE | ID: mdl-35913939

ABSTRACT

BACKGROUND: Continuous comprehensive treatment is still needed after endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) to promote the recovery of sinus mucosal morphology and function. Traditional Chinese medicine (TCM) nasal irrigation is a promising external treatment of TCM, but at present, the application of TCM nasal irrigation after ESS for CRS has not been recommended by the guidelines. Therefore, this article aims to develop a systematic overview and meta-analysis protocol to assess the effectiveness and safety of Chinese herbal nasal rinse for CRS recovery after ESS. METHODS: Seven databases shall be retrieved from their inception until December 2021. Eligible randomized controlled trials will be covered in the study. The outcome indicators of the survey will consist of efficacy, visual analogue scale score, Lund-Kennedy score for nasal endoscopy, Lund-Mackay score for sinus computed tomography and other secondary outcome indicators. The selection of literature, extraction of data, and methodological quality evaluation of literature shall be conducted by two researchers separately. If there is any dispute, it can be discussed and solved by a third researcher. Review Manager 5.3 software will be applied to data analysis. RESULTS: The article will make a detailed research programme to explore the efficacy and safety of TCM nasal irrigation on CRS recovery after ESS. CONCLUSION: This protocol is suitable for evaluating the effectiveness and safety of TCM nasal rinse for CRS recovery after ESS, and can provide corresponding evidence-based medical evidence. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework Registration DOI: 10.17605/OSF.IO/ZV73Q.


Subject(s)
Rhinitis , Sinusitis , Chronic Disease , Endoscopy/methods , Humans , Medicine, Chinese Traditional , Meta-Analysis as Topic , Nasal Lavage , Rhinitis/complications , Rhinitis/surgery , Sinusitis/complications , Sinusitis/surgery , Systematic Reviews as Topic , Treatment Outcome
11.
Rhinology ; 60(5): 368-376, 2022 Oct 01.
Article in English | MEDLINE | ID: mdl-35818923

ABSTRACT

BACKGROUND: Although extended endoscopic sinus surgery (ESS) constitutes an alternative approach in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), the surgical techniques proposed so far do not allow for an optimal control of the disease. This study introduces bilateral mucoplasty as a complementary technique to extended ESS such as reboot surgery, analyzing its benefits in healing and quality of life (QoL). METHODS: Patients diagnosed with severe Type-2 CRSwNP were selected for a prospective cohort study in two surgery groups: reboot surgery plus bilateral mucoplasty versus reboot surgery only. In the first group, an autologous endonasal mucosal graft from the nostril floor was placed bilaterally onto the ethmoidal roof. Endoscopic, radiological and QoL outcomes were compared before and one year after surgery between the two groups using Modified Lund Kennedy (LKM), Meltzer and Lund Mackay (LM) scores, and the Sino-Nasal Outcome Test 22 (SNOT-22). RESULTS: 64 patients with homogeneous baseline characteristics were included: 17 patients underwent a reboot surgery plus a bilateral mucoplasty and 47 a reboot surgery only. LKM, Meltzer and SNOT-22 scores showed significant differences before and after surgery in both groups, with higher improvement in the mucoplasty group. A greater mean improvement of 20.5 ± 6.4 points in SNOT-22 change was associated with bilateral mucoplasty. CONCLUSION: Bilateral mucoplasty plus reboot surgery constitutes a useful surgical resource in Type-2 CRSwNP patients, showing improved endoscopic, radiological and QoL outcomes one year after surgery. Further studies are needed to determine their long-term benefits.


Subject(s)
Nasal Polyps , Rhinitis , Sinusitis , Chronic Disease , Endoscopy/methods , Humans , Nasal Polyps/complications , Nasal Polyps/diagnosis , Nasal Polyps/surgery , Prospective Studies , Quality of Life , Rhinitis/complications , Rhinitis/diagnosis , Rhinitis/surgery , Sinusitis/complications , Sinusitis/diagnosis , Sinusitis/surgery , Treatment Outcome
12.
Pediatr Neurol ; 128: 20-24, 2022 03.
Article in English | MEDLINE | ID: mdl-35032886

ABSTRACT

BACKGROUND: We aimed to describe the clinical presentation, risk of bleeding and recurrent thrombosis, and perioperative anticoagulant management of children with cerebral venous thrombosis (CVT) and an associated head or neck infection. METHODS: In this subgroup analysis of the EINSTEIN-Jr study, we included children with CVT and an associated head or neck infection who received therapeutic anticoagulants with either low-molecular-weight heparin (with or without subsequent vitamin K antagonists) or rivaroxaban for a period of 3 months. Analyses are descriptive. RESULTS: Of 74 included children, 59 (80%) had otomastoiditis, 21 (28%) a central nervous system infection, 18 (24%) sinusitis, and 9 (12%) another upper respiratory tract infection; 29 (39%) had infection of multiple regions of the head or neck. All 74 children received antibiotics and therapeutic anticoagulants; 41 (55%) underwent surgery, of whom 34 were diagnosed with CVT preoperatively. Anticoagulation was started before surgery in 12 children and interrupted 0-1 days prior to surgery. Anticoagulation was (re)started in all 34 children at a median of 1 day (interquartile range: 0-1) postoperatively, in therapeutic doses in 94%. Overall, one child (1%, 95% confidence interval: 0-7) had recurrent thrombosis, and one (1%, 95% confidence interval: 0-7) had major bleeding; neither was associated with surgery. At 3 months, no children had died, 3 (4%) had persistent focal neurologic deficits, and 2 (3%) had impaired vision. CONCLUSIONS: Children with CVT and an associated head or neck infection administered therapeutic anticoagulants generally had low risks of bleeding and thrombotic complications, including those who had surgical interventions with delay or interruption of anticoagulation.


Subject(s)
Anticoagulants/therapeutic use , Intracranial Thrombosis/drug therapy , Intracranial Thrombosis/microbiology , Venous Thrombosis/drug therapy , Venous Thrombosis/microbiology , Central Nervous System Infections/complications , Child , Child, Preschool , Cohort Studies , Female , Heparin, Low-Molecular-Weight/therapeutic use , Humans , Male , Mastoiditis/complications , Rivaroxaban/therapeutic use , Sinusitis/complications
13.
Eur Arch Otorhinolaryngol ; 279(4): 1911-1917, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34175968

ABSTRACT

PURPOSE: Bleeding during Functional endoscopic sinus surgery (FESS) can have adverse effect on surgical outcomes. This study evaluates if there is any benefit of adding epinephrine to the saline nasal irrigation in patients undergoing elective FESS for chronic rhinosinusitis. METHODS: A prospective, randomized, double-blinded study was performed. Fifty ASA I or II patients undergoing FESS were randomized to have irrigation either with normal saline or (1:100,000) epinephrine in normal saline during surgery. Outcomes measure included the Boezaart grading scale to assess the intraoperative surgical field, surgeon's satisfaction with field visualization and bleeding which was evaluated in a 10 cm visual analog scale, estimated blood loss as well as hemodynamic parameters changes. RESULTS: There was no statistically significant difference in the studied variables between both groups. However in patients with higher than 12 Lund-Mackay score the volume of blood loss was significantly less in the epinephrine group. All surgical procedures were completed and there were no operative complications or any reported perioperative cardiovascular events. CONCLUSIONS: Intraoperative irrigation with saline-epinephrine solution at a concentration of (1:100,000) is safe and does not change heart rate or blood pressure but is unlikely to improve the setting of intraoperative surgical field except for decreasing the volume of blood loss in patients with high Lund-Mackay score.


Subject(s)
Endoscopy , Sinusitis , Blood Loss, Surgical/prevention & control , Chronic Disease , Endoscopy/methods , Epinephrine , Humans , Prospective Studies , Sinusitis/complications , Sinusitis/surgery
14.
Sci Rep ; 11(1): 21737, 2021 11 05.
Article in English | MEDLINE | ID: mdl-34741083

ABSTRACT

Allergic rhinitis (AR) and chronic rhinosinusitis (CRS) share some similar pathological mechanisms. In current study, we intend to investigate the impact of AR on CRS. In addition, we explored the efficacy of erythromycin (EM) treatment on CRS mice with or without AR (CRSwoAR, CRSwAR). Study subjects were divided into control, CRSwoAR, and CRSwAR groups. Experimental mice were divided similarly into control, CRSwoAR, and CRSwAR groups. In addition, CRS mice were treated with EM at 0.75, 7.5, or 75 mg/kg or with dexamethasone (Dex) at 1 mg/kg. In our results, allergy exacerbates inflammation that was evident in nasal histology and cytokine expression both in patients and in mice with CRS. Dex 1 mg/kg, EM 7.5 or 75 mg/kg treatments significantly inhibited serum IgE and IgG2a in CRS mice. EM-treated CRS mice had significantly elevated IL-10 levels and had a reversal of Th-1/Th-2 cytokine expression in nasal-associated lymphoid tissue. MUC5AC expressions were significantly reduced in the 7.5 or 75 mg/kg EM-treated mice compared with untreated mice. EM showed inhibitions on immunoglobulin production and mucus secretion stronger than Dex. We concluded that comorbid AR enhanced inflammation of CRS. EM and Dex treatments showed similar anti-inflammatory effects on CRS but through partly different mechanisms.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Erythromycin/therapeutic use , Nasal Mucosa/metabolism , Rhinitis, Allergic/complications , Sinusitis/complications , Adult , Aged , Aged, 80 and over , Animals , Anti-Bacterial Agents/pharmacology , Anti-Inflammatory Agents/pharmacology , Anti-Inflammatory Agents/therapeutic use , Chronic Disease , Cytokines/metabolism , Dexamethasone/pharmacology , Dexamethasone/therapeutic use , Drug Evaluation, Preclinical , Erythromycin/pharmacology , Female , Humans , Immunoglobulin E/metabolism , Male , Mice, Inbred BALB C , Middle Aged , Mucus/metabolism , Rhinitis, Allergic/drug therapy , Rhinitis, Allergic/metabolism , Sinusitis/drug therapy , Sinusitis/metabolism , Young Adult
15.
Curr Allergy Asthma Rep ; 21(6): 36, 2021 06 10.
Article in English | MEDLINE | ID: mdl-34110505

ABSTRACT

PURPOSE OF REVIEW: There is an emerging body of research on targeted biologic therapies for the treatment of severe inflammatory nasal disorders, especially chronic rhinosinusitis with nasal polyposis (CRSwNP). This paper will evaluate the efficacy of biologic therapies for severe nasal inflammation by summarizing key preclinical trials of biologics for animal models of allergic rhinitis and the recent phase 2 and 3 clinical trials of biologic therapies for CRSwNP. RECENT FINDINGS: Biologics that target the IL-4 receptor (dupilumab), IgE (omalizumab), and IL-5 (mepolizumab, reslizumab, and benralizumab) in patients with CRSwNP have shown improvement of various metrics including Sino-Nasal Outcome Test (SNOT-22) scores, Nasal Polyp Scores (NPS), Nasal Congestion Scores (NCS), and Lund-Mackay sinus opacification scores. The efficacy demonstrated through the dupilumab phase 3 trials (LIBERTY NP SINUS-24 and SINUS-52) led to approval of the first biologic for the treatment of CRSwNP. Phase 3 trials for omalizumab (POLYP 1 and 2) and mepolizumab (SYNAPSE study) and post hoc analyses of phase 3 asthma studies for reslizumab and benralizumab have also demonstrated positive results for the use of biologics for patients with CRSwNP. Future efficacy studies and risk/benefit and cost analyses of these biologics and other cytokine targets for allergic rhinitis with and without nasal polyposis need to be performed.


Subject(s)
Nasal Polyps , Rhinitis, Allergic , Rhinitis , Sinusitis , Biological Therapy , Chronic Disease , Humans , Nasal Polyps/complications , Nasal Polyps/drug therapy , Omalizumab , Rhinitis, Allergic/drug therapy , Sinusitis/complications , Sinusitis/drug therapy
16.
Otolaryngol Pol ; 76(1): 29-39, 2021 Dec 07.
Article in English | MEDLINE | ID: mdl-35380116

ABSTRACT

Acute rhinosinusitis (ARS) is a very common condition and mostly of viral origin. About 0.5-2% of the viral ARS are complicated by a bacterial infection. Due to viral etiology and inflammatory mechanisms of rhinitis and rhinosinusitis, symptomatic treatment including phytotherapy have been used for their treatment for decades. Scientific societies and expert groups recommend the use of herbal medicines in acute viral and acute post-viral rhinosinusitis. In 2021, Polish patients gained access to a new therapeutic option for acute sinusitis in the form of a drug containing a distillate of a mixture of rectified essential oils of eucalyptus, sweet orange, myrtle and lemon common.


Subject(s)
Bacterial Infections , Rhinitis , Sinusitis , Acute Disease , Bacterial Infections/drug therapy , Humans , Phytotherapy , Rhinitis/drug therapy , Sinusitis/complications , Sinusitis/drug therapy
17.
Am J Otolaryngol ; 41(5): 102564, 2020.
Article in English | MEDLINE | ID: mdl-32593046

ABSTRACT

Acute rhinosinusitis (ARS) can be characterized as bacterial (ABRS) and require antibiotic therapy only in 0.5-5% of cases. In most cases, the disease is in a viral and post-viral form, which requires pathogenetic and symptomatic treatment. The study objective was to determine the efficacy of BNO 1012 extract in the technology of delayed antibiotic prescribing in children with acute rhinosinusitis. METHODS: 292 children aged 6 to 11 years with ARS were randomized in the multicenter, comparative study. They received an extract of five medicinal plants in addition to standard symptomatic therapy or standard therapy only. EVALUATION CRITERIA: reduction of the sinusitis severity according to a 4-point medical assessment scale (nasal congestion, severity of anterior and posterior rhinorrhea) at each visit, dynamics of self-scoring of rhinorrhea and headache (according to a 10-point visual analogue scale), "therapeutic benefit" in days, frequency of antibiotic prescriptions due to the use of an extract of five plants. RESULTS: The use of the 5-plant extract BNO 1012 in addition to the standard symptomatic treatment of acute rhinosinusitis provides a clinically significant, adequate reduction in the severity of rhinorrhea, nasal congestion and post-nasal drip, assessed by a physician at V2 (p < 0.005). Significant differences are noted in the patient's self-scoring of rhinorrhea on the second or third day in viral RS, and from the fourth to the eighth day in post-viral RS. Symptoms of similar intensity in control group were observed at V3. Thus, in the first week of treatment, the treatment group compared to the control one showed a "therapeutic benefit" of three days. The use of BNO 1012 in patients with acute rhinosinusitis can 1.81-fold reduce the prescription of antibacterial drugs. CONCLUSION: The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years. Its use provides a significant "therapeutic benefit" when administered in addition to standard symptomatic therapy, reducing the need for antibiotic use.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Medical Overuse/prevention & control , Phytotherapy , Plant Extracts/administration & dosage , Rhinitis/drug therapy , Sinusitis/drug therapy , Acute Disease , Administration, Oral , Child , Female , Humans , Male , Nasal Obstruction/drug therapy , Nasal Obstruction/etiology , Patient Outcome Assessment , Prospective Studies , Rhinitis/complications , Rhinitis/microbiology , Rhinitis/virology , Sinusitis/complications , Sinusitis/microbiology , Sinusitis/virology
18.
Acta Biomed ; 91(1-S): 11-18, 2020 02 17.
Article in English | MEDLINE | ID: mdl-32073556

ABSTRACT

Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a frequent disorder. From a clinical and an immunopathological point of view, different phenotypes and endotypes have been identified. The frequent comorbidity with asthma allowed to pave the way to the use of biological agents for the treatment of CRSwNP. Biological agents are targeted to antagonize IgE, interleukin (IL) 4, IL-5, and IL-13 at present. However, a correct and appropriate workup is mandatory, mainly concerning the exact definition of the specific pheno-endotype. The preliminary outcomes are promising, even though there is a need for well-established indications, criteria of responsiveness, duration, and safety. On the other hand, this personalized medicine could be fruitfully integrated with gold-standard medications, such as intranasal corticosteroids. As CRSwNP is a chronic disorder, treatment should be long-lasting, so complementary anti-inflammatory treatments could be opportunely integrated and/or alternated to steroids.


Subject(s)
Integrative Medicine , Nasal Polyps/therapy , Precision Medicine , Rhinitis/therapy , Sinusitis/therapy , Chronic Disease , Humans , Nasal Polyps/complications , Rhinitis/complications , Sinusitis/complications
19.
Immunotherapy ; 12(2): 111-121, 2020 02.
Article in English | MEDLINE | ID: mdl-32075470

ABSTRACT

Chronic rhinosinusitis with nasal polyposis (CRSwNP) imparts a significant healthcare challenge, resulting in diminished quality of life for patients and high costs with resource utilization for disease management. Understanding of CRSwNP pathophysiology has progressively evolved and the identification of various inflammatory biomarkers has led to the development of monoclonal antibodies that target the underlying mechanisms of inflammation. Dupilumab, which targets IL-4 and IL-13 signaling, serves as a novel agent for CRSwNP treatment. Three clinical trials, NCT01920893, SINUS-24 and SINUS-52, have shown that dupilumab improves both subjective patient-reported outcomes and objective physician-evaluated metrics for CRSwNP. The favorable findings have resulted in approval by the US FDA in June 2019 as the first biologic therapy for CRSwNP.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Biological Therapy/methods , Nasal Polyps/complications , Nasal Polyps/drug therapy , Sinusitis/complications , Sinusitis/drug therapy , Chronic Disease , Humans , Treatment Outcome
20.
Acta Otorhinolaryngol Ital ; 40(6): 435-443, 2020 Dec.
Article in English | MEDLINE | ID: mdl-33558772

ABSTRACT

OBJECTIVE: The introduction of monoclonal antibody (mAb) therapies represents a promising treatment for refractory chronic rhinosinusitis (CRS). We assessed the effects of selected mAbs (omalizumab, mepolizumab, benralizumab) on CRS in severe asthmatic patients in a real-life setting. METHODS: A prospective observational study on severe asthmatic patients, treated with 3 different mAb (omalizumab, mepolizumab, benralizumab), and comorbid CRS was conducted. All patients were followed for 52 weeks. The degree of nasal control, SinoNasal Outcome Test (SNOT) 22, Nasal Polyp Score (NPS), Lund Kennedy Score (LKS) were collected at baseline and at 52-week. RESULTS: 40 patients (33 with nasal polyps) were studied. 33 patients (82.5%) had uncontrolled nasal disease at baseline, and 15 (37.5%) were uncontrolled after 52 weeks. Significant improvement was observed for SNOT 22 (P < 0.001), SNOT 1-12 (P < 0.001) and degree of nasal control (P < 0.001). Differences in NPS (P = 0.130) and LKS (P = 0.124) were not significant. Net change in the above-mentioned parameters among the three treatment groups was not significantly different. CONCLUSIONS: The study shows an improvement of nasal symptoms after 52 weeks of mAb treatment, which was not associated with significant improvement of endoscopic findings. Larger studies are needed to assess the real-life efficacy of mAbs in CRS.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Asthma/complications , Nasal Polyps , Rhinitis , Sinusitis , Biological Therapy , Chronic Disease , Humans , Nasal Polyps/complications , Nasal Polyps/drug therapy , Rhinitis/complications , Rhinitis/drug therapy , Sinusitis/complications , Sinusitis/drug therapy
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