Chinese Expert Consensus on the Use of Biologics in Patients with Chronic Rhinosinusitis (2022, Zhuhai).

BACKGROUND: Chronic rhinosinusitis (CRS) is a common inflammatory disease in otolaryngology, mainly manifested as nasal congestion, nasal discharge, facial pain/pressure, and smell disorder. CRS with nasal polyps (CRSwNP), an important phenotype of CRS, has a high recurrence rate even after receiving corticosteroids and/or functional endoscopic sinus surgery. In recent years, clinicians have focused on the application of biological agents in CRSwNP. However, it has not reached a consensus on the timing and selection of biologics for the treatment of CRS so far. SUMMARY: We reviewed the previous studies of biologics in CRS and summarized the indications, contraindications, efficacy assessment, prognosis, and adverse effects of biologics. Also, we evaluated the treatment response and adverse reactions of dupilumab, omalizumab, and mepolizumab in the management of CRS and made recommendations. KEY MESSAGES: Dupilumab, omalizumab, and mepolizumab have been approved for the treatment of CRSwNP by the US Food and Drug Administration. Type 2 and eosinophilic inflammation, need for systemic steroids or contraindication to systemic steroids, significantly impaired quality of life, anosmia, and comorbid asthma are required for the use of biologics. Based on current evidence, dupilumab has the prominent advantage in improving quality of life and reducing the risk of comorbid asthma in CRSwNP among the approved monoclonal antibodies. Most patients tolerate biological agents well in general with few major or severe adverse effects. Biologics have provided more options for severe uncontrolled CRSwNP patients or patients who refuse to have surgery. In the future, more novel biologics will be assessed in high-quality clinical trials and applied clinically.

Evaluation of traumatic optic neuropathy in patients with optic canal fracture using diffusion tensor magnetic resonance imaging: a preliminary report.

OBJECTIVE: To investigate the role of diffusion tensor magnetic resonance imaging (DT-MRI) in the evaluation of traumatic optic neuropathy (TON). METHODS: Six patients with TON underwent DT-MRI prior to decompression surgery. DTV 2 and Volume One 1.44 software were used to measure the fractional anisotropy (FA) and the mean apparent diffusion coefficient (ADC) of the optic nerves. White matter fiber bundle tracking was used to display optic nerves. RESULTS: Visual acuity was improved in 1 of the 6 patients after surgery. The mean FA of the injured eye declined significantly with regard to that of the normal eye (0.2438 ± 0.0670 vs. 0.4524 ± 0.0531; t = 8. 711; p = 0. 000). The mean ADC on the injured side increased significantly compared with that on the normal side [(1.4172 ± 0.1208) × 10(-3) mm(2)/s vs. (1.0866 ± 0.1179) × 10(-3) mm(2)/s; t = -5.316; p = 0. 003). The continuity of the intracanalicular segment of the optic nerve was interrupted in 3 patients without improved postoperative visual acuity. In 1 patient with improved postoperative visual acuity, the fiber bundle of the optic nerve was somewhat less dense in the injured eye than in the normal eye. CONCLUSIONS: DT-MRI provides valuable information for evaluating the fibers of optic nerves in TON.

Cephalometric craniofacial features of patients with Sagliker syndrome: a primary analysis of our experience.

BACKGROUND: Sagliker syndrome (SS) is characterized by a severe uglifying facial appearance resulting from untreated or inadequately treated secondary hyperparathyroidism (SHPT). To date, the craniofacial morphology of patients with SS has yet to be analyzed. The present research sought to cephalometrically evaluate the craniofacial features of patients with SS and to perform an in-depth analysis of their serum biochemical parameters, with the aim of furthering the theoretical basis for the early diagnosis and prevention of SS. METHODS: A retrospective chart review of 9 patients who fulfilled the diagnostic criteria for SS were included in this study, and their serum biochemical parameters were collected. After subjecting standard lateral cephalometric radiographic images to correction for distortions caused by magnification followed by digitization, we conducted a cephalometric analysis. Student's two-tailed t tests or Mann-Whitney U tests were used to analyze the data. Thirty-three patients with patients with SHPT alone were also included as controls. RESULTS: The lower anterior facial height (ANS-ME) and total anterior facial height (N-Me) measurements of patients with SS were significantly increased compared to those of the controls. The angles between the Frankfort horizontal, palatal, and occlusal planes and the mandibular plane, were greater in the SS group than in the control group, as was the gonial angle. Patients with SS also exhibited a significantly larger maxillary protrusion angle and relative position of the maxilla to the mandible. Most patients with SS had class II malocclusion, whereas most of the controls exhibited normal occlusion. Soft tissue largely followed the same pattern as craniofacial changes. Our investigation also showed that among patients with SHPT, female sex, longer duration of dialysis, and higher serum levels of alkaline phosphatase and intact parathyroid hormone were associated with development to SS. CONCLUSIONS: Patients with SS show facial and biochemical differences compared to patients with SHPT. Female sex, long dialysis duration, and high serum levels of intact parathyroid hormone and alkaline phosphatase may be potential risk factors for SS.

[Systematic reviews on efficacy and safety of beclomethasone nasal spray in the treatment of chronic adenoid hypertrophy in children].

OBJECTIVE: To systematically review the efficacy and safety of beclomethasone nasal spray in the treatment of chronic adenoid hypertrophy in children. METHODS: We computerized searches of the Cochrane Central Register of Controlled Trials (CENTRAL) (issue1, 009), MEDLINE (1950 to August 2008), EMbase (1984 to August 2008), CNKI (1994 to September 2008), and VIP (1989 to August 2008), WANFANG DATA, Annual Review-s and Elsevier Science. Also the reference lists of all papers were identified for further trials. All searches were initially performed in May 2007 and updated in April 2009.Randomized controlled trials (RCT) and quasi-RCTs were identified and analyzed according to the Cochrane Handbook for Systematic Reviews of Interventions. RESULTS: Three RCT were included. Meta-analysis was not performed due to heterogeneity and the data were summarized in a narrative format. The trials showed that higher doses of beclomethasone (336 microg/d, 400 microg/d) might improve the nasal obstruction symptoms and reduce adenoid size in children with adenoid hypertrophy. CONCLUSIONS: Higher and subsequently half doses of beclomethasone (336 microg/d, 400 microg/d) can improve the nasal obstruction symptoms in children with adenoid hypertrophy.The improvement appears to be associated with a reduction of adenoid size. Because of a lack of the RCT, further studies are required to support the use of beclomethasone as a first-line approach for these children.

Postsurgical Evaluation of Secondary Nephrogenic Hyperparathyroidism.

Parathyroidectomy is useful for the treatment of secondary hyperparathyroidism (SHPT) caused by chronic renal failure. The following three types of parathyroidectomy can be performed: subtotal parathyroidectomy, total parathyroidectomy and total parathyroidectomy plus autologous transplantation (tPTX+AT). Each of the three types of surgery has advantages and disadvantages. The present study retrospectively analyzed the efficacy of tPTX+AT for the treatment of SHPT over 1 year. Thirty-seven patients who were diagnosed with secondary nephrogenic hyperparathyroidism and treated with tPTX+AT were selected between September 2014 and October 2016 and followed up for 1 year. Their average age was 66.5±46.0 years, and the average time of dialysis was 48.1±8.2 months. The patients' conditions, including the levels of intact parathyroid hormone (iPTH) and bone metabolism, were compared preoperatively and 1 and 7 days and 1, 3, 6 and 12 months after surgery. In addition, the postoperative complications, pathological data, SHPT recurrence and prognosis were examined. The results showed that the postoperative level of ostalgia and cutaneous pruritus significantly decreased in the patients. An inspection of the parathyroid tissues during the operation confirmed the presence of parathyroid gland hyperplasia with no carcinoma detected. Three patients with hoarseness recovered within 1 month, and 1 patient with unilateral recurrent laryngeal nerve injury improved after 6 months of voice training. Compared to the preoperative condition, the postoperative serum iPTH, serum calcium and serum phosphate levels were significantly decreased (P<0.001), and these differences remained significant 12 months after surgery. Compared to the preoperative condition, the alkaline phosphatase (ALP) concentration was decreased on postoperative day 1 (P<0.05), but no differences were observed on day 7 or at 1 month (P>0.05). The ALP levels continuously decreased at 3, 6 and 12 months (P<0.01). In conclusion, tPTX+AT significantly improves the quality of life and serum biomarker levels of these patients. The convenient surgical removal of the hyperplastic parathyroid gland for postoperative recurrence supports tPTX+AT as the recommended treatment for relevant patients.

Talar Dome Investigation and Talocrural Joint Axis Analysis Based on Three-Dimensional (3D) Models: Implications for Prosthetic Design.

Ankle joint kinematics is mainly stabilized by the morphology of the talar dome and the articular surface of tibiofibular mortise as well as the medial and lateral ligament complexes. Because of this the bicondylar geometry of talus dome is believed to be crucial for ankle implant design. However, little data exist describing the precise anatomy of the talar dome and the talocrural joint axis. The aim of this study is to document the anatomy of the talar dome and the axis of the talocrural joint using three-dimensional (3D) computed tomographic (CT) modeling. Seventy-one participants enrolled for CT scanning and 3D talar model reconstruction. All the ankles were held in a neutral position during the CT scanning. Six points on the lateral and medial crest of the talar dome were defined. The coordinate of the six points; radii of lateral-anterior (R-LA), lateral-posterior (R-LP), medial-anterior (R-MA), and medial-posterior (R-MP) sections; and inclination angle of the talar dome were measured, and the inclination and deviation angles of the talocrural joint axis were determined. The mean values of R-LA, R-LP, R-MA, and R-MP were 19.23 ± 2.47 mm, 18.76 ± 2.90 mm, 17.02 ± 3.49 mm, and 22.75 ± 3.04 mm. The mean inclination angle of the talar dome was 9.86 ± 3.30 degrees. Gender variation was found in this parameter. The mean inclination and deviation angles were 8.60 ± 0.07 and 0.76 ± 0.69 degrees for the dorsiflexion axis and -7.34 ± 0.07 and 0.09 ± 0.18 degrees for the plantarflexion axis. Bilateral asymmetries between the medial and lateral crest of the talar dome were found, which resulted in different dorsiflexion and plantarflexion axes of the talocrural joint. Currently, no ankle implants replicate this talar anatomy, and these findings should be considered in future implant designs.

Management of sphenoidal sinus lesions by septal-assisted approach: Surgical skills and advantages.

The aim of this study was to develop a less invasive trans-septal approach for the endoscopic management of sphenoid sinus lesions. We performed a septal-assisted surgical procedure for endoscopic sphenoidectomy in 38 patients with isolated or combined sphenoidal sinus lesions, including fungal balls, mucoceles, purulent cystic sphenoidal sinusitis, etc. The posterior portion of the nasal septum became flexible after removal of the vomer and the sphenoidal rostrum. The superior portion of the common meatus was expanded to accommodate the endoscope after the septum was repositioned contra-laterally. The lesions were individually managed through the enlarged ostiums while damage to the mucosa of the front sphenoidal wall was avoided. All the procedures were completed successfully without intraoperative complications, and the bony ostiums were identified easily and enlarged accurately. During the follow-up period of 16 weeks to 2 years, no re-atresia or restenosis was observed. The recurrence rate was 0. No postoperative complications were recorded. All the responses from the patients were satisfactory. It was concluded that endoscopic sphenoidectomy assisted by trans-septal approach is a feasible, safe, effective and minimally invasive approach for selected cases with unilateral or bilateral lesions in the sphenoid sinuses.

Full Endoscopic Transsphenoidal Surgery for Pituitary Adenoma-emphasized on Surgical Skill of Otolaryngologist.

The purpose is to summarize the experience in full endoscopic transsphenoidal resection of pituitary adenoma in 28 patients by rhinologist, and introduce the surgical skill of otolaryngologist, especially skills and cautions when operating inside nose. We removed pituitary adenoma in 28 patients via entirely endoscopic transsphenoidal approach with the help of special-designed instruments; we performed the procedure bloodlessly within limited time. The skill emphasized bilateral nostrils and four hands technique which was as delicate as possible not to scratch nasal mucosa or injure nasal frame. The special instruments included curette with suction, monopolar electrotome and bipolar coagulation forceps with suction, powered surgical equipments (Diamond Bur, Irrigation Tubing for Blades and Burs for nasal endoscopic surgery). Among 28 patients, there were 16 total resections, 8 subtotal resections, 3 partial resections, and 1 only biopsy due to excessive bleeding and hard nature. Of 19 patients with preoperative visual impairment, 12 patients had postoperative improvement in visual acuity and visual field. All the procedures were finished within 60 to 90 min. Complications seldom occurred except transient diabetes insipidus, especially no nasal-related signs or complications but 1 had epistaxis. The full endoscopic transsphenoidal surgery is a promising approach for pituitary adenoma resection. Multidisciplinary collaboration will lead to optimal cure for the patients. New technique and special-designed instruments can facilitate greatly this procedure.

Comparison of Combined Phacoemulsification, Intraocular Lens Implantation, and Goniosynechialysis With Phacotrabeculectomy in the Treatment of Primary Angle-Closure Glaucoma and Cataract.

PURPOSE: This study aimed to compare the efficacy and safety of combined phacoemulsification, intraocular lens implantation, and goniosynechialysis with phacotrabeculectomy in the treatment of primary angle-closure glaucoma (PACG) and cataract. DESIGN: A comparative case series. METHODS: Sixty-five patients (65 eyes) with PACG and cataract from the Fifth Affiliated Hospital of Sun Yat-Sen University were enrolled for this study between October 2009 and July 2011. Of these, 33 underwent combined phacoemulsification, intraocular lens implantation, and goniosynechialysis (treatment group), and 32 underwent phacotrabeculectomy (control group). The effects on intraocular pressure, best-corrected visual acuity, anterior chamber angle, number of antiglaucoma medications, and complications were evaluated. RESULTS: Both the treatment group and the control group had lowered intraocular pressure, reduced the use of antiglaucoma medications, and improved vision in patients with PACG and cataract. Complications were 8 (24.2%) of 33 in the treatment group and 12 (37.5%) of 32 in the control group. CONCLUSIONS: Combined phacoemulsification, intraocular lens implantation, and goniosynechialysis appears to be a preferred method for the treatment of PACG and cataract because it seems to have the same efficacy as phacotrabeculectomy and has much less surgical complications.

[Postoperative symptoms and life quality assessment of chronic rhinosinusitis patients received endoscopic sinus surgery].

OBJECTIVE: To implore the positive effects of endoscopic sinus surgery on the symptoms and quality of life (QOL) of patients with chronic rhinosinusitis (CRS) and their changing regularity of symptoms and QOL. METHODS: A prospective, randomized and controlled trial was conducted to survey symptoms and QOL status of 120 CRS patients undergoing endoscopic sinus surgery, in contrast to that of 200 healthy individuals passing health examination, at the baseline and at 3- and 6-months postoperatively by visual analog score (VAS) symptom instrument and QOL instruments including medical outcome study short-form 36-items health survey (SF-36) and sino-nasal outcome test-20 (SNOT-20). RESULTS: In the 3 months follow-up settings, total of individual symptom severity scores and global symptom severity scores of VAS, such domains as role physical and general health of SF-36 and total of the 20 items scores and the most important 5-item scores of SNOT-20 all began to get better markedly (P < 0.05); in the 3-6 months follow-up settings, the indices above stayed fixed (P > 0.05); and in the 6-months follow-up settings, indices of symptoms and QOL status entirely improved from the baseline, with SF-36 showing no scoring difference between CRS patients and healthy individuals, whereas VAS showed that abnormal nasal drainage and decreased sense of smell were still left and SNOT-20 showed that abnormal nasal drainage and lack of good sleep left, inferior to that of healthy objects significantly (P < 0.05). CONCLUSIONS: On the whole CRS patients undergoing endoscopic sinus surgery recover symptomatically and come back to normal level of QOL status at the 6 months postoperatively, but such significant problems as abnormal nasal drainage, decreased sense of smell and lack of good sleep still remain and need to be treated.

[Quality of life survey on patients with chronic rhinosinusitis and nasal polyps].

OBJECTIVE: To explore the health-related quality of life (QOL) status of patients with chronic rhinosinusitis and nasal polyps. METHODS: One hundred and twenty patients with chronic rhinosinusitis and nasal polyps and two hundred individuals passing health examination were enrolled by random and their QOL scores were assessed by using QOL instruments including existing SF-36 questionnaire (Chinese version ) and SNOT-20 questionnaire translated into Chinese, of which clinimetric and psychometric properties were tested. RESULTS: The feasibility, reliability, validity, and responsibility of Chinese version of SNOT-20 questionnaire all passed the test. By the assessment of SF-36 questionnaire, it revealed that scores of six domains such as physical functioning, role physical, bodily pain, mental health, vitality, and general health from patients with chronic rhinosinusitis and nasal polyps were lower than that of control group except social functioning and role emotional (P < 0.05). It showed by Chinese version of SNOT-20 questionnaire that patients exceeded healthy individuals in the scores of twenty items of three domains including physical problems, functional limitations, and emotional consequences, of which the most five important items affecting health status were respectively need to blow nose, thick nasal discharge, lack of a good night's sleep, dizziness, and post-nasal discharge (P < 0.05). CONCLUSIONS: QOL instruments such as Chinese version of SF-36 and SNOT-20 questionnaires can effectively differentiate the QOL status between patients with chronic rhinosinusitis and nasal polyps and healthy individuals. The negative impact of chronic rhinosinusitis and nasal polyps on patients' QOL includes physical functioning, role physical, bodily pain, mental health, vitality, general health, and emotional consequences. The problems of nasal discharge, sleep, and dizziness should be sufficiently emphasized in clinical treatment.

[Endoscopic evaluation of mucous membrane inflammation in chronic rhinosinusitis and analysis of correlated factors].

OBJECTIVE: The purpose of this article is to establish an endoscopic score system for quantitative evaluation of the inflammation of mucous membrane in patients with chronic rhinosinusitis (CRS) , and to investigate the correlation of this system with a variety of clinical factors. METHODS: A set of score system was constructed based on anatomic configuration, status of mucous membrane and nasal secretion to evaluate quantificationally the severity of inflammation of CRS. The clinical correlation of this system was studied prospectively in 60 CRS patients, with a variety of clinical factors which included age, duration of disease, previous recurrence and the years from recent recurrence, atopy, serum total immunoglobulin E (TIgE), serum eosinophil cationic protein (ECP), the count of blood eosinophil, the count of tissue inflammatory cell, the extension of CRS indicated by CT, smoking, concomitant chronic inflammation in lower respiratory tract. All above factors were analyzed statistically with the endoscopic score by Pearson correlation and multi-factor linear regression analysis. RESULTS: In pearson analysis, the correlative factors with the evaluated score included age (x1, r = - 0.310, P = 0.016), the extension of disease (x2, r = 0. 810, P < 0.0005), recurrence (x3, r = 0.408, P = 0.001), eosinophil of nasal tissue (x4, r = 0.279, P = 0. 031), duration of disease (x5, r = 0.536, P < 0.0005), concurrent nasal polyps (r = 0.549, P < 0.0005), plasm cell (r = 0. 317, P = 0.014) and years from the recent recurrence (r = 0.385, P = 0.002). In multi-factor linear regression, the five independent predictive factors were recurrence, age, extension of disease, tissue eosinophils, years of disease. The regressive equation is y = 10.148 - 0.152 (x1) + 2.250 (x2) + 3.348 (x3) + 1.233 (x4) + 0.270 (x5). CONCLUSIONS: Appropriate score system by nasal endoscopy is feasible to evaluate quantificationally the degree of inflammation of CRS; being appropriately modified, it is even able to reveal the underlying histological behavior finely.

[Detection of specific IgE of anti-Staphylococcus aureus enterotoxins in nasal polyps and analysis theoretically about the superantigen hypothesis].

OBJECTIVE: To search the evidence for the presence of superantigen of Staphylococcus aureus enterotoxin (SE) in the pathogenesis of nasal polyposis. METHODS: In a cohort of population composed of 42 cases who belonged to three groups: nasal polyposis, simple chronic rhinosinusitis (CRS), and control group without any rhinopathy, detecting the specific IgE against SE-A and B (SEA and SEB), total IgE (TIgE), eosinophilic cationic protein (ECP) of the local mucosa by means of FRAST (UniCAP system), as well as the serum TIgE, and serum anti-SEA and SEB SIgE (only in 8 cases); meanwhile the secretion culture was performed for aerobic bacteria from the middle meatus. RESULTS: There was no evidence to support that SE played as a superantigen in all mucosa samples (42 cases) and 8 cases serum samples out of the 42 patients. The range of TIgE in mucosa was 4.59 -70.21 kIU/2 mg tissue protein, the mean was (17.85 +/- 14.31) kIU/2 mg tissue protein; in serum the total IgE was 7.44 - 344.00 kIU/L, the mean was (88.65 +/- 80.03) kIU/L The positive culture of Staphylococcus aureus was obtained from only 3 cases from secretion of middle meatus (1 from nasal polyps, 2 from CRS). There was no significance statistically among the three groups on the tissue fluorescence value of SIgE for SE, the means of tissue TIgE and ECP. CONCLUSIONS: No evidence was found to support the role of SE acting as a superantigen among our cases who did not have persistent asthma. It is suggested that further study and investigation is required to prove the superantigen Hypothesis in the pathogenesis of NPs.

[Bacteriological study of chronic sinusitis].

OBJECTIVE: To explore the characteristics of bacteria isolated from patients with chronic sinusitis (CR) and antibiotic-resistance. METHODS: The purulent discharges taken from the maxillary sinus and posterior ethmoid sinus of 76 patients during endoscopic sinus surgery were cultured for both bacteria and fungi, then the antimicrobial susceptibility test and beta-lactamase-producing bacteria (beta-LPB) were detected. In the control group, the discharges from the nasal cavity from 10 healthy adults were also cultured for bacteria. RESULTS: Twenty species, including Staphylococcus epidermidis, Escherichia coli, Staphylococcus aureus, alpha-Hemolytic streptococcus and Streptococcus pneumoniae, were cultured from the testing group. The total positive rate of bacteria was 81.8%. The detectable rates of aerobe, anaerobe, gram-positive bacteria and gram-negative bacteria were 83.4%, 16.6%, 56.3% and 43.7%, respectively. The fungi was only detected in 1.4% patients. The antimicrobial susceptibility test demonstrated that Imipenem, Cefotaxime and Amoxicillin-clavulanate were good in vitro activity to aerobic pathogens and Metronidazole, Imipenem and Chloramphenicol was good to anaerobic pathogens. The beta-LPB was detected in 37.7% strains in which Staphylococcus epidermidis, Staphylococcus aureus, alpha-Hemolytic streptococcus and Branhamella catarrhalis were more frequent. Five species including Staphylococcus epidermidis and Escherichia coli etc were cultured from the control group. There was no significant difference of distribution of the same bacteria between the control group and the testing group (P > 0.05). CONCLUSIONS: The pathogenic bacteria of CR mostly involve aerobes. The antibiotics-resistance of these pathogen is serious. The bacterial infection plays no leading role in CR, so the need of antibiotics should not be excessively emphasized. Before treatment by antibiotics, the antimicrobial susceptibility test should be performed. The broad-spectrum antibiotics containing beta-lactamase inhibitor such as Cefotaxime and Amoxicillin-clavulanate is recommended in condition that the test can not be finished.