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.

Effect of Cellulose Powder on Human Nasal Epithelial Cell Activity and Ciliary Beat Frequency.

BACKGROUND: Cellulose powder (CP) has been reported as a safe and effective complementary treatment for allergic rhinitis (AR). Currently, CP has gained increasing application for clinical management worldwide, particularly in China. However, studies focusing on the effect of CP on normal human nasal epithelial cells (hNECs) and ciliary function are lacking. Here, we aimed to explore the adverse effects of CP on the activity and ciliary function of hNECs. METHODS: We biopsied ethmoid sinus or middle turbinate tissues during surgical resection from control subjects who underwent endoscopic sinus surgery for diseases other than AR. Cells were isolated and passaged, followed by differentiation in an air-liquid interface (ALI). Flow cytometry and cell viability test (cell counting kit-8) were performed to detect the cytotoxicity of CP (effects on cell proliferation) on normal hNECs. By using the ALI culture model, we investigated the effects of CP on ciliary beat frequency (CBF). RESULTS: There was a significant reduction in hNEC count at high concentrations of CP (2.5 mg/mL) at days 3 and 7 (both p < 0.05). As the concentration increased, cell death increased progressively from day 3 to day 7. However, these effects were not evident at low concentrations (0.25 mg/mL, p > 0.05). High-dose CP (2.5 mg) significantly reduced the CBF (p < 0.05). At lower concentrations (0.25-2.5 mg/mL), CP initially increased but subsequently reduced the CBF of hNECs compared with control group. CONCLUSIONS: Cytotoxicity and the suppression of ciliary beat at high concentrations justify more prudent use of CP for the management of AR.

Long-term results of endoscopic sinus surgery-oriented treatment for chronic rhinosinusitis with asthma.

OBJECTIVES/HYPOTHESIS: The aims of this study were to evaluate the efficacy of functional endoscopic sinus surgery (FESS)-oriented multimodality treatment in chronic rhinosinusitis (CRS) patients with asthma and its impact on asthma. STUDY DESIGN: Prospective, nonrandomized cohort. METHODS: Twenty-seven CRS patients with asthma who underwent FESS with postoperative topical corticosteroid spray were evaluated preoperatively; 25 of them were evaluated 1 year and 3 years postoperatively. CRS was evaluated by visual analogue scale, clinical control of CRS, and objective measurement endoscopy Lund-Kennedy scores. Asthma was assessed by subjective asthma control test and asthma control level, also by objective antiasthma medication use and pulmonary function tests. RESULTS: VAS scores of general symptoms (8.09 ± 0.87 preoperatively) were significantly improved at 1 year (2.94 ± 2.21) and 3 years (3.77 ± 2.16) postoperation (P = .000). No difference in these items was found between 1 year and 3 years (P = .463). Endoscopy Lund-Kennedy scores at 1 year (4.34 ± 3.09) and 3 years (5.80 ± 3.38) postoperatively were significantly better (9.33 ± 2.03 preoperatively, P = .000), and there was no difference between 1 year and 3 years of follow-up (P > .05). Significantly, asthma control level improved postoperatively (P = .025). However, antiasthma drug and pulmonary function showed no significant change postoperatively (P > .05). CONCLUSIONS: FESS-oriented multimodality treatment improves CRS with asthma significantly and persistently. Asthma control level improved. Antiasthma medication use and pulmonary function remained stable.

[Regularity of nasal mucous transitional course of different sinuses after functional endoscopic sinus surgery].

OBJECTIVES: To explore the time regularity of nasal mucous transitional course of different sinuses after functional endoscopic sinus surgery. METHODS: Seventy-seven chronic rhinosinusitis patients following functional endoscopic sinus surgery were prospectively collected. The endoscopic appearances of different sinuses were respectively evaluated with Lund-Kennedy scoring system in 2 weeks, 1, 2, 3, 6, 9 months, and 12 months postoperatively. Then the endoscopic scores and epithelization proportions of different sinuses in different stages were analyzed and compared. RESULTS: Of 77 patients, 154 maxillary sinuses, 154 ethmoidal sinuses, 138 frontal sinuses, and 129 sphenoidal sinuses were scored endoscopically and analyzed statistically. In the 2 weeks after operation, the mucosa scores of sphenoidal sinus (3.5 ± 1.5), ethmoidal sinus (3.6 ± 1.4), maxillary sinus (3.7 ± 1.5), and frontal sinus (3.8 ± 1.5) showed no significant differences by no parameter tests (χ(2) = 1.674, P = 0.643). In the 2, 3, 6, and 9 months postoperatively, the assessment of four kinds of sinuses showed separate transitional tendency and the descending deflection points of scores and ascending peaks of epithelization proportions gradually emerged. In the 12 months postoperatively, by the above statistical methods, the mucosal scores (Z = -3.417, P = 0.001) and epithelization proportions (χ(2) = 4.313, P = 0.038) of sphenoidal sinus were superior to that of ethmoidal sinus, the mucosal scores (Z = -2.218, P = 0.027) and epithelization proportions (χ(2) = 4.292, P = 0.038) of ethmoidal sinus were superior to that of maxillary sinus, and the mucosal scores (Z = -2.244,P = 0.025) and epithelization proportions (χ(2) = 4.100, P = 0.043) of maxillary sinus were superior to that of frontal sinus. CONCLUSIONS: The transitional course of different sinus mucosa after functional endoscopic sinus surgery shows significant time difference. The time sequencing to complete epithelization of sinuses is successively sphenoidal sinus, ethmoidal sinus, maxillary sinus, and frontal sinus.

[Salvage management and subsequent treatment after internal carotid artery injury during transnasal endoscopic surgery].

OBJECTIVE: To explore the cause, urgent management, further treatment, outcome and prevention of internal carotid artery (ICA) injury during transnasal endoscopic surgery. METHODS: Five ICA injury happened during transnasal endoscopic surgery of sphenoidal sinus and (or) sellar region, involving 1 case of traumatic optic neuropathy, 1 case of sphenoidal cyst, 1 case of fungal sphenoid sinusitis, 1 case of sellar adenoid cystic carcinoma and 1 case of pituitary tumor. These five cases were from three different hospitals in 1990 - 2009, and the clinical data were collected and retrospectively reviewed. RESULTS: Injury of ICA was related with improper anatomic localization and operative procedures. The locations of injury were in cavernous segment in 3 cases, lacerum segment in 1 case, and clinic segment in 1 case, respectively. The types of injury included 3 cases of bleeding of laceration, 1 case of carotid cavernous fistula and 1 case of pseudoaneurysm. Salvage sphenoid sinus packing with vaseline strip and subsequent intravascular stent graft implantation (2 cases) and endovascular embolization (2 cases) effectively controlled bleeding. Four cases were successfully treated without craniocerebral or ocular complications, only 1 case died of massive blood loss. Among 4 survival cases, 1 patient abandoned further therapy, the other 3 patients were cured of primary disease by reoperation or subsequent treatment. CONCLUSION: Preoperatively, reading carefully the imaging data, intraoperatively, identifying anatomical positions accurately, performing proper operation, and stopping bleeding decidedly, postoperatively, seeking interdisciplinary cooperation to repair vascular damages, all these procedures can effectively reduce the surgical risk of ICA injury.

[Resection of petrous apex cholesteatoma via endoscopic trans-sphenoidal approach].

OBJECTIVE: To introduce our experience of resection of petrous apex cholesteatoma through endoscopic, transnasal, trans-sphenoidal approach in 3 cases, and present a surgical technique of intracystic resection of lesion which yielded a relatively stable long-term outcome. METHODS: Resection of parasellar and petrous apex cholesteatoma via endoscopic transsphenoidal approach was performed in three patients between 2001 and 2006. Surgical technique was as follows: the ethmoid and sphenoid sinuses were opened under endoscope, the petrous apex was accessed by drilling skull base bone at the lateral wall of sphenoid sinus and anterior to the internal carotid artery, the cyst wall of cholesteatoma was incised and expanded, then intracystic removal of cholesteatoma was achieved by the suction, curette and rinsing. RESULTS: The petrous apex cholesteatoma in all 3 patients were removed clearly by endoscopic, transnasal, trans-sphenoidal surgery in one time. Before surgery, two patients with headache and orbital apex syndrome had a remarkable improvement just on the day after operation and completely recovered in 1-4 weeks. No postoperative complications happened in all three patients. All patients had no recurrence in symptoms and no imaging evidences of recurrence at a follow-up of 3 - 7 years. CONCLUSION: The petrous apex cholesteatoma around the parasellar region could be treated by intracystic removal via endoscopic, transnasal, transsphenoidal approach, without the need to strip and remove the cyst wall, and the long-term efficacy was reliable.

[Clinical observation of topical steroid for the treatment of chronic rhinosinusitis in Chinese adults].

OBJECTIVE: This study was focused on the clinical effects of topical steroid for chronic rhinosinusitis (CRS) in Chinese adults. METHODS: The CRS patients were randomly selected in the department of otorhinolaryngology, first affiliated hospital of Sun Yat-sen university between november 2010 and December 2011. Thirty-four CRS patients with polyps (CRSwNP) or CRS without polyps (CRSsNP), no prior surgeries were included. These patients were prescribed to use budesonide nasal spay for three months. Evaluation included visual analog score (VAS), sino-nasal outcome test-20(SNOT-20), CT scan (Lund-Mackay score). SPSS 16.0 software was used to analyze the data. RESULTS: Four patients were lost to follow up, while the other 30 patients finished the 3-months' follow up. Except for smelling disturbance which was not statistically changed (t = 0.902, P > 0.05), VAS for nasal blockage (baseline: 4.84 ± 3.15, after treatment: 2.26 ± 2.27), rhinorrhea (baseline: 6.03 ± 2.93, after treatment: 1.96 ± 2.23), headache (baseline: 1.68 ± 2.66, after treatment: 0.42 ± 0.95), facial pressure (baseline: 2.04 ± 2.97, after treatment: 0.58 ± 1.42) and general symptom (baseline: 6.00 ± 2.75, after treatment: 2.71 ± 1.90) were statistically decreased (t value was 4.386, 6.740, 2.445, 2.980, 6.989, respectively, all P < 0.05). VAS of nasal blockage, rhinorrhea and general symptom were statistically decreased after one-month's treatment (all P < 0.05), but no statistical improvements were observed between first, second and the third month (all P > 0.05). SNOT-20 was significantly decreased after treatment (t = 3.687, P < 0.01). 22.2% patients were cured on CT scan. CONCLUSIONS: Topical steroid improves objective symptoms and quality of life in CRS patients. Some of the patients can be cured in CT scores. The symptoms improvements begin from the first month, but do not change during the latter two months.

[Macrolide therapy on nasal mucosal persistent refractory inflammation after endoscopic sinus surgery].

OBJECTIVE: To examine the clinical effect of low-dose (250 mg/d), long-term (12 - 28 weeks) macrolide Klacid on the persistent refractory inflammation of paranasal sinus mucosa following endoscopic sinus surgery (ESS). METHODS: Thirteen patients from a consecutive series of 141 patients undergoing ESS for chronic rhinosinusitis (CRS) during 2004 - 2006 for the first time were recruited for persistent refractory inflammation over 2 years postoperatively. All patients were given Klacid 250 mg/d orally for 12 - 28 weeks and simultaneously maintained the usual treatment including intranasal corticosteroid, mucolytics, and nasal douche. At the end of treatment and the sequential 3 and 6 months, 13 patients were evaluated by symptoms of visual analogue scale and nasal endoscopy by Lund-Kennedy scoring system, respectively. RESULTS: Among the 13 patients, 1 patient stopped therapy for no obvious benefit 5 months after treatment, 12 patients finished the planned treatment till achieving the stopping therapy standard. Ultimately both symptom (8.00 [7.50, 8.50] and 1.00 [0.25, 1.00], Z = -3.201, P < 0.01) and endoscopic evaluation (7.00 [6.50, 8.00] and 1.00 [0.00, 1.00], Z = -3.194, P < 0.01) showed total remarkable improvement after therapy in 13 patients. The comprehensive assessment showed very good outcomes in 6 cases, good in 6 cases, and no good outcomes in 1 case, respectively. During the sequential 3 months and 6 months, no recurrent sinusitis and side effect happened in any patients. CONCLUSIONS: It is effective to treat chronic refractory sinusitis with a low-dose (250 mg/d), long-term (12 - 28 weeks) Klacid on nasal mucosal persistent refractory inflammation after ESS. Klacid is well tolerated and safe to CRS patients during the use of 12 - 28 weeks.

[Efficacy of endoscopic sinus surgery-based on multidisciplinary treatment for chronic rhinosinusitis with asthma].

OBJECTIVE: To evaluate the efficacy of endoscopic sinus surgery (ESS)-based on multidisciplinary treatment for patients with chronic rhinosinusitis (CRS) and asthma. METHODS: The study included 25 CRS patients with asthma who received ESS from September 2006 to March 2009, besides surgery, who also used corticosteroid nasal spray, oral macrolide antibiotics and nasal irrigation perioperatively. Evaluation was performed before ESS, 1 year and 3 years post-ESS. Evaluation index included visual analogue scale (VAS) and endoscopy Lund-Kennedy assessment for CRS, and asthma control test (ACT) and pulmonary function tests for asthma. RESULTS: Twenty-three (92%) patients were followed up for 12 months. Twelve (48%) of them were followed up for 36 months. CRS efficacy: VAS of general symptom significantly improved after ESS compared to pre-ESS (8.12 ± 0.60, x(-) ± s), after 1 year (3.20 ± 2.19) and 3 year (3.79 ± 2.32) follow up (both P = 0.000). There was no statistic difference between 1 year and 3 year follow up (P = 0.851). Endoscopy Lund-Kennedy score significantly improved in post-ESS after 1 year (4.35 ± 3.21) and 3 year (5.50 ± 2.64) follow up compared to pre-ESS (9.80 ± 2.10, both P = 0.000), and there was no difference between 1 year and 3 year follow up (P = 0.606). Asthma efficacy: ACT pre-ESS, 1 year and 3 year were 21.96 ± 2.16, 23.61 ± 1.94 and 22.33 ± 3.47, without statistic difference (F = 2.871, P = 0.065). Pulmonary function showed no significant change after surgery (Pre-ESS 74.68 ± 11.09, 1 year 73.27 ± 12.27, 3 year 73.50 ± 7.87, F = 0.076, P > 0.05). CONCLUSIONS: ESS improves CRS with asthma significantly and persistently. Asthma control level, anti-asthma drug dose and pulmonary function remain stable after ESS.

[Transnasal endoscopic frontal sinus surgery using expanded agger nasi approach].

OBJECTIVE: To explore the feasibility of endoscopic modified agger nasi approach for the surgical treatment of frontal sinus diseases. METHODS: The data of patients undergoing modified agger nasi approach for frontal diseases were prospectively collected since January 2009, including demographic data, findings at surgery, presence of postoperative symptoms, endoscopic appearance of the frontal recess and sinus, and complications. RESULTS: Nineteen patients were enrolled from January 2009 to August 2010. Seventeen patients had chronic rhinosinusitis, in which 13 patients (76.5%) completely healed, 3 patients (17.6%) improved and 1 patient (5.9%) failed. Two patients had frontal sinus and anterior ethmoid sinus inverted papilloma, with no recurrence. The patients were followed up from 6 to 24 months, medium 16 months. No severe complication occurred. No frontal recess adhesion was found. Four sides of frontal recess showed stenosis caused by tissue hypertrophy. CONCLUSION: The modified agger nasi approach provides excellent access to frontal recess and frontal sinus, with good effect for preventing re-stenosis after surgery.

[Clinical study on mometasone furoate nasal spray in the treatment of non-allergic rhinitis].

OBJECTIVE: To evaluate the outcome of mometasone furoate nasal spray (MFNS) used for 3 months on non-allergic rhinitis (NAR). METHODS: In this multicenter study, NAR patients were enrolled from eight hospitals and received MFNS 200 microgram once daily for 3 months. The patients were followed-up for three times (at baseline, month 1 and month 3) to record the symptom scores and nasal endoscopic appearances. At the same time, the adverse events frequency was recorded and analyzed. RESULTS: A total of 188 NAR cases were enrolled in the study. The total nasal symptom score assessment descended significantly at month 1 (1.70 ± 0.75) and month 3 (0.95 ± 0.79) visits versus at baseline (2.67 ± 0.68, Z value were from -11.603 to -10.491, all P < 0.01). The individual symptoms, including nasal stuffiness, nasal discharge, nasal stuffiness-related dizziness or headache, hyposmia, sleep quality, daily life activity, work or study efficiency, mental status, and whole body fatigue, also showed less scores at month 1 and month 3 visits versus at baseline (Z value were from -11.313 to -6.802, all P < 0.01). At the same time, nasal mucosal appearances assessed by endoscopy had lower scores at month 1 (1.40 ± 0.62) and month 3 (0.75 ± 0.71) visits versus at baseline (2.27 ± 0.73, Z value were from -11.484 to -10.002, all P < 0.01). Additionally, adverse events were only observed in 5.3% cases with light rhinorrhagia and nasal dryness. No other side effect was found. CONCLUSIONS: A 3-months administration of intranasal mometasone can effectively and safely improve NAR patients' clinical symptom and nasal mucosal appearances.

[Investigation of relevant factors on refractory chronic rhinosinusitis].

OBJECTIVE: To explore the relationship between the bacterial biofilm, allergy, inflammatory cytokines and refractory rhinosinusitis. METHOD: According to the assessment of symptom by visual analogue scale and nasal endoscopy by Lund-Kennedy system, 19 patients with persistent chronic rhinosinusitis and 6 patients with curative chronic rhinosinusitis were recruited from 340 chronic rhinosinusitis patients underwent functional endoscopic sinus surgery for the first time and received standard medication postoperatively. These cases were divided into the study group and the control group respectively. Electron microscope scanning and enzyme linked immunosorbent assay were used to observe the bacterial biofilm formation on ethmoid sinus mucosal surface and detect the concentration of specific IgE and interleukin (IL) 4, IL-5, IL-6, and IL-8 in ethmoid sinus mucosal tissue. Then the differences between the two groups of cases were analyzed statistically. RESULT: (1) Bacterial biofilms: nineteen cases from the study group were all found biofilm formation in ethmoid sinus, besides the damage of epithelial cells and cilia. Six cases from the control group were found no biofilm, with the integrity of epithelial cells and cilia. Statistical analysis showed significant differences in biofilm detection rate between the two groups (P < 0.01). (2) Specific IgE: specific IgE was detected in nine cases from the study group and was not found in any case from the control group, with a significant difference between them (P < 0.05). (3) IL: IL concentration was all detected under normal value both in the study group and the control group, except for only 2 cases from the study group with higher IL-8 concentration. Positive reaction to IL was detected as follows: IL-4 (7 cases), IL-5 (14 cases), IL-6 (15 cases), and IL-8 (12 cases) in the study group; IL-4 (1 case), IL-5 (5 cases), IL-6 (5 cases), and IL-8 (5 cases) in control group. No difference in IL detection rate was found between the two groups (P > 0.05). CONCLUSION: Bacterial biofilm and allergic inflammation are important factors resulting into refractory chronic rhinosinusitis.

[Transnasal endoscopic optic nerve decompression for traumatic optic neuropathy: analysis of 155 cases].

OBJECTIVE: To explore the outcome of transnasal endoscopic optic nerve decompression (TEOND) for traumatic optic neuropathy (TON). METHODS: The clinical data of 155 consecutive patients with TON treated with TEOND after failure of mega-dose steroid therapy were retrospectively analyzed, their outcomes were summarized after follow-up, and then Logistic regression was used to analyze the prognosis-related information to explore the factors influencing prognosis. RESULTS: Patients were followed up for 3 - 60 months. The total effective rate of the 155 patients was 44.5%. The effective rate of the patients with light perception or better vision was 87.5%, much higher than that of the patients without light perception (29.6%). Eyesight was improved, mostly occurring 1 - 5 days after operation and lasting for 1 - 3 months, in 69 patients. Residual vision degree after trauma (OR = 0.04) and the interval between injury and surgery (OR = 4.62) were significant prognostic factors of the general effect (P < 0.01), and the gradual or immediate visual loss history (OR = 0.22) and the interval between injury and surgery (OR = 6.34) were significant to the outcomes of the patients with no light perception (P < 0.05). Sex, age, duration of coma after trauma, pre- and post-operative duration of steroid treatment, operators, fracture site of optic canal, and nerve sheath incision were not correlated to the outcomes of patients (all P > 0.05). Intraoperative cerebrospinal fluid rhinorrhea and postoperative transient visual loss occurred in one and the other two cases, respectively, but these conditions were resolved successfully. CONCLUSION: TEOND is effective and safe for TON patients, but the visual outcome is poor for the immediate blindness cases. The surgery is indicated for the patients with some residual vision or with a gradual visual loss and is suggested to perform early within seven days after injury.

[Clinical effects of nasal glucocorticoid on amelioration of nasal obstruction in patients with persistent non-allergic rhinitis].

OBJECTIVE: To observe the efficacy of nasal glucocorticoid continuously used for 12 weeks on nasal obstruction in patients with persistent non-allergic rhinitis (PNAR). METHODS: The changes of nasal obstruction, nasal resistance, nasal mucous membrane and quality of life in 47 patients with PNAR were observed. The efficacy of nasal glucocorticoid (Mometasone Furoate Nasal Spray, MFNS 200 microg/day) on patients with PNAR was evaluated. RESULTS: The results of nasal glucocorticoid (MFNS) continuously used for 12 weeks demonstrated: (1) After treatment, the nasal obstruction, nasal discharge, nasal obstruction related dizziness, headache, hyposmia, daily life activity, whole body fatigue, mental status were significantly improved (P < 0.05). (2) Nasal resistance showed significant amelioration (pre-treatment = 0.28 +/- 0.10, post- treatment = 0.16 +/- 0.05; F = 91.471, P < 0.05). (3) SF-36 questionnaire revealed that role physical, bodily pain, general health, role emotional had significant amelioration (P < 0.01). (4) SNOT-20 questionnaire revealed that the defatigation, impaired concentration, pinch the nose, nasal discharging into the throat, sleep quality had significant amelioration (P < 0.01). (5) Continued treatment for 12 weeks was better than 4 weeks, continued treatment had good effect. CONCLUSION: The study shows that nasal glucocorticoid improved the nasal obstruction, nasal resistance, nasal mucous membrane and quality of life in patients with PNAR.

[Impact of draining mode of enlarged maxillary ostium on mucociliary transportation system].

OBJECTIVE: The purpose of this study was to investigate the proper site for enlarging maxillary natural ostium during ESS, and to compare the draining mode of mucociliary transportation system. METHODS: Three groups were designed to observe the differences of tracer agent transported from maxillary sinus to nasal cavity. Normal control group: 30 cases; Trial group A:30 cases, the maxillary natural ostium were radically enlarged by all sides; Trial group B: 30 cases, the maxillary natural ostium were enlarged by reservation of whole inferior edge and cut away anterior and/or posterior edge. The patients in two trial groups were after nasal endoscopic sinus surgery for more than 12 months and the maxillary ostium were well open. RESULTS: Tracer agent was drained from maxillary sinus to nasal cavity by inferior edge (s) of natural ostium in control group. The core area was posterior part of inferior edge. In trial group A, tracer agent was drained out by inferior edge in 4 cases (13.3%), tracer agent drained out by posterior and/or superior edge(s) and then dispersed to ethmoid sinus in 17 cases (56.7%),tracer agent stacked and/or circularly flowed in the maxillary sinus, and could not be transported out in 9 cases (30.0%). In trial group B,tracer agent drained out by inferior edge to middle meatal in all subjects (30/30,100%), and there was no redirection of the mucociliary transportation. CONCLUSIONS: The inferior edge of natural ostium is the main passage of mucociliary transportation system of maxillary sinus. If the inferior edge of maxillary natural ostium reserved, the post-operative drainage of maxillary sinus would be the same as normal ones. Radical removal of all edges of maxillary natural ostium could lead to redirection of mucociliary transportation, only few cases could drain out by inferior edge, most cases drained out by posterior and/or superior edge and then dispersed to ethmoid sinus. In some cases, tracer agent often stacked in the maxillary sinus and could not be drained out. When there was a need to enlarge the maxillary natural ostium in ESS, it should be done in the anterior and/or posterior edge of natural ostium, the inferior edge should not be damaged so as not to interfere the passage of mucociliary transportation system of the maxillary sinus.

[Quality of life outcome of patients with chronic rhinosinusitis and nasal polyposis after endoscopic sinus surgery and its influencing factors].

OBJECTIVE: To explore the quality of life (QOL) outcome of patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery (ESS) and its influencing factors. METHODS: prospective trial was conducted to survey the QOL status of 120 CRS patients undergoing ESS, in contrast that of 200 healthy individuals passing health examination, at the baseline and at 12-months after operation by Medical Outcomes Study Short Form-36 (SF-36) and Sino-Nasal Outcome Test-20 (SNOT-20). QOL changes and its influencing factors were analyzed statistically. RESULTS: (1) By the assessment of SF-36, the scores of 6 domains were less than that of healthy individuals preoperatively (P < 0.01). After 6 months, the scores of these domains resumed normal level and the proportion of scores also restored normally (P > 0.05). (2) By the assessment of SNOT-20, the total scores of 20 items and 5 most important items of patients were more than that of healthy objects (P < 0.01). After 9 and 12 months, the former and latter returned to normal, respectively (P > 0.05). In 12 months setting, the proportion of scores also restored normally (P > 0.05). (3) According to the survey of SNOT-20, we concluded the following equation: convalescent time (months) = 39--(normal scores/preoperative scores) x 50, by which the time of coming back to normal QOL status can be computed. (4) By analysis of Logistic Regression, residence in city or country, course of disease, extension of diseased sinus, and coexistence of nasal polyposis or not were correlated to the preoperative QOL scores; working environments, surgical extension, and preoperative scores of QOL were correlated to the score difference between pre and post operation. CONCLUSIONS: CRS patients undergoing ESS could obtain entirely normal QOL status at 12 months postoperatively, so we suggest that the essential follow-up period should last at least one year. The risk factors influencing patients QOL status preoperatively includes residence in country, longer course of disease, more extension of diseased sinus, and coexistence of nasal polyposis. The risk factors hindering the improvement of QOL status postoperatively includes exposure to indoor working environments, insufficient surgical extension, and lower preoperative QOL scores.

[Subjective and objective clinical outcome assessment on chronic rhinosinusitis following endoscopic sinus surgery].

OBJECTIVE: To assess the subjective and objective outcomes of chronic rhinosinusitis (CRS) following endoscopic sinus surgery (ESS) and establish an assessment system of outcome with ease of application clinically. METHODS: A prospective cohort study was conducted to survey and assess the outcomes of 120 consecutive CRS patients undergoing endoscopic sinus surgery at 12 months after operation. The subjective and objective measures comprised symptom by visual analog scale (VAS), health-related quality of life by medical outcome study short-form 36-items (SF-36) and sino-nasal outcome test-20 (SNOT-20) scales, endoscopic appearance, mucociliary function, and histological findings. The differences of subjective and objective assessments before and after operation were compared by t-test and Chi-Square test and the correlations between the parameters above were analyzed by Spearman correlation analysis. RESULTS: At 12 months after operation, the patients' total scores by VAS, SF-36 and SNOT-20 scales improved significantly beyond the preoperative survey (P < 0.01); there were 85.96%, 77.19% and 83.33% patients with the scores respectively superior to that of preoperation, of which 72.28% subjects benefited simultaneously from these parameters; and a significant correlation was observed among them before and after operation (P < 0.01) where SNOT-20 showed a more compatibility than the other two. At 12 months after operation, the patients' total scores of endoscopic appearance, mucociliary function, and histological findings significantly improved beyond the preoperative evaluation (P < 0.05); there were 86.84% , 86.81% and 75.57% patients with the scores respectively superior to that of preoperation, of which 71.85% subjects benefited simultaneously from these parameters; and a significant correlation was observed among them before and after operation (P < 0.05) where endoscopic appearance showed a more compatibility than the other two. At 12 months after operation, 74.56% patients showed an accordant improving or worsening outcome evaluated by SNOT-20 and endoscopic appearance, while 25.44% ones represented inverse endings, of which patients with comorbidity of nasal polyps more easily demonstrated this tendency significantly (P < 0.05). No significant correlation existed between the scores of SNOT-20 and endoscopic appearances both in preoperation and in postoperation (P > 0.05), but the total scores of the anterior 10-item, excluding the posterior 10-item, of SNOT-20 inventory was found significantly correlated with the quantitative appearances on nasal endoscopy throughout (0.18 < or = 0.42, P < 0.05). CONCLUSIONS: Administration of ESS can effectively improve the outcomes of CRS patients including symptom, health-related quality of life, endoscopic appearance, mucociliary function, and histological findings. A subjectively and objectively measured assessment system with tenseness, trustiness, reasonableness, and effectiveness and with ease of application clinically is established on the basis of SNOT-20 and endoscopic appearance evaluation for outcome research.

[Development of the Sino-Nasal Outcome Test-20 Chinese version (SNOT-20 CV)].

OBJECTIVE: To develop the Sino-Nasal Outcome Test-20 Chinese Version (SNOT-20 CV). METHODS: By introducing, translating, pretesting, adjusting, and performance testing of SNOT-20 inventory, a Chinese draft scale came into being. On the basis of the clinical applications and feedbacks from ten domestic hospitals, the scale was further modified and was more strictly tested in sixty patients with chronic rhinosinusitis, and then its psychometric properties were compared with that of the original edition. RESULTS: The SNOT-20 CV showed the following psychometric properties: The scale was easily accepted and answered in patients, showing a satisfactory feasibility. The split-half reliability, Cronbach' alpha and intraclass correlation coefficient were 0.95, 0.88, and 0.98, respectively. The content validity was approved by experts of working group. The criteria validity calculated between SNOT-20 and SF-36 was -0.67. Factor analysis of construct validity showed that the comparative fit index was 0.93 and the 20 items were classified into 4 domains which were accorded with the designed constructs. The category rating system was of reasonable additivity and comparability. Every domain was of sensitivity to effectively discriminate between patient population and healthy population (P < 0.01). The standardized response mean of twenty items and five important items at three months postoperatively was respectively 0.48 and 0.57, suggesting moderate responsibility to clinical change. SNOT-20 CV passed the tests of feasibility, reliability, validity, scalability, sensitivity, and responsibility, showing good properties comparable to that of the original edition. CONCLUSIONS: SNOT-20 CV passes the psychometric and clinimetric tests and can be used for measuring rhinosinusitis-specific quality of life in China.

[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.