Cost-effectiveness analysis of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in treatment of chronic rhinosinusitis / 中国中药杂志

This study aims to evaluate the effectiveness and economic efficiency of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of chronic rhinosinusitis(CRS). The randomized controlled trial(RCT) of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS was searched against EMbase, PubMed, Cochrane Library, CNKI, VIP, SinoMed, and Wanfang. The efficacy, nasal mucociliary transport time, and safety of the therapy above in the treatment of CRS were analyzed with single-group rate and Meta-analysis, and the economy and sensitivity were evaluated from the perspective of payer. A total of 9 RCTs were included, including 1 145 patients. Meta-analysis showed that compared with Triamcinolone Acetonide Nasal Spray alone, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS patients increased the effective rate(RR=1.17, 95%CI[1.11, 1.24], P<0.000 01) and shortened the nasal mucociliary transport time(MD=-3.32, 95%CI[-5.86,-0.78], P=0.01), there was no significant difference in the incidence of adverse reactions between the two groups. The incremental cost-effectiveness analysis showed that the treatment costs of the control group and the observation group were 44.15 yuan and 1 044.96 yuan, respectively. In the Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray treatment group, 75.48 yuan was spent to improve the effective rate of CRS by 1%. The one-way sensitivity analysis indicated the days of treatment, the RR of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray, the price of unit preparation of Biyuan Tongqiao Granules, and the effective rate of Triamcinolone Acetonide Nasal Spray alone had great influence on the incremental cost-effectiveness ratio. In conclusion, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray improves the therapeutic effect on CRS. The probabilistic sensitivity analysis showed that when the willingness to pay was greater than 7 920 yuan(less than 0.1 of GDP per capita 8 098 yuan), the combined therapy was economically superior to the control. Due to the limited number of articles published, it is necessary to carry out a real-world clinical trial of Biyuan Tongqiao Gra-nules and Triamcinolone Acetonide Nasal Spray in the treatment of CRS, so as to compare the cost-effectiveness of Biyuan Tongqiao Granules and Triamcinolone Acetonide Nasal Spray.

Comparative study of spray characteristics of domestic and foreign nasal spray delivery devices for live attenuated nasal influenza vaccine / 中国生物制品学杂志

@#Objective To compare the spray characteristics of domestic and foreign nasal spray delivery devices for live attenuated influenza vaccine(LAIV). Methods The particle size distribution(DV10,DV50 and DV90),the proportion of droplets smaller than 10 μm and Span of atomized particles of two brands of nasal spray delivery devices at home and abroad were measured by laser diffraction method,the spray pattern[maximum diameter(D_(max)),shortest diameter(D_(min))and ovality(D_(max)/D_(min))]and spray geometry(spray angle and width)were detected by Spray view,and the comparative analysis was performed. Results There was no significant difference in DV10,DV50,DV90 particle size distribution,proportion of droplets smaller than 10 μm and Span of atomized particles between the two kinds of domestic and foreign nasal spray delivery devices[F-values of Levene's test for equality of variances were 0. 622,0. 135,3. 067,0. 212 and 0. 058,P-values were0. 434,0. 714,0. 085,0. 647 and 0. 810,and significance(two-tailed)values of equal variances assumed were 0. 439,0. 228,0. 281,0. 539 and 0. 910,respectively];D_(max),D_(min)and ovality of the spray patterns showed no significant difference[F-values of Levene's test for equality of variances were 2. 102,2. 666 and 0. 514,P-values were 0. 158,0. 114 and0. 479,and significance(two-tailed)values of equal variances assumed were 0. 651,0. 407,and 0. 160,respectively];The geometric mean ratios of spray angle and width were 0. 92 and 0. 91,respectively,which ranged from 0. 90 to 1. 11.Conclusion Both the domestic and foreign nasal spray delivery devices meet the delivery requirement of the nasal spray LAIV,which can be used for the delivery of nasal spray vaccines and drugs.

Study on protective effect and mechanism of Modified Yupingfeng nasal spray on nasal mucosal injury in AR model rats / 中国药房

OBJECTIVE To study protective effect and potential mechanism of Modified yupingfeng nasal spray （YPF+） on nasal mucosal injury in allergic rhinitis （AR） model rats. METHODS AR model was induced by ovalbumin （OVA） and randomly divided into model group， YPF+group （50 µg/side，twice a day）， positive control group （Mometasone furoate aqueous nasal spray， 50 µg/side，once a day）； the blank group was set up， with 10 rats in each group. Administration groups were given relevant medicine， and blank group and model group were given equivalent normal saline for consecutive 4 weeks. Thirty minutes after last medication， the behavioral scores of rats were recorded， and the pathological changes of their nasal mucosa tissue were observed. The level of reactive oxygen species （ROS） in nasal mucosa tissue was detected. The protein and mRNA expressions of nucleotide- binding oligomerization domain-like receptor protein 3 （NLRP3），caspase-1，gasdermin D （GSDMD） were detected； the contents of interleukin-1β （IL-1β） and IL-18 in serum were also determined. RESULTS Compared with blank group， in model group， the nasal mucosa tissue structure was disordered， inflammatory cells infiltrated seriously， and lamina propria vascular dilation was visible； its behavioral score and pathological score， the level of ROS， protein and mRNA expressions of NLRP3， caspase-1 and GSDMD， serum contents of IL-1β and IL-18 in nasal mucosa tissue were increased significantly （P＜0.05）. Compared with model group， the symptoms of nasal mucosal injury in rats of each drug group were improved to varying degrees， and the above indicators were significantly reduced （P＜0.05）. CONCLUSIONS YPF+ may improve nasal mucosal injury of rats， relieve AR symptoms such as sneezing， itchy nose， runny nose， the mechanism of which may be associated with reducing the production of ROS in nasal mucosa and downregulating NLRP3/caspase-1/ GSDMD pathway.

Nasal irrigation with corticosteroids in Brazil: the clinical response of 1% compounded budesonide drops and betamethasone cream

Abstract Introduction: High-volume corticosteroid nasal irrigation is a treatment option in patients with chronic rhinosinusitis. In Brazil, alternatives are used to optimize its cost and popularize its use, such as 1% compounded budesonide drops or betamethasone cream, and it is necessary to study these treatment modalities. Objective: To evaluate the clinical response of nasal irrigation with 1% compounded budesonide drops or betamethasone cream compared to nasal sprays utilized in patients with chronic rhinosinusitis. Methods: This was a retrospective observational study with 257 patients. One hundred and eight patients using corticosteroid nasal irrigation (292 treatment cycles) and 149 using corticosteroid nasal spray (300 treatment cycles) were included. Evaluation of subjective improvement, adverse events, exacerbations, and objective assessments with SNOT-22 and Lund-Kennedy endoscopic score were performed, in addition to sub-analyses related to nasal polyps and previous surgery. Results: Corticosteroid nasal irrigation and corticosteroid nasal spray improved the Lund-Kennedy endoscopic score, with more adverse events in the corticosteroid nasal irrigation group. Previous surgery increased corticosteroid nasal irrigation improvement, with greater subjective improvement and fewer exacerbations. 1% compounded budesonide drops were better than betamethasone cream in the Lund-Kennedy endoscopic score, with fewer adverse events. A 1,000 μg dose of 1% compounded budesonide drops was more effective than 500 μg. Conclusion: Corticosteroid nasal irrigation was effective in improving the Lund-Kennedy endoscopic score in chronic rhinosinusitis, especially in patients with nasal polyps and previous surgery, in addition to promoting a higher rate of subjective improvement and fewer exacerbations than corticosteroid nasal spray, but with more adverse events. 1% compounded budesonide drops improved the Lund-Kennedy endoscopic score with fewer adverse events than betamethasone cream, particularly at higher doses (1000 μg).

Spray pattern and plume geometry measurement method of nasal spray and its correlation with nasal deposition / 药学学报

Nasal spray can treat local diseases such as rhinitis, it also plays an important role in the treatment of systemic diseases including vaccine immunity. As a drug-device combination product, spray pattern is often used as the quality indicator of nasal spray to ensure its quality, plume geometry can not only be combined with the spray pattern to evaluate the performance of the nasal spray, but also can predict the deposition of the nasal spray in the nasal cavity. This article systematically reviews the definition and measurement methods of the spray pattern and plume geometry of nasal spray and their correlation with nasal deposition behavior. The measurement parameters of spray pattern and plume geometry are defined. The influence of formulation, device and trigger parameters on spray pattern and plume geometry is clarified. The correlation between various parameters and nasal deposition is analyzed. The measurement parameters are classified according to the size and shape of the spray. Plume angle is closely related to the deposition of drugs in the nasal cavity. Jet-like plume with a smaller plume angle can increase the navigation ability of the nasal spray in the curved anatomical structure of the nasal cavity, which is conducive to increase drug deposition. This makes it possible to increase deposition of the nasal spray in the nasal cavity via appropriately increasing viscosity and thixotropy of the nasal spray formulation. This review provides the theoretical basis for the high quality nasal spray product development.

Efficacy of Yiqi-Tuomin decoction combined with triamcinolone acetonide nasal spray on allergic rhinitis and its effect on Th1/Th2 balance / 国际中医中药杂志

Objective To investigate the effect of Yiqi-Tuomin decoction combined with triamcinolone acetonide nasal spray on Th1/Th2 balance in allergic rhinitis (AR) and to observe the clinical efficacy.Methods A total of 100 patients who met the inclusion criteria were divided into two groups by random number table method,50 in each group.The control group was treated with triamcinolone acetonide nasal spray.The observation group was given Yiqi-Tuomin decoction on the basis of the control group.Both groups were treated for 4 weeks and followed up for 3 months.Clinical symptom score was performed before and after treatment.The serum level of interferon-γ (IFN-γ) and IL-4 was detected by ELISA,and the ratio of IFN-γ/IL-4 was calculated.The adverse reaction and recurrence rate during treatment was observed and recorded,and the clinical efficacy was evaluated.Results The total effective rate was 94.0％ (47/50) in the observation group and 80.0％ (40/50) in the control group.There was significant difference between the two groups (x2=4.332,P=0.037).After treatment,the serum IFN-γ (95.15 ± 18.49 ng/L vs.83.85 ± 16.20 ng/L,t=3.250) and the ratio of IFN-γ/IL-4 (1.35 ± 0.21 vs.0.93 ± 0.19,t=5.878) significantly increased (P＜0.01),while serum level of IL-4 (71.14 ± 14.15 ng/L vs.89.8 6 ± 17.52 ng/L,t=10.487) significantly decreased in the observation group (P＜0.01).After treatment,the score of nasal obstruction,rhinocnesmus,sneezing and nasal discharge in the observation group were significantly lower than those in the control group (t=11.229,8.921,8.253,10.464,respectively,all Ps＜0.01).Conclusions The Yiqi-Tuomin decoction combined with triamcinolone acetonide nasal spray can significantly improve the clinical symptoms of AR patients,correct the imbalance of Th1/Th2 ratio and improve the immunity of the body.

Comparison of Corticosteroids by 3 Approaches to the Treatment of Chronic Rhinosinusitis With Nasal Polyps

PURPOSE: Corticosteroids are regarded as the mainstay of medical treatment of eosinophilic chronic rhinosinusitis with nasal polyps (ECRSwNP). To date, a head-to-head comparison of the efficacy and safety of glucocorticoid preparations administered via different routes for the treatment of chronic rhinosinusitis with nasal polyps has not been reported. To compare the efficacy and safety of steroids administered via the oral, intranasal spray and transnasal nebulization routes in the management of ECRSwNP over a short course. METHODS: Overall, 91 patients with ECRSwNP were recruited prospectively and randomized to receive either oral methylprednisolone, budesonide inhalation suspension (BIS) via transnasal nebulization, or budesonide nasal spray (BNS) for 2 weeks. Nasal symptoms and polyp sizes were assessed before and after the treatment. Similarly, nasal polyp samples were evaluated for immunological and tissue remodeling markers. Serum cortisol levels were assessed as a safety outcome. RESULTS: Oral methylprednisolone and BIS decreased symptoms and polyp sizes to a significantly greater extent from baseline (P < 0.05) than BNS. Similarly, BIS and oral methylprednisolone significantly reduced eosinophils, T helper 2 cells, eosinophil cationic protein, interleukin (IL)-5, and expression of matrix metalloproteinases 2 and 9, and significantly increased type 1 regulatory T cells, IL-10, transforming growth factor-β, and tissue inhibitor of metalloproteinases 1 and 2 in nasal polyps to a greater extent than BNS. Post-treatment serum cortisol levels were significantly decreased by oral methylprednisolone compared to BIS or BNS, which did not significantly alter the cortisol levels. CONCLUSIONS: A short course of BIS transnasal nebulization is more efficacious compared to BNS in the management of ECRSwNP and is safer than oral methylprednisolone with respect to hypothalamic-pituitary-adrenal axis function.

Efficacy and Safety of Biyuan Tongqiao Granules Combined with Triamcinolone Acetonide Nasal Spray versus Triamcinolone Acetonide Nasal Spray in the Treatment of Chronic Rhinosinusitis ：A Meta-analysis and Trial Sequential Analysis / 中国药房

OBJECTIVE： To systematically evaluate clinical efficacy and safety of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis， and to provide evidence-based reference for clinical treatment. METHODS： Retrieved from Embase， PubMed， the Cochrane library， CNKI， CBM， VIP and Wanfang database， RCTs about Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray （trial group） versus Triamcinolone acetonide nasal spray （control group） in the treatment of chronic rhinosinusitis were collected during database establishment to Dec. 8th， 2018. After data extraction and quality evaluation with Cochrane bias risk evaluation tool 5.1.0， Meta-analysis was performed for total response rate， nasal mucociliary transmission rate （MTR）， the levels of IL-5 and IL-8 in nasal secretion， SNOT-20 score， VAS score， Lund-Mackey nasal sinus CT score， the incidence of ADR （nausea， rash） by using Rev Man 5.3 software. TSA 0.9 software was used for trial sequential analysis（TSA）. RESULTS： A total of 9 RCTs were included， involving 998 patients. Results of Meta-analysis showed that total clinical response rate [RR＝1.20，95％CI（1.14，1.26），P＜0.001] of trial group was significantly higher than that of control group； MTR [MD＝－231.74，95％CI（－291.89，－171.58），P＜0.001]， IL-5 [MD＝－0.86，95％CI（－1.37， －0.35），P＜0.001] and IL-8 [MD＝－0.50，95％CI（－0.76， －0.25），P＜0.001] levels of trial group were significantly lower than those of control group. SNOT-20 score， VAS score and Lund-Mackey nasal sinus CT score of trial group were all lower than those of control group， with statistical significance （P＜0.001）. There was no statistical significance in the incidence of nausea [RR＝0.57，95％CI（0.17，1.92），P＝0.37] or rash [RR＝2.25，95％CI（0.70，7.20），P＝0.17] between 2 groups. TSA analysis showed that the evidence for therapeutic efficacy of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis was reliable. CONCLUSIONS： Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray is better than Triamcinolone acetonide nasal spray alone in improving total response rate of Biyuan tongqiao granules combined with Triamcinolone acetonide nasal spray in the treatment of chronic rhinosinusitis， reducing MTR， the levels of IL-5 and IL-8， and improving SNOT-20 score， VAS score and Lund-Mackey nasal sinus CT score， without increasing the incidence of nausea， rash.

Safety of Fluticasone Furoate Nasal spray among Filipino patients with Allergic Rhinitis: A post-marketing surveillance study

Introduction@#Allergic rhinitis (AR) is a highly prevalent chronic disease affecting up to 30% of the population worldwide.1 Although AR is not life-threatening, it greatly impacts patients’ health-related quality of life and furthermore, if left untreated, it may be complicated by other respiratory co-morbidities.2 Intranasal corticosteroids are one of the several classes of medications recommended to manage AR. Fluticasone furoate nasal spray is a novel enhancedaffinity glucocorticoid for the management of AR.2 This study assessed the safety profile of Fluticasone furoate nasal spray in the treatment of Filipino patients with AR.@*Methods@#This is a multicenter, prospective, post-marketing surveillance study aimed at documenting adverse events, their frequency and severity as assessed by the investigators among Filipino patients with AR administered with Fluticasone furoate nasal spray from August 2010 to January 2013.@*Results@#Four hundred thirty-nine (439) patients were enrolled in the study. Among these, 421 patients were included in the safety analysis population. Eighteen patients were excluded from the safety analysis population due to protocol violation and lack of post-baseline safety assessment. Of the total eligible population, 10 patients (2.4%) experienced adverse events (AEs) with a total of 10 and no serious adverse events (SAEs) were reported. Eight of these 10 AEs resolved while two AEs had unknown outcome. One patient (0.2%) experienced an AE suspected to be related to study medication. The most common AE occurring in eight patients was respiratoryrelated which were nasal dryness (3 events), rhinorrhea (2 events), epistaxis (1 event), nasal discomfort (1 event) and rhinalgia (1 event).@*Conclusion@#Fluticasone furoate nasal spray, among indicated patients with AR showed AEs which approximate AE of other similar post-marketing studies with incidence of less than 1% for each event.[21] Neither SAEs nor drugrelated deaths were reported throughout the study.

Determination and Consistency Analysis of Particle Size Distribution of Budesonide Nasal Spray / 中国药房

OBJECTIVE:To establish the method for the determination of particle size distribution of Budesonide nasal spray, and to analyze the consistency of particle size distribution of spray samples. METHODS:Water was used as dispersant for mixing and dispersing(1800 r/min). The particle sizes [d(0.1),d(0.5),d(0.9)] corresponded to accumulative particle size of 10%,50%and 90%were used as characteristic value. The distribution of granularity was determined by laser scattering method. The consisten-cy of particle size distribution of samples from 2 manufacturers (A,B) were analyzed among different batches or same batch of same manufacturer by SAS 9.3 statistical software. RESULTS:The mean values of d(0.1),d(0.5) and d(0.9) were 3.96 μm, 29.58 μm and 67.10 μm in manufacturer A. The mean values of d(0.1),d(0.5)and d(0.9)were 2.00 μm,7.53 μm and 28.51 μm in manufacturer B. By analysis,there was great difference in particle size of samples from 2 manufacturers. The particle size of the samples from manufacturer A were larger than that of manufacturer B. The consistency among different batches from manufacturer B was better,and the consistency among same batch were all good from 2 manufacturers. CONCLUSIONS:The established meth-od is suitable for particle size distribution of Budesonide nasal spray and the consistency analysis of particle size distribution.

Preparation and evaluation of naloxone hydrochloride nasal spray / 国际药学研究杂志

Objective To prepare naloxone hydrochloride nasal spray and evaluate the ciliotoxicity and pharmacokinetics of the formulation. Methods The stability of naloxone hydrochloride was studied in pH3.5-5.5. Penetration promoting effects of absorp-tion enhancers on the naloxone hydrochloride were evaluated. Nasal ciliotoxicity studies were carried out using isolated toad palate. Rats were treated with naloxone hydrochloride solution by intramuscular injection of nasal drops to evaluate the pharmacokinetics. Results Naloxone hydrochloride solution was stable in pH3.5-5.5. Disodium ethylenediaminetetraacetic acid(0.2%,W/V)had the best penetration promoting effect on naloxone hydrochloride. Naloxone hydrochloride nasal spray did not exhibit obvious nasal ciliotox-icity compared to the negative control. The nasal spray had a faster therapeutic effect and its bioavailability was similar to that of the in-tramuscular injection. Conclusion Naloxone hydrochloride nasal spray prepared in this research is stable with no obvious nasal cilio-toxicity,has faster therapeutic effect,and good bioavailability,so may have a broad application prospect.

Clinical research of Yupingwind particles combing with nasal spray in treatment of allergic rhinitis / 中国生化药物杂志

Objective To research effects of Yupingwind particles combing with nasal spray on allergic rhinitis. Methods 100 patients with allergic rhinitis from lishui people's hospital from January 2014 to January 2016 were divided into two groups,with 50 cases in each group.The control group was treated with nasal spray, and observation group was treated with Yupingwind particles combing with nasal spray. Relevant indicators were analyzed between two groups. Results Recent curative effect in observation group was 92.00%,higher than control group with 76.00%(P<0.05).After treatment,Symptom score,immune factors and inflammation level in observation group were better than those in control group(all P<0.05).Conclusion Yupingwind particles can improve recent curative effect for patients with allergic rhinitis.

Therapeutic Observation of Needle-knife for Allergic Rhinitis / 上海针灸杂志

Objective To observe the clinical efficacy of needle-knife therapy in treating allergic rhinitis. Method Sixty allergic rhinitis patients were randomized into a treatment group and a control group, 30 cases in each group. The treatment group was intervened by needle-knife therapy; the control group was given Azelastine hydrochloride nasal spray plus oral administration of Desloratadine, both twice a day. The intervention lasted for 4 weeks in both groups. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and symptoms scores were observed before and after the treatment, and the clinical efficacies were compared between the two groups. Result The markedly effective rate was 90.0% in the treatment group versus 66.7% in the control group, and the between-group difference was statistically significant (P<0.05). The RQLQ and symptoms scores were significantly changed after the intervention in both groups (P<0.05). After the treatment, the RQLQ and symptoms scores in the treatment group were significantly different from those in the control group (P<0.05). Conclusion Needle-knife therapy is safe and effective in treating allergic rhinitis.

Observing the efficacy of azelastine hydrochloride nasal spray combined with budesonide nasal spray in treating persistent allergic rhinitis / 中国耳鼻咽喉头颈外科

OBJECTIVE To observe clinical efficacy of azelastine hydrochloride nasal spray plus budesonide nasal spray on persistent allergic rhinitiss(AR). METHODS 120 patients with persistent AR were devided randomly into group A(n=40), group B(n=40) and group C(n=40). Group A were treated with azelastine hydrochloride nasal spray and budesonide nasal spray, group B received only azelastine hydrochloride nasal spray and group C received budesonide nasal spray only, the treatment process were 4 weeks. Clinical efficacy were compared among 3 groups 4 weeks later. RESULTS 1. VAS scores: VAS scores of nasal symptoms in group A were lower than those both in group B and in group C after 4 weeks, the difference were statistically significant(P<0.05); 2. RQLQ scores: RQLQ scores in 3 groups were all significantly improved after 4 weeks, the RQLQ scores of sleep, nonnose/eye symptoms, nasal symptoms and emotions in group A were improved more significantly than those in group B and in group C, the difference were statistically significant(P<0.05); 3. Clinical efficacy: the significant effective rate and the total effective rate were 50.00% and 93.33% in group A, but were 30.00% and 75.00% in group B and 27.50% and 77.50% in group C, the differences between group A and group B or group A and group C were statistically significant(P <0.05). CONCLUSION Azelastine hydrochloride nasal spray plus budesonide nasal spray can rapidly relieve nasal symptoms and improve the life quality of the patients with persistent AR.

Study on HPLC Fingerprint of Bining Nasal Spray / 中国药房

OBJECTIVE:To establish HPLC fingerprint of Bining nasal spray.METHODS:HPLC method was performed.The determination was performed on Neptune C18 column with mobile phase consisted of acetonitrile-0.2 ％ phosphoric acid (gradient elution) at the flow rate of 1.0 mL/min.The detection wavelength was set at 326 nm,and the column temperature was 25 ℃.The sample size was 10 μL.Using rutin as reference,HPLC chromatograms of 20 batches of samples were determined.Common peak identification and similarity evaluation were conducted by using Similarity Evaluation System for TCM Fingerprint (2012 edition).RESULTS:There were 40 common peaks in HPLC chromatograms of 20 batches of Bining nasal spray,with similarity ＞0.9.After validation,HPLC chromatograms of 20 batches of samples were in good agreement with the control fimgerprints of those.CONCLUSIONS:Established fingerprint can provide reference for identification and quality evaluation of Bining nasal spray.

Efficacy of intranasal corticosteroids-gelatin sponge in the treatment of nasal adhesion after nasal endoscopic sinus surgery / 中国耳鼻咽喉头颈外科

OBJECTIVE To compare the effect of intranasal corticosteroids-gelatin sponge and saline-gelatin sponge in the treatment of nasal adhesion.METHODS A total of 208 noses(170 patients) with nasal adhesions after receiving the endoscopic sinus surgeries from July,2012 to December,2015 were selected.All the cases were divided randomly into two groups:the treatment group and the control group.Both groups received separation treatments of the nasal adhesions.The intranasal corticosteroidsgelatin sponges were used as the separation material for the treatment group,while saline-gelatin sponges for the control group.The severity score and the time of treatment were evaluated as the indicators for curative efficacy of the treatment in each case.The differences of efficacy between two groups were analysed statistically.RESULTS The severity scores of the two groups after the treatment were both substantially lower than those before the treatment;The after-treatment severity scores of the treatment group were significantly lower than those of the control group;the times of treatment in the treatment group were substantially lower than those of the control group.The differences stayed for 3 months,and they became insignificant after 3 months.CONCLUSION The intranasal corticosteroids-gelatin sponge can be a quicker and more effective treatment of nasal adhesion in comparison with saline-gelatin sponge.

Study on the Pharmacokinetics and Brain Targeting of Toutongning Nasal Spray in Rats in vivo / 中国药房

OBJECTIVE:To study the pharmacokinetics and brain targeting of Toutongning nasal spray in rats in vivo. METH-ODS:84 SD rats were divided into nasal administration group and vein administration group,42 in each group,with dose of 1.2 mL/kg. 5 mL sample blood was taken in abdominal aorta after 5,10,15,30,60,90,120 min of administration,and brain tissue was taken (6 rats in each time point). HPLC-MS was adopted to determine the concentration of prim-o-glucosylcimifugin and 5-O-methylvisammioside in plasma and brain tissue of rats in each group,and DAS 2.0 software was used to calculate the pharma-cokinetic parameters and brain targeting indexes. RESULTS:The cmax of prim-o-glucosylcimifugin and 5-O-methylvisammioside in plasma of rats in nasal administration group were(0.2024±0.0158),(0.3738±0.0857)μg/mL;tmax were(10.0000±0.0000) min;and AUC0-∞ were (16.5429 ± 2.1103),(27.4527 ± 5.5721)μg·h/mL,respectively. The cmax of prim-o-glucosylcimifugin and 5-O-methylvisammioside in brain tissue of rats were (0.1802 ± 0.0384),(0.3204 ± 0.0277)μg/g;tmax were (10.0000 ± 0.0000)min;and AUC0-∞ were(17.1053±2.4329),(24.5416±3.7534)μg·h/g,respectively. The cmax of prim-o-glucosylcimi-fugin and 5-O-methylvisammioside in plasma of rats in vein administration group were (0.3002 ± 0.0161),(0.5267 ± 0.0441)μg/mL;tmax were(10.0000±0.0000)min;and AUC0-∞ were(28.0105±4.1128),(60.2941±11.2902)μg·h/mL,respective-ly. The cmax of prim-o-glucosylcimifugin and 5-O-methylvisammioside in brain tissue of rats were(0.1498±0.0315),(0.1998± 0.0401)μg/g;tmax were(15.0000±0.0000)min;and AUC0-∞were(22.6434±2.8831),(36.7218±14.8856)μg·h/g,respec-tively. The brain targeting indexes of prim-o-glucosylcimifugin and 5-O-methylvisammioside were 2.3870 and 2.1761,respective-ly. CONCLUSIONS:After nasal administration of Toutongning nasal spray,parts of drugs can directly transport to the brian by na-sal absorption. It is scientific and reasonable to make nasal spray.

Clinical Study of Bencycloquidium Bromide Nasal Spray in the Treatment of Rhinitis after Cold / 中国药房

OBJECTIVE:To evaluate the effects and safety of Bencycloquidium bromide nasal spray in the treatment of acute rhinitis after a cold. METHODS:A multicenter,dose parallel controlled,randomized,double-blind,placebo-controlled clinical tri-al was conducted. Two hundred and thirty-eight patients with acute rhinitis after a cold were selected and divided into group A(24 cases),B(24 cases),C(24 cases),D(24 cases),E(23 cases),F(24 cases),G(23 cases),H(24 cases),I(24 cases),J (24 cases). Group A-C were given Bencycloquidium bromide nasal spray 22.5μg,45μg,90μg,respectively,bid,spraying it once for each nostril. Group D-F were given Bencycloquidium bromide nasal spray 22.5 μg,45 μg,90 μg,respectively,tid,spraying it once for each nostril. Group G-I were given Bencycloquidium bromide nasal spray 22.5 μg,45 μg,90 μg,respectively,qid,spray-ing it once for each nostril. Group J was given placebo. All groups were treated for(4±1)d. Rhinorrhea score and continuous rhi-norrhea duration were compared among 10 groups,and the safety was evaluated. RESULTS:The rhinorrhea score and continuous rhinorrhea duration of 10 groups were improved significantly,with statistical significance (P0.05). There was no statistical significance in the incidence of ADR among 10 groups(P>0.05). CONCLUSIONS:Bencycloquidium bromide nasal spray with 90 μg,qid times significantly improves rhinorrhea score and continuous rhinorrhea duration with good safety.

Clinical Efficacy of Montelukast Combined with Mometasone Furoate Nasal Spray in the Treatment of Pa-tients with Allergic Rhinitis / 中国药师

Objective:To investigate the clinical efficacy and safety of montelukast combined with mometasone furoate in the treat-ment of children with allergic rhinitis. Methods:Totally 91 children with allergic rhinitis were randomly divided into the observation group (n=46) and the control group (n=45) according to the random number table. The control group was given mometasone fu-roate, while the observation group was treated with montelukast additionally. Both groups were treated for two weeks. The symptom scores including nasal congestion, sneezing, itchy nose and runny nose, serum level changes of IL-4, IL-12 and IgE and adverse drug reactions before and after the treatment in both groups were evaluated and compared. Results:The total effective rate in the observation group (93. 48%) was significantly higher than that in the control group (75. 56%, P<0. 05). Compared with those before the treat-ment, the symptom scores in both groups were decreased after the treatment (P<0. 05), and those in the observation group were lower than those in the control groups (P<0. 05). After the treatment, the serum levels of IL-4 and IgE in both groups were significantly de-creased when compared with those before the treatment, while the IL-12 levels were increased significantly (P<0. 05), and the chan-ges in the observation group were more significantl than those in the control group (P<0. 05). There were no serious adverse drug re-actions during the treatment course in both groups. Conclusion:Montelukast combined with mometasone furoate in the treatment of al-lergic rhinitis shows more notable efficacy with higher security.

Clinical Observation of Leukotriene Receptor Antagonist Combined with Glucocorticoid Nasal Spray for Dif-ferent Degree of Adenoidal Hypertrophy Complicated with Allergic Rhinitis / 中国药房

OBJECTIVE:To explore the clinical efficacy and safety of Leukotriene receptor antagonist combined with Gluco-corticoid nasal spray(called“intranasal steroid”for short)in the treatment of different degree of adenoidal hypertrophy(AH)com-plicated with allergic rhinitis (AR). METHODS:240 AR children with AH were randomly divided into control group,intranasal steroid group and drug combination group,with 80 cases in each group. Control group was given physiological seawater,3 presses each nostrile,in the morning and evening. The intranasal steroid group received Momestasone furoate nasal spray,one press each nostrile,qd. Drug combination group was additionally given leukotriene receptor antagonist Montelukast sodium chewable tablet,4 mg for under 5 year-old and 5 mg for 5-year-old or above,qd,at bedtime. Treatment course of 3 groups lasted for 12 weeks. The change of clinical symptoms and signs(such as nasal obstruction,snore,mouth breathing,etc)and adenoid/pharyngeal ratio(A/N ratio)were compared among 3 groups after treatment as well as the occurrence of ADR. Each group was divided into two sub-groups (medium and severe) according to the severity of AH so as to evaluate therapeutic efficacy. RESULTS:21 children withdrew from the study,including 11 cases in control group,6 in intranasal steroid group and 4 in drug combination group. After treatment,clinical symptom score and A/N in subgroups of drug combination group and intranasal steroid group were all lower than those of control group,with statistical significance(P0.05). Clini-cal symptom score and A/N of AR complicated with severe AH subgroup from drug combination group were lower than intranasal steroid group,with statistical significance (P<0.05). No obvious ADR occurred in 3 groups. CONCLUSIONS:Intranasal steroid alone and intranasal steroid combined with leukotriene receptor antagonist can improve clinical symptom of AR patients with AH, and reduce adenoid volume. It is suggested to use intranasal steroid firstly for medium AH complicated with AR,and additionally use Leukotriene receptor antagonist for severe AH complicated with AR.