Budesonide Inhalation Suspension Research Articles

Clinical features of plastic bronchitis in children after congenital heart surgery

BackgroundPlastic bronchitis (PB) can occur in patients who have undergone congenital heart surgery (CHS). This study aimed to investigate the clinical features of PB in children after CHS.MethodsWe conducted a retrospective cohort study using the electronic medical record system. The study population consisted of children diagnosed with PB after bronchoscopy in the cardiac intensive care unit after CHS from May 2016 to October 2021.ResultsA total of 68 children after CHS were finally included in the study (32 in the airway abnormalities group and 36 in the right ventricular dysfunction group). All children were examined and treated with fiberoptic bronchoscopy. Pathogens were detected in the bronchoalveolar lavage fluid of 41 children, including 32 cases in the airway abnormalities group and 9 cases in the right ventricular dysfunction group. All patients were treated with antibiotics, corticosteroids (intravenous or oral), and budesonide inhalation suspension. Children with right ventricular dysfunction underwent pharmacological treatment such as reducing pulmonary arterial pressure. Clinical symptoms improved in 64 children, two of whom were treated with veno-arterial extracorporeal membrane oxygenation (ECMO) due to recurrent PB and disease progression.ConclusionsChildren with airway abnormalities or right ventricular dysfunction after CHS should be alerted to the development of PB. Pharmacological treatment such as anti-infection, corticosteroids, or improvement of right ventricular function is the basis of PB treatment, while fiberoptic bronchoscopy is an essential tool for the diagnosis and treatment of PB. ECMO assistance is a vital salvage treatment for recurrent critically ill PB patients.

Clinical effect of Shenfu injection combined with glucocorticoid on patients with acute left heart failure complicated with bronchospasm

To investigate the clinical effect of Shenfu injection combined with glucocorticoid in the treatment of acute left heart failure complicated with bronchospasm. A prospective study was conducted.Ninety patients with acute left heart failure complicated with bronchospasm admitted to Huai'an Second People's Hospital from January 2021 to July 2022 were selected and divided into conventional treatment group, hormone therapy group and combined treatment group according to random number table method, with 30 cases in each group. All patients in the 3 groups received basic Western medicine treatment. On this basis, the conventional treatment group was given 0.25-0.50 g aminophylline injection plus 5% glucose injection or 0.9% sodium chloride injection (diabetes patients) 100 mL slow intravenous infusion, 1-2 times a day. In the hormone treatment group, 1 mg of budesonide suspension for inhalation was diluted to 2 mL by 0.9% sodium chloride injection, twice a day, and applied until 48 hours after the pulmonary wheezing disappeared. The combined treatment group was given glucocorticoid combined with Shenfu injection 80 mL plus 5% glucose injection or 0.9% sodium chloride injection (diabetes patients) 250 mL intravenously, once a day. All treated for 1 week. The general data, traditional Chinese medicine (TCM) syndrome score, TCM syndrone efficacy index, acute left heart failure efficacy, bronchospasm efficacy, systolic blood pressure (SBP), mean arterial pressure (MAP), serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level and safety of the 3 groups were compared. The patients were followed up for 6 months, and the mortality and re-hospitalization rate of the 3 groups were recorded. Among the 90 patients, a total of 83 patients completed the study, excluding the cases dropped due to death and other reasons. There were 29 cases in the combined treatment group, 25 cases in the hormone therapy group and 29 cases in the conventional treatment group. There were no significant differences in age, gender, course of disease, and previous history (history of diabetes, history of hypertension, history of hyperlipidemia) among the 3 groups. Therefore, they were comparable. The difference of TCM syndrome score before and after treatment, TCM syndrome efficacy index of combined treatment group and hormone therapy group were higher than those of conventional treatment group [difference of TCM syndrome score: 15.14±5.74, 13.24±5.75 vs. 10.62±5.87, TCM syndrome efficacy index: (67.84±14.31)%, (59.94±14.26)% vs. (48.92±16.74)%, all P < 0.05], and the difference of TCM syndrome score and TCM syndrome efficacy index of combined treatment group were higher than those of hormone treatment group (both P < 0.05). The total effective rate of acute left heart failure and bronchospasm in the combined treatment group was significantly higher than that in the conventional treatment group (total effective rate of acute left heart failure: 96.55% vs. 75.86%, total effective rate of bronchospasm: 93.10% vs. 65.52%, both P < 0.05). The difference of serum NT-proBNP before and after treatment in combination therapy group and hormone therapy group was significantly higher than that in conventional treatment group (ng/L: 7 922.86±5 220.31, 7 314.92±4 450.28 vs. 4 644.79±3 388.23, all P < 0.05), and the difference of serum NT-proBNP before and after treatment in the combined treatment group was significantly higher than that in the hormone treatment group (P < 0.05). There were no significant differences in SBP difference, MAP difference, mortality and re-hospitalization rate among the 3 groups. No adverse reactions occurred in the 3 groups during treatment. Shenfu injection combined with glucocorticoid is effective in the treatment of patients with acute left heart failure complicated with bronchospasm. It is superior to glucocorticoid and aminophylline in relieving bronchospasm, reducing NT-proBNP level and improving total effective rate, and has good prognosis and safety.

The Efficacy and Safety of Xinjia Xuanbai Chengqi Granules in Acute Exacerbation of COPD: A Multicentre, Randomised, Double-Blind, Controlled Trial.

Purpose The study aimed to explore the efficacy and safety of Xinjia Xuanbai Chengqi granules (XJXBCQ) combined with conventional medicine in the treatment of acute exacerbation of chronic pulmonary disease (AECOPD). Patients and Methods. This multicentre, double-blind, parallel, placebo-controlled, randomised clinical trial conducted in China from January 2019 to February 2021 recruited 330 participants who were allocated into three groups. All participants underwent conventional basic treatment with oxygen therapy, antibiotics, and a bronchodilator. Besides, group A received XJXBCQ granules and budesonide suspension for inhalation; group B received XJXBCQ granules and half dosage of budesonide suspension; and group C received budesonide suspension and a placebo. All therapies lasted for 5 days, and participants were followed up for 30 days after discharge. The primary outcomes were efficacy, traditional Chinese medicine (TCM) syndrome score, and clinical symptom score. Secondary outcomes included the blood gas analysis, serum inflammatory markers, adverse events, mortality, theoretical discharge time, actual hospitalisation time, proportion of patients requiring invasive mechanical ventilation, proportion of patients transferred to an intensive care unit (ICU), and readmission rate within 30 days after discharge. Results XJXBCQ adjunct with conventional treatment could significantly improve the total efficacy (P < 0.05). Meanwhile, group A showed significantly better results than group C in the TCM syndrome score, phlegm score, and Wexner constipation score (P < 0.05). For modified British medical research council (mMRC), on day 3 (−0.17, 95% confidence interval [CI]: −0.33–−0.01) and day 4 (−0.20, 95% CI: −0.39–−0.02), group A performed statistically better than group C. No significant differences in other secondary outcomes were detected. Conclusion XJXBCQ is beneficial and safe for AECOPD treatment and could be considered an adjunctive therapy for promoting the relief of clinical symptoms. This trial is registered with ChiCTR1800016915.

Separation of budesonide enantiomers with amylose-tris-[(S)-1-phenylethyl carbamate] chiral stationary phase and determination of its contents in pharmaceutical preparations

22R-布地奈德的药物活性比22S-布地奈德的强2~3倍,开发布地奈德对映体拆分和定量分析方法,可为其药物研发及质量控制提供重要依据。目前,主要以反相C18固定相对布地奈德对映体进行拆分,而采用手性固定相对其进行拆分少有报道。通过考察固定相、流动相和柱温对布地奈德对映体拆分的影响,建立了基于直链淀粉-三[(S)-1-苯乙基氨基甲酸酯]手性固定相快速拆分和检测布地奈德对映体的高效液相色谱方法,其色谱条件如下:色谱柱为Chiralpak AS-RH色谱柱(150 mm×4.6 mm, 5.0 μm),流动相为乙腈-水(45:55, v/v),柱温40 ℃,流速1.0 mL/min,二极管阵列检测器(DAD),检测波长246 nm,进样量10 μL。在该色谱条件下,布地奈德的两个对映体得到较好拆分,22R-布地奈德和22S-布地奈德的保留时间分别6.40 min和7.77 min,分离度为4.64; 22R-布地奈德和22S-布地奈德分别在各自范围内线性关系良好,相关系数(R2)均为0.9999,检出限分别为0.05 μg/mL和0.07 μg/mL,定量限分别为0.16 μg/mL和0.20 μg/mL; 4个添加水平的样品加标回收率为102.63%~104.17%,相对标准偏差(RSD)为0.08%~0.57%(n=6)。将该方法应用于1批次4个吸入用布地奈德混悬液实际样品进行检测,22R-布地奈德和22S-布地奈德的含量分别为283.15~284.63 μg/mL和259.86~261.51 μg/mL。该方法操作简便,分析时间短,重复性好,准确度高,可用于布地奈德对映体的拆分及其制剂的质量控制。

Treatment of pediatric mild persistent asthma with low-dose budesonide inhalation suspension vs. montelukast in China.

There are limited studies comparing budesonide inhalation suspension (BIS) withmontelukast in real-world settings where treatment adherence and persistency may be suboptimal. This real-world study aims to investigate the control effectiveness of montelukast or BIS as amonotherapy in Chinese children with mild asthma. Data were derived from a retrospective questionnaire-based analysis of 2‒14-year-old children with mild persistent asthma, who received either 500 µg of BIS (n = 153) or 4‒5mg of montelukast (n = 240) once daily. The indicators of asthma control, the Asthma Control Test (ACT)/Childhood ACT (C-ACT) score, and the asthma-related medical costs were assessed. The differences between the two groups were compared using an unpaired t-test (normally distributed), Mann-Whitney U test (non-normally distributed) or chi-squared test (categorical variables). Medication compliance in the past 3-month period was better in the montelukast group than in the BIS group (P = 0.042). The montelukast group exhibited better asthma control in the past 4-week period, including lower percentages of asthmatic children with symptoms more than twice a week (P = 0.021), had night waking or night coughing (P = 0.022), or required reliever medication more than twice a week (P < 0.001). The montelukast group had a lower percentage of children with an ACT/C-ACT score ≤ 19 (P = 0.015). Caregivers reported a significantly better exercise tolerance in the children who received montelukast vs. BIS in the past 12months (P < 0.001). Significantly higher medical expenditures attributable to asthma in the past 12months were observed in the BIS group vs. montelukast group (P < 0.001). Both treatments provided acceptable overall asthma control in children with mild persistent asthma; however, more reliever medication and more medical expenditures attributable to asthma were needed for BIS vs. montelukast in real-world settings, where factors such as compliance were also taken into account.

The therapeutic effect of budesonide on childhood asthma and its influence on growth and development 1 to 2 years after the treatment

Objective To explore the effect of budesonide suspension for inhalation in the treatment of childhood asthma and its influence on growth and development in 1-2 years. Methods The 68 children with asthma admitted to our hospital from October 2016 to January 2017 were selected. Every patient had acute attacks and received continued medication. 34 patients treated with salbutamol sulfate inhaled aerosol were used as the control group. 34 patients treated with budesonide suspension combined with salbutamol sulfate aerosol were classified as the observation group. The interleukin-6 (IL-6), tumor necrosis factor-α(TNF-α), high-sensitivity-C-reactive protein (hs-CRP), maximum respiratory flow, IS maximum expiratory volume, regulatory B cell ratio, wheezing disappearance time, shortness of breath relief time, wet rales disappearing time, cough disappearing time, and the two year follow-up indicators of growth and development were compared. Results After medication, IL-6, TNF-α, hs-CRP, regulatory B cell ratio, wheezing disappearance time, shortness of breath relief time, moist rales disappearance time, and cough disappearance time were lower in the observation group(P Conclusion Budesonide suspension combined with salbutamol sulfate aerosol inhalation therapy can alleviate the inflammatory reaction, improve the lung function and immune function of children, and accelerate the disappearance of clinical symptoms, but it will affect the growth and development of children to a certain extent.

Validation of Novel Analytical RP-HPLC Method for determination of Formoterol Fumarate and Budesonide in Inhalation Suspension Pharmaceutical Dosage Form

Formoterol Fumarate and Budesonide inhalation suspension is prescribed for treatment of Asthmatic patient. Formoterol Fumarate is anti-asthmatic drug (Bronchodilator) and Budesonide is Anti Inflammatory Drug (Glucocortico steroid) drug. A bronchodilator is a substance that dilates the bronchi and bronchioles, decreasing resistance in the respiratory airway and increasing airflow to the lungs while Anti Inflammatory drug is used for the treatment of inflammation occurred on respiratory tract. The present study aimed to Validate HPLC method for combined determination of Assay of Formoterol Fumarate and Budesonide Analytes. This study covers Precision, Limit of Detection, Limit of Quantification, Linearity, Accuracy, Robustness, Ruggedness, Solution stability and Specificity. The chromatographic method uses a reversed phase column Hypersil ODS 125mm ×4.0mm x 5μm). The mobile phase was prepared by mixing Acetonitrile: Phosphate buffer (35:65, %v/v) at flow rate 1.0ml/min with Ultraviolet and Diode array detector at wavelength 215nm, column oven adjusted to 40°C and with injection volume 50μL. The method Found Precise, Accurate, Linear, Rugged, Robust and Sensitive. The method showed a successful application for determination of Formoterol Fumarate and Budesonide in Inhalation suspension pharmaceutical formulation.

Cost-effectiveness analysis of double low-dose budesonide and low-dose budesonide plus montelukast among pediatric patients with persistent asthma receiving Step 3 treatment in China

Aims For children aged 1–5 years with persistent asthma, double low-dose inhaled corticosteroids (ICS) are recommended as the preferred Step 3 treatment and low-dose ICS plus leukotriene receptor antagonists (LTRA) as an alternative. Budesonide inhalation suspension (0.5 mg daily) and montelukast (4.0 mg daily) are commonly used low-dose ICS and LTRA, respectively, among children in China. This study compared the cost-effectiveness of double low-dose budesonide vs. low-dose budesonide plus montelukast from a Chinese healthcare payer’s perspective. Methods A Markov model was constructed with four health states (i.e. no exacerbation, mild exacerbation, moderate-to-severe exacerbation, and death). Transition probabilities were estimated based on exacerbation rates, case-fatality of hospitalized patients due to exacerbation, and natural mortality. Treatment adherence was considered and assumed to impact both drug costs and exacerbation rates. Costs (in 2019 Chinese Yuan [¥]) included drug costs and exacerbation management costs. Cost inputs and utilities for each health state were obtained from a public database and the literature. In-depth interviews were conducted with a health economics expert to validate the model, and a clinical expert to verify inputs and assumptions related to clinical practice. Costs and quality-adjusted life-years (QALYs) were estimated over a year. Deterministic and probabilistic sensitivity analyses were performed. Results Compared with low-dose budesonide plus montelukast, double low-dose budesonide was associated with lower costs (¥1,534 vs. ¥2,327), fewer exacerbation events (0.43 vs. 1.67) and slightly better QALYs (0.98 vs. 0.97). Sensitivity analyses supported the robustness of the results and the generalizability of findings across geographic regions in China. Conclusion The cost-effectiveness analysis suggests that double low-dose budesonide is a dominant Step 3 treatment strategy compared with low-dose budesonide plus montelukast for patients aged 1–5 years with persistent asthma in China.

Relationship between interleukin-13 rs20541 single nucleotide polymorphisms and therapeutic efficacy in children with asthma.

ObjectiveTo investigate the relationship between therapeutic efficacy in children with asthma and interleukin-13 (IL-13) rs20541 polymorphisms.MethodsFifty children with moderate-to-severe asthma were assigned to the GG, GA, and AA groups according to the IL-13 gene locus rs20541 polymorphism. The patients received budesonide inhalation suspension 1 mg twice daily combined with fluticasone propionate 80 µg/inhalation. The improvement of clinical symptoms (gasping, coughing, and wheezing), improvement of lung function, and adverse reactions were observed.ResultsLung function did not significantly differ among three groups before treatment. After treatment, the time to symptom relief was significantly shorter in the GG group than that in the other two groups. The forced expiratory volume in one second and percent predicted peak expiratory flow were also significantly better in the GG group than in the other two groups.ConclusionBudesonide inhalation suspension combined with fluticasone propionate is an effective treatment regimen for moderate-to-severe asthma. Polymorphism of the IL-13 rs20541 locus may be correlated with therapeutic efficacy. Patients carrying the GG allele were more responsive than their counterparts with the GA or AA allele.

The impact of budesonide inhalation suspension for asthma hospitalization: In terms of length of stay, recovery time from symptoms, and hospitalization costs

BackgroundHospitalization is a major cause of medical expenditure for asthma. Budesonide inhalation suspension (BIS) may assist in reducing asthma-related symptoms in severe asthma exacerbation. However, its effectiveness for hospitalized patients remains poorly known. The objective of this study is to determine associations of BIS with asthma hospitalization. MethodsWe retrospectively analyzed 98 patients who were admitted to our hospital due to severe asthma exacerbation (24 treated with BIS in combination with procaterol) from April 2014 to January 2019. Length of stay, recovery time from symptoms (wheezes), and hospitalization costs were compared between the 2 groups according to clinical factors including the use of BIS and sings of respiratory infections (i.e. C-reactive protein, the presence of phlegm, and the use of antibiotics). Multivariate logistic regression analysis was performed to determine factors contributing to hospitalization outcomes. ResultsThe use of BIS was associated with shorter length of stay, faster recovery time from symptoms, and more reduced hospitalization costs (6.0 vs 8.5 days, 2.5 vs 5.0 days, and 258,260 vs 343,350 JPY). Signs of respiratory infection were also associated with hospitalization outcomes. On a multivariate regression analysis, the use of BIS was a determinant of shortened length of stay and reduced symptoms and medical costs for asthma hospitalization along with signs of respiratory infection. ConclusionsBIS may contribute to shorten length of hospital stay and to reduce symptoms and medical expenditure irrespective of the presence or absence of respiratory infection.

Comparative effectiveness of budesonide inhalation suspension and montelukast in children with mild asthma in Korea

Objective: The comparative effectiveness of low-dose budesonide inhalation suspension (BIS) versus oral montelukast (MON) in managing asthma control among children with mild asthma was assessed in Korea.Methods: Claims from Korea’s national health insurance database for children (2–17 years) with mild asthma (GINA 1 or 2) who initiated BIS or MON during 2015 were retrospectively analyzed. Pre- and post-index windows were 1 year each. Adherence, persistency, asthma control, asthma-related health-care resource utilization, and costs were evaluated using unadjusted descriptive statistics and propensity score-matched regression analyses.Results: The number of children identified was 26,052 for unmatched (n = 1,221 BIS; n = 24,831 MON) and 2,290 for matched populations (n = 1,145 per cohort). Medication adherence, measured by proportion of days covered, was low for both cohorts but significantly higher for MON versus BIS (13.8% vs. 4.5%; p < .001). Time to loss of persistency was longer for MON versus BIS (82.3 vs. 78.4 days, respectively; p < .001). Mean number of post-index asthma-related office visits was 6.6 for BIS versus 8.3 for MON (p < .001). However, a greater proportion of patients in the BIS cohort had an asthma exacerbation-related office visit than the MON cohort (78.3% vs. 56.1%; p < .001). Asthma-related total health-care costs were higher with MON versus BIS (₩ 190,185 vs. ₩ 167,432, respectively; p < .001), likely driven by higher pharmaceutical costs associated with MON (₩ 69,113 vs. ₩ 49,225; p < .001).Conclusions: Montelukast patients had better adherence, a longer time to loss of persistency, and were less likely to experience an exacerbation-related office visit in the post-index period than BIS patients.

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

PurposeCorticosteroids 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.MethodsOverall, 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.ResultsOral 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.ConclusionsA 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.

PRS6 - Comparative Assessment of Asthma Control Outcomes Among Pediatric Asthma Patients: Learnings From Database Studies in The U.S and South Korea

This study descriptively compares asthma control risk factors and outcomes observed in two recent observational studies in the US and South Korea. The US study, a cross-sectional pediatric asthma study (ages 6-17 years old) conducted using the Medical Expenditure Panel Survey (MEPS) database between 2007-2013, explored socio-demographics (SD), healthcare resource utilization (HRU), asthma control, and cost outcomes. The Korean study, a longitudinal cohort pediatric asthma study (ages 2-17 years old) using the Health Insurance Review and Assessment (HIRA) database between 2014-2016, compared patient demographics, clinical outcomes, HRU, medication utilization (adherence/persistence), asthma control and costs between patients initiated on low dose budesonide inhalation suspension (BIS) or montelukast (MON). The MEPS database is comprised of patient interview responses and utilization/expenditure data; the HIRA database consists of national insurance claims for covered healthcare utilization. Both studies explored exacerbation risk, acute HRU (hospitalization, ER visits, etc.), and rescue medication use as proxy measures of asthma control. Both studies demonstrated that there was poor utilization of asthma controller medications and an over-reliance on rescue inhalers. In the US study, only 19% of pediatric asthma patients used a daily controller medication for asthma but 59% experienced an exacerbation (self-reported) in the previous year. In the Korean study, treatment adherence as measured by percent of days covered (PDC) was very low in both cohorts (13.33% MON vs. 4.86% BIS), and patients in both cohorts were highly non-persistent (>80% non-persistency rate after 1 year), with > 80% of BIS and MON patients not in control over the 1 year post-index. Under-utilization of controller agents and an over-reliance on rescue medication use are major drivers for poor asthma control outcomes in both countries. Better asthma management education of providers, patients and parents should be explored in both countries.

Efficacy of systemic glucocorticoids combined with inhaled steroid on children with acute laryngitis

Objective: To evaluate the efficacy of systemic glucocorticoid (steroid) combined with high dose inhaled steroid in the treatment of children with acute laryngitis. Methods: A total of 78 children with acute laryngitis were randomly divided into study group(n=40) and control group(n=38) between November 2016 and April 2017. In addition to routine treatment of anti infection and symptomatic treatment, Dexamethasone injection(0.3-0.5 mg/kg, 1-3 d, according to the patient's condition) was provided to each group. In addition to the treatment mentioned above, the study group were assigned to receive 1.0 mg Budesonide suspension for inhalation, oxygen-driven atomizing inhalation, every/30 minutes, 2 times in a row, after that every 12 hours. The improvement of inspiratory dyspnea, hoarseness, barking cough and wheezing of both groups was evaluated at 30 min, 1 h, 2 h, 6 h, 12 h, 24 h and 72 h after treatment.Sigmaplot 11.5 software was used to analyze the data. Results: No significant difference was detected in terms of inspiratory dyspnea, hoarseness, barking cough or stridor score before treatment between the two groups(P>0.05). Compared with those before treatment, symptoms of inspiratory dyspnea, hoarseness, barking cough and stridor score of both groups improved markedly at 12 h and 24 h after treatment(P<0.05). While there was no significant difference regarding inspiratory dyspnea, hoarseness, barking cough or stridor score at each time point after treatment between the two groups(P>0.05). The effective rate was 92.50% and 92.11% in study group and control group, respectively, and no significant difference was noted (P>0.05). Conclusion: Compared with single systemic glucocorticoid, systemic glucocorticoids combined with inhaled steroid possessed similar efficacy in treating acute laryngitis and relieving laryngeal obstruction of children.

Montelukast Reduces Serum Levels of Eosinophil-Derived Neurotoxin in Preschool Asthma.

PurposeSeveral markers for eosinophilic inflammation have been proposed to predict response to asthma treatment. However, definitive criteria for treatment decisions have not yet been established. We investigate a potentially useful relatively non-invasive biomarker, eosinophil-derived neurotoxin (EDN), to predict favorable responses to budesonide or montelukast, common treatment for children with asthma.MethodsYoung children (1 to 6 years old) were enrolled in this randomized, parallel, 2-group, open-label trial. Criteria for eligibility included: 1) being symptomatic during the run-in period; and 2) having a serum EDN (sEDN) level ≥ 53 ng/mL, with positive specific immunoglobulin E to house dust mite. Eligible patients were randomly placed into 2 groups: the BIS group received budesonide inhalation suspension (BIS) 0.5 mg once daily; the MONT group received montelukast 4 mg once daily. Ineligible patients were invited to receive montelukast 4 mg once daily (OBS group). Treatment period was 12 weeks.ResultsAsthma control days increased significantly in the BIS and MONT groups (P < 0.000) over the 12-week study period. There was no significant change in sEDN in the BIS group but there was a significant decrease in the MONT group (P < 0.000). Patients in the OBS group with high EDN levels (< 53 ng/mL) showed a significant decrease due to MONT treatment (P = 0.023). Rescue medication usage significantly decreased in the BIS and MONT groups (P < 0.000).ConclusionsEDN is a useful relatively non-invasive biomarker for predicting responses to montelukast and budesonide treatment of preschool children with beta2-agonist responsive recurrent wheeze and multiple-trigger wheeze (Trial registry at UMIN Clinical Trials Registry, UMIN000008335).

Usefulness of inhaled budesonide suspension in preventing POST during tracheal intubation

Background: Postoperative sore throat and hoarseness are common complaints from patients receiving tracheal intubation. The present study was conducted to assess the usefulness of inhaled budesonide suspension in preventing POST during tracheal intubation. Materials & Methods: The present study was conducted on 56 patients of both genders undergoing surgical procedure. The patients were randomly divided into 2 groups of 28 each. Group I received 200 μg budesonide inhalation suspension, using a metered dose inhaler and in group II, no such intervention was performed before intubation or after extubation. In both groups, POST was assessed at 2, 6, 12 and 24 hours. Results: At 2 hours, 6 patients in group I and 25 in group II had symptoms. At 6 hours, 4 in group I and 20 in group II had symptoms. At 12 hours, 2 in group I and 16 in group II had symptoms. At 24 hours, none in group I and 14 in group II had symptoms. The difference was significant (P< 0.05). Conclusion: Inhaled budesonide suspension is effective in patients undergoing any procedure and preventing postoperative sore throat.

Effect of inhaled budesonide suspension, administered using a metered dose inhaler, on post-operative sore throat, hoarseness of voice and cough.

Background and Aims:Post-operative sore throat (POST) is often considered an inevitable consequence of tracheal intubation. This study was performed to compare the effect of inhaled budesonide suspension, administered using a metered dose inhaler, on the incidence and severity of POST.Methods:In this prospective randomised study, 46 patients undergoing laparoscopic surgeries lasting <2 h were randomly allotted into two equal groups. Group A received 200 μg budesonide inhalation suspension, using a metered dose inhaler, 10 min before intubation, and repeated 6 h after extubation. No such intervention was performed in Group B. The primary outcome was the incidence and severity of POST. Secondary outocomes included the incidence of post-operative hoarseness and cough. Pearson's Chi-square test, Fisher's exact test and Independent sample t-test were used as applicable.Results:Compared to Group B, significantly fewer patients had POST in Group A at 2, 6, 12 and 24 h (P < 0.001). Although more patients in Group B had post-operative hoarseness of voice and cough at all-time points, the difference was statistically significant only at 12 h and 24 h for post-operative hoarseness and at 2 h and 12 h for post-operative cough. Severity as well as the incidence of POST showed downward trends in both groups over time, and by 24 h no patient in Group A had sore throat.Conclusion:Inhaled budesonide suspension is effective in significantly reducing the incidence and severity of POST.

Method Development for Clinical Comprehensive Evaluation of Pediatric Drugs Based on Multi-Criteria Decision Analysis: Application to Inhaled Corticosteroids for Children with Asthma.

Establishing a comprehensive clinical evaluation system is critical in enacting national drug policy and promoting rational drug use. In China, the 'Clinical Comprehensive Evaluation System for Pediatric Drugs' (CCES-P) project, which aims to compare drugs based on clinical efficacy and cost effectiveness to help decision makers, was recently proposed; therefore, a systematic and objective method is required to guide the process. An evidence-based multi-criteria decision analysis model that involved an analytic hierarchy process (AHP) was developed, consisting of nine steps: (1) select the drugs to be reviewed; (2) establish the evaluation criterion system; (3) determine the criterion weight based on the AHP; (4) construct the evidence body for each drug under evaluation; (5) select comparative measures and calculate the original utility score; (6) place a common utility scale and calculate the standardized utility score; (7) calculate the comprehensive utility score; (8) rank the drugs; and (9) perform a sensitivity analysis. The model was applied to the evaluation of three different inhaled corticosteroids (ICSs) used for asthma management in children (a total of 16 drugs with different dosage forms and strengths or different manufacturers). By applying the drug analysis model, the 16 ICSs under review were successfully scored and evaluated. Budesonide suspension for inhalation (drug ID number: 7) ranked the highest, with comprehensive utility score of 80.23, followed by fluticasone propionate inhaled aerosol (drug ID number: 16), with a score of 79.59, and budesonide inhalation powder (drug ID number: 6), with a score of 78.98. In the sensitivity analysis, the ranking of the top five and lowest five drugs remains unchanged, suggesting this model is generally robust. An evidence-based drug evaluation model based on AHP was successfully developed. The model incorporates sufficient utility and flexibility for aiding the decision-making process, and can be a useful tool for the CCES-P.

Effect of nebulized budesonide on decreasing the recurrence of allergic fungal rhinosinusitis

ObjectiveThe aim of this study was to evaluate the clinical efficacy and the effects on decreasing the recurrence of AFRS (allergic fungal rhinosinusitis) of a budesonide inhalation suspension delivered via transnasal nebulization to patients following endoscopic sinus surgery. Subjects and methodsThirty-five patients were recruited into this study. Final diagnoses were reached using Bent and Kuhn's criteria. The eligible patients were randomly divided into two groups: the budesonide transnasal nebulization group (group A) and the topical nasal steroids group (group B). Nasal symptoms, Lund-Mackay scores, and Kupferberg grades were evaluated before surgery, after surgery and during the follow-up to assess the effects of these two approaches. ResultsA total of 30 patients with AFRS who were eligible were included in the study. Four of the 15 patients in group B (26.67%) developed recurrent disease, whereas no patients in group A developed recurrent disease. This difference was statistically significant (p=0.032). ConclusionNebulized budesonide is an effective and safe treatment for patients with AFRS following endoscopic sinus surgery, as evidenced by the reduced recurrence rate observed in the budesonide transnasal nebulization group relative to the topical nasal steroids group.

Effect of Budesonide combined with Poractant Alfa preventing bronchopulmonary dysplasia in preterm infants

Objective To evaluate the effect of Budesonide combined with Poractant Alfa(pulmonary surfactants, PS) on preventing the bronchopulmonary dysplasia(BPD) in preterm infants. Methods One hundred and twenty preterm infants 6 hours after birth(gestational ages≤32 weeks and birth weights≤1 500 g)admitted to the Department of Newborn Medicine, the Affiliated Hospital of Southeast Medical University from October 2013 to February 2015 were randomly divided into 4 group(30 cases in each group). Group A was a control group, group B was neonatal respiratory distress syndrome(NRDS) group, group C was NRDS with PS group, and group D was NRDS with PS and Budesonide group.Thirty-two-week preterms without other diseases and without uptaking oxygen within 48 h were assigned as group A. Group B were treated by continuous uptaking oxygen with continuous positive airway pressure(CPAP)(oxygen uptaken lasting more than 48 h and oxygen concentrations more than 40%). Group C were treated with 100 mg/kg PS within 48 h on the basis of group B. Group D were treated with 0.25 mg/kg Budesonide suspension for inhalation on the basis of group C. The pH value, partial pressure of oxygen[pa(O2)], partial pressure of carbon dioxide [pa(CO2)]in the blood gas analysis were all detected in all groups before treatment, 1, 6, 12, 24 and 48 hours after using drug, respectively.All groups were also observed for whether to use respirator assisted ventilation, the duration of high oxygen use, the total time of uptaking oxygen, the rate of using PS again, the rate of BPD, the total hospitalization days and the adverse effects.The adverse effects included high blood pressure, high blood sugar, necrotizing enterocolitis and the incidence of nosocomial infection. Results Compared with group B, the pH value at 1 and 6 hours after using drugs, the pa(O2) and pa(CO2) at 1, 6 and 12 hours after using drugs were improved obviously in the group C, and the differences were statistically significant(all P 0.05). Conclusions Budesonide combined with Poractant Alfa can prevent BPD in preterm infants.Its effect is better than the simple use of Poractant Alfa, and the rate of adverse effects are not increased significantly. Key words: Budesonide; Poractant Alfa; Bronchopulmonary dysplasia; Preterm infant