OBJECTIVES: To study the efficacy and safety of early intratracheal administration of budesonide combined with pulmonary surfactant (PS) in preventing bronchopulmonary dysplasia (BPD). METHODS: A prospective randomized controlled trial was designed. A total of 122 infants with a high risk of BPD who were admitted to the neonatal intensive care unit of the Third Affiliated Hospital of Zhengzhou University from January to July 2021 were enrolled. The infants were randomly divided into a conventional treatment group with 62 infants (treated with PS alone at an initial dose of 200 mg/kg, followed by a dose of 100 mg/kg according to the condition of the infant) and an observation group with 60 infants (treated with PS at the same dose as the conventional treatment group, with the addition of budesonide 0.25 mg/kg for intratracheal instillation at each time of PS application). The two groups were compared in terms of the times of PS use, ventilator parameters at different time points, oxygen inhalation, incidence rate and severity of BPD, incidence rate of complications, and tidal breathing pulmonary function at the corrected gestational age of 40 weeks. RESULTS: Compared with the conventional treatment group, the observation group had a significantly lower proportion of infants using PS for two or three times (P<0.05). Compared with the conventional treatment group, the observation group had a significantly lower fraction of inspired oxygen at 24 and 48 hours and 3, 7, and 21 days after administration, significantly shorter durations of invasive ventilation, noninvasive ventilation, ventilator application, and oxygen therapy, a significantly lower incidence rate of BPD, and a significantly lower severity of BPD (P<0.05). There was no significant difference in the incidence rate of glucocorticoid-related complications between the two groups (P>0.05). CONCLUSIONS Compared with PS use alone in preterm infants with a high risk of BPD, budesonide combined with PS can reduce repeated use of PS, lower ventilator parameters, shorten the duration of respiratory support, and reduce the incidence rate and severity of BPD, without increasing the incidence rate of glucocorticoid-related complications.
Bronchopulmonary Dysplasia/prevention & control* ; Budesonide ; Humans ; Infant ; Infant, Newborn ; Infant, Premature ; Prospective Studies ; Pulmonary Surfactants/therapeutic use* ; Respiration, Artificial ; Respiratory Distress Syndrome, Newborn/therapy*

This study discusses the effect of Biyanning Granules on local symptoms and systemic immune function of patients with chronic rhinosinusitis with nasal polyps(CRSwNP) within the 6 months of treatment by glucocorticoid nasal spray after surgical treatment. To be specific, a total of 237 CRSwNP patients, treated in Otorhinolaryngology Head and Neck Surgery in Shanxi Bethune Hospital, were enrolled. All patients were treated by nasal endoscopy and classified into hormone group(Budesonide Nasal Spray after surgery), Chinese medicine group(Biyanning Granules after surgery), and combination group(Budesonide Nasal Spray+Biyanning Granules after surgery) with random number table method, 79 cases in each group, and the treatment lasted 3 months. The follow-up was performed from the day of discharge to 12 months after the surgery. The clinical effect was observed. The visual analogue scale(VAS) scores and sino-nasal outcome test-20(SNOT-20) scale scores were used to assess patient's subjective symptoms and quality of life. Lund-Kennedy endoscopic score(LKES), Japanese T&T olfactometry, and standard olfactory test were used to evaluate the objective curative effect on patients. The levels of interleukin(IL)-21, CD4~+CD25~+Foxp3~+Treg, and CD4~+Th17 in peripheral blood were analyzed. The incidence of complications, recurrence rate, and adverse reactions during treatment were also recorded. The total effective rate after treatment in the combination group was higher than that in the hormone group and Chinese medicine group(P<0.05). VAS scores and SNOT-20 scale scores were lower in the three groups after treatment than before treatment and lower in the combination group than in the other two groups(P<0.05). The improvement in LKES and T&T standard olfactometry test was better in the combination group than in the other two groups(P<0.05). Serum levels of IL-21 and CD4~+Th17 in the three groups were lower than before treatment. The levels in the combination group were lower than those in the other two groups and lower in the hormone group than in the Chinese medicine group(P<0.05). Serum CD4~+CD25~+Foxp3~+Treg level was higher in the three groups after treatment than before, higher in the combination group than in the other two groups, and higher in the Chinese medicine group than in the hormone group(P<0.05). During the treatment, no serious adverse reactions were observed. After treatment, the combination group showed no significant difference in the incidence and recurrence rate of complications from the hormone group and Chinese medicine group. In the treatment of CRSwNP with glucocorticoid, Biyanning Granules reduced the side effects of glucocorticoid and assisted glucocorticoid in alleviating the symptoms of patients. It significantly improved the curative effect, regulated immune imbalance, accele-rated the recovery of immune function, reduced the recurrence rate of inflammatory reaction, and improved the quality of life. The combination of Chinese and western treatment is more effective than glucocorticoid alone and warrants further clinical study in large sample size.
Budesonide/therapeutic use* ; Chronic Disease ; Forkhead Transcription Factors/metabolism* ; Glucocorticoids/therapeutic use* ; Humans ; Immunity ; Medicine, Chinese Traditional ; Nasal Sprays ; Quality of Life ; Rhinitis/surgery* ; Sinusitis/surgery*

PURPOSE: We evaluated the severity of olfactory disturbance (OD) in the murine model of allergic rhinitis (AR) and local allergic rhinitis (LAR) in mice. We also investigated the therapeutic effect of an intranasal steroid on OD. METHODS: Forty BALB/c mice were divided into 5 groups (n = 8 for each). The control group was sensitized intraperitoneally (i.p.) and challenged intranasally (i.n.) with saline. Mice in the AR group got i.p. and i.n. ovalbumin (OVA) administration for AR induction. The LAR group was challenged i.n. with 1% OVA for inducing local nasal allergic inflammation, without inducing the systemic allergy. The OD group got an i.p. methimazole administration (75 mg/kg) to induce total destruction of olfactory mucosa. Mice in the intranasal budesonide group received i.n. budesonide (12.8 μg per time, 30 minutes after the i.n. OVA challenge) while using OVA to cause systemic allergies. We conducted a buried-food pellet test to functionally assess the degree of OD in each group by measuring the time taken until finding hidden food. We evaluated the damage to olfactory epithelium using histopathologic evaluation and compared the degree of olfactory marker protein (OMP) expression in olfactory epithelium using immunofluorescent staining. RESULTS: Mice of the AR (81.3 ± 19.8 seconds) and LAR groups (66.2 ± 12.7 seconds) spent significantly more time to detect the pellets than the control group (35.6 ± 12.2 seconds, P < 0.01). After treatment, the intranasal budesonide group exhibited significantly better results (35.8 ± 11.9 seconds) compared with the AR and LAR groups (P < 0.01). The AR and LAR groups showed considerable olfactory epithelial damage and suppression of OMP expression compared with the control group. In the intranasal budesonide group, the olfactory lesions and OMP expression had improved substantially. CONCLUSIONS: OD may be caused by olfactory epithelial damage and suppression of OMP expression in nasal allergic inflammation and could be reversed using an intranasal steroid.
Animals ; Budesonide ; Hypersensitivity ; Inflammation ; Methimazole ; Mice ; Olfaction Disorders ; Olfactory Marker Protein ; Olfactory Mucosa ; Ovalbumin ; Ovum ; Quality of Life ; Rhinitis, Allergic ; Steroids

PURPOSE: The effect of air pollution-related particulate matter (PM) on epithelial barrier function and tight junction (TJ) expression in human nasal mucosa has not been studied to date. This study therefore aimed to assess the direct impact of PM with an aerodynamic diameter less than 2.5 μm (PM2.5) on the barrier function and TJ molecular expression of human nasal epithelial cells. METHODS: Air-liquid interface cultures were established with epithelial cells derived from noninflammatory nasal mucosal tissue collected from patients undergoing paranasal sinus surgery. Confluent cultures were exposed to 50 or 100 µg/mL PM2.5 for up to 72 hours, and assessed for 1) epithelial barrier integrity as measured by transepithelial resistance (TER) and permeability of fluorescein isothiocyanate (FITC) 4 kDa; 2) expression of TJs using real-time quantitative polymerase chain reaction and immunofluorescence staining, and 3) proinflammatory cytokines by luminometric bead array or enzyme-linked immunosorbent assay. RESULTS: Compared to control medium, 50 and/or 100 µg/mL PM2.5-treatment 1) significantly decreased TER and increased FITC permeability, which could not be restored by budesonide pretreatment; 2) significantly decreased the expression of claudin-1 messenger RNA, claudin-1, occludin and ZO-1 protein; and 3) significantly increased production of the cytokines interleukin-8, TIMP metallopeptidase inhibitor 1 and thymic stromal lymphopoietin. CONCLUSIONS: Exposure to PM2.5 may lead to loss of barrier function in human nasal epithelium through decreased expression of TJ proteins and increased release of proinflammatory cytokines. These results suggest an important mechanism of susceptibility to rhinitis and rhinosinusitis in highly PM2.5-polluted areas.
Asthma ; Budesonide ; Claudin-1 ; Cytokines ; Enzyme-Linked Immunosorbent Assay ; Epithelial Cells ; Fluorescein ; Fluorescein-5-isothiocyanate ; Fluorescent Antibody Technique ; Humans ; Interleukin-8 ; Mucous Membrane ; Nasal Mucosa ; Occludin ; Particulate Matter ; Permeability ; Polymerase Chain Reaction ; Rhinitis ; RNA, Messenger ; Tight Junctions

OBJECTIVE: To observe the therapeutic effect of herb-separated moxibustion combined with budesonide nasal spray (rhinocort) on moderate to severe persistent allergic rhinitis (AR) of kidney- deficiency type, and to explore the correlation between nasal temperature and condition of allergic rhinitis. METHODS: A total of 70 patients with moderate to severe persistent AR were randomized into an observation group (35 cases) and a control group (35 cases, 3 cases dropped off). Both groups were treated with rhinocort, one spray on each side of the nostril (approximately 64 μg each spray), once in the morning and once in the evening, for 4 weeks. On the basis of the above treatment, the observation group was treated with herb-separated moxibustion at Shenshu (BL 23), Feishu (BL 13), Zhiyang (GV 9), Dazhui (GV 14), 3 moxibustions per acupoint, a single treatment lasting about 30 min. This treatment was given once every other day, 3 times every week, and totally continuous 4 weeks. The changes of AR symptom visual analogue scale (VAS) scores were observed before and after treatment and at 3 months follow-up after treatment. The heat variation (temperature, range) on projection areas of the nose, lungs, large intestine and kidneys of the two groups' patients before and after treatment were detected by the infrared thermal imaging diagnostic system, and the correlation between the VAS scores and nasal temperature before and after treatment was analyzed. The clinical effects of both groups were evaluated according to the VAS score. RESULTS: The total effective rate in the observation group after treatment was 85.7% (30/35), which was higher than 71.9% in the control group (23/32, <0.05). After treatment and at follow-up, the VAS scores of both groups were lower than those before treatment (<0.05), and the VAS score of the observation group was lower than that of the control group at follow-up (<0.05). After treatment, the nasal temperature, pulmonary range, large intestinal range and renal range of the observation group were all lower than those before treatment (<0.05), the nasal temperature and nasal range of the control group were lower than before treatment (<0.05), and the reduction of nasal temperature, nasal range and renal range in the observation group was greater than that of the control group (<0.05). Before and after treatment, there was a correlation between VAS score and nasal temperature (<0.05). CONCLUSION The herb-separated moxibustion combining western medication has a better effect and long-term effect than western medication alone for moderate to severe persistent AR, which can improve heat variation on projected areas of the nose, lung, large intestine and kidney of patients. In addition, nasal temperature can reflect the severity of the symptoms of patients with moderate to severe persistent AR, or it can be used as a secondary indicator to evaluate condition of AR.
Acupuncture Points ; Acupuncture Therapy ; Budesonide ; therapeutic use ; Humans ; Moxibustion ; Rhinitis, Allergic ; therapy ; Yang Deficiency

OBJECTIVE: To study the effect of intermittent versus daily inhalation of budesonide on pulmonary function and fractional exhaled nitric oxide (FeNO) in children with mild persistent asthma. METHODS: A total of 120 children, aged 6-14 years, with mild persistent asthma who attended the hospital from January 2016 to January 2018 were enrolled. The children were divided into an intermittent inhalation group with 60 children (inhalation of budesonide 200 μg/day for 6 weeks when symptoms of asthma appeared) and a daily inhalation group with 60 children (continuous inhalation of budesonide 200 μg/day) by stratified randomization. The children were followed up at months 3, 6, 9, and 12 of treatment. The two groups were compared in terms of baseline data, changes in FeNO and pulmonary function parameters, amount of glucocorticoid used, number of asthma attacks, and asthma control. RESULTS: At the start of treatment, there were no significant differences in baseline data, FeNO, and pulmonary function between the two groups (P>0.05). Over the time of treatment, FeNO gradually decreased and pulmonary function parameters were gradually improved in both groups (P<0.001). Compared with the intermittent inhalation group, the daily inhalation group had a better effect in reducing FeNO and increasing the predicted percentage of forced expiratory volume in 1 second (FEV1%pred) (P<0.001). The inhalation method and treatment time had an interaction effect on FeNO and pulmonary function parameters (P<0.001). In the daily inhalation group, FeNO and lung function parameters were improved rapidly and stabilized after 3 months of treatment, while those in the intermittent inhalation group stabilized after 6 months. After 12 months of treatment, there were no significant differences in the increases in body height and body weight and the degree of disease control between the two groups (P>0.05). Compared with the daily inhalation group, the intermittent inhalation group had a significantly lower amount of budesonide inhaled (P<0.05) and a significantly higher number of asthma attacks (P<0.05). CONCLUSIONS Intermittent inhalation and daily inhalation of budesonide can achieve the same level of asthma control in children with mild persistent asthma and both have no influence on the increases in body height and body weight. Daily inhalation of budesonide can produce a better efficiency in reduing FeNO and increasing FEV1%pred. Although intermittent inhalation can reduce the amount of glucocorticoid used, it may lead to a higher risk of asthma attacks.
Administration, Inhalation ; Adolescent ; Asthma ; drug therapy ; Budesonide ; therapeutic use ; Child ; Forced Expiratory Volume ; Humans ; Nitric Oxide

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.
Adrenal Cortex Hormones ; Budesonide ; Eosinophil Cationic Protein ; Eosinophils ; Glucocorticoids ; Humans ; Hydrocortisone ; Inhalation ; Interleukin-10 ; Interleukins ; Matrix Metalloproteinases ; Methylprednisolone ; Nasal Polyps ; Polyps ; Prospective Studies ; Steroids ; T-Lymphocytes, Regulatory ; Tissue Inhibitor of Metalloproteinases

Astragalus membranaceus may be a potential therapy for childhood asthma but its driving mechanism remains elusive. The main components of A. membranaceus were identified by HPLC. The children with asthma remission were divided into two combination group (control group, the combination of budesonide and terbutaline) and A. membranaceus group (treatment group, the combination of budesonide, terbutaline and A. membranaceus). The therapeutic results were compared between two groups after 3-month therapy. Porcine peripheral blood mononuclear cells (PBMCs) were isolated from venous blood by using density gradient centrifugation on percoll. The levels of FoxP3, EGF-β, IL-17 and IL-23 from PBMCs and serum IgE were measured. The relative percentage of Treg/Th17 cells was determined using flow cytometry. The main components of A. membranaceus were calycosin-7-O-glucoside, isoquercitrin, ononin, calycosin, quercetin, genistein, kaempferol, isorhamnetin and formononetin, all of which may contribute to asthma therapy. Lung function was significantly improved in the treatment group when compared with a control group (P < 0.05). The efficacy in preventing the occurrence of childhood asthma was higher in the treatment group than the control group (P < 0.05). The levels of IgE, IL-17 and IL-23 were reduced significantly in the treatment group when compared with the control group, while the levels of FoxP3 and TGF-β were increased in the treatment group when compared with the control group (P < 0.05). A. membranaceus increased the percentage of Treg cells and reduced the percentage of Th17 cells. A. membranaceus is potential natural product for improving the therapeutic efficacy of combination therapy of budesonide and terbutaline for the children with asthma remission by modulating the balance of Treg/Th17 cells.
Animals ; Asthma ; drug therapy ; immunology ; Astragalus propinquus ; chemistry ; Budesonide ; administration & dosage ; Cells, Cultured ; Child ; Child, Preschool ; Cytokines ; metabolism ; Drugs, Chinese Herbal ; administration & dosage ; pharmacology ; Female ; Humans ; Immunologic Factors ; administration & dosage ; pharmacology ; Leukocytes, Mononuclear ; drug effects ; metabolism ; Lung ; drug effects ; physiology ; Male ; Swine ; T-Lymphocytes, Regulatory ; cytology ; drug effects ; Terbutaline ; administration & dosage ; Th17 Cells ; cytology ; drug effects ; Treatment Outcome

The aim of this study was to examine the daily practice patterns of Symbicort® Maintenance and Reliever Therapy (SMART) in Korean asthmatic patients and to analyze clinical signs related to overuse. This study used an observational, multicenter, noninterventional, prospective, uncontrolled design for examining asthmatic patients prescribed SMART to assess the frequency and pattern of Symbicort® usage as a maintenance and reliever medication. The characteristics of patients showing signs of overuse (frequency of inhalation: 8 or more times per day) were also analyzed. Among the 1,518 patients analyzed, 1,292 (85.1%) completed the trial. The number of mean inhalations per day was 2.14±1.15; the number of patients who had at least 1 as needed usage (PRN) inhalation per day was 843 (55.5%); the mean frequency of PRN use was 0.25±0.67 inhalations per day. The number of patients who overused for at least 1 day was 260 (17.1%). In particular, young patients, patients with limited physical activity, and patients with nocturnal symptoms demonstrated high frequency of overuse. The frequency of overuse during SMART was not high in Korean asthmatic patients and the asthma status of follow-up outpatients improved overall. However, there is a need for careful education targeted toward younger patients, patients with limited physical activity, and patients with nocturnal symptoms owing to their tendency to frequently overuse.
Asthma ; Budesonide ; Education ; Follow-Up Studies ; Formoterol Fumarate ; Humans ; Inhalation ; Korea ; Motor Activity ; Outpatients ; Prescription Drug Overuse ; Prospective Studies

Symptomatic ulcerative colitis (UC) can be a chronic, disabling condition. Flares in disease activity are associated with many of the negative impacts of mild-to-moderate UC. Rapid resolution of flares can provide benefits to patients and healthcare systems. i Support Therapy–Access to Rapid Treatment (iSTART) introduces patient-centered care for mild-to-moderate UC. iSTART provides patients with the ability to self-assess symptomology and self-start a short course of second-line treatment when necessary. An international panel of experts produced consensus statements and recommendations. These were informed by evidence from systematic reviews on the epidemiology, mesalazine (5-ASA) treatment, and patient use criteria for second-line therapy in UC. Optimized 5-ASA is the first-line treatment in all clinical guidelines, but may not be sufficient to induce remission in all patients. Corticosteroids should be prescribed as second-line therapy when needed, with budesonide MMX® being a preferred steroid option. Active involvement of suitable patients in management of UC flares has the potential to improve therapy, with patients able to show good accuracy for flare self-assessment using validated tools. There is a place in the UC treatment pathway for an approach such as iSTART, which has the potential to provide patient, clinical and economic benefits.
Adrenal Cortex Hormones ; Budesonide ; Colitis, Ulcerative* ; Consensus* ; Delivery of Health Care ; Epidemiology ; Humans ; Mesalamine ; Patient-Centered Care ; Self-Assessment ; Ulcer*