1.Efficacy and safety of salmeterol/fluticasone compared with montelukast alone (or add-on therapy to fluticasone) in the treatment of bronchial asthma in children and adolescents: a systematic review and meta-analysis.
Xiao-Jian ZHOU ; Zhen QIN ; Jiao LU ; Jian-Guo HONG
Chinese Medical Journal 2021;134(24):2954-2961
BACKGROUND:
Despite the recommendation of inhaled corticosteroids (ICSs) plus long-acting beta 2-agonist (LABA) and leukotriene receptor antagonist (LTRA) or ICS/LTRA as stepwise approaches in asthmatic children, there is a lack of published systematic review comparing the efficacy and safety of the two therapies in children and adolescents aged 4 to 18 years. This study aimed to compare the safety and efficacy of salmeterol/fluticasone (SFC) vs. montelukast (MON), or combination of montelukast and fluticasone (MFC) in children and adolescents aged 4 to 18 years with bronchial asthma.
METHODS:
A systematic search was conducted in MEDLINE, EMBASE, the Cochrane Library, China BioMedical Literature Database, Chinese National Knowledge Infrastructure, VIP Database for Chinese Technical Periodical, and Wanfang for randomized controlled trials (RCTs) published from inception to May 24, 2021. Interventions are as follows: SFC vs. MON, or combination of MFC, with no limitation of dosage or duration. Primary and secondary outcome measures were as follows: the primary outcome of interest was the risk of asthma exacerbation. Secondary outcomes included risk of hospitalization, pulmonary function, asthma control level, quality of life, and adverse events (AEs). A random-effects (I2 ≥ 50%) or fixed-effects model (I2 < 50%) was used to calculate pooled effect estimates, comparing the outcomes between the intervention and control groups where feasible.
RESULTS:
Of the 1006 articles identified, 21 studies met the inclusion criteria with 2643 individuals; two were at low risk of bias. As no primary outcomes were similar after an identical treatment duration in the included studies, meta-analysis could not be performed. However, more studies favored SFC, instead of MON, owing to a lower risk of asthma exacerbation in the SFC group. As for secondary outcome, SFC showed a significant improvement of peak expiratory flow (PEF)%pred after 4 weeks compared with MFC (mean difference [MD]: 5.45; 95% confidence interval [CI]: 1.57-9.34; I2 = 95%; P = 0.006). As for asthma control level, SFC also showed a higher full-controlled level (risk ratio [RR]: 1.51; 95% CI: 1.24-1.85; I2 = 0; P < 0.001) and higher childhood asthma control test score after 4 weeks of treatment (MD: 2.30; 95% CI: 1.39-3.21; I2 = 72%; P < 0.001) compared with MFC.
CONCLUSIONS:
SFC may be more effective than MFC for the treatment of asthma in children and adolescents, especially in improving asthma control level. However, there is insufficient evidence to make firm conclusive statements on the use of SFC or MON in children and adolescents aged 4 to 18 years with asthma. Further research is needed, particularly a combination of good-quality long-term prospective studies and well-designed RCTs.
PROSPERO REGISTRATION NUMBER
CRD42019133156.
Acetates
;
Administration, Inhalation
;
Adolescent
;
Adrenal Cortex Hormones/therapeutic use*
;
Albuterol/therapeutic use*
;
Anti-Asthmatic Agents/therapeutic use*
;
Asthma/drug therapy*
;
Child
;
Cyclopropanes
;
Drug Therapy, Combination
;
Fluticasone/therapeutic use*
;
Humans
;
Quinolines
;
Salmeterol Xinafoate/therapeutic use*
;
Sulfides
2.Effects of inhaled short-acting bronchodilators on diaphragm function and neural respiratory drive during maximal isocapnic ventilation in patients with chronic obstructive pulmonary disease.
Yun LI ; Yin-Huan LI ; Yu-Wen LUO ; Rui XIAO ; Jin-Lun HUANG ; Kai WANG ; Xin CHEN
Journal of Southern Medical University 2016;36(2):232-237
OBJECTIVETo investigate the effects of inhaled short-acting bronchodilators on diaphragm function and neural respiratory drive in patients with chronic obstructive pulmonary disease (COPD) during maximal isocapnic ventilation (MIV).
METHODSForty-seven patient with moderate to severe COPD were randomized into 4 groups: placebo group (n=12), salbutamol group (n=13), ipratropium group (n=10), and combined group (salbutamol and ipratropium, n=12). Each subject received an initial MIV for 3 min at baseline and inhaled placebo (400 µg), salbutamol (400 µg), ipratropium (80 µg), or both salbutamol and ipratropium, followed 30 min later by another 3 min of MIV. The parameters of diaphragm function and neural respiratory drive were monitored continuously and calculated during MIV.
RESULTSDuring the initial MIV, all the patients experienced a linear increase in root mean square (RMS) of diaphragm electromyogram with a gradual decrease in transdiaphragmatic pressure (Pdi), minute ventilation (VE), and VE/RMS, and these parameters all improved significantly after inhalation of the bronchodilators. Compared with the placebo group at the same time point, the 3 bronchodilator-treated groups showed significantly decreased RMS and Borg score and increased Pdi, VE and VE/RMS; VE/RMS was the highest in the combined treatment group (P<0.05). The Delta Borg was significantly correlated with Delta Pdi, Delta VE, Delta RMS, and Delta VE/RMS (P<0.05).
CONCLUSIONSIn COPD patients, inhaled short-acting bronchodilators can alleviate diaphragm fatigue during MIV, increase lung ventilation, reduce neural respiratory drive, and improve neuro-ventilatory coupling to relieve dyspnoea, and the combination of β-2 agonists and anti-muscarinic antagonists produces a stronger efficacy.
Administration, Inhalation ; Albuterol ; therapeutic use ; Bronchodilator Agents ; therapeutic use ; Diaphragm ; drug effects ; Humans ; Ipratropium ; therapeutic use ; Pulmonary Disease, Chronic Obstructive ; drug therapy ; Respiration
3.Heliox as a driving gas to atomize inhaled drugs on acute exacerbation of chronic obstructive pulmonary disease: a prospective clinical study.
Yongjiu XIAO ; Longxiang SU ; Bingchao HAN ; Xin ZHANG ; Lixin XIE
Chinese Medical Journal 2014;127(1):29-35
BACKGROUNDAcute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a common condition, which affects not only the quality of life of patients but also their prognosis. The purpose of this study was to explore the effects of an inhaled salbutamol sulfate solution and an inhalation suspension of the glucocorticoid budesonide that were atomized with heliox to treat patients with AECOPD.
METHODSTwenty-three patients with AECOPD were divided into a treatment group (He/O2 = 70%/30%) and a control group (N2/O2 = 70%/30%). The salbutamol sulfate and budesonide were administered by inhalation twice a day for 7 days. Vital signs, arterial blood gas levels, pulmonary function and the levels of serum myostatin (sMSTN) were measured and lung vibration imaging was performed.
RESULTSWe found that the PaO2 and PaCO2 values were not significantly different between the two groups at the various time points (P > 0.05). There were also no significant differences in any of the parameters of pulmonary function between the two groups. However, after baseline correction, the increase rate of the forced expiratory volume in one second (FEV1), the forced vital capacity (FVC), and the maximum minute ventilation (MVV) appeared to be significantly increased at some time points compared with the baseline (before treatment) in both groups (P < 0.05). Although the values of quantitative lung distribution (QLD) for different regions and the levels of sMSTN were slightly different between the two groups, the repeated measures analysis of variance (ANOVA) revealed that there were no significant differences between the two groups or within any group (P > 0.05).
CONCLUSIONAlthough the use of heliox as a driving gas can improve symptoms and benefit patients with AECOPD, the heliox treatment group did not have significant differences in arterial blood gases, lung function, lung vibration response imaging or the levels of sMSTN compared with the control group. (Chinese Clinical Trial Register Center ChiCTRTRC-00000273).
Administration, Inhalation ; Aged ; Albuterol ; administration & dosage ; therapeutic use ; Budesonide ; administration & dosage ; therapeutic use ; Drug Interactions ; Female ; Helium ; administration & dosage ; therapeutic use ; Humans ; Male ; Middle Aged ; Oxygen ; administration & dosage ; therapeutic use ; Prospective Studies ; Pulmonary Disease, Chronic Obstructive ; drug therapy
4.Efficacy on chronic obstructive pulmonary disease at stable stage treated with cutting method and western medication.
Jian-hua XU ; Bin XU ; Yan-qing DENG
Chinese Acupuncture & Moxibustion 2014;34(10):951-955
OBJECTIVETo compare the difference in clinical efficacy on chronic obstructive pulmonary disease (COPD) at stable stage in the patients among the combined therapy of cutting method and western medication (combined therapy), simple cutting method and simple western medication.
METHODSOne hundred and twenty cases of COPD were randomized into three groups, 40 cases in each one. In the cutting method group, for excessive phlegm pattern/syndrome, Feishu (BL 13), Danzhong (CV 17), Dingchuan (EX-B 1) and Yuji (LU 10) were selected as the main acupoints, and Lieque (LU 7) and Pianli (LI 6) were as the supplementary acupoints. For the pattern/syndrome of failure to consolidate kidney primary, Shenshu (BL 23), Pishu (BL 20), Guanyuan (CV 4) and Yuji (LU 10) were selected as main acupoints, and Jueyinshu (BL 14) and Zusanli (ST 36) were as the supplementary acupoint. Three acupoints were selected alternatively in each treatment and the cutting method was applied once every 10 days. Three treatments made one session. Two sessions of treatment were required. In the western medication group, salbutamol sulfate aerosol, one press (200 μg/press) was used each night, as well as salmeterol xinafoate and fluticasone propionate powder for inhalation, one inhalation each night. The treatment of 1 month made one session. Two sessions were required. In the combined therapy group, the cutting method and western medication were applied in combination. The results of clinical symptom score, lung function test, arterial blood gas analysis, degree of inflation as well as clinical efficacy were observed before and after treatment in each group.
RESULTSExcept the degree of lung inflation, the clinical symptom score, indices of lung function test, partial pressure of arterial blood gas (PaO2) and partial pressure of carbon dioxide (PaCO2) were all obviously improved after treatment as compared with those before treatment in each group (all P<0.05). They were apparently improved after treatment in the combined therapy group and the cutting method group as compared with those in the western medication group (all P<0.05). The total effective rate was 77.5% (31/40) in the combined therapy group and was 75.0% (30/40) in the cutting method group, both better than 60.0% (24/40) in the western medication group (both P<0.05).
CONCLUSIONThe simple cutting method based on syndrome differentiation and the combined therapy with western medication achieve the superior efficacy on COPD at stable stage as compared with the simple western medication. The effect mechanism is possibly related to the improvement of bronchial airway function through constant acupoint stimulation.
Acupuncture Points ; Acupuncture Therapy ; Aged ; Albuterol ; administration & dosage ; analogs & derivatives ; Androstadienes ; administration & dosage ; Combined Modality Therapy ; Female ; Fluticasone ; Humans ; Lung ; physiopathology ; Male ; Middle Aged ; Pulmonary Disease, Chronic Obstructive ; drug therapy ; physiopathology ; therapy ; Salmeterol Xinafoate ; Treatment Outcome
5.Efficacy and safety of tulobuterol patch versus oral salbutamol sulfate in children with mild or moderate acute attack of bronchial asthma: a comparative study.
Qian LIN ; Quan-Hua LIU ; Yi-Xiao BAO
Chinese Journal of Contemporary Pediatrics 2013;15(6):462-465
OBJECTIVETo compare tulobuterol patch and oral salbutamol sulfate in terms of efficacy and safety in children with mild or moderate acute attack of bronchial asthma.
METHODSA total of 92 children with mild and moderate acute asthmatic attack were randomly divided into salbutamol group (n=46) and tulobuterol group (n=46). Both groups received routine treatment with antihistamine, selective leukotriene receptor antagonist and glucocorticoid. In addition, the salbutamol group was given slow-release capsules of salbutamol sulfate, and the tulobuterol group was treated with tulobuterol patch. The two groups were compared with respect to symptom scores of cough, wheeze, respiratory rate, wheezing sound, three depression sign and peak expiratory flow, as well as adverse events.
RESULTSAs the treatment proceeded, symptom scores decreased in both groups; on the third day of treatment, all symptom scores except cough score showed a significant decrease in both groups (P<0.05), but the tulobuterol group had significantly lower symptom scores than the salbutamol group (P<0.05). On the fourteenth day of treatment, both groups had a significant decrease in cough score (P<0.05), but the tulobuterol group had a significantly lower cough score than the salbutamol group (P<0.05). One child developed hand trembling in the salbutamol group, while no adverse event occurred in the tulobuterol group.
CONCLUSIONSCompared with oral salbutamol sulfate, tulobuterol patch has a better therapeutic efficacy and a higher safety in children with mild or moderate acute asthmatic attack.
Acute Disease ; Administration, Oral ; Adrenergic beta-2 Receptor Agonists ; therapeutic use ; Albuterol ; administration & dosage ; adverse effects ; therapeutic use ; Asthma ; drug therapy ; Female ; Humans ; Terbutaline ; administration & dosage ; adverse effects ; analogs & derivatives ; therapeutic use
6.Clinical significance of bronchial reversibility test in the treatment of childhood asthma.
Yun LI ; Dan LIU ; Hong-Ling YI ; Chun GUO ; Min CHEN ; Wen-Kai LI
Chinese Journal of Contemporary Pediatrics 2013;15(2):105-108
OBJECTIVETo observe changes in the lung function of asthmatic children with different symptoms during treatment, and to investigate the clinical significance of bronchial reversibility test in the treatment of asthma in children.
METHODSA total of 417 asthmatic children were treated by salmeterol/fluticasone inhalation for more than 3 months. These patients were divided into asymptomatic, single cough, paroxysmal cough and wheeze (cough+wheeze or wheeze alone) groups based on the symptoms when they revisited the clinic. Thirty-four healthy children were used as a control group. All children underwent bronchial reversibility test using nebulized salbutamol. Lung function testing was performed before and after the test.
RESULTSAfter nebulization of salbutamol, each asthma group showed significantly decreased rate of abnormal lung function and significantly increased forced expiratory volume in one second percent (FEV1%) predicted (P<0.05). Before salbutamol nebulization, the single cough, paroxysmal cough and wheeze groups had significantly higher rates of abnormal lung function and significantly lower FEV1% predicted than the control group (P<0.05). There were significant differences in the rate of abnormal lung function and FEV1% predicted among the asthma groups (P<0.05). After salbutamol nebulization, the paroxysmal cough and wheeze groups had significantly higher rates of abnormal lung function than the control group (P<0.05), but there were no significant differences between other asthma and control groups; the wheeze group had significantly lower FEV1% predicted than the control group, but no significant differences were found between other asthma and the control groups. The positive rate of bronchial reversibility test in each asthma group was significantly higher than in the control group (P<0.05). There were significant differences in the positive rate of the test between the asthma groups except between the asymptomatic and single cough groups (P<0.05).
CONCLUSIONSAsthmatic children with different symptoms demonstrate different lung functions during treatment. Bronchial reversibility test combined with lung function test is useful in assessing asthma control and guiding treatment.
Administration, Inhalation ; Adolescent ; Albuterol ; administration & dosage ; adverse effects ; analogs & derivatives ; Androstadienes ; administration & dosage ; adverse effects ; Asthma ; drug therapy ; physiopathology ; Bronchi ; physiopathology ; Child ; Drug Combinations ; Female ; Fluticasone-Salmeterol Drug Combination ; Forced Expiratory Volume ; Humans ; Lung ; physiopathology ; Male
7.Observation on the effects of the treatment of sillicosis merger asthma.
Xian-hui WU ; Cuang CAI ; Jian-pu XU ; Chu-hui RU ; Fei HE
Chinese Journal of Industrial Hygiene and Occupational Diseases 2013;31(5):386-388
OBJECTIVETo investigate Salmeterol/Fluticasone Propionate and Totropiumi treatment of Sillicosis merger Asthma.
METHODS30 patients with Sillicosis merger Asthma were randomly divided into group Salmeterol/Fluticasone Propionate( Single group) ( n=14) and group Salmeterol/Fluticasone Propionate and Totropiumi (Joint group) ( n= 16), patient in single group were only given Salmeterol/Fluticasone Propionate (50 f.Lg Bid) inhaling,and those in Joint group were given Salmeterol/Fluticasone Propionate (50 f.Lg Bid) and Totropiumi ( 18 f.Lg Qd) inhaling. The treatment was last for 6 months.Before the treatment,evaluation of the two groups of Sillicosis installment,determination their foungation lung function and ACT score .. After the cause of treatment, lung function FEV10/FVC(% ), FEV10 pred%, FEV10(ml), ACT score, the incidence of side effects of two groups were compared and analyzed.
RESULTThe two groups before the treatment of lung fuction and ACT score had no statistically significant difference. The two groups after treatment of lung fuction FEV10/FVC (% ),FEV10 pred%, ACT score obviously higher than before treatment (P<0.05), Joint group in FEV1/FVC(% ), ACT score significantly higher than in Single group (?<0.05), Joint group acute attack times(0.98±0.79)/time lower than Single group (2.10 ± 0.81 )/time (t=3.86,P<0.05). There were no significant side effect in two groups.
CONCLUSIONSalmeterol/Fluticasone Propionate or the combination of Salmeterol/Fluticasone Propionate and Totropiumi can improve lung function and clinical symptoms of patients with Sillicosis merger Asthma. It is also better that the combination of Salmeterol/Fluticasone Propionate and Totropiumi obviously improve clinical symptoms of patients and reduice acute attack times.
Administration, Inhalation ; Adult ; Albuterol ; analogs & derivatives ; therapeutic use ; Androstadienes ; therapeutic use ; Asthma ; complications ; drug therapy ; Drug Combinations ; Female ; Fluticasone-Salmeterol Drug Combination ; Humans ; Male ; Middle Aged ; Silicosis ; complications ; drug therapy ; Treatment Outcome
8.Therapeutic efficacy of salbutamol and dexamethasone added into whole lung lavage fluid in patients with pneumoconiosis.
Jian-yong ZHU ; Yu-qin ZENG ; Gong CHEN ; Jun KUANG ; Li-bo ZHANG ; Yong-lan WANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2013;31(5):383-385
OBJECTIVETo investigate the therapeutic efficacy and safety of salbutamol and dexamethasone added into large-volume whole lung lavage (WLL) fluid in patients with pneumoconiosis.
METHODSA total of 176 patients with pneumoconiosis were randomly divided into control group (n=86) and treatment group (n=90). The control group received WLL with 0.9% sodium chloride solution, while for the treatment group, salbutamol and dexamethasone were added into the WLL fluid for both lungs at the 1st and 4th WLLs.Before and after WLL, the pulmonary wheezing, arterial partial pressure of oxygen (Pa02), peak airway pressure(Pa peak), amount of intrapulmonary residual fluid, forced expiratory volume in one second (FEVw) (72 h later),diffusion capacity for carbon monoxide (DLCO ), and forced vital capacity (FVC) were measured for comparison between the two groups.
RESULTSAfter WLL, the treatment group had a significantly lower detection rate of pulmonary wheezing than the control group ( 13.3% vs 29.1 %, x2=5.028, ?=0.025), and the control group had a significantly higher incidence rate of pulmonary wheezing than the treatment group (21.8% vs 3.7%, 0R=5.423,95%CI 2.036-9.568 ). Compared with the control group, the treatment group had significantly higher Pa02 and significantly lower Pa peak and amount of intrapulmonary residual fluid (t =2.163 -4.132, P<0.05) and significantly higher FEV1, DLCO, and FVC (t=1.986-2.345, P<0.05) after WLL.
CONCLUSIONSalbutamol and dexamethasone added into large-volume WLL fluid may effectively alleviate bronchial spasm, reduce hypoxemia, and decrease Pa peak in patients with pneumoconiosis, thus promoting lung function recovery after WLL.
Adult ; Albuterol ; administration & dosage ; Bronchoalveolar Lavage ; Bronchoalveolar Lavage Fluid ; Dexamethasone ; administration & dosage ; Humans ; Male ; Middle Aged ; Pneumoconiosis ; therapy ; Young Adult
9.Redistributed Regional Ventilation after the Administration of a Bronchodilator Demonstrated on Xenon-Inhaled Dual-Energy CT in a Patient with Asthma.
Korean Journal of Radiology 2011;12(3):386-389
We report here on the redistributed regional ventilation abnormalities after the administration of a bronchodilator and as seen on xenon-inhaled dual-energy CT in a patient with asthma. The improved ventilation seen in the right lower lobe and the decreased ventilation seen in the right middle lobe after the administration of a bronchodilator on xenon-inhaled dual-energy CT could explain a positive bronchodilator response on a pulmonary function test. These changes may reflect the heterogeneity of the airway responsiveness to a bronchodilator in patients with asthma.
Albuterol/*administration & dosage
;
Asthma/*physiopathology/*radiography
;
Bronchodilator Agents/*administration & dosage
;
Child
;
Female
;
Humans
;
Pulmonary Ventilation
;
Radiation Dosage
;
Tomography, X-Ray Computed/*methods
;
Xenon/diagnostic use
10.Isobutane driven salbutamol sulfate metered dose inhaler: formulation selection and respiratory tract absorption in guinea pigs.
Acta Pharmaceutica Sinica 2009;44(9):1040-1045
This paper is to study the iso-butane (A-31)-driven salbutamol sulfate (SS) metered dose inhaler (MDI) formulations and inhaling status in guinea pigs. Solubility determination and orthogonal design were used to screen non-chlorofluorocarbon (CFC) SS MDI formulations. Intubation inhalation of MDI in guinea pigs was used as a main administration method. Fluorescence HPLC detection method was testified as a potential method in assaying the concentration of SS in plasma of guinea pigs after inhaling various SS MDI formulations. Analysis of the data was executed with statistical moment calculation from which pharmacokinetic parameters were obtained. The results show that A-31 based on SS MDI formulations were screened and the guinea pigs in vivo determination method after inhaling SS MDI was established. The zero-moment rations of SS/A-31 MDI formulation to contrast sample and CFC SS MDI was 143.26% and 147.01%, respectively. The first moment value of SS/A-31 MDI formulation was the highest. It is a preliminary conclusion that the absorption result of SS/A-31 MDI formulation inhaled by guinea pigs is equivalent to HFA-134a formulation in sale and better than CFC formulation. A-31 could be used as a potential substitute candidate for CFC MDI propellant.
Administration, Inhalation
;
Aerosol Propellants
;
Albuterol
;
administration & dosage
;
pharmacokinetics
;
Animals
;
Butanes
;
adverse effects
;
pharmacokinetics
;
Female
;
Guinea Pigs
;
Male
;
Metered Dose Inhalers
;
Respiratory System
;
metabolism

Result Analysis
Print
Save
E-mail