OBJECTIVES: To investigate the clinical efficacy and safety of salbutamol in the treatment of children with later-onset spinal muscular atrophy (SMA). METHODS: This study is a prospective single-arm phase Ⅲ clinical study. Pediatric patients with SMA type Ⅱ and Ⅲ who visited Department of Neurology, Children's Hospital, Zhejiang University School of Medicine from December 2020 to June 2022 were enrolled. All patients were evaluated with motor function scales, pulmonary function test and drug safety before study. Patients were treated with salbutamol tablets orally, with an initial dose of 1 mg (tid). If tolerable, the dose was increased to 1.5 mg (tid) in the second week, then increased to 2 mg (tid) from the third week and maintained for 6 months. Patients were followed up at 1, 3 and 6 months of treatment. RESULTS: Twenty-six patients were enrolled, including 10 boys and 16 girls. There were 16 cases of SMA type Ⅱ and 10 cases of type Ⅲ with age at treatment initiation of 5.67 (3.13, 7.02) years and disease duration of 2.54 (1.31, 4.71) years. The Hammersmith Functional Motor Scale-Expanded (HFMSE) scores were increased from 14.0 (6.5, 43.0) before treatment to 26.0 (15.0, 46.5) after treatment (Z=－4.144, P<0.01) in 25 cases. The Revised Upper Limb Module Scale scores were increased from 33.0 (25.5, 36.0) before treatment to 35.0 (31.0, 36.5) after treatment (Z=－2.214, P<0.05) in 9 cases. In 7 ambulant children with SMA type Ⅲ, the six minutes walking distance was increased by 30 (15, 52) m after a 6-month treatment (Z=－2.366, P<0.05). Compared with the baseline pulmonary functions the patients showed a significant increase in forced vital capacity (FVC), forced expiratory volume in one second (FEV₁), and peak expiratory flow (PEF) in 15 cases after treatment (all P<0.05). According to patients and caregivers subjective reporting, there were various degrees of improvement in coughing, sputum production ability and exercise endurance. No serious adverse events were observed during the study. CONCLUSIONS Short-term oral administration of salbutamol may improve motor and pulmonary functions in later-onset SMA children with good safety.
Male ; Female ; Humans ; Child ; Albuterol/therapeutic use* ; Prospective Studies ; Muscular Atrophy, Spinal/drug therapy* ; Spinal Muscular Atrophies of Childhood/drug therapy* ; Treatment Outcome

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

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

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

BACKGROUNDThe interleukin (IL)-32/tumor necrosis factor (TNF) a pathway is supposed to play a key role in the amplification of the immune response in chronic obstructive pulmonary disease (COPD) inflammation. Inhaled corticosteroids (ICS) in combination with long-acting β2-agonists (LABA) have shown airway anti-inflammatory effects in recent studies, but the mechanism is still uncertain.

METHODSPatients were treated in a randomized, open-labeled, parallel group clinical trial with either a combination of salmeterol xinafoate/fluticasone propionate (SF; Seretide, GlaxoSmithKline) Diskus (50/500 µg twice daily) or ipratropium bromide/salbutamol (IS; Combivent, Boehringer Ingelheim) MDI (42 µg/240 µg quartic daily) for 12 weeks. At the start and the end of treatment, induced sputum was collected and the concentration of IL-32 and TNF-α, the number of neutrophils and eosinophils were measured.

RESULTSFollowing 12 weeks of treatment, a statistically significant fall from baseline in the concentration of TNF-α in sputum (P = 0.004) was seen after treatment with SF but not with IS. However, neither treatment had significant effects on the concentration of IL-32 in sputum. There was a decrease from baseline in the number of sputum neutrophils with SF that approached statistical significance (P = 0.028) but not with IS, while the number of sputum eosinophils did not change significantly from baseline in either treatment group. There was a statistically significant decline from baseline in the quality of life as assessed by the St George's respiratory questionnaire in both the SF (P = 0.004) and IS (P = 0.030) treatment groups, but no evidence of improvement in lung function was observed in either group.

CONCLUSIONThe sputum TNF-α and neutrophils, but not IL-32 and macrophages, could be reduced by ICS/LABA treatment, suggesting that IL-32 could be involved in the corticosteroid resistance of COPD inflammation.

Adult ; Aged ; Aged, 80 and over ; Albuterol ; analogs & derivatives ; therapeutic use ; Androstadienes ; therapeutic use ; Anti-Inflammatory Agents ; therapeutic use ; Drug Combinations ; Female ; Fluticasone-Salmeterol Drug Combination ; Humans ; Interleukins ; metabolism ; Male ; Middle Aged ; Pulmonary Disease, Chronic Obstructive ; drug therapy ; metabolism

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

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

OBJECTIVETo observe the difference in the efficacy on the symptoms of bronchial asthma at the chronic persistent stage between acupoint heat-sensitive moxibustion and western medicine with Seretide.

METHODSSixty-four cases were randomly divided into a heat-sensitive moxibustion group (32 cases) and a western medication group (32 cases). In the heat-sensitive moxibustion group, the sensitized points located between Feishu (BL 13) and Geshu (BL 17) or in the region 6-cun lateral from the 1st and the 2nd intercostal spaces of the chest were selected. The heat-sensitive moxibustion was adopted, continuously for 8 days, once per day. In the later 22 days of the 1st month, 12 treatments should be ensured. Two months later, 15 treatments should be guaranteed each month. The time of each treatment was 30 to 90 min. Totally 50 treatments were required. In the western medication group, Seretide inhaler was adopted, one inhalation each time, twice per day, for 3 months totally. The asthmatic symptoms were scored for the patients in two groups and the comparison was made between the two groups.

RESULTSAfter 3 months of treatment, the asthmatic symptom scores were all improved for the patients in the heat-sensitive moxibustion group and the western medication group as compared with those before treatment (both P < 0.05). In 6 months of follow-up visit, the asthmatic symptom scores in the heat-sensitive moxibustion group were stable, but those in the western medication group were reduced, there was significant difference between the two groups (P < 0.05).

CONCLUSIONThe acupoint heat-sensitive moxibustion effectively relieves the clinical symptoms for the patients with bronchial asthma at the chronic persistent stage. Its efficacy is similar to that of Seretide inhaler. But the long-term efficacy of the heat-sensitive moxibustion is much better.

Acupuncture Points ; Adolescent ; Adult ; Albuterol ; analogs & derivatives ; therapeutic use ; Androstadienes ; therapeutic use ; Asthma ; therapy ; Chronic Disease ; Drug Combinations ; Female ; Fluticasone-Salmeterol Drug Combination ; Humans ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Moxibustion ; methods

Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease and responses to therapies are highly variable. The aim of this study was to identify the predictors of pulmonary function response to 3 months of treatment with salmeterol/fluticasone in patients with COPD. A total of 127 patients with stable COPD from the Korean Obstructive Lung Disease (KOLD) Cohort, which were prospectively recruited from June 2005 to September 2009, were analyzed retrospectively. The prediction models for the FEV1, FVC and IC/TLC changes after 3 months of treatment with salmeterol/fluticasone were constructed by using multiple, stepwise, linear regression analysis. The prediction model for the FEV1 change after 3 months of treatment included wheezing history, pre-bronchodilator FEV1, post-bronchodilator FEV1 change and emphysema extent on CT (R = 0.578). The prediction models for the FVC change after 3 months of treatment included pre-bronchodilator FVC, post-bronchodilator FVC change (R = 0.533), and those of IC/ TLC change after 3 months of treatment did pre-bronchodilator IC/TLC and post-bronchodilator FEV1 change (R = 0.401). Wheezing history, pre-bronchodilator pulmonary function, bronchodilator responsiveness, and emphysema extent may be used for predicting the pulmonary function response to 3 months of treatment with salmeterol/fluticasone in patients with COPD.
Aged ; Albuterol/*analogs & derivatives/therapeutic use ; Androstadienes/*therapeutic use ; Bronchodilator Agents/*therapeutic use ; Emphysema ; Female ; Humans ; Linear Models ; Lung/physiopathology ; Male ; Middle Aged ; Prognosis ; Pulmonary Disease, Chronic Obstructive/*drug therapy ; Republic of Korea ; Respiratory Function Tests ; Retrospective Studies ; Tomography Scanners, X-Ray Computed ; Treatment Outcome

BACKGROUNDEvidence suggests that systemic inflammation may play an important role in the progression and morbidity of chronic obstructive pulmonary disease. It remains controversial whether inhaled corticosteroid in combination with a long-acting beta(2)-adrenoceptor agonist can attenuate systemic inflammation. We evaluated the effect of salmeterol/fluticasone propionate on circulating C-reactive protein level in stable chronic obstructive pulmonary disease patients.

METHODSAn open-label clinical trial was conducted to recruit 122 outpatients with stable moderate-to-severe chronic obstructive pulmonary disease from department of respiratory medicine in two teaching hospitals between June 2007 and March 2008. Patients were randomized into two groups (1:1) to receive either the combination of 50 microg salmeterol and 500 microg fluticasone twice daily (n = 61), or the combination of 206 microg albuterol and 36 microg ipratropium q.i.d (n = 61) over 6 months. Circulating C-reactive protein concentrations were measured before randomization and during the follow-up. The efficacy of treatment was also assessed by spirometry, as well as health status and dyspnea score at baseline and after 6-month treatment.

RESULTSBaseline characteristics of two groups were similar. Compared with ipratropium/albuterol, the combination of salmeterol/fluticasone significantly reduced circulating level of C-reactive protein (-1.73 vs. 0.08 mg/L, respectively, P < 0.05) after 6-month treatment. Forced expiratory volume in one second (FEV(1)) and health status also improved significantly in salmeterol/fluticasone group compared with ipratropium/albuterol. Salmeterol/fluticasone treatment subjects who had a decrease of circulating C-reactive protein level had a significant improvement in FEV(1) and St George's Respiratory Questionnaire total scores compared with those who did not (185 vs. 83 ml and -5.71 vs. -1.79 units, respectively, both P < 0.01).

CONCLUSIONSalmeterol/fluticasone treatment reduced circulating C-reactive protein concentration in clinically stable moderate-to-severe chronic obstructive pulmonary disease patients after 6-month treatment.

Albuterol ; analogs & derivatives ; therapeutic use ; Androstadienes ; therapeutic use ; C-Reactive Protein ; metabolism ; Female ; Fluticasone ; Humans ; Male ; Middle Aged ; Pulmonary Disease, Chronic Obstructive ; drug therapy ; metabolism ; Salmeterol Xinafoate ; Treatment Outcome