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ABSTRACT Objective: Ethyl alcohol (EA) is a substance that is used commonly worldwide and known to have toxic effects on the liver. The aim of this study was to investigate the effect of montelukast sodium (MK) on acute hepatopathy induced by a single dose of EA in rats. Methods: The study consisted of four groups each containing eight Wistar albino male rats. The groups were classified as follows: the control group received distilled water; the EA group received 6 g/kg EA diluted with distilled water orally by gavage; the MK group received 30 mg/kg MK orally by gavage; the EA + MK group received, 2 hours after the EA administration, ie 30 mg/kg MK orally by gavage. After 24 hours, all the rats were sacrificed, and their blood and liver tissue samples were taken for biochemical and histopathological examinations. Results: The administration of EA caused a statistically significant increase in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels compared with the control group (220.50 ± 66.90 and 92.38 ± 5.90 versus 84.88 ± 15.66 and 43.75 ± 10.22). The administration of EA + MK caused a statistically significant decrease in the AST and ALT levels compared with the EA alone group. Ethyl alcohol administered to the rats caused lesion in the liver including congestions, hydropic degeneration and irregular shaped area caused coagulation necrosis. The histopathological changes seen in the EA group were not detected in the EA + MK group. Conclusion: Consequently, these data suggested that MK had beneficial effects in alleviating EA-induced hepatotoxicity in rats.
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Objective:To evaluate the efficacy of Jiedu-Huaban Decoction combined with montelukast sodium chewable tablets in the treatment of children with henoch schonlein purpura (HSP). Methods:A total of 80 children with HSP and blood heat syndrome who met the inclusion criteria, from January 2017 to December 2019, were randomly divided into two groups by random number table method, 40 in each group. The control group took montelukast sodium chewable tablets at night, and the study group took Jiedu-Huaban Decoction on the basis of the control group. Both groups were treated for 2 weeks. The disappearance time of gastrointestinal disease, skin purpura, kidney disease, joint swelling and pain were observed. The improvement score of skin purpura was evaluated before and after treatment. The serum levels of IL-6, IL-4, interferon-γ (IFN-γ) and TNF-α were detected by ELISA, and the levels of IgG, IgA and IgM. The T lymphocyte subsets (CD4 + and CD8 +) were measured by nephelometry, and the CD4 +/CD8 +values were calculated. The clinical efficacy was evaluated. Results:The total effective rate was 87.5% (35/40) in the study group and 67.5% (27/40) in the control group, with significant difference between the two groups ( χ2 =4.588, P=0.032). The disappearance time of gastrointestinal disease, skin purpura, kidney disease and joint swelling and pain in the study group were significantly earlier than those in the control group ( t=7.802, 12.167, 7.309, 9.365, all Ps<0.001). After treatment, the serum levels of IL-6, IL-4, IFN-γ and TNF-α in the study group were significantly lower than those in the control group ( t=9.319, 6.738, 8.221, 6.553, all Ps<0.001). The improvement score of skin purpura at 1 week after treatment (2.75 ± 0.69 vs. 3.92 ± 0.83, t=6.856) and 2 weeks after treatment (0.41 ± 0.15 vs. 1.55 ± 0.37, t=18.095) in the study group were significantly lower than those in the control group ( P<0.01). After treatment, the level of IgG, CD4 +, CD4 +/CD8 + in the study group were significantly higher than those in the control group ( t=5.160, 4.558, 3.442, all Ps<0.01), the level of IgA, IgM, CD8 + in the study group were significantly lower than those in the control group ( t=2.614, 6.712, 5.468, all Ps< 0.05). During the treatment, the incidence of adverse reactions in the control group was 17.5% (7/40), and that of the study group was 15.0% (6/40), wherer there was no statistical difference between the two groups ( χ2=0.092, P=0.762). Conclusion:Jiedu-Huaban Decoction combined with montelukast sodium chewable tablets can improve the clinical symptoms of children with HSP and blood heat syndrome, reduce the body inflammatory reaction, improve immunity, with good safety.
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Montelukast sodium is an effective and well-tolerated anti-asthmatic drug. Long non-coding RNAs (lncRNAs) are involved in the treatment of asthma. Therefore, this study aimed to investigate the effect of montelukast sodium on children with cough-variant asthma (CVA) and the role of lncRNA prostate cancer gene expression marker 1 (PCGEM1) in drug efficacy. The efficacy of montelukast sodium was evaluated by assessing the release of inflammatory factors and pulmonary function in CVA children after a 3-month treatment. An ovalbumin (OVA)-sensitized mouse model was developed to simulate asthmatic conditions. PCGEM1 expression in clinical peripheral blood samples and lung tissues of asthmatic mice was determined. Asthmatic mice experienced nasal inhalation of PCGEM1 overexpression with simultaneous montelukast sodium to investigate the roles of PCGEM1 in asthma treatment. The NF-κB axis after PCGEM1 overexpression was detected to explore the underling mechanisms. Consequently, montelukast sodium contributed to reduced levels of pro-inflammatory factors and improved pulmonary function in CVA children. PCGEM1 was poorly expressed in OVA-sensitized asthmatic mice and highly expressed in CVA children with response to the treatment. PCGEM1 overexpression enhanced the anti-inflammatory effects and promoted effects on pulmonary function of montelukast sodium in CVA children and OVA-sensitized asthmatic mice. Furthermore, PCGEM1 inhibited the activation of the NF-κB axis. This study demonstrated the anti-inflammatory and lung-protective effects of montelukast sodium on CVA, which was strengthened by overexpression of PCGEM1. Findings in this study highlighted a potential anti-asthmatic target of montelukast sodium.
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Quinolines/therapeutic use , Asthma/drug therapy , Anti-Asthmatic Agents/therapeutic use , Protective Agents/therapeutic use , Cough/drug therapy , RNA, Long Noncoding/metabolism , Acetates/therapeutic use , Asthma/blood , Cough/blood , Disease Models, Animal , Mice, Inbred BALB CABSTRACT
OBJECTIVE: To investigate the taste-masking effect of montelukast sodium orally disintegrating tablets using electronic tongue technology and human sensory evaluation and determine the optimum formulation. METHODS: Orally disintegrating tablets were prepared with five different concentrations of flavoring agents or without flavoring agent.The tastes of those tablets were determined by electronic tongue, and principal component analysis and linear discriminant analysis were used to evaluate differences of different formulations. The taste-masking effect of the tablets was investigated combined with electronic tongue analysis and sensory evaluation of subjects. RESULTS: The taste of orally disintegrating tablet was the best when the total amount of flavoring agent was 1.6 mg, and the ratio of sweetening agent to aromatic agent was 5∶3. CONCLUSION: The combination of electronic tongue and human sensory assess can evaluate the taste-masking effect of orally disintegrating tablets and provide the basis for determining the optimum formulation.
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OBJECTIVE：To study the effects of montelu kast sodium in the treatme nt of pertussis in children. METHODS ：A total of 160 children aged 6 months-6 years with pertussis admitted to our hospital from Jan. 2017 to Jul. 2018 were randomly divided into control group and observation group ，with 80 cases in each group. Control group received routine treatment such as antibiotics. Observation group was additionally given Montelukast sodium granule or chewable tablets orally （granule for age below 2 years old ，taking with warm water ；chewable tablets for age more than 2 years old ），4 mg/d，once a night. Treatment course of 2 groups lasted for 2 weeks. The changes of clinical indexes as clinical symptoms ，clinical efficacy ，the occurrence of ADR ，and lab indexes as lung function [VPEF/VE，TPTEF/TE，FEV1，FVC，FEV1/FVC]，T lymphocyte subsets （CD4+，CD8+ and CD 4+/CD8+） level，immunoglobulin（IgE，IgG，IgA）level，serum leukotriene （LTB4，LTC4，LTD4）level were compared between 2 groups. RESULTS：Compared with control group （80.00％），total effective rate rate of observation group （95.00％）was significantly increased（P＜0.05）；the cough time of spasm ，the echo time of cockcrow ，the blue and purple time of face caused by cough ，the time of vomit caused by cough ，the time of lung rale and the time of hospitalization were significantly shorter （P＜0.05）；new respiratory tract infection incidence of observation group was lower than that of control group （P＜0.05）；but there was no significant difference in the incidence of ADR between 2 groups after treatment （P＞0.05）. The levels of VPEF/VE ，TPTEF/TE or FEV1，FVC，FEV1/FVC，the levels of peripheral CD 4+ and CD 4+/CD8+，serum levels of IgG and IgA in observation group were significantly increased ，compared with control group ；the level of peripheral CD 8+ and the serum levels of IgE ，LTB4，LTC4 and LTD4 were significantly decreased ，compared with control group （P＜0.05）. CONCLUSIONS ：The addition of montelukast sodium to the routine treatment of pertussis can improve clinical symptoms and lung function of children ，regulate immune function of children and inhibit the release of airway leukotrienes ，which has certain clinical application value.
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Objective To investigate the clinical efficacy of montelukast sodium combined with glucocorti-coids in the treatment of patients with acute asthma attack and its effects on serum inflammatory mediators and humoral immune function.Methods From March 2018 to March 2019,82 patients with acute asthma attack admitted to the First People's Hospital of Wenling were randomly divided into control group (41 cases) and observation group (41 cases) according to random number table method.The control group was treated with glucocorticoid ,while the observation group was treated with montelukast sodium on the basis of the control group.Both two groups were treated for 2 weeks.The therapeutic effect, pulmonary function,main symptom score,inflammatory mediators and humoral immune function before and after treatment were compared between the two groups .Results The total effective rate of the observation group (92.68%) was higher than that of the control group (70.73%) ( χ2 ＝6.609,P＜0.05). After treatment,FEV1%and FEV1／FVC in the observation group were higher than those in the control group ( t＝6.420,12.206,all P＜0.05).After treatment,the scores of asthma,cough and expectoration in the observation group were lower than those in the control group (t＝14.318,7.368,15.653,all P＜0.05).After treatment,the levels of IL-6,IL-17 and IL-33 in the observation group were lower than those in the control group (t＝10.123,10.144, 9.893,all P＜0.05).The levels of serum IgA,IgG and IgM in the observation group were higher than those in the control group (t＝7.695,7.698,7.835,all P＜0.05).Conclusion Montelukast sodium combined with glucocorti-coid has good clinical effect on patients with acute asthma attack.It can alleviate inflammation and improve immune function of patients,which is worthy of clinical reference.
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Objective@#To investigate the clinical efficacy of montelukast sodium combined with glucocorticoids in the treatment of patients with acute asthma attack and its effects on serum inflammatory mediators and humoral immune function.@*Methods@#From March 2018 to March 2019, 82 patients with acute asthma attack admitted to the First People's Hospital of Wenling were randomly divided into control group (41 cases) and observation group (41 cases) according to random number table method.The control group was treated with glucocorticoid, while the observation group was treated with montelukast sodium on the basis of the control group.Both two groups were treated for 2 weeks.The therapeutic effect, pulmonary function, main symptom score, inflammatory mediators and humoral immune function before and after treatment were compared between the two groups.@*Results@#The total effective rate of the observation group (92.68%) was higher than that of the control group (70.73%) (χ2=6.609, P<0.05). After treatment, FEV1% and FEV1/FVC in the observation group were higher than those in the control group (t=6.420, 12.206, all P<0.05). After treatment, the scores of asthma, cough and expectoration in the observation group were lower than those in the control group (t=14.318, 7.368, 15.653, all P<0.05). After treatment, the levels of IL-6, IL-17 and IL-33 in the observation group were lower than those in the control group (t=10.123, 10.144, 9.893, all P<0.05). The levels of serum IgA, IgG and IgM in the observation group were higher than those in the control group (t=7.695, 7.698, 7.835, all P<0.05).@*Conclusion@#Montelukast sodium combined with glucocorticoid has good clinical effect on patients with acute asthma attack.It can alleviate inflammation and improve immune function of patients, which is worthy of clinical reference.
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OBJECTIVE: To study the in vitro dissolution and permeation process of montelukast sodium chewable tablets, and establish the in vivo-in vitro correlation models to predict the bioequivalence of the generic preparations. METHODS:The Macro Flux drug dissolution absorption test system was used, and the satiety intestinal simulated liquid ( pH 5. 0) was used as the medium to compare the penetration of the reference preparation and test preparation. The rate, release and absorption process of the drug were examined by the quality parameters, and the bioavailability of the test preparation was predicted, thereby predicting whether the preparation was bioequivalent. RESULTS: In the satiety small intestine simulating solution, the permeation rate, ρmax and AUC0-t of the test preparation and the reference preparation were basically the same. The bioavailability was approximately 97% of the reference formulation. CONCLUSION: It is preliminarily predicted that the test preparation of montelukast sodium chewable tablets is bioequivalent with the reference preparation.
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@#The aim of this paper was to study the species and sources of related substances in montelukast sodium granules based on HPLC-MS/MS. The related substances of the already marketed montelukast sodium granules(Singulair, 4 mg)were firstly separated and identified by HPLC-MS/MS method, and their chemical structures and sources were confirmed according to the pulished synthesis process and degradation studies. The results revealed that there were 7 related substances, whose chemical structures and sources were confirmed based on the MS/MS technique and the related literature. Impurity 7, montelukast quinoline ring oxynitride, had not been reported. This study systematically analyzed the related substances in the commercical product, which provides useful information for the development and quality control of the product.
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Objective To study the efficacy of Liangxue-Zhuyu decoction combined with montelukast in the treatment of henoch schonlein purpura (HSP) and its influence on immunologic function. Methods A total of 95 HSP children treated in department of pediatrics from February 2014 to December 2016 were enrolled, and then were randomly divided into observation group (n=48) and control group (n=47), meanwhile another 48 healthy children admitted to a medical examination were selected as the healthy group. The patients in the control group were given the treatment of oral montelukast sodium chewable tablets before sleeping (the dose:2-6 years old 4 mg/d, 6-14 years old 5 mg/d), and the patients in the observation group accepted the therapy of Liangxue-Zhuyu decoction based on the treatment of the control group.The course of the treatment in the two groups were 30d. The time of clinical symptom regression and adverse reactions were recorded, and the clinical efficacy was evaluated. Monoclonal antibody immunofluorescence method and Enzyme-linked immunosorbent assay (ELISA) were used to detect the levels of serum T lymphocyte subsets and INF-γ and IL-10 before and after treatment, and their differences among three groups were compared. Results The effective rates of the observation group was 95.8% (46/48), which was significantly higher than 76.6% (36/47) of control group (x 2=7.441,P<0.05).The subsided time of the symptoms,including purpura(5.0 ± 1.3 d vs.6.6 ± 2.6 d,t=3.816), abdominal pain(3.1 ± 2.1 d vs.4.1 ± 2.6 d,t=2.139),joint pain(4.3 ± 1.5 d vs.5.4 ± 1.9 d,t=3.416),fecal occult blood(4.5 ± 1.5 d vs.6.1 ± 1.9 d,t=4.404)of the observation group were significantly shorter than those of the control group(P<0.05).After the treatment,the CD4(45.14% ± 9.32% vs.41.02% ± 9.97%),CD8(25.10% ± 4.69% vs.21.52% ± 5.71%)of the observation group was significantly higher than those of the control group, and the CD4/CD8(1.62 ± 0.32 vs.1.95 ± 0.35)and IL-10(33.07 ± 1.86 pg/ml vs.53.92 ± 2.98 pg/ml)of the observation group was significantly lower than this of the control group (P<0.05). Conclusions The efficacy of the Liangxue-Zhuyu decoction combined with montelukast for HSP was definite,and the effect was rapid with little side effects. The mechanism might be related to regulating the secretion of T lymphocyte and IL-10, thereby to correct Th1/Th2 cell balance and disturbance of immune function.
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OBJECTIVE: To prepare montelukast sodium orally disintegrating tablets and investigate the bioequivalence in Beagle dogs. METHODS: The orally disintegrating tablets were prepared by direct compression method,and the optimal formulation was screened by orthogonal test.HPLC-fluorescence method was developed for determination of montelukast sodium plasma concentration in Beagle dogs. RESULTS: The optimized formulation(1 000 tablets) was montelukast sodium 10.4 g, microcrystalline cellulose 60 g, cross linked povidone 30 g, mannitol 15 g, magnesium stearate 2 g, aerosil 1 g, aspartame 1 g, flavor 0.6 g. CONCLUSION: Montelukast sodium orally disintegrating tablets made of the optimized formulation could disintegrate rapidly. Relatively bioavailability of montelukast sodium orally disintegrating tablets is 90.7%.
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Objective To investigate the application value of montelukast in patients with stable chronic obstructive pulmonary disease (COPD).Methods 64 patients with stable COPD in Jinqiu Hospital of Liaoning Province from December 2015 to December 2016 were randomly divided into observation group and control group according to the digital table,32 cases in each group.The two groups were given routine treatment,including cough,phlegm,oxygen therapy,smoking cessation,rehabilitation treatment,regular use of long-acting bronchodilators,on this basis,the observation group was treated with montelukast sodium.After 12 weeks of treatment,the patients were assessed for airway improvement and quality of life before and after treatment,and recorded the two groups of acute exacerbation and adverse drug reactions.Results The two groups had improved lung function and quality of life after treatment,but after treatment,the FEV1,FVC and FEV1 actual/FEV1 prediction of the observation group were significantly higher than those of the control group,the differences were statistically significant (t =2.49,1.77,1.85 all P ＜ 0.05).After treatment,the 6 minutes walking distance of the observation group was longer than that of the control group,Borg score of the observation group was lower than that of the control group,the differences were statistically significant (t =1.83,6.66,all P ＜0.05).After treatment,the SGRQ score in the observation group was lower than that of the control group,the difference was statistically significant[(51.15 ± 3.14)points vs.(54.83 ± 4.03)points,t =3.94,P ＜ 0.01].Conclusion Montelukast can effectively improve the stability of COPD pulmonary function and quality of life,and with high safety.
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Objective To investigate the clinical efficacy and mechanism of montelukast sodium chewable tablet in the treatment of children with bronchial asthma.Methods A total of 180 children with bronchial asthma were selected from March 2015 to June 2016 in Suizhou Maternal and Child Health Hospital.The children were divided into montelukast group (n =120) and control group (n =60) according to the therapeutic method.The children in the control group were treated with conventional treatment,including budesonide atomization,expectorant,maintaining electrolyte and acid-base balance,anti-infective therapy,β-agonists and so on.The children in the montelukast group were treated with montelukast sodium chewable tablet on the basis of conventional treatment.The children in the two groups were treated for 14 days.The clinical effect,lung function and the levels of serum nuclear factor-κB (NF-κB) and interleukin-8 (IL-8) were compared between the two groups.Results There was no significant difference in serum NF-κB and IL-8 levels between the two groups before treatment (P ＞ 0.05).The levels of serum NF-κB and IL-8 after treatment were significantly lower than those before treatment in the two groups (P ＜ 0.05).The levels of serum NF-κB and IL-8 in the montelukast group were significantly lower than those in the control group (P ＜ 0.05).There was no significant difference in the forced expiratory volume in first second (FEV1),peak expiratory flow (PEF) and percentage of FEV1 to forced vital capacity (FEV1％) between the two groups before treatment (P ＞ 0.05).The FEV1,PEF and FEV1％ after treatment were significantly higher than those before treatment in the two groups (P ＜ 0.05).The FEV1,PEF and FEV1％ in the montelukast group were significantly higher than those in the control group after treatment (P ＜ 0.05).The total effective rate in montelukast group and control group was 95.83 ％ (115/120) and 71.67 ％ (43/60) respectively,the total effective rate in montelukast group was significantly higher than that in control group (x2 =6.989,P ＜ 0.05).The incidence of adverse reactions in montelukast group and control group was 10.83％ (13/120) and 11.67％ (7/60) respectively,there was no significant difference in the incidence of adverse reactions between the two groups (x2 =0.345,P ＞ 0.05).There was no serious adverse reaction in the two groups during the treatment.Conclusion Montelukast sodium chewable tablet can significantly reduce the respiratory tract inflammatory reaction,improve the lung function,improve the clinical symptoms and have better safety in children with bronchial asthma.
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Objective To explore the clinical efficacy of montelukast sodium in the treatment of chronic cough with small airway disease.Methods 50 chronic cough patients with small airway disease were selected,and they were randomly divided into montelukast sodium group and control group according to the digital table,25 cases in each group.The control group was given conventional treatment,the montelukast sodium group was treated with montelukast sodium on the basis of routine treatment.At the end of treatment,the clinical effect of the two groups was compared.Results The total effective rate of the montelukast sodium group was 92.0％,which of the control group was 84.0％,the difference was not statistically significant between the two groups (x2 =1.05,P ＞ 0.05).After 3 months of treatment,the pulmonary function of the two groups was significantly improved.Compared with the control group,the FEV1,FVC and FEV1/FVC％ of the montelukast sodium group showed no statistically significant differences(t =0.71,0.64,1.46,all P ＞ 0.05),but the FEF25 ％-75 ％,FEF50％,FEF75 ％ improved significantly with significant differences (t =7.07,2.62,3.83,all P ＜ 0.01).After 6 months of treatment,the difference of FEF75 ％ was statistically significant between the two groups (t =1.92,P ＜ 0.05).Compared with the control group,the level of serum IgE was significantlylower in the montelukast sodium group(t =4.02,P ＜0.01).There were no serious adverse reactions in the two groups,the difference was not statistically significant (x2 =1.42,P ＞ 0.05).Conclusion Montelukast sodium in the treatment of chronic cough with small airway disease has significant effcet,it is conducive to improve small airway disease and reduce serum IgE level,it is safe,effective and worthy of clinical application.
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Objective To investigate the clinical effect of salmeterol fluticasone propionate combined with montelukast in the treatment of moderate and severe bronchial asthma. Methods 112 patients with moderate and severe bronchial asthma in Taizhou hospital from January 2014 to December 2016 were selected and divided into the control and the study group according to the time of visiting hospital, 56 cases in each group. The control group were given salmeterol fluticasone propionate for treatment, the study group were treated with salmeterol fluticasone propionate combined with montelukast .Keep a record of the asthma control test (ACT), forced expiratory volume (FEV1) percentage expected index changes of pre-treatment and 8 weeks after treatment. Results ACT score and FEV1 percentage expected index changes of two groups there was no significant difference before the treatment. After treatment, ACT score and FEV1 percentage expected index changes of the study group was better than the control group(P<0.05). Conclusion Salmeterol fluticasone propionate combined with montelukast in the treatment can significantly improve the clinical efficacy of patients.
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Objective To investigate the clinical effect of salmeterol fluticasone propionate combined with montelukast in the treatment of moderate and severe bronchial asthma. Methods 112 patients with moderate and severe bronchial asthma in Taizhou hospital from January 2014 to December 2016 were selected and divided into the control and the study group according to the time of visiting hospital, 56 cases in each group. The control group were given salmeterol fluticasone propionate for treatment, the study group were treated with salmeterol fluticasone propionate combined with montelukast .Keep a record of the asthma control test (ACT), forced expiratory volume (FEV1) percentage expected index changes of pre-treatment and 8 weeks after treatment. Results ACT score and FEV1 percentage expected index changes of two groups there was no significant difference before the treatment. After treatment, ACT score and FEV1 percentage expected index changes of the study group was better than the control group(P<0.05). Conclusion Salmeterol fluticasone propionate combined with montelukast in the treatment can significantly improve the clinical efficacy of patients.
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Objective To study the montelukast sodium chewable tablets for the treatment of obstructive sleep apnea hypopnea syndrome(OSAHS)patients and treatment of tonsil and adenoid effect.Methods 84 cases of OSAHS patients in our hospital from January 2014 to August 2016 were randomly divided into the observation group and the control group,42 cases in each group.The control group was treated with conventional symptomatic treatment,on this basis,the patients in the observation group received montelukast sodium chewable tablets treatment,compared the two groups of the total efficiency,and compared before and after treatment of symptoms total score,apnea hypopneaIndex(AHI),the lowest arterial oxygen saturation(LSaO2),and adenoid and tonsil classification indexing.Results the total efficiency of observation group(90.48％)was significantly higher than the control group(69.04％,χ2=5.97,P<0.05); after treatment,the observation group of the total symptom score and AHI were significantly lower than the control group(P<0.05),LSaO2 was significantly higher than the control group(P<0.05),adenoid grade one and grade two were significantly higher than the control group(χ2=9.82,P<0.05),there was no significant difference between the one and two degrees of tonsil dividing ratio.Conclusion The clinical efficacy of montelukast sodium chewable tablets in the treatment of children with OSAHS is significant,can effectively reduce the volume of tonsil and adenoid body,and improve the clinical symptoms and sleep treatment significantly,which is worthy of clinical promotion.
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<p><b>OBJECTIVE</b>To observe the effects of micro-invasive embedding combined with montelukast sodium and simple montelukast sodium for children cough variant asthma (CVA).</p><p><b>METHODS</b>A total of 240 patients were randomly assigned into an observation group and a control group, 120 cases in each one. Considering of cases dropping, 101 patients in the observation group and 105 cases in the control group were included. Montelukast sodium chewable tablets were applied before sleep for 3 months in the control group, 5 mg a time, once a day. Based on the treatment as the control group, micro-invasive embedding was used for 3 months in the observation group, twice in the first month and once in the other two months. The acupoints were Feishu (BL 13), Danzhong (CV 17), Dingchuan (EX-B 1), and Zusanli (ST 36). Follow-up was conducted 9 months after treatment in the two groups. The cough score, serum immunoglobulin (IgE, IgG, IgA), platelet activating factor (PAF) were observed before and after treatment. The indices were compared before and after treatment and at follow-up, including pulmonary function indices[peak expiratory flow rate (PEF), forced expiratory volume at the 1st second (FEV1)], and small airway function indices[forced expiratory flow rate with remaining 25% vital capacity (MEF25%), forced expiratory flow rate with remaining 50% vital capacity (MEF50%), forced expiratory flow rate with remaining 75% vital capacity (MEF75%) and mid expiratory flow rate (MEF25%-75%)]. Also, the total effects were evaluated.</p><p><b>RESULTS</b>①The total effective rate in the observation group was 93.1% (94/101), which was better than 87.6% (92/105) in the control group (<0.05). The cough disappearance time of the cured children in the observation group was (10.38±2.64) d, and it was shorter than (10.72 ±2.60) d of those in the control group (<0.05). After treatment, the cough score apparently decreased compared with those before treatment in the two groups (both<0.05), with better result in the observation group (<0.05). At follow-up, the recurrence frequency of the observation group was (1.43±1.20), and it was less than (1.91±1.71) in the control group (<0.05). ②The levels of serum IgA and IgG after treatment in the two groups increased, and those of serum IgE and PAF decreased, compared with those before treatment. There was statistically significance except IgG in the control group before and after treatment (all<0.05), with better Results in the observation group after treatment (all<0.05). ③ Compared with those before treatment, all the pulmonary function indices were improved obviously after treatment and at follow-up in the two groups (all<0.05), without statistically significance between the two groups (both>0.05). ④ There was no statistically significance before and after treatment on small airway function indices in the two groups (all>0.05). The indices at follow-up increased compared with those before treatment in the two groups (all<0.05), with better Results in the observation group (all<0.05).</p><p><b>CONCLUSIONS</b>Micro-invasive embedding combined with montelukast sodium achieved de-finite effect for children CVA, which can improve the body's immune and microcirculation. The effect is better than that of simple montelukast sodium on improving small airway function, etc.</p>
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Objective To study the physicochemical properties of aqueous solution of surface active drug montelukast so-dium (MS) ,which could provide experimental basis for further development of micelle or mixed micelle preparations .Methods Critical micelle concentration (CMC) of MS at different temperatures were determined by conductivity measurements .The absorbance and transmittance of MS aqueous solution were measured by UV at different sodium chloride concentration levels . The micelle stability was evaluated via high speed centrifugal .Results The CMC of MS aqueous solution at 25℃ ,30℃ ,35℃were 0 .75 ,0 .82 ,0 .90 mmol/L .The absorbance and transmittance of MS aqueous solution were affected by the sodium chlo-ride concentration and the concentration of MS itself .It was observed that a clear solution was obtained when MS concentration>7 .5 mmol/L and no precipitation was noticed even after high speed centrifugal .Conclusion Montelukast sodium is a surface active drug .Its solubility is related to MS concentration .The solubility is also sensitive to the temperature and the electrolyte concentration .These unique physicochemical properties could be used to develop micelle or mixed micelle pharmaceutical prepa-rations .
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OBJECTIVE:To compare the clinical efficacy and safety of salmeterol-fluticasone alone versus fluticasone propio-nate combined with montelukast sodium in the treatment of children with moderate persistent asthma. METHODS:275 children with moderate persistent asthma were randomly divided into inhaled corticosteroids(ICS)+ long acting β2 receptor agonist(LABA) group (139 cases) and ICS+ leukotriene receptor antagonists (LTRA) group (136 cases). ICS+LABA group was given Salmeter-ol-fluticasone powder inhalant,1 inhalation,bid;ICS+LTRA was given Fluticasone propionate inhalation aerosol,bid+Montelu-kast sodium chewable tablet 5 mg,before bedtime,qd. Both groups received more than 12 weeks of treatment. Body indexes of 2 groups were observed after treatment,such as asthma control degree,asthma score,the percentage of peak expiratory flow(PEF) in estimated value,aberration rate of PEF,the levels of eosinophi cationic protein(ECP)and leukotrienes E4(LTE4)in peripheral blood,the times of taking short acting β2 receptor agonist (SABA) during treatment,asymptomatic days,compliance,the inci-dence of ADR,etc. RESULTS:Total effective rate of ICS+LABA group(86.33%)after 4 weeks treatment was higher than that of ICS+LTRA group(58.09%),with statistical significance(P0.05). The day and night asthma score of 2 groups decreased significantly and the percentage of PEF in estimated value increased significantly after treatment,there was statisti-cal significance compared to before treatment(P0.05). The levels of ECP and LTE4 decreased significantly in 2 groups after treatment,there was statistical signif-icance compared to before treatment(P0.05). CONCLUSIONS:Salmeterol-fluticasone alone versus fluticasone propionate combined with montelukast sodi-um in the treatment of children with moderate persistent asth-ma both have good therapeutic efficacy and safety,while thelatter one has stronger inhibition effect on ECP and LTE4,and to control asthma symptoms more rapidly.