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SUMMARY OBJECTIVE: The aim of this study was to investigate the efficacy and safety of combined doxofylline and salbutamol in the treatment of acute exacerbation of chronic obstructive pulmonary disease. METHODS: A total of 68 acute exacerbation of chronic obstructive pulmonary disease patients were randomly divided into control group (34 cases) and experimental group (34 cases), who received the doxofylline treatment and combined doxofylline and salbutamol treatment for 1 week, respectively. During the treatment, the remission time of typical respiratory manifestations was recorded, and the adverse reactions were observed. At the end of treatment, the treatment efficacy was evaluated. Before and after treatment, the pulmonary function indexes and serological indicators were detected. RESULTS: After treatment, compared with control group, in experimental group, the effective rate of treatment was significantly increased (p<0.05), the remission time of typical respiratory manifestations was significantly shortened (p<0.05), the pulmonary function indexes were significantly improved (p<0.05), the serum high-sensitivity C-reactive protein and cystatin C levels were significantly decreased, respectively (p<0.05), and the serum prealbumin level was significantly increased (p<0.05). In addition, the adverse reaction rate had no significant difference between two groups (p>0.05). CONCLUSIONS: In the treatment of acute exacerbation of chronic obstructive pulmonary disease, the combined use of doxofylline and salbutamol can quickly relieve the respiratory symptoms, mitigate the pulmonary dysfunction, and reduce the inflammatory response, thus promoting the outcome of patients.
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Humans , Theophylline/therapeutic use , Pulmonary Disease, Chronic Obstructive/drug therapy , Albuterol , Theophylline/administration & dosage , LungABSTRACT
Objective@#To study the effect of doxofylline on acute exacerbation of chronic obstructive pulmonary disease (COPD) and reduce the risk of early recurrence.@*Methods@#From January 2016 to January 2018, 164 patients with acute exacerbation of COPD in Binzhou Central Hospital were randomly divided into two groups by random digital table: control group (n=82) and observation group (n=82). The control group was given tiotropium bromide and budesonide/formoterol.The observation group was treated with oral doxophylline bid for 8 weeks on the basis of inhaled drugs.The recovery time, acute exacerbation rate, FEV1, CAT score and 6-minute walking test were compared between the two groups.@*Results@#The time of convalescent stage in the observation group was shorter than that in the control group[(16.89±5.15)d vs.(19.12±6.29)d, t=2.48, P=0.014], and the acute exacerbation rate of the observation group was lower than that of the control group (26.83% vs.41.46%, χ2=4.58, P=0.032). There was no statistically significant difference in FEV1[(45.59±9.82)% vs.(44.26±9.03)%, t=0.90, P=0.369], and the CAT score of the observation group was better than that of the control group [(19.32±6.16)points vs.(21.71±6.62)points, t=2.39, P=0.018]. The 6-minute walking distance of the observation group was longer than that of the control group[(146.32±10.20)m vs.(135.69±11.59)m, t=6.23, P=0.000], and the finger pulse oxygen of the observation group was higher than that of the control group[(94.12±5.09)% vs.(92.06±6.21)%, t=2.23, P=0.026]. The respiratory rate in the observation group was slower than that in the control group[(20.38±7.32)times/min vs.(22.86±6.53)times/min, t=2.29, P=0.023], and there was no statistically significant difference in heart rate[(98.24±12.35)bpm vs.(101.38±15.03)bpm, t=1.46, P=0.146]. No serious adverse drug reactions were found in both two groups.@*Conclusion@#As a beneficial supplement of inhaled drugs in convalescent COPD, doxofylline can shorten the recovery time, reduce the early acute exacerbation rate and improve the symptoms, which is worthy of clinical reference.
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Background: Studies have shown that doxofylline is endowed with a remarkable bronchodilator activity with less extra respiratory effects than other methylxanthines. To compare the efficacy and tolerability of doxofylline over other methylxanthines in mild to moderate persistent bronchial Asthma patients.Methods: It is a comparative study conducted in patients of mild to moderate persistent bronchial Asthma in the outpatient department of regional chest hospital. The subjects were randomly assigned into 2 groups, one group treated with oral doxofylline and the other with theophylline oral or Deriphylline. Efficacy was measured objectively using spirometric parameters like FEV1 (Forced Expiratory Volume at the end of 1 second), FVC (Forced Vital Capacity), FEV1/FVC and PEFR (Peak Expiratory flow Rate), Subjectively by the Asthma control test questionnaire, subjective rating of Asthma control and the need for use of rescue medications like β2 agonists in the previous four weeks. Tolerability were done at base line and at the end of study.Results: Doxofylline compared to other methylxanthines groups was statistically better with respect to subjective parameters like Asthma control tests questionnaire, subjective rating of Asthma control. Doxofylline had equal efficacy with spirometric parameters compared to other methylxanthines. Doxofylline was significantly better tolerated with adverse drug reactions noted in 10% compared to 28% in other methylxanthins group.Conclusions: Doxofylline with better tolerability profile and equivalent efficacy seemed to be a good alternative to other methylxanthines in the treatment of bronchial Asthma.
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Background: COPD is a major cause of health care burden worldwide and leading cause of death that is increasing in prevalence. Methylxanthines are used in the treatment of patients with asthma and COPD. Doxofylline (methylxanthine) shows improved disease control, reduced total daily dose of inhaled b2 agonists and improved patient compliance.Methods: This was a prospective, open labelled, randomized, two-arm, parallel group, controlled, clinical trial. 115 patients were randomized to two groups. Patients in group A received tablet doxofylline 400mg BD whereas patients in group B received tablet doxofylline 800mg SR for 4 weeks. Primary outcome measure of trial was change in FEV1 and secondary outcome measure were change in FVC/FEV1, change in symptoms score, effect on health-related quality of life (HRQOL) and safety of study medication.Results: At 4 week the FEV1increase by 13.028% and 17.647% in group A and B respectively. In group A FEV1/FVC increase by 5.79% and in group B it increases by 9.57% at 4 weeks. The symptom score of cough decrease by 77.35% and 97.43% in group A and group B respectively at 4 weeks. In group A shortness of breath decrease by 77.60% and in group B it decreases by 95.90% at 4 weeks. Tightness in chest decrease by 86.29% and 98.40% in group A and group B respectively at 4 weeks.Conclusions:Doxofylline 800mg sustained release tablet provided significantly greater improvement in FEV1, symptomatic control and health related quality of life compared to doxofylline 400mg.
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OBJECTIVE:To establish the method for the determination of doxofylline in human serum. METHODS:Online two-dimensional column switching-HPLC was adopted to determine the concentration of doxofylline in human serum. First-dimensional chromatographic column was Waters C18column,and middle column was SC2. First-dimensional and second-dimensional column mobile phrase were methanol-water(70 : 30,V/V). The detection wavelength was 273 nm,and column temperature was 40 ℃. Sample volume was 10 μL. RESULTS:The linear range of doxofylline were 0.5-50.00 μg/mL(r=0.999 9), and the detection limit was 0.01 μg/mL. The quantitative limit was 0.5 μg/mL. RSDs of intra-day and inter-day were 1.51%-1.89%and 1.52%-1.92%(n=5). The accuracy were 97.91%-104.19%(n=5). Extraction recoveries rate were 91.63%-93.44%(RSD<2.00%,n=3). RSD of matrix effect were lower than or equal to 3.01%(n=6),and RSD of stability test was lower than 5.00%(n=6). After 3 patients were given intravenous injection of Doxofylline and glucose injection(0.3 g/d)up to steady state,the serum concentrations of doxofylline were 3.23,3.35,3.68 μg/mL before medication on the next day(RSD=2.28%,2.34%, 2.14%,n=5). CONCLUSIONS:The method is simple,rapid,accurate and suitable for the determination of plasma concentration of doxofylline.
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Objective To compare the clinical effects of aminophylline and doxofylline in the treatment of bronchial asthma , thus to provide guidance for clinical practice .Methods 130 patients with bronchial asthma admitted in Zhejiang Rongjun Hospital from January 2015 to January 2017 were selected as the objects of observation , and they were randomly divided into two groups according to the digital table ,with 65 cases in each group .The control group was given aminophylline treatment ,the observation group was given doxofylline treatment .The clinical curative effect,pulmonary function index[forced vital capacity (FVC),forced expiratory volume in one second(FEV1),FEV1/FVC],quality of life scores and the incidence rate of adverse reactions were observed in the two groups .Results The total effective rate of observation group was 92.31％,which was higher than 70.77％of the control group ,the difference was statistically significant(χ2 =10.015,P<0.05).After treatment,the FEV1 [(2.72 ±0.64)L],FVC[(2.96 ± 0.67)L],FEV1/FVC[(89.35 ±7.77)％] in the observation group were significantly better than those in the control group[(2.05 ±0.35)L,(2.41 ±0.52)L,(80.58 ±7.69)％] (t=7.405,5.228,6.467,all P<0.05).The quality of life score in the observation group was (87.87 ±5.31) points,which was significantly higher than (75.35 ± 5.40)points in the control group (t=13.328,P<0.05).The incidence rate of adverse reactions in the observation group was 9.23％,which was lower than 27.69％ in the control group,there was statistically significant difference between the two groups (χ2 =7.358,P <0.05).Conclusion Aminophylline and doxofylline in the treatment of bronchial asthma can obtain certain curative effect ,but the effect of doxofylline is better ,and with less adverse reactions .
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Objective To explore the effect of combined treatment of the combined treatment of bronchial asthma with the combined treatment of dried ephedrine and doxyline. Methods According to the regimen, divide 84 patients with bronchial asthma for two groups, 39 cases with doxofylline treatment of western medicine group, 45 cases in doxofylline treatment at the same time correlation dry ephedra soup for application for group of Chinese and western, compared two groups of curative effect. Results After treatment, the group of Chinese and western of TCM symptom score was significantly lower than western medicine group, the group of Chinese and western PEF, FEV1, ESO improved significantly compared with western medicine group is superior, and the Chinese and western group total effective rate is 95.56 %, contrast to 76.92 % of the western medicine group was significantly higher, the differences between the two groups were statistically significant (P<0.05). on the side of adverse reactions, the two groups showed no significant differences. Conclusion For patients with bronchial asthma, to doxofylline the treatment of at the same time, the correlation of dry ephedra soup for application can promote the ascension of curative effect, make the patients' lung function, inflammatory symptoms improved significantly, and will not increase adverse reactions.
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Objective To investigate the effect of Doxofylline plus Budesonide in treatment of bronchial asthma. Methods The control group was given routine nursing, the observation group was given quality nursing care on the routine nursing. Results Effects of nursing intervention in the observation group was better than the control group, and the improvement of patients psychological status, and pulmonary function was better than the control group with statistical significance (P<0.05). Conclusion Doxofylline plus Budesonide plus routine nursing and quality nursing care intervention in patients with bronchial asthma could quickly improve the psychological status of patients, relieve / eliminate pulmonary dysfunction with significant efficacy.
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Objective:To study the safety and efficacy of doxofylline for treating the patients with ticagrelor caused dyspnea.Methods:A total 172 coronary artery disease (CAD) patients with ticagrelor caused dyspnea in our hospital from 2015-02 to 2016-07 were studied.The patients were divided into 2 groups:Intervention group,patients received doxofylline at 200 mg twice per day for 5 days and Control group,patients received placebo.n=86 in each group.Dyspnea remission rate of was recorded at 1 day after treatment;platelet aggregation rate before and after treatment,cardiac death,myocardial infarction (MI),stroke,bleeding and other adverse cardiovascular and cerebral events were compared at 6 month after treatment.Results:Compared with Control group,Intervention group had improved dyspnea remission rate at 1 day after treatment (93％ vs 63％),P＜0.05;platelet aggregation rate [before doxofylline application:(35.53±5.1)％ vs (35.16±4.6)％,after doxofylline application:(26.48±4.3)％ vs(25.98±4.7)％]adverse cardiovascular and cerebral events were similar between 2 groups before and after doxofylline application,P＞0.05.Conclusion:Doxofylline was effective for treating the patients with ticagrelor caused dyspnea,it does not affect platelet aggregation effect of ticagrelor.
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Objective To explore the effect of combined treatment of the combined treatment of bronchial asthma with the combined treatment of dried ephedrine and doxyline. Methods According to the regimen, divide 84 patients with bronchial asthma for two groups, 39 cases with doxofylline treatment of western medicine group, 45 cases in doxofylline treatment at the same time correlation dry ephedra soup for application for group of Chinese and western, compared two groups of curative effect. Results After treatment, the group of Chinese and western of TCM symptom score was significantly lower than western medicine group, the group of Chinese and western PEF, FEV1, ESO improved significantly compared with western medicine group is superior, and the Chinese and western group total effective rate is 95.56 %, contrast to 76.92 % of the western medicine group was significantly higher, the differences between the two groups were statistically significant (P<0.05). on the side of adverse reactions, the two groups showed no significant differences. Conclusion For patients with bronchial asthma, to doxofylline the treatment of at the same time, the correlation of dry ephedra soup for application can promote the ascension of curative effect, make the patients' lung function, inflammatory symptoms improved significantly, and will not increase adverse reactions.
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Objective To investigate the effect of Doxofylline plus Budesonide in treatment of bronchial asthma. Methods The control group was given routine nursing, the observation group was given quality nursing care on the routine nursing. Results Effects of nursing intervention in the observation group was better than the control group, and the improvement of patients psychological status, and pulmonary function was better than the control group with statistical significance (P<0.05). Conclusion Doxofylline plus Budesonide plus routine nursing and quality nursing care intervention in patients with bronchial asthma could quickly improve the psychological status of patients, relieve / eliminate pulmonary dysfunction with significant efficacy.
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Objective To study the application of implantable telemetry and whole-body plethysmography to observe the changes of circadian rhythm in conscious rats and evaluate the pharmacological safety of doxofylline, and to provide a basis for the future application of this technological system for drug safety evaluation.Methods Eight healthy SPF Sprague-Dawley rats were used in this study, 4 males and 4 females.The rats were implanted with telemetry transmitters by surgery to establish a telemetry system combined with plethysmography to observe the changes of 24 h physiological parameters and circadian rhythm in conscious rats at 14 d after operation, including heart rate (HR), blood pressure, the time interval from the Q wave to point A in the ECG of the aortic pressure wave (QA interval), respiration, activity, body temperature and pulmonary function parameters.The rats were divided into 3 groups: normal control group, doxofylline 40 mg/kg and 80 mg/kg groups, and the performance was validated by aerosolizing saline, doxofylline 40 mg/kg and 80 mg/kg inhalation, respectively, to observe the changes in physiological parameters after the drug administration.Results The physiological parameters of rats showed obvious changes in circadian rhythms at 14 d after operation.Compared with the normal control group, the doxofylline 40 mg/kg-treated group showed significantly increased changes of HR, tidal volume (TV), minute ventilation (MV), 50% expiratory flow (EF50), peak inspiratory flow (PIF) and peak expiratory flow (PEF) (P0.05).Compared with the normal control group, the group treated with doxofylline 80 mg/kg had significantly increased HR, blood pressure, TV, MV, EF50, PIF and PEF (P0.05).Conclusions The application of implantable telemetry and whole-body plethysmography in this study does not obviously affect the circadian rhythm, and can sensitively monitor the relevant cardiovascular and respiratory parameters in conscious rats.It can be used in drug safety pharmacological research of cardiovascular and respiratory systems in conscious rats.
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Objective To observe the effect of doxofylline and budesonide combined with psychological intervention on the treatment of the patients with bronchial asthma, and evaluate its clinical effect. Methods From March 2014 to February 2017 in Guangfu hospital, 148 cases with bronchial asthma were divided into the control group and the experimental group by randomized double blind digit table with 74 cases in each group. The control group were given doxofylline and budesonide combined with routine nursing intervention, at this basis, the experimental group were receive psychological intervention. The clinical effect in the two groups were compared. Results The total effective rate was 95.95% (71/74) in the experimental group while 79.73%(59/74) in the control group, the difference was statistically significant between the two groups(P<0.05); Compared with before treatment, FEV1, FVC, VC and other indicators after treatment were significantly improved, and the experimental group improved significantly better than those in the control group (P<0.05). Conclusion Doxofylline and budesonide combined with psychological intervention on the treatment of the patients with bronchial asthma has obvious curative effect, which can effectively improve the lung function, accelerate the symptoms disappeared time, and worthy of clinical application.
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Objective To compare the clinical effect of Doxofylline and aminophylline in the treatment of bronchial asthma.Methods The clinical data of 112 patients with bronchial asthma treated in Jiaxing Second Hospital from February 2015 to December 2016 were retrospectively analyzed.The patients were divided into two groups: the treatment group(56 cases), the use of doxofylline treatment, and the control group(56 cases), the use of aminophylline treatment.After 1 w treatment, the curative effect and adverse reactions were compared between the two groups to observe the changes of lung function before and after treatment.Results The total effective rate of the treatment group and the control group were 91.07% and 76.79% respectively(P<0.05).After treatment, the FVC of the treatment group was(2.24±0.63)L, FEV1 was(1.59±0.47)L, VC was(2.94±0.77)L, the incidence of adverse reactions was 10.71%, which was superior to the control group, the difference was statistically significant(P<0.05).Conclusion Doxofylline treatment of bronchial asthma clinical efficacy is remarkable, worthy of clinical promotion.
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Objective To observe the clinical nursing effect of doxofylline in the treatment of bronchial asthma and intervention. Methods 98 cases of bronchial asthma patients in our hospital from June 2014 to November 2016 received as the object of nursing, the patients were divided into control group and treatment group, 49 cases in each group, using multiple theophylline treatment, the control group was given routine care, the treatment group on the basis of the comprehensive nursing, the clinical effects of two groups were compared before and after, adverse reactions and treatment of pulmonary function. Results The total effective rate of treatment group was 89.80％, control group total effective rate was 73.47％, the total effective rate of treatment group was significantly better than the control group (P<0.05), the difference was statistically significant; the treatment group adverse reaction rate was 6.12％, the control group adverse reaction rate was 18.37％, incidence of adverse reaction in treatment group was significantly better than the control group (P<0.05), the difference was statistically significant; two groups of patients after treatment of FEV1, FFV1/FVC and PEF indexes were improved, but the treatment group was significantly better than the control group (P<0.05), the difference was statistically significant. Conclusion Doxofylline the treatment of bronchial asthma in the process of the comprehensive nursing has a good effect, and less adverse reactions. It is worthy of clinical application.
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Objective:To study the safety and efficacy of doxofylline for treating the patients with ticagrelor caused dyspnea.Methods:A total 172 coronary artery disease (CAD) patients with ticagrelor caused dyspnea in our hospital from 2015-02 to 2016-07 were studied.The patients were divided into 2 groups:Intervention group,patients received doxofylline at 200 mg twice per day for 5 days and Control group,patients received placebo.n=86 in each group.Dyspnea remission rate of was recorded at 1 day after treatment;platelet aggregation rate before and after treatment,cardiac death,myocardial infarction (MI),stroke,bleeding and other adverse cardiovascular and cerebral events were compared at 6 month after treatment.Results:Compared with Control group,Intervention group had improved dyspnea remission rate at 1 day after treatment (93％ vs 63％),P＜0.05;platelet aggregation rate [before doxofylline application:(35.53±5.1)％ vs (35.16±4.6)％,after doxofylline application:(26.48±4.3)％ vs(25.98±4.7)％]adverse cardiovascular and cerebral events were similar between 2 groups before and after doxofylline application,P＞0.05.Conclusion:Doxofylline was effective for treating the patients with ticagrelor caused dyspnea,it does not affect platelet aggregation effect of ticagrelor.
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OBJECTIVE:To observe the efficacy and safety of doxofylline combined with ceftazidime in the treatment of elder-ly patients with chronic emphysema. METHODS:Data of 78 elderly patients with ceftazidime was collected and divided into single drug group(31 cases)and combined medication group(47 cases)according to different treatment methods. All patients adopted flu-id infusion,oxygen inhalation and nutrition support. Based on it,single drug group received 0.05 g Doxofylline injection,once ev-ery 12 h. Combined medication group additionally received 1.0 g Ceftazidime for injection,once every 12 h. If the symptoms were out of control,20 mg prednisone was given,twice a day. The courses of 2 groups were 10 d. Total efficacy,pulmonary functions [maximum mid-expiratory flow(MMEF),1s forced expiratory volume percent predicted(FEV1%),peak expiratory flow(PEF)] before and after treatment,American Concise Health Survey Questionnaire(SF-36 scale)(QLS)and the incidence of adverse reac-tions in 2 groups were observed. RESULTS:The total effective rate in combined medication group was significantly higher than sin-gle drug group,the difference was statistically significant (P0.05). After treatment,MMEF,FEV1%,PEF and QLS scores in 2 groups were significantly higher than before,and combined medication group MMEF,FEV1%、PEF were higher than single drug group,the difference was statistically significant (P0.05). And there was no significant difference in the incidence of adverse reactions in 2 groups (P>0.05). CONCLUSIONS:Based on conventional treatment,doxofylline combined with ceftazidime shows better efficacy than doxofylline alone in the treat-ment of elderly patients with chronic emphysema,it can improve pulmonary functions,with better safety.
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OBJECTIVE:To compared the efficacy and safety of doxofylline and aminophylline in the treatment of children with capillary bronchitis. METHODS:Totally 120 children with capillary bronchitis were randomly divided into observation group and control group. All children were given routine treatment,including oxygen inhalation,sputum suction and infusion supporting. Based on it,the observation group was treated by doxofylline 4 mg/kg adding into 15% glucose injection 50 ml by infusion,qd;control group was treated by aminophylline 4 mg/kg adding into 15% glucose injection 50 ml by infusion,bid. The course was 7 d. The capillary bronchitis severity scores,remission time of clinical symptoms,hospitalization time,utilization rate of glucocorticoid and the incidence of adverse reactions were observed. RESULTS:The total effective rate in observation group was significantly higher than control group,with significant difference(P<0.05). After 48 h and 72 h,the capillary bronchitis severity scores were significantly lower than before,and observation group was lower than control group after 72 h,with significant differences(P<0.05). The cough disappeared time and hospitalization time in observation group were significantly shorter than control group,and the utilization rate of glucocorticoid and the incidence of adverse reactions were significantly lower than control group,with signifi-cant differences(P<0.05). CONCLUSIONS:Based on the routine treatment,doxofylline has better efficacy and safety than amino-phylline in the treatment of children with capillary bronchitis.
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OBJECTIVE: To identify the structures of the major impurities of doxofylline injection. METHODS: HPLC-QTOF-MS was adopted to analyze the structures of two major impurities; the impurities were further separated and prepared by prep-HPLC and the structures were elucidated by NMR spectral data. RESULTS: The two major impurities were elucidated as 7-(2', 2'-dihydroxy ethyl) theophylline and 9-(1, 3-dioxolan-2-ylmethyl) theophylline. CONCLUSION: The two major impurities are thermo-degradation impurity and process related impurity respectively. This study provides reference for the improvement of quality control and process optimization of doxofylline injection.
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Objective To observe the effect of budesonide/doxofylline on patients with persistent asthma. Methods Sixty patients with moderate asthma were randomly divided into treatment group and control group. Patients in treatment group accepted the inhalation budesonide 400μg/d and doxofylline tablet 0.2 bid po but those in control group accepted the inhalation budesonide/formoterol 160/4.5μg bid. FeNO, sputum eosinophils, PEF and ACT scores were compared between two groups. Results PEF and ACT scores in treatment group were lower to those in control group (P0.05). After three months, sputum eosinophils in treatment group were better than that in control group (P0.05). Conclusion There is no significant difference in controlling asthma between budesonide/doxofylline and budesonide/formooterol