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Objective To compare the efficacy and safety of long-term treatment (48 weeks) with tiotropium bromide (5 μg) via Respimat(R) with placebo in patients with chronic obstructive pulmonary disease (COPD).Methods A total of 338 patients were randomized in this double-blind,placebo controlled,parallel study.All patients received either tiotropium bromide or placebo.Tiotropium bromide solution 5 μg (2 × 2.5 μg/puff) or matching placebo was delivered via Respimat(R) at a dosage of once daily for 48 weeks.Co-primary endpoints were trough forced expiratory volume in one second (FEV1) and the time to first exacerbation.Results Statistically significant improvements of both trough FEV1 and trough forced vital capacity (FVC) in the tiotropium group were achieved at weeks 4,24,and 48 compared with those in the placebo group(P ＜ 0.000 1).Tiotropium treatment delayed the time to first exacerbation.The time was 157 days in the tiotropium group and 85 days in the placebo group.A statistically significant difference (P =0.002 7) in favor of tiotropium was also observed.The total numbers of exacerbation during treatment were 90 and 128 in the tiotropium and placebo groups,respectively.The Poisson regression analysis gave a mean exacerbation rate per patient year exposure of 0.67 in the tiotropium group compared to 0.98 in the placebo group with a rate ratio of 0.69 (95％ CI O.50-0.93,P =0.016 4).A much larger improvement from baseline in St.George's respiratory questionnaire (SGRQ) total score was observed for the tiotropium group than in the placebo group(P =0.036 7),SGRQ symptom and activity scores of patients in the tiotropium group were also superior to those of patients receiving placebo.The drugs-related adverse events in the tiotropium and placebo groups were 12 cases and 11 cases,respectively.Conclusions Tiotropium significantly improved lung function and quality of life,delayed the time to first exacerbation,reduced the number of exacerbation.Overall,tiotropium was well tolerated.
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Objective To explore the effect of different ages on behavioral dimensions of anxiety animal models in Kunming mice.Methods Young/Old,male,Kunming mice were recorded twice,for five minutes,with a one-week inter-trial interval in open field test (OFT),elevated plus maze (EPM) and light/dark box (LDB).The following parameters were evaluated:percentage of time spent in the OFT central area (Ctime％),percentage of number of squares visited in the OFT central area (Ccross％),the total number of horizontal squares in OFT (Cross),the total number of rears in OFT (Rear),percentage of time spent in the EPM open arms (Otime％),percentage of number of entries into the EPM open arms (Oentries％),the total number of entries into the EPM open and closed arms (Entries),percentage of time exploring in the LDB light area (Ltime％),percentage of number of squares crossing in the LDB light area (Lcross％),percentage of rears in the LDB light area (Lrear％),the total number of transition in LDB (Transition),the total number of horizontal squares in LDB (Cross) and the total number of rears in LDB (Rear).Results OFT-Ctime％,OFT-Ccross％,EPM-Otime％,EPM-Oentries％,LDB-Ltime％,LDB-Lcross％ and LDB-Lrear％ had significant loadings on anxiety factor; OFTCross,EPM-Entries,LDB-Transition and LDB-Cross loaded on locomotion-exploration factor.Old mice had higher anxiety emotion (Ctime％,t =3.12,P＜ 0.01; Ccross％,t =2.37,P＜ 0.01; Otime％,t =1.31,P＜ 0.05; Oentries％,t=1.57,P＜0.05; Ltime％,t=4.15,P＜0.01 ; Lcross％,t=3.28,P＜0.01 ; Lrear％,t=2.73,P＜0.01) and lower locomotion and exploratory activity (Cross,t =2.05,P ＜ 0.01 ; Entries,t =2.09,P ＜ 0.05 ;Transition,t=2.51,P＜0.01; Cross,t=3.02,P＜0.01),compared with Young.Conclusion Ages have no effect on structural dimensions of anxiety animal models.With the growth of ages,old mice have higher anxiety emotion but lower locomotion and exploratory activity.
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OBJECTIVE:To evaluate the clinical efficacy and safety of guaifenesin,pseudoephedrine hydrochloride- codeine phosphate oral solution in relieving cough,eliminating phlegm,relieving nasal stuffiness and other cold symptoms. METHODS:A total of 240 patients with cold symptoms(120 cases in trial group and another 120 cases in control group) were enrolled in our multicenter,randomized,double-blinded and parallel controlled study and treated with guaifenesin-pseudoephedrine hydrochloride-codeine phosphate oral solutionI or compound codeine phosphate liquor 10mL tid for(5?2)d.RESULTS:227(112 in trial group and 115 in control group) were the valid cases with completed trial.Compared with pre-treatment,both of the 2 groups had a significant improvement in symptoms including cough,expectoration and nasal stuffiness after treatment(P